[House Hearing, 116 Congress]
[From the U.S. Government Publishing Office]




 
                  CANNABIS POLICIES FOR THE NEW DECADE

=======================================================================

                                HEARING

                               BEFORE THE

                         SUBCOMMITTEE ON HEALTH

                                 OF THE

                    COMMITTEE ON ENERGY AND COMMERCE
                        HOUSE OF REPRESENTATIVES

                     ONE HUNDRED SIXTEENTH CONGRESS

                             SECOND SESSION

                               __________

                            JANUARY 15, 2020

                               __________

                           Serial No. 116-89


      Printed for the use of the Committee on Energy and Commerce

                   govinfo.gov/committee/house-energy
                        energycommerce.house.gov
                        
                        
                        
                        
                          ______                       


             U.S. GOVERNMENT PUBLISHING OFFICE 
48-043PDF           WASHINGTON : 2022                    
                        
                        

                    COMMITTEE ON ENERGY AND COMMERCE

                     FRANK PALLONE, Jr., New Jersey
                                 Chairman
BOBBY L. RUSH, Illinois              GREG WALDEN, Oregon
ANNA G. ESHOO, California              Ranking Member
ELIOT L. ENGEL, New York             FRED UPTON, Michigan
DIANA DeGETTE, Colorado              JOHN SHIMKUS, Illinois
MIKE DOYLE, Pennsylvania             MICHAEL C. BURGESS, Texas
JAN SCHAKOWSKY, Illinois             STEVE SCALISE, Louisiana
G. K. BUTTERFIELD, North Carolina    ROBERT E. LATTA, Ohio
DORIS O. MATSUI, California          CATHY McMORRIS RODGERS, Washington
KATHY CASTOR, Florida                BRETT GUTHRIE, Kentucky
JOHN P. SARBANES, Maryland           PETE OLSON, Texas
JERRY McNERNEY, California           DAVID B. McKINLEY, West Virginia
PETER WELCH, Vermont                 ADAM KINZINGER, Illinois
BEN RAY LUJAN, New Mexico            H. MORGAN GRIFFITH, Virginia
PAUL TONKO, New York                 GUS M. BILIRAKIS, Florida
YVETTE D. CLARKE, New York, Vice     BILL JOHNSON, Ohio
    Chair                            BILLY LONG, Missouri
DAVID LOEBSACK, Iowa                 LARRY BUCSHON, Indiana
KURT SCHRADER, Oregon                BILL FLORES, Texas
JOSEPH P. KENNEDY III,               SUSAN W. BROOKS, Indiana
    Massachusetts                    MARKWAYNE MULLIN, Oklahoma
TONY CARDENAS, California            RICHARD HUDSON, North Carolina
RAUL RUIZ, California                TIM WALBERG, Michigan
SCOTT H. PETERS, California          EARL L. ``BUDDY'' CARTER, Georgia
DEBBIE DINGELL, Michigan             JEFF DUNCAN, South Carolina
MARC A. VEASEY, Texas                GREG GIANFORTE, Montana
ANN M. KUSTER, New Hampshire
ROBIN L. KELLY, Illinois
NANETTE DIAZ BARRAGAN, California
A. DONALD McEACHIN, Virginia
LISA BLUNT ROCHESTER, Delaware
DARREN SOTO, Florida
TOM O'HALLERAN, Arizona
                                 ------                                

                           Professional Staff

                   JEFFREY C. CARROLL, Staff Director
                TIFFANY GUARASCIO, Deputy Staff Director
                MIKE BLOOMQUIST, Minority Staff Director
                         Subcommittee on Health

                       ANNA G. ESHOO, California
                                Chairwoman
ELIOT L. ENGEL, New York             MICHAEL C. BURGESS, Texas
G. K. BUTTERFIELD, North Carolina,     Ranking Member
    Vice Chair                       FRED UPTON, Michigan
DORIS O. MATSUI, California          JOHN SHIMKUS, Illinois
KATHY CASTOR, Florida                BRETT GUTHRIE, Kentucky
JOHN P. SARBANES, Maryland           H. MORGAN GRIFFITH, Virginia
BEN RAY LUJAN, New Mexico            GUS M. BILIRAKIS, Florida
KURT SCHRADER, Oregon                BILLY LONG, Missouri
JOSEPH P. KENNEDY III,               LARRY BUCSHON, Indiana
    Massachusetts                    SUSAN W. BROOKS, Indiana
TONY CARDENAS, California            MARKWAYNE MULLIN, Oklahoma
PETER WELCH, Vermont                 RICHARD HUDSON, North Carolina
RAUL RUIZ, California                EARL L. ``BUDDY'' CARTER, Georgia
DEBBIE DINGELL, Michigan             GREG GIANFORTE, Montana
ANN M. KUSTER, New Hampshire         GREG WALDEN, Oregon (ex officio)
ROBIN L. KELLY, Illinois
NANETTE DIAZ BARRAGAN, California
LISA BLUNT ROCHESTER, Delaware
BOBBY L. RUSH, Illinois
FRANK PALLONE, Jr., New Jersey (ex 
    officio)
                             C O N T E N T S

                              ----------                              
                                                                   Page
Hon. Anna G. Eshoo, a Representative in Congress from the State 
  of California, opening statement...............................     1
    Prepared statement...........................................     3
Hon. Michael C. Burgess, a Representative in Congress from the 
  State of Texas, opening statement..............................     4
    Prepared statement...........................................     5
Hon. Frank Pallone, Jr., a Representative in Congress from the 
  State of New Jersey, opening statement.........................     6
    Prepared statement...........................................     7
Hon. Greg Walden, a Representative in Congress from the State of 
  Oregon, opening statement......................................     9
    Prepared statement...........................................    10
Hon. Eliot L. Engel, a Representative in Congress from the State 
  of New York, prepared statement................................    93

                               Witnesses

Nora Volkow, M.D., Director, National Institute on Drug Abuse, 
  National Institutes of Health..................................    12
    Prepared statement...........................................    14
    Answers to submitted questions...............................   283
Douglas C. Throckmorton, M.D., Deputy Director for Regulatory 
  Programs, Center for Drug Evaluation and Research, Food and 
  Drug Administration............................................    23
    Prepared statement...........................................    25
    Answers to submitted questions...............................   297
Matthew J. Strait, Senior Policy Advisor, Diversion Control 
  Division, Drug Enforcement Administration......................    36
    Prepared statement...........................................    38
Answers to submitted questions\1\

                           Submitted Material

H.R. 171, the Legitimate Use of Medicinal Marihuana Act..........    95
H.R. 601, the Medical Cannabis Research Act of 2019..............    99
H.R. 1151, the Veterans Medical Marijuana Safe Harbor Act........   109
H.R. 2843, the Marijuana Freedom and Opportunity Act.............   115
H.R. 3797, the Medical Marijuana Research Act of 2019 \2\
H.R. 3884, the Marijuana Opportunity Reinvestment and Expungement 
  Act of 2019 \3\
Statement of January 15, 2020, from Greenwich Biosciences to Ms. 
  Eshoo, submitted by Ms. Eshoo..................................   125
Letter of January 14, 2020, from Stephen A. Frangos, M.D., 
  President, American College of Occupational and Environmental 
  Medicine, to Ms. Eshoo and Mr. Burgess, submitted by Ms. Eshoo.   129
Statement of January 15, 2020, from the National Safety Council, 
  submitted by Ms. Eshoo.........................................   131

----------
\1\ Mr. Strait did not answer submitted questions for the record 
  by the time of publication.
\2\ The information has been retained in committee files and also 
  is available at https://docs.house.gov/meetings/IF/IF14/
  20200115/110381/BILLS-1163797ih.pdf.

\3\ The information has been retained in committee files and also 
  is available at https://docs.house.gov/meetings/IF/IF14/
  20200115/110381/BILLS-1163884ih.pdf.
Letter of January 14, 2020, from the National Consumers League, 
  to Members of the Energy and Commerce Health Subcommittee, 
  submitted by Ms. Eshoo.........................................   135
Statement of January 15, 2020, by David L. Nathan M.D., Board 
  President, Doctors for Cannabis Regulation, submitted by Ms. 
  Eshoo..........................................................   137
Statement of January 15, 2020, by Aaron Smith, Executive 
  Director, National Cannabis Industry Association, submitted by 
  Ms. Eshoo......................................................   141
Letter of August 1, 2020, from over 100 organizations in support 
  of H.R. 3884, to Ms. Nancy Pelosi, et al., submitted by Ms. 
  Eshoo..........................................................   149
Letter of January 15, 2020, from Aaron Smith, Executive Director, 
  National Cannabis Industry Association, et. al., to Ms. Eshoo, 
  and Mr. Burgess, submitted by Ms. Eshoo........................   154
Statement of January 15, 2020, from the California Cannabis 
  Industry Association, submitted by Ms. Eshoo...................   157
Statement of January 15, 2020, from Congressman Hakeem Jeffries, 
  to Ms. Eshoo and Mr. Burgess, submitted by Ms. Eshoo...........   161
Statement of January 15, 2020, from Kris Krane, President of 
  4Front Ventures, submitted by Ms. Eshoo........................   162
Statement of January 15, 2020, from Americans for SafeAccess, 
  submitted by Ms. Eshoo.........................................   166
Report of October 2019, from the National Cannabis Industry 
  Association entitled ``Adapting a Regulatory Framework for the 
  Emerging Cannabis Industry'', submitted by Ms. Eshoo...........   170
Letter of January 13, 2020, from Bruce A. Jarrell, M.D., Interim 
  President, University of Maryland, to Mr. Sarbanes, submitted 
  by Ms. Eshoo...................................................   218
Statement of January 15, 2020, from the American Property 
  Casualty Insurance Association, submitted by Ms. Eshoo.........   220
Statement of January 15, 2020, by Paul Armentano, Deputy 
  Director, National Organization for the Reform of Marijuana 
  Laws, submitted by Ms. Eshoo...................................   224
Letter of August 27, 2019, from Norman E. Sharpless, M.D., Acting 
  Commissioner, FDA and Francis S. Collins, M.D., Ph.D., 
  Director, NIH to Mr. Schatz, submitted by Ms. Eshoo............   227
Letter of December 16, 2019, from Greg Walden, et al., to Hon. 
  Pallone and Hon. Eshoo, submitted by Ms. Eshoo.................   231
Letter of January 22, 2019, from Ralph L. Sacco, President, the 
  American Academy of Neurology, to Mr. Griffith, submitted by 
  Ms. Eshoo......................................................   236
Letter of June 6, 2018, from Ralph L. Sacco, President, American 
  Academy of Neurology, to Mr. Gaetz, submitted by Ms. Eshoo.....   237
Article of January 12, 2020, ``Pot Imports Grow as U.S. Stalls on 
  Medical Research'' by Kristine Owram, Bloomberg News, submitted 
  by Ms. Eshoo...................................................   239
Article, ''Support for the Medical Marijuana Research Act of 
  2019,'' by Mr. Blumenauer, et al., submitted by Ms. Eshoo......   243
Letter of January 15, 2020, by George B. Hodgin, 
  Biopharmaceutical Research Company, to Mr. Pallone, et al., 
  submitted by Ms. Eshoo.........................................   255
Statement of July 16, 2019, by Kevin A. Sabet, Ph.D., President, 
  Smart Approaches to Marijuana, to Mr. Harris, submitted by Ms. 
  Eshoo..........................................................   259
Letter of September 19, 2018, from Ted Thompson, JD, Senior Vice 
  President of Public Policy, the Michael J. Fox Foundation, to 
  Hon. Gaetz, submitted by Ms. Eshoo.............................   269
Statement of January 15, 2020, by Dr. Betsy Booren, Senior Vice 
  President, Consumer Brands Association, submitted by Ms. Eshoo.   270
Letter of August 26, 2019, from Neil D. Doherty, Acting Assistant 
  Administrator, Drug Enforcement Administration, to George B 
  Hodgin, submitted by Ms. Eshoo.................................   272
Fact sheets, by Nora D. Volkow, M.D., Director, National 
  Institute on Drug Abuse, submitted by Ms. Eshoo................   275


                  CANNABIS POLICIES FOR THE NEW DECADE

                              ----------                              


                      WEDNESDAY, JANUARY 15, 2020

                  House of Representatives,
                            Subcommittee on Health,
                          Committee on Energy and Commerce,
                                                    Washington, DC.
    The subcommittee met, pursuant to call, at 10:01 a.m., in 
the John D. Dingell Room 2123, Rayburn House Office Building, 
Hon. Anna G. Eshoo (chairman of the subcommittee) presiding.
    Present: Representatives Eshoo, Engel, Butterfield, Matsui, 
Castor, Sarbanes, Lujan, Schrader, Kennedy, Cardenas, Ruiz, 
Dingell, Kuster, Kelly, Barragan, Blunt Rochester, Rush, 
Pallone (ex officio), Burgess (subcommittee ranking member), 
Upton, Shimkus, Guthrie, Griffith, Bilirakis, Long, Bucshon, 
Brooks, Hudson, Carter, Gianforte, and Walden (ex officio).
    Also Present: Representatives Schakowsky and Rodgers.
    Staff Present: Joe Banez, Professional Staff Member; 
Jeffrey C. Carroll, Staff Director; Waverly Gordon, Deputy 
Chief Counsel; Tod Guidry, Health Fellow; Meghan Mullon, Policy 
Analyst; Tim Robinson, Chief Counsel; Rebecca Tomilchik, Staff 
Assistant; Kimberlee Trzeciak, Chief Health Advisor; C. J. 
Young, Press Secretary; Madison Wendell, Intern; S. K. Bowen, 
Minority Press Assistant; Jordan Davis, Minority Senior 
Advisor; Theresa Gambo, Minority Human Resources/Office 
Administrator; Tyler Greenberg, Minority Staff Assistant; Peter 
Kielty, Minority General Counsel; Ryan Long, Minority Deputy 
Staff Director; Brannon Rains, Minority Legislative Clerk; 
Kristin Seum, Minority Counsel, Health; and Kristen Shatynski, 
Minority Professional Staff Member, Health.
    Ms. Eshoo. Good morning, everyone. The Subcommittee on 
Health will now come to order. Welcome to everyone who is here 
in the hearing room.
    The Chair now recognizes herself for 5 minutes for an 
opening statement.

 OPENING STATEMENT OF HON. ANNA G. ESHOO, A REPRESENTATIVE IN 
             CONGRESS FROM THE STATE OF CALIFORNIA

    According to the Department of Health and Human Services' 
National Survey on Drug Use, 44 million Americans reported 
using cannabis in the last year. Thirty-three States now allow 
the medicinal use of cannabis and 11 States in the District of 
Columbia have legalized cannabis for adult use.
    But State laws and Federal policy are a 1,000 miles apart. 
As more States allow cannabis, the Federal Government still 
strictly controls and prohibits it, even restricting legitimate 
medical research.
    Given the widespread availability of cannabis, the purpose 
of today's hearing is to examine the pressing need for medical 
research about cannabis and its chemical compounds with CBD 
being one of them.
    A half century ago, Congress listed cannabis as a highly 
controlled schedule I substance. Other schedule I drugs include 
heroin, LSD and ecstasy. Schedule I drugs have no medical value 
and high potential for abuse. Schedule II drugs, such as 
cocaine and Vicodin through schedule V drugs, such as 
Robitussin, all have some medical value but differ in ranking 
depending on their potential for abuse.
    The schedule I designation restricts legitimate medical 
research about cannabis. Today scientists who wish to study 
cannabis must seek approval from three Federal agencies: the 
NIH, the FDA and the DEA. Once scientists are federally 
approved, which can take more than a year, they are allowed to 
only research cannabis grown by a government-authorized farm at 
the University of Mississippi.
    This cannabis lacks the properties and potency of 
commercially available cannabis and leads to inadequate 
research. So researchers are in a catch-22, they can't conduct 
cannabis research until they show cannabis has a medical use, 
but they can't demonstrate cannabis as a medical use until they 
can conduct research. It doesn't make sense, at least to me.
    So why is it concerning that research about cannabis is 
blocked by Federal law? First, cannabis has therapeutic 
potential for chronic pain, nausea, and the treatment of 
neurological disorders such as seizures. In 2018, the FDA 
approved the first cannabis-derived medication, Epidiolex, 
which treats seizures in patients two years of age or older. 
Second, the restrictions on cannabis research has led to 
unanswered questions about the safety and quality of products 
containing CBD.
    In December 2018, the farm bill removed hemp, including CBD 
derived from hemp, from the Controlled Substances Act. The farm 
bill explicitly preserved the FDA's authority over CBD 
products, but the FDA has yet to issue regulations due to its 
unanswered questions about the intrinsic safety of the CBD. The 
FDA says it will take three to five years to finalize CBD 
regulations. And in the meantime, the CBD market is predicted 
to reach $20 billion in sales by 2024. Meanwhile, CBD is now 
available in everything from fast food hamburgers, to scented 
lotions, to over-the-counter pills.
    Today, we are considering six bills that offer a range of 
solutions to update Federal policy to advance research on 
cannabis and its compounds. I want to thank the leaders of the 
bills. Representatives Barbara Lee and Congressman Earl 
Blumenauer who have joined us. They are sitting in the front 
row. Thank you for being here and for your work. Congressman 
Jerry Nadler, Hakeem Jeffries, Matt Gaetz, and our fellow 
subcommittee member Congressman Morgan Griffith: Thank you to 
each one of you for your good work.
    Now I would like to yield to Mr. Kennedy for the remainder 
of my time.
    [The prepared statement of Ms. Eshoo follows:]

                Prepared statement of Hon. Anna G. Eshoo

    According to the Department of Health and Human Services 
National Survey on Drug Use, 44 million Americans reported 
using cannabis in the past year. Thirty-three states now allow 
the medicinal use of cannabis and 11 states and the District of 
Columbia have legalized cannabis for adult use.
    But states' laws and federal policy are a thousand miles 
apart. As more states allow cannabis, the Federal Government 
still strictly controls and prohibits it, even restricting 
legitimate medical research.
    Given the widespread availability of cannabis, the purpose 
of today's hearing is to examine the pressing need for medical 
research about cannabis and its chemical compounds with CBD 
being one of them.
    Fifty years ago, Congress listed cannabis as a highly-
controlled Schedule I substance. Other schedule I drugs include 
heroin, LSD, and ecstasy.
    Schedule 1 drugs have no medical value and high potential 
for abuse. Schedule 2 drugs (for example, cocaine and Vicodin) 
through Schedule 5 drugs (for example, Robitussin) all have 
some medical value but differ in ranking depending on their 
potential for abuse.
    The Schedule I designation restricts legitimate medical 
research about cannabis. For example, scientists who wish to 
study cannabis must seek approval from three federal agencies--
the NIH, the FDA, and the DEA.
    Once scientists are federally-approved, which can take more 
than a year, they're allowed to only research cannabis grown by 
a government-authorized farm at the University of Mississippi. 
This cannabis lacks the properties and potency of commercially-
available cannabis and leads to inadequate research.
    Researchers are in a catch-22. They can't conduct cannabis 
research until they show cannabis has a medical use, but they 
can't show cannabis has a medical use until they can conduct 
research.
    Why is it concerning that research about cannabis is 
blocked by federal law?
    First, cannabis has therapeutic potential for chronic pain 
or nausea and the treatment of neurological disorders such as 
seizures. For example, in 2018, the FDA approved the first 
cannabis-derived medication, Epidolex, which treats seizures in 
patients two years of age or older.
    Second, the restrictions on cannabis research has led to 
unanswered questions about the safety and quality of products 
containing CBD.
    In December 2018, the Farm Bill removed hemp, including CBD 
derived from hemp, from the Controlled Substances Act. The Farm 
Bill explicitly preserved the FDA's authority over CBD 
products, but the FDA has yet to issue regulations due to its 
unanswered questions about the intrinsic safety of CBD.
    The FDA says it will take three to five years to finalize 
CBD regulations, and in the meantime, the CBD market is 
predicted to reach $20 billion in sales by 2024. CBD is now 
available in everything from fast food hamburgers, to scented 
lotions, to over-the-counter pills.
    Today we'll consider six bills that offer a range of 
solutions to update federal policy to advance research on 
cannabis and its compounds.
    I thank the leaders of the bills for their work: 
Representatives Barbara Lee and Earl Blumenauer, who have 
joined us in the audience today, as well as Representatives 
Jerry Nadler, Hakeem Jeffries, Matt Gaetz, and our fellow 
Subcommittee Member Representative Morgan Griffith.
    Working together, I hope our Subcommittee can move forward 
on a commonsense proposal that stops the Federal Government 
from impeding medical research and allows Americans to have 
access to the information they need about the harmful and 
therapeutic effects of cannabis.
    I yield the remainder of my time to Representative Kennedy.

    Mr. Kennedy. Thank you, Madam Chair. I want to thank you 
for the time for yielding.
    This is a critical debate and it is long overdue. Federal 
prohibition has failed, from our criminal justice system, to 
our healthcare system, to our State and local governments that 
are forced to navigate an impossible landscape. To that end, 
government officials and elected representatives are important 
witnesses and bring an important perspective to this 
conversation.
    But there are also critical stakeholders who are missing, 
those who lives have been directly touched by our broken 
marijuana policies. The people unjustly incarcerated, patients 
who rely on medical cannabis, and researchers with expertise 
yearning to learn more, small businesses owners trying to find 
fair footing in a new industry.
    I am grateful for woman who is committed to continue 
working with us on a second hearing that will center those 
voices in this debate.
    Thank you, Madam Chair. I yield back.
    Ms. Eshoo. The gentleman yields back. It is a pleasure to 
recognize Dr. Burgess, the ranking member of our subcommittee 
for his opening statement.

OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A REPRESENTATIVE 
              IN CONGRESS FROM THE STATE OF TEXAS

    Mr. Burgess. And I thank the Chair. I appreciate--and 
thanks to our witnesses who are here with us today to help 
advise us in this important matter. I appreciate that we are 
holding the hearing today to discuss this policy. It is a topic 
that is of interest to many members of this subcommittee. In 
fact, that was evidenced when we had our discussion on the 
smokeless tobacco products. At the end of last year, some of 
the Republican members of the full Energy and Commerce 
Committee and myself sent a letter to request a hearing on 
three of the bills before us today that focus on easing 
pathways to marijuana research. So I am glad that we followed 
through with that. It included H.R. 171, the Legitimate Use of 
Medical Marijuana Act; H.R. 601, The Medical Cannabis Research 
Act of 2019; and H.R. 3797, the Medical Marijuana Research Act 
of 2019 in this hearing.
    States and localities across the country have moved 
forward, they have different policies to address marijuana, 
including both recreational and medicinal. I am concerned that 
there is a lack of available research on the benefits and the 
risks of the medical and recreational use of this product and 
that we really don't justify the actions that some of the 
States have taken. Thus far the Food and Drug Administration, 
the National Academies have found that there is a lack of 
evidence to demonstrate effective medical use for marijuana. So 
certainly we need more research.
    It is concerning that there are arguments over what may or 
may not be a great medicinal use for marijuana, but we don't 
have any data. So it is time to get the data and let the 
decision be driven by the data. Additionally, some of the data 
that we do have includes some concerning results. For example, 
a study conducted by researchers at Kaiser Permanente in 
northern California found that cannabis use among pregnant 
mothers nearly doubled between 2009 and 2016. Research has also 
found that prenatal marijuana may impair fetal growth and 
neural development but added that more studies are necessary as 
the THC potency continues to vary, but appears to be continuing 
to rise. So, as someone who has practiced obstetrics for a 
number of years, I worry about the health of the mothers and 
their babies that could be at risk.
    So one of the key hurdles to research is that researchers 
require DEA approval. And for decades they have only been 
allowed to obtain marijuana from one source, the University of 
Mississippi, which is the only contract that the National 
Institute on Drug Abuse has for research-grade cannabis.
    In the past, it may have made some sense to have this 
single source for research purposes. Certainly if there are 
variations in quality or gradation, that could be minimized by 
having that single source. But because of the diversity now of 
the quality potency and other aspects of the marijuana that is 
available for individuals to obtain from medical and 
recreational purposes, and it does vary across the United 
States, research using the single-source marijuana may not 
adequately assess what the current landscape represents. Not to 
mention, it is difficult to obtain the quantity necessary to 
conduct research in the existing structure.
    To that point, the Drug Enforcement Agency--we are grateful 
that you are with us this morning--announced in 2016 that it 
would establish a new policy to increase the number of approved 
sources of research grade marijuana, but I don't think that has 
quite gotten across the finish line. Maybe we can hear about 
that today. I hope that we will get an update on the 
administrative efforts to streamline the research process 
today. I hope that we can identify ways to work together to 
achieve that goal.
    While three of the bills before us today aim to enhance 
research efforts, there are two that may go a step too far. 
H.R. 2843 and H.R. 3884 completely remove marijuana from the 
controlled substances list. It is worth noting and I believe 
the Food and Drug Administration will explain this in more 
detail, that in order for the Drug Enforcement Agency to 
reschedule a drug, doing it administratively without 
congressional direction, the Food & Drug Administration must 
conduct a medical evaluation of the drug and provide a 
recommendation to the Drug Enforcement Agency as to what the 
scheduling should be. This recommendation is binding; 
therefore, the DEA must do what the FDA recommends. My opinion, 
completing descheduling marijuana using or congressional 
authority, which can override this scenario, could possibly be 
a dangerous move, especially given the lack of research to back 
up the decision.
    So it is critical that the American public, the medical 
community understands what marijuana does to our bodies and our 
brains at different potencies throughout our lifecycle. We have 
a way to go before we have a full understanding of all of these 
factors. Some of the bills before us are a step in the right 
direction. Some go a step too far, but I look forward to 
learning more about the issues of our Federal agencies and the 
efforts they are taking to work on this problem.
    Thank you all for being here, and I yield back my time.
    [The prepared statement of Mr. Burgess follows:]

             Prepared statement of Hon. Michael C. Burgess

    Thank you, Madame Chair. I appreciate that we are holding 
this hearing today to discuss marijuana policy, a topic that is 
of interest to many Members on this subcommittee. At the end of 
last year, a few Republican Members of the full Energy & 
Commerce Committee and I sent a letter to request a hearing on 
three of the bills before us today that focus on easing 
pathways to marijuana research. I am glad that you have 
followed through and included H.R. 171, the Legitimate Use of 
Medicinal Marihuana Act, H.R. 601, Medical Cannabis Research 
Act of 2019, and H.R. 3797, Medical Marijuana Research Act of 
2019, in this hearing.
    States and localities across the country have moved forward 
with different policies to address marijuana, including both 
recreational and medical use.
    As a physician, I am concerned that the available research 
on the benefits and risks of marijuana, both medical and 
recreational, do not adequately justify the actions states have 
taken. Thus far, the Food and Drug Administration and the 
National Academies have found that there is a lack of evidence 
to demonstrate effective medical use for marijuana. That being 
said, we need more research.
    It is concerning that there are arguments over what may or 
may not be a great medicinal use for marijuana, but we don't 
even have the data. It's time to get the data and let the 
decision be driven by the data. Additionally, some of the data 
that we do have includes some concerning results. For example, 
a study conducted by researchers at Kaiser Permanente in 
Northern California found that cannabis use among pregnant 
mothers nearly double between 2009 and 2016.
    Researchers also found that ``prenatal marijuana may impair 
fetal growth and neurodevelopment,'' but added that more 
studies are necessary as THC potency continues to rise. As an 
OB/GYN, I worry that the health of mothers and their babies 
could be at risk.
    One of the key hurdles to research is that researchers 
require DEA-approval, and for decades they have only been 
allowed to obtain their marijuana from one source--the 
University of Mississippi--which is the only contract that the 
National Institute on Drug Abuse has for research-grade 
cannabis.
    In the past it may have made sense to have a single source 
for research purposes. However, because the diversity of the 
quality, potency, and other aspects of marijuana that 
individuals obtain for medical and recreational purposes varies 
across the United States, research using this sole source of 
marijuana may not adequately assess the current landscape. Not 
to mention that it is difficult to obtain the quantity 
necessary to conduct research under the existing structure.
    To that point, the Drug Enforcement Agency announced in 
2016 that it would establish a new policy to increase the 
number of approved sources of research-grade marijuana but has 
failed to do so. I hope that the DEA will update us on its 
administrative efforts to streamline the research process 
today, and that we can identify ways to work together to 
achieve that goal.
    While three of the bills before us today aim to enhance 
research efforts, there are two that take a step too far. H.R. 
2843 and H.R. 3884 completely remove marijuana from the list of 
Controlled Substances.
    It is worth noting, and I believe that the Food and Drug 
Administration will explain this in more detail, that in order 
for the Drug Enforcement Agency to reschedule a drug 
administratively without Congressional direction, the Food and 
Drug Administration must conduct a medical evaluation of the 
drug and provide a recommendation to the DEA as to what the 
rescheduling should be. That recommendation is binding; 
therefore, the DEA must do what the FDA recommends. I think 
that completely descheduling marijuana using our Congressional 
authority is a dangerous move, especially given the lack of 
research to back up that decision.
    It is critical that the American public, and the medical 
community, understand what marijuana does to our bodies and to 
our brains, at different potencies, and throughout our life 
cycle. We have a way to go before we will have a full 
understanding all of those factors, but some of the bills 
before us are a step in the right direction.
    I look forward to learning more about the issues our 
federal agencies are facing and the current efforts they are 
working on. Thank you to all of our agency witnesses for being 
here today to discuss this important topic. I yield back.

    Ms. Eshoo. The gentleman yields back.
    It is a pleasure to yield 5 minutes to the chairman of the 
full committee, Mr. Pallone, for his opening statement.

OPENING STATEMENT OF HON. FRANK PALLONE, Jr., A REPRESENTATIVE 
            IN CONGRESS FROM THE STATE OF NEW JERSEY

    Mr. Pallone. Thank you, Chairwoman Eshoo.
    Today the subcommittee will have an important hearing about 
Federal cannabis policies. While State laws and public 
perception around cannabis and its derivatives have evolved 
over the years, much of the Federal framework that regulates 
cannabis has stayed the same. In my home State of New Jersey, 
for example, State law allows for the use of medical cannabis, 
and at the end of last year, State lawmakers passed a 
referendum that will put the question of legalizing adult 
cannabis use to New Jersey voters on the 2020 ballot this 
coming November.
    New Jersey is not alone in its State-level changes, in fact 
the National Conference of State Legislatures reports that 33 
States, as well as Puerto Rico, Guam, the U.S. Virgin Islands, 
and the District of Columbia approved medical cannabis programs 
while 11 States, DC, Guam, the Northern Mariana Islands 
approved adult-use cannabis. And although some States have 
changed their own policies, national laws, such as the 
Controlled Substances Act, have yet to change in the same way. 
And that is why we are looking forward to this hearing from a 
panel of agency witnesses who agreed to appear before the 
subcommittee today. The Drug Enforcement Agency, the FDA, the 
National Institute on Drug Abuse all play crucial roles on the 
Federal cannabis policy. From researching its benefits and 
harms to protecting the American public from bad actors. And I 
hope that we can learn about what the agencies believe works 
and what needs to be changed.
    We will discuss six bills offered by both Democrats and 
Republicans, some bipartisan. These bills propose various 
policy changes, such as rescheduling or descheduling marijuana, 
providing a safe harbor for patients and veterans who use 
medical marijuana, and streamlining cannabis research 
processes.
    Given the evolving landscape in the States, these bills are 
worthy of further discussion. And I am particularly interested 
in hearing about how Federal agencies are reducing barriers to 
research and enabling research on cannabis to thrive. I am also 
interested in how the agencies are working together to regulate 
a cannabis derivative recently removed from the Controlled 
Substances Act, and that is CBD or cannabidiol, I guess is how 
it is pronounced.
    Before I conclude, I did want to recognize, as Ms. Eshoo 
did, Representatives--first--Blumenauer and Representative 
Barbara Lee. I know they have talked to many us on a regular 
basis, and we are pleased to see that you are here in the 
audience today. And they are the co-chairs of the bipartisan 
Cannabis Caucus with Representatives Young and Joyce. Together 
they foster a continued dialogue on cannabis issues and both 
have offered bills before us today. And I thank them for 
joining us and commend them for their ongoing leadership in 
this area.
    Thank you again, Madam Chair. I don't know if anybody are--
I have two minutes left if anybody wants it. If not, I yield 
back.
    [The prepared statement of Mr. Pallone follows:]

             Prepared statement of Hon. Frank Pallone, Jr.

    Today the Subcommittee will have an important hearing about 
federal cannabis policies. While state laws and public 
perception around cannabis and its derivatives have evolved 
over the years, much of the federal framework that regulates 
cannabis has stayed the same.
    In my home state of New Jersey, for example, state law 
allows for the use of medical cannabis and, at the end of last 
year, state lawmakers passed a referendum that will put the 
question of legalizing adult cannabis use to New Jersey voters 
on the 2020 ballot.
    New Jersey is not alone in its state-level changes. In 
fact, the National Conference of State Legislatures reports 
that 33 states as well as Puerto Rico, Guam, the U.S. Virgin 
Islands, and the District of Columbia approved medical cannabis 
programs while 11 states, the District of Columbia, Guam, and 
the Northern Mariana Islands approved adult-use cannabis. 
Although some states have changed their own policies, national 
laws, such as the Controlled Substances Act, have yet to change 
in the same way.
    That is why I am looking forward to hearing from the panel 
of agency witnesses who agreed to appear before the 
Subcommittee today. The Drug Enforcement Agency, the Food and 
Drug Administration, and the National Institute on Drug Abuse 
all play crucial roles on federal cannabis policy--from 
researching its benefits and harms to protecting the American 
public from bad actors. I hope that we can learn about what the 
agencies believe works, and what needs to be changed.
    We will discuss six bills offered by both Democrats and 
Republicans, and some bipartisan in nature. These bills propose 
various policy changes such as rescheduling or descheduling 
marijuana, providing a safe harbor for patients and veterans 
who use medical marijuana, and streamlining cannabis research 
processes.
    Given the evolving landscape in the states, these bills are 
worthy of further discussion. I am particularly interested in 
hearing about how federal agencies are reducing barriers to 
research and enabling research on cannabis to thrive. I am also 
interested in how the agencies are working together to regulate 
a cannabis derivative recently removed from the Controlled 
Substances Act--cannabidiol, or CBD.
    Before I conclude, I would like to recognize 
Representatives Lee and Blumenauer, who are joining us in the 
audience today. They serve as the cochairs of the bipartisan 
Cannabis Caucus with Representatives Young and Joyce. Together 
they foster a continued dialogue on cannabis issues, and both 
helped author bills before us today. I thank them for joining 
us and commend them for their ongoing leadership in this area.
    Thank you again to the witnesses for testifying before us. 
I am looking forward to this discussion. Thank you, and I yield 
back.

    Mr. Griffith. Mr. Chairman, will take it.
    I appreciate that. As one of the sponsors of the bills, a 
lot of times people think, why does a conservative Republican 
get into this and champion it?
    Well, let me tell you a story. When I was a young man in 
the 1980s, some of my friends were smuggling marijuana into the 
hospital in our community there in the Roanoke Valley because 
there was an individual whom I did not know who was dying of 
cancer, but he wanted to spend every day he could with his son 
who was about two at the time. And that formed my policy that 
we need to have a rational medical marijuana policy; thus the 
LUMMA bill.
    But I decided when I got to Congress that, you know, well, 
it is kind of controversial, and maybe I shouldn't do that. But 
I would talk about it. And when I was at a high school townhall 
as I call them--I go to the high schools and talk to students--
they ask about marijuana policy.
    I told them my position on medical marijuana, which I went 
public with in 1998 on the floor of the Virginia House of 
Delegates. And I was standing there, and I thought--all the 
hands went up, and I thought one of the kids was going to say 
to me, ``Well, what about for just for recreational use or for 
fun?'' And I will never forgot it: I was in Wise, Virginia, and 
a young man on this side of the room raised his hand, and I 
went to him expecting to get the recreational question. And he 
said, ``They did that for my daddy, too.'' Now my district is a 
big district. These two communities, 20 years apart--30 years 
apart, and hours apart from one another. And yet doctors were 
turning a blind eye to allow marijuana to be brought into the 
hospital because they recognized for those patients who were 
dying, this was the only way they could have a little bit of 
relief and get the nutrients that they needed to stay alive a 
little bit longer to spend a little bit more time with their 
children. I came back to DC, and I said: You know what? I am in 
Congress now. I can do something about the DEA and the FDA not 
making marijuana available for patients who need it. And today 
is that day.
    I yield back.
    Mr. Pallone. And I yield back, Madam Chair.
    Ms. Eshoo. The gentleman yields back. There is nothing like 
a real-life story.
    It is a pleasure to recognize the ranking member of the 
full committee, my friend Mr. Walden, for 5 minutes for his 
opening statement.

  OPENING STATEMENT OF HON. GREG WALDEN, A REPRESENTATIVE IN 
               CONGRESS FROM THE STATE OF OREGON

    Mr. Walden. Thank you, Madam Chair.
    We appreciate the hearing today because we will finally 
have an opportunity to review initiates aimed at improving 
federally sanctioned research on cannabis. Representatives 
Burgess, Griffith, Rodgers, and others, we sent a letter asking 
for this hearing. We appreciate your willingness to have it, 
Madam Chair.
    Federally sanctioned reached on cannabis is challenging. It 
is a schedule I controlled substance under theControlled 
Substances Act. This means that researchers seeking to 
investigate cannabis must work with the Food & Drug 
Administration, the National Institute of Drug Abuse and the 
drug enforcement administration just to meet the Federal 
guidelines, requirements specified in the CSA to conduct 
research. In addition, international obligations set forth in 
the United Nations drug control treaties impose additional 
requirements on the substance impacting the supply of research-
grade cannabis.
    So researchers now can only use cannabis for products 
sourced through the NIDA's drug supply program single DEA 
licensee, the University of Mississippi.
    Now, unfortunately, that cannabis is distinct from what is 
commercially available from State legal dispensaries, such as 
in my home State of Oregon, meaning that we have little to no 
data on the health impacts of products in States that have 
legalized cannabis for medical or recreational use.
    Now, in Oregon, you can purchase a range of THC-infused 
products, like these cookies we have a photo of right there. If 
you look up on the screen behind you, I guess, it is sort of 
stereo on this other side, but right there. And each of you, by 
the way, has a cookie in front of you. I have a pizza stand 
opening in an hour out in a hallway. Don't worry; I didn't get 
that carried away. You can actually eat these, as far as I 
know. Unless Safeway inserted something beyond the normal 
ingredients, it is just a cookie.
    The question is, how do you know if your child stumbled 
upon it? So serious side. Oregon, these cookies in this photo 
are limited to five milligrams of THC per serving, 50 
milligrams per package. Now, if you go across the Columbia 
River to Washington State, you find they have a different 
limit, ten milligrams and 100 milligrams per package. The 
difference is arbitrary. You see we lack data. We do not know--
what we do know is there have been an elevated number of 
cannabis-related poison center calls, emergency room visits, 
and impaired driving incidents. But we need the research that 
reflects the reality of what is on today's market.
    Additionally, products containing CBD derived from the hemp 
plant have become commonplace across the country in pharmacies, 
food health stores, even fast food chains since hemp was 
removed from the CSA in 2018 farm bill. Now these products 
often contain claims they can effectively treat depression, 
inflammation, and even cancer or Alzheimer's. However, none of 
these claims have been evaluated or approved by the Food and 
Drug Administration, which means patients may be relying on the 
unsubstantiated claims of CBD products and foregoing other 
proven medical treatments.
    And while there is potential for CBD to provide real 
patient benefit, the research and science lags far behind the 
market, and the agencies are struggling to catch up.
    So nationwide exposure in youth is increasing. From 2006 to 
2013, children's exposure to marijuana products rose 147.5 
percent nationwide. And in States that have legalized medical 
marijuana, exposure has risen 610 percent. And while alcohol 
use is going down in teens, last month, NIDA reported record 
numbers of eighth through twelfth grade students regularly 
vaping marijuana, a subject we have talked about before this 
committee.
    So we need more research, and we need more data. Americans 
are consuming more cannabis, and policy decisions on this 
substance has been made in a virtual information vacuum. States 
that have legalized marijuana, such as my State, have done so 
with far less information than they have on legal substances 
that are easily abused, such as alcohol or tobacco. 
Rescheduling cannabis may help improve the research landscape 
and allow for more medical treatments. However, administrative 
rescheduling necessitates robust data on potential medical 
uses, and the current research restrictions on fully studying 
cannabis have effectively created a catch-22 in this 
rescheduling debate. Evaluations by the FDA and the National 
Academies have both concluded that lack of research was a 
significant factor in denying previous rescheduling petitions.
    So I would like to note that two of the six bills we are 
reviewing today completely descheduled cannabis, removing it 
from the Controlled Substances Act, even though we do not have 
the necessary data to justify doing so, in my opinion. 
Descheduling cannabis is a step too far and a step I cannot 
support because descheduling removes it from the Controlled 
Substances Act and cuts the DEA completely out of the picture. 
So any discussion of descheduling must be preceded by a fuller 
understanding of the potential risks associated with cannabis 
use, which we currently do not have.
    Research is the first step in making it easier to get our 
research on cannabis. It is common ground we should pursue as 
we improve the Federal-State relationship and the marijuana 
policy gap.
    And, with that, Madam Chair, I yield back.
    And you can eat your cookies now.
    [The prepared statement of Mr. Walden follows:]

                 Prepared statement of Hon. Greg Walden

    At today's hearing, we will have the opportunity to review 
initiatives aimed at improving federally-sanctioned research on 
cannabis. Republican Leader, Burgess, Reps. Griffith, Rodgers 
and I sent a letter requesting this hearing last month, and I'd 
like to thank the Majority for responding and getting a hearing 
on the books in such a timely fashion.
    Federally sanctioned research on cannabis is challenging. 
It is a Schedule I controlled substance under the Controlled 
Substances Act (CSA). This means that researchers seeking to 
investigate cannabis must work with the Food and Drug 
Administration (FDA), the National Institute on Drug Abuse 
(NIDA), and the Drug Enforcement Administration (DEA) to meet 
the federal requirements specified in the CSA to conduct 
research. In addition, international obligations set forth in 
three United Nations (U.N.) drug control treaties impose 
requirements on the substance, impacting the supply of 
research-grade cannabis.
    Currently, researchers can only use cannabis products 
sourced through the NIDA's Drug Supply Program single DEA 
licensee: the University of Mississippi. Unfortunately, that 
cannabis is distinct from what is commercially available from 
state-legal dispensaries, such as in my home state of Oregon, 
meaning that we have little to no data on the health impacts of 
products in states that have legalized cannabis for medical or 
recreational use.
    In Oregon, you can purchase a range of THC infused 
products, like these cookies we have a photo of here.
    Now everyone on the dais has a cookie in front of them that 
looks a lot like this photo. Don't worry, yours are just from 
Safeway. But how would you know if you, or a child, stumbled 
upon it.
    That serious concern aside, in Oregon, the cookies in this 
photo are limited to 5mg of THC per serving. 50mg per package. 
Washington state has limits of 10mg and 100mg.
    The difference is largely arbitrary. We lack data. We do 
know there have elevated numbers of cannabis-related poison 
center calls, emergency room visits, and impaired driving 
incidents.\1\ We need research that reflects the reality of 
what's on the market.
---------------------------------------------------------------------------
    \1\ https://www.oregon.gov/oha/PH/PREVENTIONWELLNESS/MARIJUANA/
Documents/fact-sheet-marijuana-consequences.pdf.
---------------------------------------------------------------------------
    Additionally, products containing CBD derived from the hemp 
plant, have become commonplace across the country in 
pharmacies, health food stores, and even fast food chains since 
hemp was removed from the CSA in the 2018 Farm Bill. These 
products often contain claims that they can effectively treat 
depression, inflammation, and even cancer or Alzheimer's. 
However, none of these claims have been evaluated or approved 
by the FDA, meaning patients may be relying on the 
unsubstantiated claims of CBD products and forgoing other, 
proven, medical treatments. While there is potential for CBD to 
provide real patient benefit, the research and science lags far 
behind the market and the agencies are struggling to catch up.
    Nationwide, exposure in youth is increasing. From 2006 to 
2013, children's exposure to marijuana products rose 147.5 
percent nationwide. In states that have legalized medical 
marijuana, exposure has risen 610 percent. \2\ And while 
alcohol use is going down in teens, last month NIDA reported 
record numbers of eighth through 12th grade students regularly 
vaping marijuana. \3\
    We need more research and better data. Americans are 
consuming more cannabis and policy decisions on this substance 
have been made in a virtual information vacuum. States that 
have legalized marijuana have done so with far less information 
than they have on legal substances that are easily abused, such 
as alcohol or tobacco. Rescheduling cannabis may help improve 
the research landscape and allow for more medical treatments. 
However, administrative rescheduling necessitates robust data 
on potential medical uses; and the current research 
restrictions on fully studying cannabis have effectively 
created a Catch-22 in the rescheduling debate. Evaluations by 
the FDA and the National Academies have both concluded that 
lack of research was a significant factor in denying previous 
rescheduling petitions. \4\
    I would like to note that two of the six bills we are 
reviewing today completely de-schedule cannabis, removing it 
from the Controlled Substances Act, even though we do not have 
the necessary data to justify doing so. De-scheduling cannabis 
is a step too far and is something I cannot support, as de-
scheduling removes it from the Controlled Substances Act and 
cuts the DEA completely out of the picture.
---------------------------------------------------------------------------
    \2\  https://journals.sagepub.com/doi/abs/10.1177/0009922815589912.
    \3\  https://www.nih.gov/news-events/news-releases/vaping-
marijuana-rise-among-teens.
    \4\ https://www.nap.edu/catalog/24625/the-health-effects-of-
cannabis-and-cannabinoids-the-current-state.
---------------------------------------------------------------------------
    Any discussion of de-scheduling MUST be preceded by a 
fuller understanding of the potential risks associated with 
cannabis use--which we currently do not have. Research is the 
critical first step. Making it easier to conduct research on 
cannabis is common ground that we can pursue together in 
improving the state-federal marijuana policy gap, and I'm 
looking forward to hearing from our distinguished federal 
witnesses on potential solutions to help improve the research 
landscape.

    Ms. Eshoo. The gentleman yields back. The Chair would like 
to remind Members that, pursuant to committee rules, all 
members' written opening statements shall be made part of the 
record.
    Now I would like to introduce our witnesses for today's 
hearing and to thank each one of you for being with us today. 
Dr. Nora Volkow is the director of the National Institute of 
Drug Abuse at the National Institutes of Health.
    Thank you to you.
    Dr. Douglas Throckmorton is the deputy director for 
regulatory programs at the Center for Drug Evaluation and 
Research at the FDA, at the Food & Drug Administration.
    And Mr. Matthew Strait is senior policy adviser for the 
Diversion Control Division of the Drug Enforcement 
Administration.
    So welcome to each one of you. Thank you for essentially 
your life's work that brings you to the table to testify today. 
We look forward to the testimony that each one of you are going 
to offer.
    I think you are familiar with the lights. It is like a 
traffic system. Green is go. Yellow is caution, and when red 
turns up, it is time to stop.
    So we will start with Dr. Volkow.
    You are recognized for your 5 minutes of testimony. And, 
again, thank you not only for your work, but for being here 
with us today. Turn your microphone on.

    STATEMENTS OF NORA D. VOLKOW, M.D., DIRECTOR, NATIONAL 
INSTITUTE ON DRUG ABUSE, NATIONAL INSTITUTES OF HEALTH; DOUGLAS 
C. THROCKMORTON, M.D., DEPUTY DIRECTOR FOR REGULATORY PROGRAMS, 
    CENTER FOR DRUG EVALUATION AND RESEARCH, FOOD AND DRUG 
 ADMINISTRATION; AND MATTHEW J. STRAIT, SENIOR POLICY ADVISOR, 
  DIVERSION CONTROL DIVISION, DRUG ENFORCEMENT ADMINISTRATION

               STATEMENT OF NORA D. VOLKOW, M.D.

    Dr. Volkow. I want to say good morning to everybody, and I 
want to than Chairwoman Eshoo, Ranking Member Burgess, and all 
of the members of the subcommittee for inviting us to discuss 
cannabis research.
    Cannabis is the most widely used illicit drug in the world 
and in the United States. THC is responsible for cannabis 
rewarding and addictive effects. And it is content has tripled 
in the past two decades. On the other hand, the content of 
cannabidiol, or CBD, which is not rewarding but of interest 
because of its potential therapeutic effects, has decreased in 
cannabis plants while food, drinks, and other products 
containing it have proliferated it.
    THC exerts its effects by interacting with cannabinoid 
receptors, which are part of our own endogenous cannabinoid 
system. The system is involved in brain development and 
multiple brain functions, memory, emotions, reward, among 
others. Cannabinoid receptors also modulate immune, 
inflammatory, hormonal, metabolic processes in our body. Thus, 
it is not surprising that cannabis, which basically hijacks 
that systems can negatively affect health. Of particular 
concern are its effects on the developing fetal and adolescent 
brain. Cannabis exposure, as was mentioned before, during 
pregnancy has increased and is associated with fetal growth 
restriction, lower birth rate, and preterm delivery. In 
adolescents, cannabis use has been consistently associated with 
lower academic achievement, higher risk of dropping out of 
school, lower IQ, disruptions in brain connectivity and 
structure as the brain transitions into adulthood. Cannabis use 
at a young age increases the risk of addiction to cannabis and 
to other drugs.
    Another area of major concern is the association of 
cannabis use with psychosis, the risk of which increases with 
consumption of high-content THC. The while most episodes of 
psychosis are short lasting, they can become chronic. Concerns 
have also emerged regarding higher risk for depression and 
suicide, though these associations have been less studied.
    The availability of high-THC products has markedly 
increased emergency department visits and hospital admissions 
associated with cannabis exposures. Vehicle-related injuries 
while driving under the influence of THC are one of the main 
causes. Another frequent cause is severe cycles of nausea, 
vomiting, and abdominal pain referred to as cannabis 
hyperemesis syndrome.
    However, our understanding of the adverse effects of 
cannabis is incomplete. This was made clearly evident by the 
outbreak of e-cigarette or vaping product use associated lung 
injury or EVALI, a condition reported in June 2019 
predominantly associated with THC vaping that has, over six 
months, resulted in 2,500 more hospitalizations and 55 deaths.
    Consumption of cannabis edibles packaged in food and drinks 
disproportionately accounts for cannabis-related emergency 
department visits. The slow absorption can prompt the user to 
take further doses, resulting in very high THC levels. Toxicity 
was frequently manifest as acute psychosis, severe anxiety, and 
cardiovascular complaints, and they also contribute 
increasingly to intoxication in children. Cannabis plants have 
been legalized for medical use for multiple indications in many 
States, even though FDA has not approved any of them for any 
indication.
    Though not meeting FDA requirements, there is evidence 
though that cannabis may be effective for treating spasticity 
multiple sclerosis and for pain, but otherwise there is little 
evidence for other indications for which patients are using it.
    NIH is helping to close this knowledge gap, including 
supporting stories to examine CBD for treating pain, 
inflammation, PTSD, and addiction. Understanding the effects of 
cannabis on brain development is a NIDA priority. And the 
adolescent brain cognitive development study will follow more 
than 11,000 children into early adulthood to investigate how 
cannabis affects their brains.
    Despite the urgency for advancing research, the fact that 
cannabis is a schedule I substance proposes major challenges. 
NIDA's contract with the University of Mississippi is currently 
the only DEA source of research cannabis, and researchers are 
unable to access cannabis for research from dispensaries and 
other sources resulting in a gap in our understanding of their 
impact on health.
    Cannabis research is urgently needed both to guide policy 
and to develop therapeutics; thus the importance of 
facilitating their ability to do so.
    Thank very much.
    [The prepared statement of Dr. Volkow follows:]
    
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]    
    
        
    Ms. Eshoo. Thank you, Doctor.
    We will now recognize Dr. Throckmorton for his 5 minutes of 
testimony.
    And thank you again for being here today. Do you have your 
microphone on?
    Dr. Throckmorton. I do. Thanks.
    Ms. Eshoo. You are recognized.

           STATEMENT OF DOUGLAS C. THROCKMORTON, M.D.

    Dr. Throckmorton. Chairman Eshoo, Ranking Member Burgess, 
and members of the subcommittee, I am Dr. Douglas Throckmorton 
Morton from the Center for Drug Evaluation and Research at the 
Food & Drug Administration. Thank for the opportunity to be 
here today to discuss the important role that FDA plays in 
research involving cannabis and cannabis-derived compounds for 
potential medical uses in the United States.
    I would also like to discuss the recent work the FDA is 
doing to respond to the recent legislation affecting the 
availability of compounds derived from cannabis, such as 
cannabidiol.
    First, with regards to drug development, FDA continues to 
believe that the drug approval process represents the best way 
to ensure that safe and effective new medicines, including 
medicines derived from cannabis, are available for patients. 
FDA stands ready today provide information to investigators on 
the progress and process and specific requirements needed to 
develop a human drug that is derived from plants such as 
cannabis. For example, FDA has ways to speed drug development 
programs, including programs such as fast track, breakthrough 
therapy, accelerated approval, and priority review, all 
designed to facilitate the development of and to expedite the 
approval of novel and effective drug products.
    We have also established a botanical review team to assist 
the development of plant-based drugs, including those derived 
from cannabis. Using these resources, the FDA has successfully 
approved one cannabis-derived drug product, Epidiolex, 
containing cannabidiol or CBD, and three synthetic cannabis-
derived drug products: Marinol, Syndros and Cesamet.
    While FDA is aware of the activities of States in this 
area, to date FDA has not approved any other cannabis, 
cannabis-derived, or CBD products currently available on the 
market. Turning our activities through recent work under 
legislation, in December of 2018, the farm bill removed hemp 
defined as cannabis and its derivatives with extremely low 
concentrations of THC from the definition of marijuana in the 
Controlled Substances Act. The farm bill explicitly preserved 
FDA's authorities over products derived from hemp, such as CBD, 
which means the products must still meet any applicable FDA 
requirements and standards just like any other FDA-regulated 
product. Because we understand the broad interest in making 
compounds found in cannabis more widely available to the 
public, FDA is working hard to respond to these changes quickly 
and appropriately.
    For example, we have reached several conclusions about the 
use of CBD in nondrug products. First, it is prohibited under 
our statute to introduce into interstate commerce any human or 
animal food to which certain drug ingredients have been added. 
In addition, drug ingredients are excluded from the definition 
of dietary supplement. Because CBD is an active ingredient of 
an approved drug, these restrictions apply to products made 
with CBD.
    These provisions make sense. It is easy it to understand 
why we generally don't want blood pressure medicines or pain 
medicines in our food are in our dietary supplements. 
Additionally, FDA is concerned that the marketing of CBD in 
nondrug products could put consumers at risk, such as by making 
unsubstantiated claims to prevent or cure serious diseases such 
as cancer or Alzheimer's disease. The proliferation of such 
products may deter consumers from seeking proven, safe medical 
therapies for serious illnesses.
    We also know that CBD can cause adverse effects, including 
drug interactions, sleepiness that could impair driving, and 
potential liver injury. There are many unanswered questions 
about the safety and quality of products containing CBD, and 
the agency has made it a priority to address these questions, 
including questions about the safety of long-term use of CBD by 
different populations. For example, we have very little 
information about the use of CBD by pregnant women, by 
children, and by the elderly. To address these gaps, FDA is in 
the process of systematically collecting all of the data that 
are available to us to make the best science based and public-
health-focused decisions about the availability of the 
compounds in hemp.
    To close, FDA understands the broad interest in making that 
compounds more available to the public and is considering the 
possibilities and new legal pathways for CBD products. However, 
it is important to maintain adequate incentives for drug 
development as we do so. Drugs have important therapeutic value 
and are approved after rigorous scientific studies that provide 
important, new information about their safety and 
effectiveness. It is critical that we continue to do what we 
can to support quality science needed to develop new products 
in cannabis.
    With that, I thank you and look forward to answering any 
questions I can.
    [The prepared statement of Dr. Throckmorton follows:]
    
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]    
    
    
    Ms. Eshoo. Thank you, Doctor.
    Now it is a pleasure to recognize Mr. Matthew Strait for 
his 5 minutes of testimony.
    And thank you again for joining us today.

                 STATEMENT OF MATTHEW J. STRAIT

    Mr. Strait. Thank you. Chairwoman Eshoo, Ranking Member 
Burgess, and distinguished members of committee, on behalf of 
the Administrator Dillon and 9,000 men and women of the Drug 
Enforcement Administration. I appreciate the invitation to be 
here today to discuss DEA's regulatory requirements for those 
who perform research with schedule I controlled substances, 
including marijuana.
    Much like our partners at HHS, the Department of Justice 
and DEA fully support research into the effects of marijuana 
and the potential medical utility of its component. The 
procedures for evaluating an application for registration by 
statute is an interagency process. At HHS, the Food and Drug 
Administration conducts a review of the qualifications and 
competency of the researcher as well the merits of the 
scientific protocol. The DEA is charged with ensuring that 
adequate steps are in place to safeguard against diversion. 
These procedures have been in place for several decades, and in 
my 20 years, there has not been a single incident in which a 
researcher who has put forth a valid research protocol and has 
implemented safeguards to prevent diversion has been denied.
    Given the public interest in marijuana research, DEA has 
taken a number of proactive steps to do its part in improving 
research with marijuana. First, in December 2015, DEA executed 
a change intended to ease the requirements to modify existing 
registrations in order to conduct research with cannabidiol or 
CBD, which at the time was being investigated for use in 
children with certain epilepsy disorders. I believe this action 
ultimately contributed to the 2018 approval of Epidiolex.
    Second, in August 2016, the Department of Justice and DEA 
took steps to increase the number of entities registered under 
the Controlled Substances Act to grow marijuana to supply 
researchers. To ensure that this program is consistent with 
applicable laws and treaties, the Department, in consultation 
with other Federal agencies, continues to be engaged in a 
policy review process. In August 2019, DEA published a list of 
the 33 entities who have applied for registration and whose 
applications remain pending to grow marijuana pursuant to that 
policy. A forthcoming proposed rule, which has been drafted and 
submitted to the Office of Management and Budget, remains under 
development at this time.
    Third, in February 2018, DEA announced its development of 
and implementation of an online portal for researchers to 
safely and securely submit their research protocol, curriculum 
vitae, and institutional approval, materials required by DEA 
regulations to be submitted for FDA and DEA review. This online 
portal has streamlined the process and improved the amount of 
time for obtaining a schedule I research registration. 
Presently the average time it takes to approve a new 
application is 52 days, while the time required to modify an 
existing registration is far less.
    Finally, two months ago, DEA increased the aggregate 
production quota for marijuana to 3,200 kilograms. The increase 
was based on a close collaboration with NIDA, who provides 
high-quality marijuana to NIH and non-NIH-funded researchers. 
The 2020 quota represents a 575-percent increase for marijuana 
since 2017.
    I believe these efforts are working. Today DEA has 829 
active researchers; 70 percent of those researchers, 605 in 
total, are performing research with marijuana or its 
constituent parts, making it far and away the most researched 
schedule I controlled substance in the United States.
    Despite these efforts and our successes the multistep 
process for approving research with schedule I controlled 
substances is perceived as onerous by some of the research 
community. Unfortunately, this perception has translated into a 
false narrative that DEA does not support research. I am here 
today to tell you that this is simply not true. This belief has 
hampered efforts to pass practical commonsense legislation 
aimed at addressing the more than 30,000 overdose deaths in the 
United States from fentanyl and fentanyl-related substances. In 
just 23 days, DEA's temporary scheduling action which placed 
schedule I controls on substances chemically similar to 
fentanyl will expire unless Congress acts. DEA and the 
Department of Justice have worked with HHS and ONDCP to put 
forth a proposal that addresses this public health emergency 
while improving access for research. On behalf of the 
Department of Justice, I urge the committee to take up this 
important legislation.
    In conclusion, DEA is fully committed to supporting 
research for schedule I controlled substance. We will continue 
to work with our partners within the administration to find 
commonsense approaches to improve and enhance research of 
marijuana.
    Thank you and I look forward to your questions.
    [The prepared statement of Mr. Strait follows:]
    
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]    
       
    Ms. Eshoo. Thank you, Mr. Strait. Now we have concluded not 
only the opening statements of members but the testimony of the 
witnesses. We are going to move to members' questions now, and 
I recognize myself for 5 minutes.
    I would like to ask a few foundational questions of the 
panel, and I think that the following can be answered with a 
simple yes or no. Is more medical research needed on the 
therapeutic effects and the health consequences of cannabis?
    Dr. Volkow. Yes.
    Dr. Throckmorton. Yes.
    Mr. Strait. Yes.
    Ms. Eshoo. Is the cannabis from the University of 
Mississippi, which is the only approved cannabis for Federal 
research, adequate for medical research?
    Dr. Volkow. No.
    Dr. Throckmorton. No.
    Mr. Strait. We would like additional sources, but we also 
recognize that importation is allowed in certain circumstances.
    Ms. Eshoo. Should legitimate researchers be able to access 
a wider array of cannabis products for their research?
    Dr. Volkow. Yes.
    Dr. Throckmorton. It would help drug development.
    Mr. Strait. Yes.
    Ms. Eshoo. Have there been, in your view, real-life 
consequences to researchers not being able to conduct research 
on a variety of cannabis products?
    Dr. Volkow. Yes.
    Dr. Throckmorton. Product development has been slow.
    Ms. Eshoo. So there has been an effect because of that.
    Dr. Throckmorton. Uh-huh.
    Mr. Strait. I don't disagree with what my colleagues have 
said.
    Dr. Volkow. I know one point that we haven't discussed 
enough, which has been hindered, is our ability to actually 
recognize when drugs may be particularly harmful. So that is 
another aspect of the limitations.
    Ms. Eshoo. The main reason cannabis research is restricted 
is because cannabis is listed as a schedule I drug. Yet two 
active compounds in cannabis, THC and CBD, are both approved 
ingredients for drugs that are scheduled as schedule III and 
schedule V respectively. So how can cannabis be schedule I and 
considered to have no accepted medical use because that is part 
of the schedule I, but both of its major active ingredients can 
be considered to have medical use?
    Dr. Volkow. I defer to my colleagues at the FDA for 
answering that.
    Dr. Throckmorton. Separately those two compounds are safe 
and effective for intended uses and so meet the statutory 
standard for accepted medical use.
    Ms. Eshoo. How do you pull them out and separate them?
    Dr. Throckmorton. That is what the drug development process 
is meant to encourage. It is to have people----
    Ms. Eshoo. So, if FDA decides to pull those out to be 
applied to and used and be part of a certain drug, you just 
automatically vanish--schedule I vanishes as a result of that?
    Dr. Throckmorton. When Congress defined what the schedules 
were to be, they said that there were tests to be applied for 
whether you had accepted medical use. There are five that we 
would be happy to talk in greater detail offline. When you 
apply those tests to marijuana, at least when the FDA and NIDA 
have applied those tests to marijuana three times in the recent 
20 years or so, our conclusion, our recommendation to the DEA 
is that it did not meet the test for accepted medical use. It 
mostly has to do with whether you have identified a therapeutic 
value for the product and whether you can describe it.
    Ms. Eshoo. It is more the trigger than anything else.
    Dr. Throckmorton. Yes.
    Ms. Eshoo. To Dr. Throckmorton, does the FDA have all the 
authorities it needs to regulate CBD products for consumer 
safety?
    Dr. Throckmorton. I believe we do. When I talk to drug----
    Ms. Eshoo. Are you sure?
    Dr. Throckmorton. When I talk to drug developers that come 
in and talk to me and they say, ``We are interested in studying 
a compound found in cannabis,'' whether it is CBD or it is one 
of the other 80 cannabinoids or the terpenes or whatever else, 
I say: If you can get me a legal source for that compound, a 
legal source for that compound, I am going to treat you exactly 
the same way I would treat any other drug in development.
    Ms. Eshoo. OK.
    Dr. Throckmorton. Except I am going to give you some 
additional resources in the forms of----
    Ms. Eshoo. I still have more questions. Now, the FDA has 
estimated that it will take three to five years to complete 
rulemaking in relation to CBD products. Is this still accurate?
    Dr. Throckmorton. We understand the----
    Ms. Eshoo. Is it?
    Dr. Throckmorton. It is unfortunately not a yes-or-no 
question, ma'am. We know that there is interest in moving 
quickly. We understand that three to five years is longer than 
people would like. We are looking----
    Ms. Eshoo. What is the estimate today?
    Dr. Throckmorton. We are looking at a full range of 
options. We are interested----
    Ms. Eshoo. You don't want to tell me. It seems to me that 
maybe three to five is still in place, but you don't want to 
say.
    In your testimony, you said the FDA knows of CBD products 
that may not contain the amount of CBD indicated on the label 
or may contain other potentially dangerous compounds. Has the 
FDA issued any labeling requirements for CBD? My time is--you 
may answer.
    Dr. Throckmorton. The labeling requirements would be 
imposed on the approved drugs, Epidiolex. That product is well 
manufactured, possesses--we have no concerns like that that I 
am aware of. The products that the warning letters are subject 
to that that comment related to are the unapproved products 
that have been marketed in the States.
    Ms. Eshoo. Thank you.
    Well, my time has expired, and I recognize the ranking 
member now for his 5 minutes of questions.
    Mr. Burgess. Thank you, Madam Chair.
    And, Dr. Throckmorton, staying with you for just a minute 
on the Epidiolex question. When I look at my drug discount app, 
it is like $1,300 a month for a therapeutic course of that. So, 
if somebody didn't have $1,300, could they just go buy CBD oil 
and supplant the use of Epidiolex?
    Dr. Throckmorton. Well, we always recommend that you use an 
approved product for a number of really good reasons. But what 
we learned when we did that sampling of unapproved products is 
that we don't know what will be in that oil if you choose to 
take it. It may contain things that would be dangerous to you. 
We also know it is reasonably likely that it could not contain 
the amount of CBD that you were looking to take for whatever 
condition.
    Mr. Burgess. Just along the lines of the timeframe that 
Chairwoman Eshoo asked you about just, for point of reference, 
when we did the Cures for 21st Century bill, pretty much 
standard accepted lengths of time in FDA for approval of a new 
drug was 14 to 16 years, and about a billion and a half 
dollars. Do I remember that correctly? So three to five years 
actually sounds like you are moving with great dispatch, would 
that be a fair statement?
    Dr. Throckmorton. The three to five years comes from our 
general experience with rulemaking rather than any specific----
    Mr. Burgess. So it is not a recent----
    Dr. Throckmorton. It is not related specifically to drug 
development or product development. It is just that rulemaking 
has steps that we have to use.
    Mr. Burgess. We will move forward with the DEA with this. 
Has DEA ever done an administrative change in a scheduled drug 
without being prompted by Congress?
    Mr. Strait. Oh, absolutely, yes. We initiate scheduling 
actions with some frequency. It could come through a petition 
received from a public citizen. It could come as a direct 
result of an approval of a new drug, a new molecular----
    Mr. Burgess. Would that not come through the FDA, though?
    Mr. Strait. Yes. In that circumstance, yes.
    Mr. Burgess. So you couldn't just do that de novo and say, 
``We are going to change the schedule of this medication on an 
administrative basis''?
    Mr. Strait. The agency retains the ability to initiate its 
own proposal as well. In that instance, we would put together--
--
    Mr. Burgess. Initiate, but you can't complete it without 
input from the FDA.
    Mr. Strait. No. As you say in your opening remarks quite 
correctly that we are tethered to the science that we are given 
by our colleagues over at HHS.
    Mr. Burgess. Yes, I don't know if that is inappropriate; 
being tethered to science can be a good thing.
    Dr. Volkow, you actually mentioned in your written 
testimony about the risk of addiction with cannabis products. 
Presumably you are talking about marijuana. That is a thing? 
That is a real thing?
    Dr. Volkow. It is a real thing, and it is THC, the active 
ingredient responsible for the addictiveness of marijuana. And 
the plants contain higher and higher content of THC.
    Mr. Burgess. So is marijuana a gateway drug? Some people 
call it that. Is that a fair statement?
    Dr. Volkow. It decreases the likelihood that you are 
sensitive to the addictive effects of other drugs, and that is 
why it has coined the term of ``gateway drug''; it makes you 
more sensitive.
    Dr. Burgess. So yesterday we spent a full hearing in 
Oversight and Investigations on the scourge of opiate 
addiction. We do worry that, if we go too far in one direction 
or another, that ten years from now, we will be having a 
hearing on perhaps we have gone too far with what we did with 
liberalizing marijuana laws. But let me just ask you this: You 
also mentioned the National Highway Traffic Safety 
Administration, the effects of driving under the influence. Our 
traffic laws and our State partners, have they kept up with all 
of the changes in marijuana policy that have occurred across 
the country?
    Dr. Volkow. No. One of the major challenges in doing so is 
that it is very difficult to quantify whether someone is 
intoxicated with marijuana or not. With alcohol, you actually 
measure the alcohol content in plasma, but that measure does 
not guarantee for marijuana that you are under the influence of 
the drug or not. So you can have very high levels from having 
taken it three days ago in a regular user. So that has been a 
major challenge.
    Mr. Burgess. So you can't really quantitate to the degree 
of behavioral disruption that may occur.
    Dr. Volkow. That has been much harder to do
    Mr. Burgess. And as a consequence for our law enforcement 
partners and our partners at the State that are writing State 
traffic laws, that becomes a difficulty. Is that correct?
    Dr. Volkow. Correct. And that is an area that we are trying 
to bring up new strategies to identify intoxication with 
marijuana from NIDA.
    Mr. Burgess. As a practical matter, that actually happened 
in my district: A pedestrian who was struck by an automobile, 
the driver of the automobile had under the 0.08 limit in their 
blood alcohol, but they also had a positive quantitative test 
for THC. That individual was no billed by the grand jury. I 
don't know whether that was right or wrong, but it seems to me 
that the potential for the additive effects should be something 
that law enforcement would bear in mind when deciding whether 
or not to bring a case like that. It was clearly a very tragic 
situation, young high school athlete who got hit. So it was a 
high-profile case in the community and something I will never 
forget.
    Thank you, Madam Chair.I yield back.
    Ms. Eshoo. The gentleman yields back.
    It is an pleasure to recognize the gentlewoman from 
California, Ms. Matsui, for her 5 minutes of questions.
    Ms. Matsui. Thank you very much, Madam Chair.
    And I really appreciate the hearing we are having today. 
This issue really needs to be examined.
    And thank you very much for the witnesses for being here 
today.
    At the University of California, researchers are doing 
important work to study the health effects, public safety, and 
environmental impacts of marijuana. I would like to discuss how 
our existing Federal regulations may be limiting researchers 
from fully understanding cannabis' potential risks and 
benefits.
    Now despite the fact that cannabis is being cultivated 
right in California to sell at local dispensaries, under 
current law, UC researchers must obtain their study samples 
through the NIDA contracted site in Mississippi. In order to 
study what the public is purchasing in dispensaries, UC 
researchers have applied for a license to cultivate cannabis 
locally. However, these researchers have not heard back from 
the DOJ and DEA as to the status of their applications.
    Mr. Strait, where is the Department of Justice in its 
process of granting or denying applications some researchers 
have put forth at a university to study to cultivate cannabis 
at a university?
    Mr. Strait. As I said in my opening, we certainly support 
all research endeavors.
    One of the challenges we see that often leads to this 
misperception about delays on the DEA side is we look for a 
complete application before we forward that application to our 
colleagues at the Department of Health and Human Services. So 
there are three things that we need: We need a protocol, which 
most researchers if they are federally funded or even State 
funded have; a CV for the researcher, which every researcher 
certainly has; but sometimes the delay is the result of the 
third piece, which is that institutional review approval. 
Sometimes, for purposes of timing, the researchers will submit 
an application, knowing that their State university or their 
State system, their university has not met to review their 
application.
    Ms. Matsui. Well, I now the University of California, I 
think they pretty good about doing this. And so we would like 
to be able to expedite as much as possible because their 
research is going to be very important as far as all of this.
    From the researcher's perspective I understand there is 
some ambiguity around the ability to conduct research with 
synthetic CBD for potential applications in humans. For the 
panel, what is your agency's position on the current status of 
CBD? Is there a distinction between marijuana-derived CBD and 
hemp or synthetically derived CBD when it comes to regulating 
these products? Dr. Volkow?
    Dr. Volkow. From our perspective, we are interested in 
understanding what are the effects of the chemical compound 
that goes by the name of CBD. With respect to actually its 
pharmacological actions, but the potential of negative effects 
and the potential of therapeutic actions. So, for all, the 
molecule is the one that is of interest. At the same time, 
though, we are doing research to try to investigate how, when 
it is mixed with other cannabinoids, that may influence its 
effects.
    Ms. Matsui. OK.
    Dr. Throckmorton, do you agree?
    Dr. Throckmorton. Yes. One of the things that happened in 
the results of the farm bill was that cannabidiol was removed 
from oversight from the Controlled Substances Act. In some 
sense that allows us to encourage its conduct--studies and 
things using it without interacting----
    Ms. Matsui. It opens it up.
    Dr. Throckmorton [continuing]. With DEA. We believe that is 
a powerful, potentially powerful, in terms of getting new 
studies done.
    Ms. Matsui. Great. Mr. Strait?
    Mr. Strait. Yes, and Dr. Throckmorton is 100 percent 
correct. I think the passage of the farm bill created a little 
bit of a question mark as to the legal status of synthetic CBD 
versus that derived from natural sources. Very clearly that 
which is derived from natural sources, if it contains less than 
0.3 percent THC, it is no longer controlled under the CSA.
    Ms. Matsui. Dr. Throckmorton, if a researcher wants to 
conduct clinical cannabis research that may lead to a new drug, 
what requirements need to be fulfilled with the FDA?
    Dr. Throckmorton. When you say ``cannabis,'' are you 
talking about farm-bill-compliant low-THC cannabis? It is 
important, when we talk to investigators, we think about it in 
sort of two tracks, an arrow going one way, and arrow----
    Ms. Matsui. Right. Right. Right.
    Dr. Throckmorton. One arrow, the farm-bill-compliant 
cannabidiol and other compounds extracted from hemp, we view as 
subject to the Food, Drug, and Cosmetics Act. They are able to 
be used for investigational use. Come in and talk to us; we 
will treat you as any other drug substance for study.
    If it is high-THC cannabis, then that still applies, but in 
addition, we would want to make certain that they work with the 
DEA because there are other requirements under those 
circumstances.
    Ms. Matsui. OK. Fine. Thank you, and I have gone over my 
time.
    I yield back.
    Ms. Eshoo. The gentleman yields back.
    Mr. Strait, would you respond after you get back to your 
agency with Congresswoman Matsui on University of California's 
application, please?
    Mr. Strait. Absolutely.
    Ms. Eshoo. This is the greatest public university in the 
world. They know how to do applications. They know how to do 
applications. Well, it is causing a ruckus, but I will stand--
--
    Mr. Upton. You do not have any right to object.
    Ms. Eshoo. I will stand with my statement representing the 
greatest private university in the world, Stanford.
    It is now a pleasure to recognize the gentleman from 
Michigan, Mr. Upton, for his 5 minutes of questions.
    Mr. Upton. You are just lucky Pete Olson is not here this 
morning, but I do not have my jersey on.
    Thank you, Madam Chair, for this hearing. I do have a 
couple of questions.
    Dr. Throckmorton, you mentioned that Epidiolex is one of 
the three drugs that have been approved, and two others in 
addition to that. What are the illnesses or conditions that 
they were approved for?
    Dr. Throckmorton. Right. So Epidiolex is approved for two 
genetic seizure disorders, severe seizure disorders in 
children, and that contains cannabidiol.
    Mr. Upton. Is it injected? Is it oral? Is it shot? Is it--
--
    Dr. Throckmorton. It is oral.
    Mr. Upton. Oral?
    Dr. Throckmorton. It is given in an oil form. It is fat 
soluble, and so it is a syringe basically.
    The other compounds are all synthetic. They are not 
extracted from the cannabis plant, and they are approved for 
wasting diseases. There are nausea and vomiting associated with 
chemotherapeutics. We can get you a full list of those, but it 
is more general. Those compounds contain THC. So they have a 
different active ingredient than the Epidiolex does.
    Mr. Upton. So Greg Walden talked about something. As 
consumers, 33 States now have approved medical uses. Eleven 
States--Michigan is one--that is both medical as well as 
recreational, or adult use. And I guess consumers are very 
interested in, you know, how much is in here? I mean, we know, 
when we drink a beer, different alcohol content, whether it is 
a craft beer, you know, maybe a State like--that has a smaller 
threshold like Utah.
    But, in addition, you have got the law enforcement issues. 
I was with one of my sheriffs last week. He, unfortunately, 
had--we had a situation like Dr. Burgess had in his district 
with a student returning back to Michigan State, and, sadly, he 
was involved in a terrible auto accident, and, in fact, 
afterwards, they--he survived, but they found out that he was--
had a high level of THC, as I understand it.
    Where are we in terms of some visible standards or some 
review that folks can look at as it relates to the cookies or 
the brownies or whatever it is, the cereal that they are going 
to eat and consume as relates to perhaps the safety of that, 
and where are we as relates to law enforcement who, as--you 
know, it is not like the breathalyzer. They have got to do a 
variety of different cognitive exercises to try and determine 
whether or not that individual has taken too much, and it is a 
blood sample, but where are we in terms of trying to help the 
consumer know the right information if they choose to take, in 
these States, a legal substance?
    Dr. Volkow. I can speak on the research perspective. We are 
interested in understanding what content of THC is associated 
with specific pharmacological effects, including side effects, 
and so research has been done to show that, if you consume 
anywhere between two and eight milligrams, you are going to get 
high, but, in general, you do not have any adverse effects.
    So what we would like to be able to do from the research 
perspective is to create a unit of marijuana that can be 
utilized consistently across research to help us understand how 
exposures of different content THC----
    Mr. Upton. And how long--when is that research going to be 
completed?
    Dr. Volkow. The research on doses has been done. The 
research on creating a unit of THC that can be used 
consistently is something that we are working on to try to 
consolidate and get a perspective of what are the differences 
on the consumption by people----
    Mr. Upton. Are we a year out? How long do you think that 
will take? What is----
    Dr. Volkow. I would hope that we will be able to implement 
the standard dose for research purposes within one year, but 
that is very different from implementing a unit dose for 
legal--for products that are not legally accepted federally, 
and that is the States are trying to come themselves with 
standard doses, and you mentioned it for the cookies, or--but 
that varies also between the States.
    Mr. Upton. Yes. Anybody else have a comment?
    Dr. Throckmorton. I do, Mr. Upton. You raised an incredibly 
important point that is important to understand about the 
development of nondrug products containing things like CBD. So, 
as the FDA thinks about how to develop those products, one 
thing we remember is that there would be requirements on a 
product that we approved regarding accurate labeling, regarding 
dosing.
    So, for instance, the cookie that we are discussing, if 
that packaging was approved, if we found a pathway that enabled 
us to allow CBD in a cookie, along with that packaging would 
come labeling that would say it contains ten milligrams or a 
hundred milligrams or whatever else; could include other 
conditions of use that could help understand when it would 
appropriately be used and things like that. So part and parcel 
with the work we are doing is to think about the consequences, 
the important consequences, which would include that kind of 
labeling improvement. We would have more understanding. People 
would have a better understanding. They would also have more 
assurance that the product actually contained the CBD----
    Mr. Upton. I know my time has expired, but just a ``yes'' 
or ``no.'' Do you have authority for that labeling now?
    Dr. Throckmorton. It is--absolutely, we have that 
authority. What we need is to determine the pathways to take--
--
    Mr. Upton. Right.
    Dr. Throckmorton [continuing]. For those nondrug-containing 
CBD products.
    Mr. Upton. I yield back.
    Ms. Eshoo. The gentleman yields back.
    It is a pleasure to recognize the Chairman of the full 
committee, Mr. Pallone, for his 5 minutes of questions.
    The Chairman. Thank you, Chairwoman Eshoo.
    As I said in my opening statement, the cannabis policy 
landscape is evolving across the States and territories. Yet, 
at the Federal level, the policy has remained largely the same, 
and one issue that researchers across the Nation have raised 
with the committee is the fact that they are not able to 
conduct research on cannabis products available through State 
cannabis dispensaries.
    Dr. Volkow notes in her testimony that the cannabis 
available in States to consumers is much more potent than what 
has been available in the past, and that means that Federal 
researchers cannot adequately study the health potential or 
adverse health consequences of products that are more readily 
available.
    So this poses a legitimate public health challenge as it 
impedes the ability for researchers to truly understand the 
impact of products regularly used by consumers and prevents us 
from advancing sound science.
    So, Dr. Volkow, you noted in your testimony that having 
only a single domestic source of research of cannabis limits 
the diversity of products and formulations available to 
researchers and slows the development of cannabis-based 
medications, so let me ask, yes or no, Dr. Volkow, do you 
believe Federal researchers should have access to cannabis has 
State-authorized dispensaries?
    Dr. Volkow. Yes. 
    The Chairman. And, Dr. Throckmorton, yes or no, would 
access to cannabis outside of the University of Mississippi be 
beneficial to drug developers in the U.S.?
    Dr. Throckmorton. Yes.
    The Chairman. And, Mr. Strait, as you mentioned in your 
testimony, DEA is actively working to consider applications for 
additional cannabis growers. What is the status--this is not 
yes or no--what is the status of this effort, and when can we 
expect that the agencies would finalize rulemaking?
    Mr. Strait. So we actually have a draft regulation in 
place. In August of 2019, we were able to get to the point of 
our policy review process where we were able to publicly 
acknowledge, consistent with our regulations, who our pending 
applicants were as of August 27th, 2019.
    We know that we have to probably do notice-and-comment 
rulemaking to implement regulations on two matters. One is how 
we are going to evaluate all of our pending applications; and 
then, two, what additional types of regulations might need to 
be in place in order to--you know, in order to impose on those 
that would grow. So that regulation is in a draft form. I 
cannot talk too much about it, but rest assured we have 
submitted it to OMB. It has been drafted, and, tomorrow, many 
of us will be getting on a call to talk through it.
    The Chairman. All right. Thank you.
    I want to switch to CBD. A Google search can lead any 
consumer to Web sites that offer CBD-infused gummies, cereal 
cookie. This is in addition to personal care products and 
dietary supplements. One recent estimate by an independent 
company suggested that the CBD market can bring in as much as 
$15 billion by 2025.
    So, Dr. Throckmorton, I understand your agency is working 
to regulate CBD products. However, FDA has suggested that it 
could take three to five years before rulemaking to clarify the 
regulatory pathway work to be completed.
    Can you explain to the committee the scientific and 
regulatory activities the agency believes are needed to ensure 
the safety of CBD in other products, such as food and dietary 
supplements?
    Dr. Throckmorton. Sure. And I want to start by saying that 
three to five years was an estimate, that we understand the 
importance that people have in identifying in a rapid process 
to a pathway for nondrug CBD products.
    Having said that, rulemaking is the one pathway that is 
identified in statute for an exception to the prohibition 
against the use of drug substances in foods and dietary 
supplements. So that prohibition, as I just--you know, as I 
mentioned in my opening remarks, exists, and, for the agency to 
change, we need to find a mechanism to allow a path forward for 
nondrug CBD products to be developed.
    We are in the process of doing that. The rulemaking is one 
thing that is under consideration. As has been mentioned, there 
are a number of legislative ideas that people have had. We have 
had other meetings where people have raised other suggestions 
regarding this as well.
    Bottom line is we get it. Bottom line is we understand that 
we need to identify a path as quickly as we can, but we need to 
be grounded in science. You mentioned yourself--many of us have 
mentioned--fundamentally, there are many unknowns about 
cannabidiol. There are things that we know that it can do, 
adverse effects that I mentioned in my testimony related to 
liver jury, related to potential male reproductive injury that 
we need to know more about.
    We need to know more about its uses in vulnerable 
populations and for long periods of time because, if it is 
placed in a nondrug product, there will be no learned 
intermedia. There will not be a doctor or a nurse or anyone 
that will talk to the patient or to help them make their 
choices about the use of that product.
    You could get up in the morning, take your CBD--to get 
started--in your coffee, take another dose of CBD for lunch 
when you have your sandwich, and then end in the late afternoon 
with an alcoholic beverage containing CBD; and the aggregate 
amounts of CBD then matter. We need to decide how to do that 
safely.
    Our fundamental focus for foods and dietary supplements is 
safety, and we need to have more data than we do available at 
present in order to make that determination, in order to help 
inform what the right, best steps are.
    The Chairman. All right. Thank you.
    Thank you, Madam Chair.
    Ms. Eshoo. And, in the appropriations bill that was passed 
last year, there were moneys that go directly to FDA to move up 
the work on CBD, correct?
    Dr. Throckmorton. That is correct.
    Ms. Eshoo. Yes. All right.
    Dr. Throckmorton. And focused, I believe, in the----
    Ms. Eshoo. Yes.
    Dr. Throckmorton [continuing]. Nondrug space----
    Ms. Eshoo. Yes. So you have the money, and now you have got 
to get it going.
    It is a pleasure to recognize Mr. Guthrie for his 5 minutes 
of questioning, the gentleman from Kentucky.
    Mr. Guthrie. Thank you very much. Thank you for being here.
    And, Dr. Volkow, we have heard that it can take up to a 
year to get a schedule I registration. That process of adding 
new cannabinoids to an existing registration, and getting 
approval for protocol modifications is time consuming, and how 
does the DEA registration processes for modifying a schedule I 
registration to conduct research of cannabis impact ability to 
do research? But I also understand, Mr. Strait, you said--oh, 
actually, I wanted to ask you something first, if that is OK.
    Mr. Strait. Sure.
    Mr. Guthrie. Before I get to answer your questions, last 
October, myself and others sent a letter asking about the 
implementation and recommendations included in the committee 
staff report on the opioid distribution. To date, we have not 
received DEA's response, and I would ask that, after the 
hearing, that we follow up together to see if we can get DEA's 
responses to that report.
    Mr. Strait. I would be happy to follow up with that.
    Mr. Guthrie. OK. Thank you. So, getting to my other 
question, just the time-consuming process in ability to do 
research, and I do believe, Mr. Strait, you said it was like 52 
days to get a registration, and it seems like we are hearing 
different than that. Can both of you, both Dr. Volkow, you talk 
about the time-consuming process for that?
    Dr. Volkow. Yes. And there are two issues with it. One of 
them has to do with the process of how lengthy it is to get an 
approval to do a human subjects protocol, and, if it is 
schedule I, that is much longer. And, on average, about 52 days 
by the DEA actually counts the moment that that protocol has 
been deemed complete and moves forward, but what we have heard 
from the researchers is that it is not so straightforward to 
get the protocol in a way that the DEA can work with it, 
because it is complex.
    And another issue that becomes--makes it harder is that the 
DEA State local agents interpret the rule differently, and, as 
a result of that, that further hinders the problem. So those 
are the issues that we see.
    The other aspect where we are also seeing an impact on 
schedule I is that there are certain scientists that do not 
even want to go there because they say, ``I do not want to go 
there; it is going to take too much effort to do research on a 
schedule I,'' and so we lose potentially-valuable scientists 
into looking at things that are important.
    Mr. Guthrie. OK. Mr. Strait, do you have any comment on 
that, or----
    Mr. Strait. Yes. Thank you. Thank you for giving me the 
opportunity.
    You know, this is a common refrain we have heard from our 
partners over at HHS. One of the challenges that they have is 
that, when we try to get information from them about who the 
concerns are being raised by, maybe it plays into the fear of 
DEA, but we are kind of cited with PII, that they cannot 
disclose information to us, that they are prohibited from doing 
it. So we struggle to try to understand who the people are that 
are having these difficulties so that we can give them some 
special attention, and we are happy to give them that special 
attention.
    The other point I wanted to make is the inconsistent 
applicability of our DEA regulations across our 23 field 
divisions or the concerns of that, and, as I mentioned to some 
staff before we started this call, we are actually getting 
ready to host a management conference across our entire 
division from all across the country, and we are going to 
actually invite Dr. Volkow or her designee to come in and 
address this because I think that is something that we can 
solve easily. That is not anything that we need Congress' help 
on.
    Mr. Guthrie. OK. Thank you.
    And I will yield a minute and a half, my remaining time, to 
Mr. Griffith.
    Mr. Griffith. Thank you very much.
    Virginia actually has the oldest medicinal marijuana law on 
the books. It was passed in 1979 with Chip Woodrum, who is now 
deceased, as the House patron, and former member of this 
committee, Rick Boucher, who was then a State senator, as the 
Senate companion, to say that they would allow the use of 
medicinal marijuana in the Commonwealth of Virginia. However, 
the DEA had not allowed it, and so the doctors did not want to 
risk their license by prescribing it. It required a legitimate 
prescription. And that is where my bill came from, was that 
this is what Virginia has stood for, for decades.
    In 1998, there was an attempt to repeal it because they 
thought it was like California's law that just said, you know, 
``if it makes you feel good, you can try it'' kind of thing, 
which Virginia rejected, but, still, the DEA has not acted. So, 
when I hear people talking about, you know, ``It will take us 
three to five years; we have to do the research,'' my question 
is, why hasn't the research been done?
    And, Dr. Throckmorton, I would have to say that it causes 
me some great concern that apparently the FDA thinks it is OK 
for opioids and opiates and barbiturates, but somehow marijuana 
should stay schedule I. That is illogical to me. And so I 
just--I lay that out.
    Marinol, in the case of my two fathers, was available. The 
problem is they were so sick, they could not swallow it and 
hold it on their stomachs. That is why their friends were 
smuggling in--with the doctors turning a blind eye--smuggling 
in the marijuana so they could smoke it and then eat.
    So we need to find a solution, and we should have started 
working on this back in 1979 or earlier, but we have not done 
it.
    I yield back.
    Mr. Guthrie. I yield back also.
    Ms. Eshoo. The gentleman yields back. Excellent points.
    Pleasure to recognize the gentlewoman from Florida, Ms. 
Castor, for her 5 minutes.
    Ms. Castor. Well, thank you, Madam Chair, for calling this 
hearing. Thank you to our witnesses for being here today.
    I think it is clear that cannabis research is caught up in 
conflicting regulations. You cannot remove cannabis from 
schedule I because it lacks proof for medical and controlled or 
controlled recreational use, but you can't research to 
determine if it is safe because it is included on the schedule 
I.
    Dr. Volkow, you ended your testimony by saying that 
cannabis research is urgently needed, so let's focus on how we 
can streamline our research process for cannabis and possibly 
other schedule I substances.
    First, what are the requirements and challenges for 
conducting research on schedule I substances?
    Dr. Volkow. What I was commenting before, the main 
difference relates to the fact that you have to get the DEA 
registration, so that makes the process much more complex than 
just doing research with any other substance, and that can take 
time.
    Ms. Castor. And that clearly deters research----
    Dr. Volkow. Yes.
    Ms. Castor [continuing]. On those substances?
    Dr. Volkow. Correct.
    Ms. Castor. In thinking about how we reduce those barriers 
for research with cannabis and possibly other schedule I 
substances, you did answer to Representative Guthrie--you 
pointed out a few of the barriers.
    What do you recommend should change in the process right 
now?
    Dr. Volkow. Well, we have been working among the agencies 
to come to--to try to come up with a process that will allow it 
to safeguard the public, but at the same time to facilitate and 
accelerate research. So those are the two issues that coming up 
with a category that enables researchers to be able to 
accelerate the pace at which they are doing research without in 
any way jeopardizing the public, and that is wherein, again, 
the DEA, the FDA, and the NIH have been working together.
    Ms. Castor. There are a number of bills that have been 
highlighted for the committee's consideration today. Would you 
point to any of those pieces of legislation that would help 
streamline the process appropriately?
    Dr. Volkow. You are putting me in a little difficult 
position because there are six of them, and we do not 
legislate; we basically bring science. And what I can tell is 
that the science tells us that marijuana is a substance that 
can produce addiction.
    Now, we also know from studies that it is likely that there 
is potential for the therapeutic use of the cannabinoids within 
marijuana, and, thus, to the extent that we, among the six ones 
that you are proposing, can accelerate research while 
protecting the public, then that is what you all have to weigh.
    Ms. Castor. All right.
    Dr. Throckmorton, has FDA seen an uptick or change in the 
number of applications from researchers to conduct research on 
hemp or other low-THC cannabis products since these are no 
longer considered schedule I substances?
    Dr. Throckmorton. Thank you for that question, and short 
answer: yes.
    Ms. Castor. Do you support removing marijuana from the 
Controlled Substances Act to remove barriers to research?
    Dr. Throckmorton. At present, my focus is on cannabidiol, 
and focused on supporting those new INDs, those new 
investigational studies that we have seen in house.
    So your first question is worth going back to for just a 
moment. We now have almost 40 investigators that have come in 
to us proposing to use CBD and other substances found in hemp. 
We believe that represents an important new opportunity for us 
in terms of investigating CBD and those compounds for drug 
development, and I want to make sure that we give them every 
opportunity, every support that we possibly can.
    The question about marijuana is more complicated. It has to 
do with what you mean by ``marijuana.'' Obviously, one street 
corner sells one kind of marijuana, and another street corner 
sells a different kind of marijuana. Making a conclusion that 
both of those marijuanas somehow have medical value is 
challenging scientifically, and I think Dr. Volkow would agree 
with me with that, and that is one of the findings that we 
would be obliged to make were we to try to make a 
recommendation to the DEA to reschedule marijuana from schedule 
I. So, from a scientific perspective, there are real challenges 
to making that conclusion.
    We have been asked to look at it three times in the past, 
and, each time, we have decided, as I had mentioned before, 
that it was not possible given where we were with the science.
    Ms. Castor. You know, when it comes to CBD, it is like the 
cat is already out of the bag. It is amazing, the marketing for 
CBD. What would you advise the public about the efficacy of the 
products on the market today? Do they really help? And do we 
even have a handle on what is truly in all of those products?
    Dr. Throckmorton. Both questions would be: We don't know. 
We don't know whether the various claims being made are 
accurate to the standard that I would expect for a drug product 
being developed, and we don't know well enough what is found in 
those products that are being sold under a variety of State 
initiatives. We need more data in both of those places.
    With regards to efficacy, my job is to make sure that those 
manufacturers, those around 40 that want to study this are able 
to do that quickly, study what works and study what does not 
quickly.
    With regards to safety, the agency understands that we 
desperately need to collect all of the available information 
about the safety of CBD in all of those various uses. That is 
challenging for us. We have been in the process of a yearlong 
effort to collect all of those available data. We have 
identified some gaps. I think I mentioned some in my testimony 
previously--things we believe we absolutely need to know. We 
are in the process of figuring out how to close those gaps.
    Ms. Eshoo. The gentlewoman's time has expired.
    Pleasure to recognize the gentleman from Virginia, Mr. 
Griffith.
    Mr. Griffith. I thank the----
    Ms. Eshoo. Looking for another good story here.
    Mr. Griffith. Well, I may or may not have one at this 
point. I have got lots of stories, but we may not have time.
    Mr. Strait, I know that you disagreed with the earlier 
assessment on the University of California, having attended the 
great university in Blacksburg, Virginia, Virginia Tech, which 
I am so proud to represent.
    That being said, going back to Dr. Burgess' questions, if 
the FDA recommends that the DEA reschedule a compound, is the 
DEA required to comply with that rescheduling recommendation?
    Mr. Strait. If they recommended rescheduling, we are bound 
to their--the statute actually says that the Attorney General 
shall be bound by the recommendations of the Secretary as it 
pertains to scientific and medical matters.
    Mr. Griffith. As the Secretary determines?
    Mr. Strait. Correct.
    Mr. Griffith. All right. So you can confirm that the DEA 
has never refused to reschedule a compound after being given a 
recommendation to do so by the FDA or the Secretary?
    Mr. Strait. I am certainly not aware of any instance where 
that would be the case.
    Mr. Griffith. All right. Now, continuing, Mr. Strait, as 
you know, the U.S. is a party to the United States Single 
Convention on Narcotic Drugs, which imposes manufacturing and 
distributing restrictions on marijuana. Some have cited our 
involvement in that agreement as a potential reason why the 
Federal Government should not lift restrictions on marijuana.
    Regarding American domestic manufacturing of research- 
grade cannabis, why is it that other countries who have signed 
the same treaty, such as Canada, Israel, Ireland, New Zealand, 
Australia, and the Netherlands have several legal manufacturers 
of research-grade cannabis, and their products are legally 
imported to the U.S., but the U.S. has only one, the University 
of Mississippi, as we have heard earlier?
    Mr. Strait. So you are precisely right; there is a growing 
number of countries that have implemented laws in their 
countries that fully effectuate their requirement, their 
obligations under the Single Convention on Narcotic Drugs. We 
have, too, and that is the reason why we have the University of 
Mississippi, or this NIDA drug supply program. What we are 
trying to do is, as we expand the number of growers, we are 
trying to take a look at whether or not there are things that 
need to be changed--altered, I would say; not newly created, 
but just altered slightly--in order to make sure that we are in 
compliance with our treaty obligations.
    Mr. Griffith. Well, then I hope that you all would work on 
that quickly. You said earlier applications for research are 
being approved, but you said regulations and paperwork--and I 
am paraphrasing--are perceived to be so onerous that people 
will not do it. Well, connect the dots. The paperwork and the 
regulations, the perception becomes reality, and, as we have 
heard from Dr. Volkow, sometimes that becomes a problem, and I 
think that is why you have not received more applications.
    Do you want to say something on that point? And I just have 
a couple minutes.
    Mr. Strait. If I may?
    Mr. Griffith. Quickly.
    Mr. Strait. And I am going to be very quick. But I did want 
to go back to your comment and that of Congresswoman Castor's, 
which is to say that there is a solution that this interagency 
group and others worked on all throughout the summer as it 
relates to some important legislation dealing with the 
permanent control of fentanyl-related substances in schedule I. 
We as an administration came out with kind of some commonsense 
practical solutions to address all of the concerns raised by 
the research community. We are happy to share that if----
    Mr. Griffith. And whatever--and if you could share that, 
and whatever you can--whatever help you need from us, I think 
this committee would be willing to help in any way it can.
    The DEA's 2016 policy statement said it would be consistent 
with the 1961 Single Convention on Narcotic Drug Treaty if the 
DEA were to register research-grade marijuana growers outside 
of the NIDA contract system so long as the growers agreed to 
only distribute marijuana with prior written approval from the 
DEA. However, in your testimony, you said DEA has changed 
course, saying that, quote, since publication of the 2016 
policy statement, the Department of Justice determined that 
adjustments to the DEA's policies and procedures may be 
necessary to be consistent with certain treaty functions.
    What changes need to be made in order to be consistent with 
those treaty functions?
    Mr. Strait. Well, I cannot really get into too many details 
because, again, it is a deliberative process that we are 
engaged in right now as we speak with the Office of Management 
and Budget.
    Mr. Griffith. Can you get that to me as quickly as you can?
    Mr. Strait. I absolutely will.
    Mr. Griffith. And I appreciate that. If you would give it 
to the committee and to me as well, that would be appreciated.
    Can you provide any additional rationale that would mandate 
the DEA to re-evaluate the 2016 policy statement beyond the 
volume of the applicant pool?
    Mr. Strait. I am sorry. Can you repeat that? I am not sure 
I understand.
    Mr. Griffith. Yes, sir. Can you provide any additional 
rationale that would mandate DEA to re-evaluate its 2016 policy 
statement beyond the volume of the applicant pool?
    Mr. Strait. I would say the size of the applicant pool is 
probably one of the single greatest issues that we are trying 
to contend with, is how to meet the statutory text of the basis 
by which we are supposed to be evaluating all applications for 
both manufacturers of schedule I controlled substances.
    Mr. Griffith. We will be happy to change that statutory 
text if need be.
    I yield back. Thank you, Madam Chair.
    Ms. Eshoo. Gentleman yields back.
    Pleasure to recognize the gentleman from Maryland, Mr. 
Sarbanes, for his 5 minutes of questions.
    Mr. Sarbanes. Thank you, Madam Chair. I thank the panel for 
being here today.
    Dr. Volkow, first of all, thank you for your work, which I 
know well, and you have brought a lot of important testimony to 
this committee in the past.
    I have heard from schools in my State, such as University 
of Maryland-Baltimore, that have communicated to me the 
difficulty in conducting research due to the current 
regulations and are nervous that any unintended violation of 
these strict and arduous restrictions can result in loss of 
their Federal research grants. Obviously, we have had a lot of 
discussion about that here today.
    Despite these barriers, schools and researchers are eager 
to advance the understanding of the topic, and, just last year, 
the University of Maryland School of Pharmacy began offering a 
master of science in medical cannabis science and therapeutics. 
They now have this degree and focus opportunity.
    I have a letter here, Madam Chair--I would like to submit 
this for the record--from the University of Maryland-Baltimore 
on the topic of cannabis research and cannabis training 
programs for the record. I would ask that this be accepted into 
the record.
    [Material submitted for inclusion in the record follows:]
    Mr. Sarbanes. Dr. Volkow, would you agree that, as more 
patients are accessing cannabis products in States where they 
have been legalized for medical or recreational use in 
Maryland--of course we have taken that step with medical use--
that our provider workforce should be educated on these topics 
and ready to respond to patients' questions?
    Dr. Volkow. I agree that we need to have much more 
education with respect to actually how and that the use of 
marijuana products can negatively impact or help someone. The 
problem is that we do not have sufficient evidence that could 
help us mount those programs in a way that it is actually 
required. So, at this point, I don't feel that the evidence, 
like the National Academy of Science concluded, is sufficient 
to say we are going to recommend that this product be used by 
this patient.
    There are many concerns, and it is not trivial. One of the 
problems that was noted is many patients--for example, the 
elderly may be given some of these products; they are on other 
medications, and they are not told what effects of the 
combination of THC with these medications, and the clinicians 
do not even know about it, nor do the patients.
    So I do believe in the importance of expanding our 
knowledge so that we can then develop educational training 
programs that are based on knowledge, not on anecdote. And that 
is why I highlight the urgency of doing research on its 
therapeutic, as well as on its potentially adverse, effects.
    Mr. Sarbanes. Well, I think you are highlighting the 
impediment to creating workforce categories that can be a 
resource of expertise and perspective when it comes to cannabis 
that is presented by the kind of research issue that we are 
talking about today because, if you cannot--it is sort of a 
chicken-and-egg situation. If you cannot open the doors to more 
effective research, then, obviously, creating specific 
workforce categories that can take advantage of that and help 
push it forward and sustain it is made more complicated.
    I would note that a survey of health providers from 2015 
concluded that the health providers themselves perceive a 
knowledge gap in areas relating to medical cannabis dosing, 
development of therapeutic treatment plans, differences between 
various cannabis products and other areas. So the providers 
themselves have certainly perceived that there is the need for 
more research and expertise to be developed in this area, and I 
assume you would agree that incentivizing research on medical 
cannabis, for starters, would help address these knowledge gaps 
and support a more informed and robust provider workforce?
    Dr. Volkow. Yes. I think we have an obligation to do the 
research to determine, what are the consequences of the 
products that people are taking with the expectation that they 
are going to be beneficial? We owe it to them to give them that 
knowledge, whether it is true or not. That is why we do 
research. So I completely agree of the urgency of expanding our 
understanding of the so-called medical properties of marijuana 
in diverse patient populations.
    Mr. Sarbanes. Thank you. I yield back.
    Ms. Eshoo. The gentleman yields back.
    Pleasure to recognize the gentleman from Oregon, Mr. 
Walden, for his 5 minutes of questions.
    Mr. Walden. I walked back in from the other hearing, Madam 
Chair, so thank you because I know how important this issue is 
to all of us and especially to Oregonians.
    Mr. Strait, I want to shift gears to hemp, as there is a 
lot of interest in my district from farmers who are growing 
hemp for CBD, and Oregon State University is working with the 
USDA's Ag Research Service to launch Federal hemp research. 
Given that the 2018 farm bill removed hemp from the CSA, is a 
DEA registration required to conduct research on hemp-derived 
CBD?
    Mr. Strait. No.
    Mr. Walden. No. Relatedly, USDA's interim final rule for 
hemp production, DEA is supposed to participate in oversight. 
Is the DEA prepared to handle registration of the private and 
public labs to handle hemp-compliance sampling?
    Mr. Strait. The issue of hemp testing, which is actually 
baked into the U.S. Department of Agriculture----
    Mr. Walden. So to speak, yes.
    Mr. Strait [continuing]. Interim final rule--no pun 
intended. Sorry about that.
    Mr. Walden. There you go.
    Mr. Strait [continuing]. Was predicated on the concept that 
those who performed testing probably made reasonable sense for 
them to hold a schedule I license in the event that they ended 
up procuring a sample that was not hemp; it actually ended up 
being hot and contained more than 0.3 percent THC. So that is 
an interim final rule. I know they are soliciting comments on 
that, and I know that that is an issue of concern that has been 
raised by some in the public.
    Mr. Walden. Yes. There are quite a few of these issues. I 
know somebody that had a commercial driver's license who was 
using CBD oil to deal with something, or taking it, and then 
did a drug test, and it triggered the drug test as if he had 
used marijuana, which of course affected his CDL. So these are 
issues we are running into in real lives. He was not a 
marijuana user. You can have your own opinion on that, but he 
tried CBD.
    And I want to go to Dr. Throckmorton. When it comes to CBD, 
are you able to tell us if FDA is any closer to determining if 
there are appropriate regulatory frameworks for nondrug uses, 
including for products marked as food and dietary supplements, 
and has the lack of research on the substance been an 
impediment to that process?
    Dr. Throckmorton. I can tell you that process is a high 
priority for us. We understand the interest. As I said before, 
we are committed to working with you to find a path forward on 
that.
    I would also say that the lack of information we have about 
the safety regarding cannabidiol is a challenge for us that we 
are looking to fill. We need to understand the use of CBD, the 
safety of CBD, in order for us to decide how best to place it 
in nondrug products.
    Mr. Walden. And so I guess I want to push a little just in 
terms of the impediments to getting answers because this is 
playing out in real life. I have friends that swear by CBD. I 
have friends whose doctors have said, ``Do not worry. Go ahead 
and take it. It does not impact anything else you may be 
taking.'' They know that? Have you done the research?
    Dr. Throckmorton. Well, in fact, we know that is likely not 
accurate. Based on what we know from the Epidiolex, the 
approval of the product that contains cannabidiol, cannabidiol 
does interact with other drugs, and we can get you that list if 
you are interested, but, in fact, there are interactions that 
could occur that could be clinically significant, and I think 
blood thinners are one, for instance.
    Mr. Walden. Yes.
    Dr. Throckmorton. And so we would want to make sure that 
information is available to people.
    Mr. Walden. Let me suggest they don't know that is 
available. They are actually being told by medical providers, 
at least this one case I know, that ``don't worry, there is no 
interaction,'' and this is a legitimate doctor telling a 
patient.
    This is happening in real--I mean, I have got colleagues 
that have been on television proclaiming the importance of CBD 
in food products and drinks and consuming it. That is fine. 
That is up to them, but I do not think--and if people want to 
use it, that is their business. I got it. But I just want 
people to have the facts and the data.
    So I think what we are trying to do here is figure out what 
are the impediments to getting that data, and what does it take 
to get the agencies to a point where you are leading, not way 
trailing? Because the States are way ahead of where we are 
federally. We have got legacy rules we are trying to figure out 
here. Doctor?
    Dr. Throckmorton. And we have been fortunate to work with 
the States. So you are right; the States are further ahead in 
some ways because they have had to be. You have had to face the 
use of these products in your own jurisdictions. The States 
have been very interested in understanding these same things. 
The State public health officials get that we need to 
understand the safe uses of cannabidiol and then make it--
educate the prescribers, educate the choices that they are 
making very quickly. Unfortunately, historically, marijuana was 
used for its THC content.
    Mr. Walden. Sure.
    Dr. Throckmorton. And it has only been recently that the 
cultivars containing large amounts of CBD have sort of come to 
the floor.
    The State data collection has been, historically, largely 
focused in that other direction.
    Mr. Walden. Yes.
    Dr. Throckmorton. And so they are changing course. It is 
just a matter of time.
    Mr. Walden. Oh, yes. No, I understand all that. If you 
could get me that list, if it is readily available.
    Dr. Throckmorton. Absolutely.
    Mr. Walden. Is it on the FDA Web site? Is it--I mean----
    Dr. Throckmorton. Absolutely.
    Mr. Walden. Please do. Thank you.
    And thanks for your indulgence, Madam Chair, and I yield 
back.
    Ms. Eshoo. The gentleman yields back, and I think it is 
terrific that we have our next member, another gentleman from 
Oregon, so we have got a set of bookends here, Mr. Schrader, 
for his 5 minutes of questions.
    Mr. Schrader. Thank you very much, Madam Chair.
    I think it is great that, if we have--all three witnesses 
agree we need medical research into the effects of the hemp or 
CBD or marijuana products. The sad part is we are not testing 
the right stuff.
    I fail to understand, with all due respect, Mr. Strait, why 
we have one bloody facility in an artificial environment, 
Mississippi, that is the really the sole nexus for research and 
analysis of CBD products.
    Could you explain why that is?
    Mr. Strait. So that location is actually more--probably 
better asked of Dr. Volkow because it is pursuant to a contract 
administered by the National Institutes of Health. DEA is 
mainly interested in----
    Mr. Schrader. Well, I guess if I may interrupt briefly 
here. It is limited time. You know, it seems to me we ought to 
be testing the products that are on the marketplace. That is 
where FDA, NIDA, you are most concerned. What is the consumer--
what is the American citizen actually being exposed to or 
hopefully benefiting from?
    Mr. Strait. Yes.
    Mr. Schrader. The idea that we are using a specific 
facility that does not mirror what people are actually 
ingesting, smoking, whatever, is ludicrous. I am worried--you 
are talking about more regulations coming out. We should be 
making less regulations and just say there is a legally 
approved facility in the State of Oregon, Colorado, District of 
Columbia. Those are things that people are actually going to be 
exposed to. We approve that research for that facility. Why are 
you not doing that?
    Mr. Strait. And, Dr. Schrader, I cannot agree more in what 
you are saying, and that is certainly a conversation we have 
been having internally. The challenge, of course, is that the 
underlying principles of the CSA, the Controlled Substances 
Act, require that people who are going to lawfully possess, 
distribute, conduct research with schedule I controlled 
substances have to procure those substances from a valid 
source, and that valid source is--you know, at this point, it 
is another DEA-registered facility.
    Mr. Schrader. Well, valid source in the eyes of the Federal 
Government----
    Mr. Strait. Correct.
    Mr. Schrader [continuing]. Not just you, perhaps, is this--
you know, is whatever. I am arguing respectfully that the 
committee should be looking at legislation, if need be. I do 
not think we need legislation. It just should be something FDA, 
NIDA, and DEA can say, ``Hey, you know, there is all these 
approved facilities out there in these States. We are not 
adjudicating whether or not it is a controlled substance or 
not. They are here. They are being used for certain products 
that consumers are being exposed to. We need to investigate 
them and make sure that they are not affecting adolescents 
adversely, fetal development, male fertility, whatever the deal 
is,'' and get it out there. There is so many benefits.
    My colleague from Oregon talked about benefits. I have got 
a farmer in the State of Oregon, a farm that is very 
conservative by nature. They had a father that was ailing, 
facing terminal illness. Pain relief was not getting done. They 
turned to CBDs. Their father was able to communicate for the 
first time in weeks with them, and he had a productive quality 
of life to the very end.
    These are the products we need to be starting to get 
engaged in, or I just do not see that happening.
    Talk to me a little bit, Mr. Strait, about approvals by 
both Tilray and Biopharmaceutical Research. Talk to me a 
little--these are not from Mississippi. How come they get 
through and not other products?
    Mr. Strait. I am not familiar with those two companies in 
particular, but there are instances where pharmaceutical 
companies can be manufacturing through synthetic means some of 
these substances and then making those substances available for 
research purposes.
    Mr. Schrader. OK. It concerns me that you are not aware of 
those being approved by DEA. I guess I would like to get more 
information after the hearing on that.
    And there is an apparent tendency to approve more foreign 
applications than domestic applications that get held in limbo 
for years. We have got, what, 12 or 15 different applications 
that are pending and going through this long, exhaustive 
regulatory process. That seems incongruent with the fact that 
these products are out there now. We need the research now. 
Everyone on the panel has agreed to the research. Let's just 
get it done. What is the holdup?
    Mr. Strait. Congressman Schrader, we have the same 
frustration you do.
    Mr. Schrader. Very good. Well, Madam Chair, I will yield 
back. I just appreciate everyone's interest, and we just need 
to move forward and test the products that people are being 
exposed to.
    Ms. Eshoo. I agree 100 percent. I do not understand--I 
still do not understand why the agencies, the three that are 
before us, can't get this done, but we will keep questioning, 
and the next one to question is the gentleman from Indiana, Dr. 
Bucshon.
    Mr. Bucshon. Thank you very much, Madam Chairwoman.
    This hearing is really very important. I was a physician 
before I was in Congress. I am still a physician; I just do not 
practice. And, as a doctor, data is critical. You practice 
medicine based on facts and data. So I really appreciate this 
hearing.
    And I do support the legitimate medicinal use for THC, but 
our knowledge on this subject actually is very limited and 
needs more research.
    Dr. Volkow, I am going to go along the lines of the 
developing brain. Up to what age would you say the brain 
continues to develop?
    Dr. Volkow. The fastest growth is during the first two 
decades and then until probably age 24 and then it slows down, 
but it never really goes away.
    Mr. Bucshon. Right. So I think people, a lot of times, have 
a misunderstanding. When we are talking about the developing 
brain, people think it is little children, but, actually, it 
really goes up substantially until your mid-20s approximately?
    Dr. Volkow. Right.
    Mr. Bucshon. Great. Thanks. And you presented this, but we 
all know THC can have damaging effects on the developing brain, 
as you mentioned. In fact, the studies you conducted, the 
National Institute of Drug Abuse, show a direct correlation 
between persistent cannabis use and cognitive decline from 
one's childhood to midlife.
    Epidemiologic studies have further found that youth who 
regularly use cannabis have lower academic achievements and a 
higher risk of dropping out of school. Frequent cannabis use 
during adolescence is associated with changes in the area of 
the brain involved in attention, memory, emotions, and 
motivation. And, Madam Chairwoman, I have a slide deck that Dr. 
Volkow presented to the Doctors Caucus a number of years ago, 
and I would like to introduce that into the record.
    Ms. Eshoo. So ordered.
    Mr. Bucshon. It outlines some of the things that you have 
been talking about today.
    Additionally--and this is where I am going to focus my 
question on. NIDA recently put out research describing record 
levels of teens vaping marijuana, vaping THC products. Can you 
elaborate on that data?
    Dr. Volkow. Yes. We have seen overall vaping has increased 
among teenagers, and, in the United States, 40 percent of the 
teenagers have vaped in their lives, and despite the fact that 
this is a new technology. Three years ago, most of the vaping 
was related to flavors. Two years ago, most of the vaping was 
related to nicotine. And what we saw this last December was 
there was a significant--a doubling of the number of teenagers 
vaping for THC.
    Now, considering that vaping THC delivers very high content 
of THC, this is worrisome. It is also worrisome because, as you 
know, the injuries from--the acute injuries from vaping are 
predominantly associated with vaping of THC.
    Mr. Bucshon. Right.
    Dr. Volkow. So this is concerning, and we are seeing also 
significant increases from in the past two years up on the 
regular use of cannabis, which we think are driven in part by 
the vaping.
    So it is affecting the pattern of use of marijuana among 
teenagers.
    Mr. Bucshon. OK. So, then, along those lines, are 
researchers able to conduct Federal research on the THC and e-
liquids and THC vape liquids sold at vape shops in States that 
have legalized marijuana for recreational use, and, if they 
can't, why not?
    Dr. Volkow. The researchers are afraid that, if they use 
Federal funds to purchase products that are illicit by buying 
them in dispensaries, they will lose their funding. So, as a 
result of that, overall, research is not done by investigators 
that are being funded through the NIH, which is a Federal 
agency.
    Mr. Bucshon. And, based on what you just talked about, 
about the rapid increase in vaping amongst teenagers, would you 
say that we need to do something about that?
    Dr. Volkow. I would completely agree. We need to be able to 
move rapidly into the field and understand the products that 
patients or citizens are being exposed to.
    Mr. Bucshon. I think that just confirms what all of us have 
been saying throughout this hearing.
    And I am also concerned that law enforcement is not 
equipped to address cannabis-impaired driving. I did have also 
a case in my district where a young lady was sledding and was 
hit by a car, and the person that hit her was not impaired by 
alcohol or opioids, failed a field sobriety test, and 
subsequently we find out it is marijuana, but there is no legal 
standard. Unlike alcohol, obviously, there is no reliable test.
    For that reason, I introduced H.R. 3890, the Combating 
Impaired Driving Act, in 2019, to direct the Department of 
Transportation to provide funding for grants and pilot programs 
to address impaired driving.
    Dr. Volkow, according to your organization, marijuana is 
the illicit drug most frequently found in the blood of drivers 
who have been involved in vehicle crashes, including fatal 
ones, and in your testimony, you describe that the risk of 
being involved in a crash significantly increases after 
cannabis uses.
    Can you describe the difficulties law enforcement may have 
in testing for marijuana? Do you agree we need more funding to 
provide advanced measuring testing for cannabis- impaired 
driving?
    Dr. Volkow. Yes, and, as I mentioned before, the problem 
that we have is the content in alcohol, you know a certain 
level is associated with motor impairment, but, in marijuana, 
it has a very long half-life, and it accumulates in the fatty 
tissues in our body. So, if you are a regular marijuana user, 
you may get high, and, three hours later, you still have very 
high levels even though you are not intoxicated.
    On the other hand, if you are a naive user and you consume 
marijuana, have very low levels, you may be intoxicated. So 
there is not a one-to-one correspondence.
    Mr. Bucshon. Right.
    Dr. Volkow. So we are trying to actually incentivize 
researchers to come up with innovative ways of determining 
whether someone is intoxicated or not, and we are funding 
researchers in that way.
    Mr. Bucshon. My time has expired, but, Madam Chairwoman, I 
think that again outlines why we need more research. I yield 
back.
    Ms. Eshoo. I think, if there is anything to come out of 
this hearing is that the research is absolutely essential--
absolutely essential. So much of this is two and two equals 
five. Well, it does not.
    So the gentleman from Massachusetts, Mr. Kennedy, is 
recognized for 5 minutes.
    And I want to say how much I appreciate his--the input that 
he gave the Chair, and we will, as he said earlier, have a 
followup hearing with other stakeholders. Important to start 
out with our three government agencies, but I think that our 
subcommittee will benefit from the additional testimony of 
others. So he is recognized for his 5 minutes of questions.
    Mr. Kennedy. Thank you, Madam Chair. Thanks for holding 
this hearing, and thanks for adding the weight of the committee 
behind this conversation. Thank you to our witnesses for being 
here, for your service, for your work, and for your diligence.
    As some of you know, I was initially hesitant to support 
legalization. My concerns stemmed from my work with the mental 
health community where many advocates have told me that they 
are worried about the impact of increased access to another 
controlled substance on the patients that they serve. But as 
States have moved forward with legalization, including my own, 
I tried to understand how we could protect for the public 
health concerns. I talked to experts. I talked to doctors. I 
talked to families. I talked to advocates. I talked to 
regulators. I have talked to some of you.
    And that is where I started to get frustrated; frustrated 
that, as a Federal legislator, my hands were tied because our 
Federal policies still rested on Richard Nixon's decision to 
put marijuana in the same category as heroin; frustrated, as 
constituents told me that marijuana was the only thing that 
eased their pain. We have heard some of those stories today.
    But when I asked regulators and subject agencies how we 
could ensure that this drug, like all drugs, was subject to the 
highest patient safety standards, I was told that we could not 
until we had more research. So I asked, how do we get more 
research?
    Remove marijuana from schedule I, I was told.
    How do we do that?
    Well, we need more research.
    The Federal Government has hid behind that catch-22 for a 
long, long time, and, meanwhile, millions of Americans, mostly 
Black and Brown, have been locked up for nonviolent drug 
offenses.
    Meanwhile, desperate parents are forced to turn to a black 
market with no concern for patient safety to get their children 
the relief that they need. Meanwhile, our cities and States are 
trying, at times stumbling, to put in place a thoughtful and 
thorough regulatory framework with zero support from Federal 
partners. And, meanwhile, a brand new corporate industry is 
rising up, rife with predictable economic injustices that 
spring up whenever government fails to regulate.
    Prohibition has clearly failed, and America is not waiting 
for its government anymore. That is why I decided to co-sponsor 
Congressman Nadler's MORE Act, which would finally deschedule, 
not reschedule, cannabis. It would expand critical research, 
and the reason I think this bill is superior to the policy on 
the table today, it makes an intentional and aggressive 
commitment to restorative justice in communities of color.
    But, to the witnesses today, I understand and appreciate 
the deliberative detailed approached that you have outlined. I 
commend and I share your commitment to public health and 
safety. Clearly, that is why you are here. But I think it is 
clear that we are also out of time. States just are not waiting 
anymore. Incremental adjustments and the long path and a little 
more research are not enough. If the Federal Government wants 
to be active and honest and a smart stakeholder in marijuana 
policy, we have to break free from that catch-22.
    So, in your testimony, you each pointed to the restrictions 
imposed by research because marijuana is a schedule I drug.
    Dr. Throckmorton and Dr. Volkow, you have already 
indicated, and I just wanted to make sure I am clear, in your 
opinion, would those barriers be eased if marijuana was 
descheduled. Dr. Volkow?
    Dr. Volkow. What was the question specifically?
    Mr. Kennedy. Would those restrictions on research be eased 
if marijuana was descheduled?
    Dr. Volkow. The scheduling of marijuana--and that is why I 
want to comment on it because that is not specifically what we 
do. We have to recognize that marijuana has harmful effects. We 
know that, and the harmful effects can actually be very 
consequential, and, at the same time, it is a drug that is 
addictive.
    So my perspective is--that is why I keep on saying it--what 
is the policy that will protect the public of the adverse 
effects of marijuana while at the same time accelerate our 
ability to take advantage of the potentially beneficial effects 
that the plant has? That is my perspective.
    Whether it is descheduled or not, that is not what our 
agency does.
    Mr. Kennedy. Understood. And so let me just be clear about 
the question. Would the barriers to research be eased if 
marijuana was descheduled?
    Dr. Volkow. If it were descheduled, it would be easier to 
do research; we know that.
    Mr. Kennedy. Yes. Dr. Throckmorton as well?
    Dr. Throckmorton. I agree.
    Mr. Kennedy. And, additionally, in your opinion, would your 
office or agency be unable to continue its regulatory role 
regarding marijuana if it were to be descheduled, Dr. Volkow?
    Dr. Volkow. Well, we do not regulate marijuana. We do 
research. So our agency is not involved. That would be 
transparent to us.
    Mr. Kennedy. So it would--your agency would not be harmed 
in any way by continuing to conduct its regulatory authority?
    Dr. Volkow. It will--I mean, it is--by descheduling a drug, 
it is not--it is going to accelerate the ability to do 
research, but at the same time, it may have unintended negative 
consequences in that more people may be afflicted. So that is, 
again, why we bring the science, and the policy decisions of 
what is the optimal way of moving forward takes other factors 
into consideration, like the ones that the FDA has described.
    Mr. Kennedy. And, Doctor, again, just to clarify, I 
understand the balance, and I appreciate that balance. I think 
that is what we are all trying to strike today.
    My question was, does the role of your agency change if 
marijuana is descheduled?
    Dr. Volkow. No.
    Mr. Kennedy. Yes. Dr. Throckmorton?
    Dr. Throckmorton. Well, it would matter how it happened 
obviously. It is, in essence, another system on a subset of 
drugs under development. So drugs containing compounds for 
marijuana potentially are used--go through the Controlled 
Substances Act, as well as the Food, Drug, and Cosmetic Act. To 
the extent that that step was removed and the authorities of 
the Food, Drug, and Cosmetic Act were maintained, it would not 
have an impact.
    Mr. Kennedy. Mr. Strait, I assume that the answer for you 
would be, yes, it would change from DEA?
    Mr. Strait. Yes.
    Mr. Kennedy. Yes.
    Mr. Strait. Since our obligation is to enforce the 
Controlled Substances Act, yes.
    Mr. Kennedy. Understood.
    I yield back. Thank you.
    Ms. Eshoo. Gentleman yields back.
    Pleasure to recognize the gentleman from Florida, Mr. 
Bilirakis, for his 5 minutes of questions.
    Mr. Bilirakis. Thank you, Madam Chair.
    And I really thank the witnesses for testifying today. It 
has been very informative. Unfortunately, I was at 
Telecommunications for a while, but I am back now.
    Dr. Volkow, do you think that the process for conducting 
research on schedule I substances coupled with the limitation 
on the supply of research-grade cannabis have discouraged some 
researchers from investigating the compound?
    Dr. Volkow. The answer is yes, and it has slowed it down, 
yes.
    Mr. Bilirakis. OK. Let's see. I have a couple of questions 
here that I want to go over.
    Mr. Bilirakis. Mr. Strait, would you agree that scientists 
studying cannabis and its effects, either bad or good, is it a 
fundamentally different question than legalizing, 
decriminalizing, or even discussing medical or recreational 
cannabis?
    Mr. Strait. Absolutely. We want DEA just like our 
colleagues at HHS want to be tethered to science as it pertains 
to research with marijuana
    Mr. Bilirakis. Very good.
    Next question is for Mr. Throckmorton--Dr. Throckmorton, 
excuse me. Are products available in State-regulated markets 
like edibles, concentrates, oils, wax, tropicals, for example, 
et cetera? I mean, those particular products, are they commonly 
available to clinical investigators through Federal sources? 
And if not, how might that pose a risk to the public health?
    Dr. Throckmorton. So I wouldn't be able to comment on their 
availability to the nondrug centers because that isn't part of 
what I regulate. I focus on the drug side.
    On the drug side, with the passage of the farm bill, hemp-
derived compounds are now available for research. And we are 
eager to support that any way that we possibly can. We think 
that is an exciting new avenue to get some of the questions we 
really desperately need answered.
    Mr. Bilirakis. Doctor, one more question. With the recent 
spate of lung illnesses related to illicit THC vaping products, 
what were some of the key takeaway lessons learned regarding 
the Federal state of oversight and research into current 
products and consumption methods?
    Dr. Volkow. Sorry. I thought you were asking----
    Mr. Bilirakis. Yes. No, this is for----
    Dr. Volkow. You are bringing up an example about why----
    Mr. Bilirakis. And I would like----
    Dr. Volkow. We need so much more knowledge. We did not know 
about hyperemesis until 2006. And as a result of that, we 
didn't know how to diagnose it. Now we are seeing it in the 
medical emergency rooms, and it is associated with high content 
THC and chronic use. But we are just assuming based on what the 
patients are telling us, since we are unable to actually sample 
from the sources that they are consuming. And that is just one 
example about why we need to understand the consequences of 
consumption of different products of marijuana, because we are 
seeing adverse effects.
    And so if we want to proclaim, well, there are medical 
qualities to it and we need to have evidence to show that it is 
the case, we also need to understand how to optimally dose it 
and what product characteristics are safe, and we don't have 
that data.
    Mr. Bilirakis. Thank you.
    Dr. Throckmorton?
    Dr. Throckmorton. I just want to say Dr. Volkow is raising 
an incredibly important point. Patterns of use, how these 
substances are being used are changing year to year. The new 
use of cannabidiol vaping, things like that. Just the ways 
these are being consumed, the doses they are being consumed, 
the populations, the perceived benefits are all changing. We as 
a Federal architecture need to find some way to track that, to 
understand it, to identify new risks as they emerge quickly, 
ideally find new ways to assess efficacy and things like it 
that are identified. But it is a central challenge, I think, 
for all of us working in this area.
    Mr. Bilirakis. Thank you very much. And I agree.
    I am going to yield the rest of my time to Mr. Griffith, 
please.
    Mr. Griffith. Thank you very much.
    Mr. Strait, several studies found that research-grade 
marijuana from the University of Mississippi is genetically 
distinct from the marijuana coming from State dispensaries, 
such as we heard of earlier in the testimony from Oregon. Four 
years ago, DEA announced that it would accept applications for 
the manufacture of research-grade marijuana in order to 
increase the diversity of products for scientists to study. 
Thus far, the agency has not acted. And as we heard earlier 
today, DEA intends to propose new regulations that will govern 
the marijuana growers program for scientific and medical 
research.
    Can we have your assurance publicly and on the record that 
the DEA will work expeditiously to review legitimate 
applications to produce marijuana for federally approved 
scientific research? And will current applicants be permitted 
to amend their applications to conform to the new rules so they 
are not caught in a catch-22 or a vortex of time?
    Mr. Strait. On your first comment, yes, we definitely will 
move expeditiously. We are moving expeditiously, although I 
know it is not acceptable for anyone here in public office. So 
we appreciate your patience on that.
    And your second question?
    Mr. Griffith. The second question was, if you already have 
an application pending and the rules change, instead of having 
to start back at go, you know, proceed directly to go and do 
not collect your $200, can they just amend so they can move 
forward? And a yes or no, because my time is up.
    Mr. Strait. On that point, when we announced the notices of 
application in August of 2019, some of those applicants had 
been--had applied two years ago. We gave them the opportunity 
then to get a full refund. And, of course, we would do that.
    Ms. Eshoo. The gentleman's time has expired.
    The Chair now recognizes the gentlewoman from Michigan, Ms. 
Dingell, for her 5 minutes of questions.
    Mrs. Dingell. Thank you, Madam Chair.
    I want to associate my comments today with everybody at 
this podium. And I think there is bipartisan frustration on 
this issue. I think my colleague, Mr. Kennedy, probably 
summarized where I am very deeply. I--Michigan is one of the 
States that is now one of the legal States that this is being 
traded in. I was--I will be very blunt, I did not support it 
when it was on the ballot. I come from a family that has seen 
what drug addiction does to people. But like my colleague, Mr. 
Griffith, Mr. Schrader, my husband, who many know in this room, 
suffered from great pain, and many people said that marijuana 
would be the only thing. Though would he try it, and he would 
not try it--can you see John Dingell smoking marijuana--because 
it was not legal, you didn't know the side effects, and it 
might have given him relief in the end.
    But I was the keynote speaker at Hash Bash this past year. 
Yes, you should laugh. My staff told me--I don't even know how 
it got scheduled, if you want to know the truth. I am still 
trying to figure that out.
    Ms. Eshoo. It wasn't schedule I.
    Mrs. Dingell. But I got up and said, I have never smoked 
marijuana, and don't think I ever will smoke marijuana, but I 
was getting a lot of indirect smoke that day. But I made the 
point--I talked to a lot of the scientists, and there were very 
clearly three things that need to happen. And I am as committed 
as anybody at this--we need to get more research on this issue. 
And we all keep asking you the same questions because we are 
not--we don't understand what the answers are or why if we all 
agree we need more research and we need it for medicinal 
purposes, we need it for automobile. I am working on impaired 
driving legislation right now too. Every one of us has got a 
story from our districts somehow, some way that there is a 
problem. And we are in the biggest catch-22 that you can ever 
see or imagine. So you have got to help us figure out how we 
are going it to get out of this catch-22.
    It is one of the reasons I introduced, with my colleague, 
Representative Blumenauer, the Medical Marijuana Research Act, 
because just in case you can't tell, I am pretty passionate 
about it now. Even though it is legal for recreational use in 
11 States, Michigan being one, we have just started it, it has 
gone recreational marijuana the last couple of weeks. The 
National Academy of Sciences has done a study, which I have 
right here, that found that the research of the health effects 
of cannabis and cannabidiol has been limited in the United 
States. And this lack of knowledge poses a public health risk.
    I would like to make sure it is submitted for the record, 
Madam Chair.
    Ms. Eshoo. So ordered.
    [Material submitted for inclusion in the record follows:]
    Mrs. Dingell. So having agreed with all of my colleagues 
here, having the three of you already establish we have got 
problems, can we go back and look at some of these questions 
that everybody keeps asking?
    Dr. Volkow, you talked about the administrative burden that 
current Federal rules mandate. We keep asking you why it takes 
months to navigate, but we are looking for those details. How 
would simplifying Federal guidance surrounding schedule I 
registration improve NIDA's ability to conduct this research? 
What do we need to do? And why is it only one kind of marijuana 
that is OK at the University of Mississippi? Can you give us 
more detail and highlight, you know, why Federal research is 
done only a single source of cannabis? How does this reliance 
on a single source limit our understanding of the health 
impacts?
    Dr. Volkow. We agree, and we are also, of course, 
frustrated by the challenges of advancing the science and at 
the same time recognizing that we have a problem. I wish 
marijuana had no untoward effect; it would be quite remarkable. 
But unfortunately, high content THC can have, as I mentioned, 
pretty adverse effects.
    Now, there is, as the national academy mentioned, there is 
evidence, though it is not solid enough for FDA approval, that 
there are some benefits clinically for some effects of the 
active ingredients of marijuana. So how could it--what is one 
of the things that we have been proposing? And again, we are 
not legislators. And it is the FDA and the DEA that regulate. 
But what we wanted to achieve is can there be a subcategory for 
schedule I that allows researchers to do research with the 
proper regulations but expedited. That is one of the things 
that we have been working with our colleagues on.
    Mrs. Dingell. How do we keep you from working and getting 
it done?
    Dr. Volkow. We need to actually solve the problem, and I--
and I agree. And I also think that we need to figure out a way 
to be able to also take advantage of some of the new producers 
of different cannabis plants in order to evaluate the diversity 
of problems that are out there, as opposed to limiting us with 
a Mississippi farm. These are regulations. This is not us 
wanting to say territorially we are the only place that can 
provide it. It is impeding research and knowledge.
    Mrs. Dingell. I am unfortunately out of time, but I could 
have asked a lot more questions.
    Thank you, Madam Chair.
    Ms. Eshoo. The gentlewoman yields back.
    A pleasure to recognize the gentlewoman from Indiana, Ms. 
Brooks, for her 5 minutes of questions.
    Mrs. Brooks. Thank you, Madam Chairwoman.
    And I apologize to the panel, there is another hearing 
going on, so I have been going back and forth a bit, but your 
testimony is critically important to us. And I think from my 
colleague across the aisle there has been frustration, because 
I think we are trying, as Members of Congress, to figure out 
what specifically we need to be doing to help to accelerate 
medical research. I think that is the top priority of this 
committee, I believe, and the purpose in having this hearing.
    And so--and with that, you know, hearing testimony and 
knowing friends who have suffered from tremendous pain, 
particularly from cancer, I want to focus a little bit on pain 
therapy. We have talked a little bit about it and, Dr. Volkow, 
thank--and thank all of you for your work. I have very mixed 
feelings about the issues around marijuana, having long ago 
been a criminal defense attorney and seeing so many of my 
clients have substance abuse problems and many of them starting 
at a young age with marijuana, and then later as a former 
United States attorney working with the DEA and involved in, 
you know, disrupting trafficking organizations, drug 
trafficking organizations that ruined neighborhoods and 
communities and caused a lot of significant problems. I--but 
yet I also have a number of friends and people I know who have 
suffered tremendously, whether it is with cancer or other 
things, where marijuana has helped them with their pain, or 
those at end of life, as we have heard those stories. So we are 
really conflicted here.
    We as a Congress, I think, have a lot of issues around we 
are trying to figure out how to break through and move the ball 
forward because it is taking years, and we just don't have the 
answers and we are so behind.
    So what barriers, Dr. Volkow, remain at NIH to study the 
new therapies around pain and where cannabis can particularly 
help with pain? And even addiction therapies we are hearing. 
Can you share with us what are the barriers around the research 
specifically relative to pain?
    Dr. Volkow. We are prioritizing as it relates to cannabis 
research, its potential value for the treatment of pain, for 
addiction, and also for HIV, and as an anti-inflammatory drug. 
So researchers are being funded both for THC as well as for 
CBD. We would like to have more investigators involved, and 
that is where the whole discussion has been going back and 
forth. Many investigators that don't have the infrastructure 
support that is necessary shy away because they feel it is too 
much of an obstacle to try to go through a schedule I. But we 
are funding research.
    Mrs. Brooks. Dr. Volkow, would these be private sector 
investigators or these university investigators or hos---what 
type of investigators do we--what kind of investigators do we 
need?
    Dr. Volkow. We want both of them. And one of the areas that 
we are very interested is actually pairing academic 
investigators with industry so that the products that are being 
developed then can go into the market. So we fund different 
mechanisms to try to facilitate those interactions. So you 
don't want to limit it just to the academicians. You want to 
also facilitate research by the private sectors.
    Mrs. Brooks. Are there any significant pieces of research 
that have been completed? I know you talked about 11 year--or 
studies over long periods of time of adolescents and of 
children that you are following, and I appreciate. What are the 
numbers of years that you are typically looking for relative to 
research?
    Dr. Volkow. Well, it depends on what you are aiming for. 
For example, to try to understand how marijuana affects the 
developing brain, you need to follow it up doingbrain 
development. So that will take 10, 15 years. If you are trying 
to determine, for example, to what extent THC can have 
analgesic effects for, say, in a patient suffering from low 
back pain, I am just--that may be a study that you can complete 
in three or four years. So it depends very much what the aim 
is, what the study is going to be doing.
    Mrs. Brooks. And approximately how many studies are we 
funding now, you know, focused specifically on pain management?
    Dr. Volkow. On pain management we are funding $39 million 
for therapeutics of cannabis. And of them, I would sort of say 
probably 35 to 40 percent may be pain, but I have to check the 
figures, but I just guesstimate.
    Mrs. Brooks. Off the top of your head, are there any 
significant negative results that have shown in your current 
research?
    Dr. Volkow. Too early to say, from the ones that are 
ongoing.
    Mrs. Brooks. Thank you so much. Thank you all for your 
work.
    I yield back.
    Ms. Eshoo. The gentlewoman yields back.
    Pleasure to recognize the gentlewoman from Illinois, Ms. 
Kelly, for her 5 minutes of questions.
    Ms. Kelly. Thank you, Madam Chair. And thank you to the 
witnesses for being here today.
    My State of Illinois was the 11th State to approve adult 
use cannabis. But with that said, I am interested in hearing 
about the research that exists about cannabis, particularly for 
vulnerable populations. I am the chair of the Congressional 
Black Caucus Health Brain Trust and have worked with my 
colleagues to create legislative and policy solutions to reduce 
health disparity and promote good health in all communities.
    So, Dr. Volkow, your testimony discusses the adverse health 
effects of cannabis when it comes to prenatal and adolescent 
development. What is the state of the science in this area? And 
are there studies that focus on minority populations?
    Dr. Volkow. Yes. And based on the science, we do know that 
the use of THC during pregnancy is associated with 
significantly negative outcomes for the newborn and the mother. 
There are cannabinoid receptors in the placenta, and the 
cannabinoid receptors emerge very early on in fetal development 
and they guide, tell the brain actually how neurons in the 
brain are moving and connecting. So it is something that needs 
to be taken with caution.
    We know that in adolescents, as has been mentioned, in all, 
every single story has shown overall independently that it 
leads to worse educational outcomes. And what we are now using 
is more sophisticated technology, larger samples, to understand 
how factors differs between one individual and the other. For 
example, through the ABCD study, we have shown that adverse 
social environments have a very negative effect in amplifying 
the consequences of insults into the brain. So if you come from 
a deprived environment, your brain is actually going to have a 
much slower development than if you are in an environment that 
enriches your experience. And in those circumstances, drugs 
have a greater negative effect.
    So we--I mean, these are stories that are ongoing, but it 
is clear drug and marijuana is not a good thing for the 
developing brain.
    Ms. Kelly. Well, I am glad to hear that you have a more 
diverse sample than it sounds like you did from the beginning. 
You said you are bringing more diversity.
    Dr. Volkow. Absolutely. We need to understand diversity. 
Diversity in terms of ethnic background, diversity in terms of 
economic opportunities, because those are influencing multiple 
factors on the development of a child.
    Ms. Kelly. And, Dr. Throckmorton, in your testimony, you 
mention that the FDA is actively working to learn more about 
the safety of CBD and CBD products. Among the list is work to 
understand the effects of CBD of special populations, such as 
the elderly, children, adolescents, and pregnant and lactating 
women. Can you elaborate more on this?
    Dr. Throckmorton. The best data we have available comes 
from the control trials that were used to approve Epidiolex, 
which is the product for procedure disorders. It was conducted 
largely in young children. And so we simply don't have any 
extensive randomized controlled trials in those populations. We 
all sort of acknowledge they are terribly important.
    When we approved Epidiolex, we also posted on the web what 
we do know about the demographics of response to the drug. So 
you can go on to what we call our drug trial snapshot page, and 
it will show you the safety and effectiveness of Epidiolex 
broken down by sex, gender, age, ethnicity. And you can look 
and see for yourself what we know about Epidiolex, but we need 
to have a lot more information to expand that to understand the 
impact on the elderly, for instance, and on pregnant and 
lactating women, because they just simply weren't in the trials 
and so we haven't had that opportunity yet. But it is something 
we recognize, and we are working to try to fill as quickly as 
we can.
    Ms. Kelly. Assuming you are working to get more diversity 
in the trials.
    Dr. Throckmorton. Absolutely, yes.
    Ms. Kelly. I, like my colleague, I go back and forth about 
how I feel about recreational marijuana. I don't know if that 
is because I went to college in the 1970s, if that is the 
reason why. But I just read in the paper, you know, Chicago 
allowed it starting January 1. And the paper talked about how 
the emergency room visits have gone up because of this. And 
even places that treat dogs, because people are, I guess, 
careless with the edibles. I don't know. And they found more 
dogs are getting sick too. So it just seems like we need to 
educate the public more too about the effects. And I don't know 
if it is just an early overexuberance because it just became 
legal or will we continue to see increased emergency room 
visits.
    Dr. Volkow. And I am just going to comment on that because, 
actually, one of the aspects that have been coming back and 
back, marijuana is not a safe drug. It has negative effects. 
And among the ones that we are more concerned is that is what 
affects young people. And one of the ones of greatest concern 
has been the association of the use of marijuana with 
psychosis. And stories across the world, for example, as a 
psychiatrist, I was trained that the prevalence of 
schizophrenia is the same across the world, it is one percent. 
Well, it so happens that that is not the case. And in some 
places, it is six to eightfold higher. And in those places, it 
is associated with the consumption of very high content THC.
    So in the Netherlands, for example, which has the highest 
rate of schizophrenia linked with the consumption of THC, you 
can have plants that have 38 percent THC. And this is not just 
explained by having the genetic risks. There is something about 
high-content THC that is triggering psychosis, and we need to 
recognize it.
    Ms. Kelly. I know my name time is up. Thank you, Madam 
Chair.
    Ms. Eshoo. The gentlewoman's time has expired.
    Pleasure to recognize the gentleman from Montana, Mr. 
Gianforte.
    Mr. Gianforte. Thank you, Madam Chair. And thank you for 
the panel being here today.
    Understanding the full consequences of readily available 
marijuana on public health and individuals is imperative. We 
have heard that today. We should be concerned about the lack of 
Federal research on marijuana because, when we consider such a 
drastic change, we must ensure that that policy is based on 
sound science. So the focus today on research is very 
appropriate.
    In November, I joined with 16 other Members of Congress in 
asking Attorney General Barr to study the societal impacts of 
legalizing marijuana for recreational purposes. As we start to 
see preliminary data from States like Colorado and Oregon, it 
is important to fully evaluate their experiments before making 
Federal policy. I appreciate that Mr. Walden and Mr. Burgess 
have asked for a hearing on this research, and we should 
continue to investigate.
    We should know how best to help people who need medical 
marijuana and how greater access to recreational marijuana will 
impact our communities, families, and users. However, expanding 
access to marijuana without the benefit and guidance of the 
facts and sound science is of grave concern. This is incredibly 
concerning because we have an addiction crisis in my home State 
of Montana. Methamphetamines and now opioids devastate our 
communities and tear up too many families.
    Meth accounted for 86 percent of drugs trafficked in 
Montana in the past five years. Montana has worked hard to 
support people fighting addiction through drug treatment 
courts. These courts help people get clean and get back on 
their feet while staying engaged in their communities, all at a 
fraction of the cost of incarceration.
    To consider making any schedule I drug legal and more 
readily available without adequate research is a misplaced 
priority when addiction continues to ravage our country. 
Instead, we should support focusing on combating addiction, 
building on this committee's bipartisan work and the success of 
the SUPPORT Act from last Congress. We need to continue to 
support those who face addiction and need the help the most, 
rather than making marijuana easier to access when we don't 
know the full effects on our communities.
    Dr. Volkow, ensuring access to mental health services is a 
top priority of mine. Unfortunately, Montana has the highest 
suicide rate in the country. I have introduced the National 
Suicide Hotline Designation Act, which makes 988 the national 
suicide hotline number. This important bill will protect 
emergency access to care for those facing a mental health 
crisis, especially those in rural areas who lack access to 
mental health professionals.
    In your testimony, you state that serious mental illness 
and suicides are on the rise in our country. And while multiple 
factors very likely contribute to this rise, it is imperative 
to understand if exposure to cannabis in adolescents is one of 
them. Does current research draw a connection between marijuana 
use and increased risk for suicide or mental health problems?
    Dr. Volkow. There have been some large epidemiological 
studies that have noted an increased risk for suicide among 
regular users of THC, but the evidence is not as extensive as 
associated with psychosis. And so we cannot ignore it, but we 
need to determine if it is reproducible and understand the 
extent to which it is contributing indeed to suicidally. So it 
is something that has been noted by large epidemiological 
studies.
    Mr. Gianforte. OK. And from your experience as a researcher 
in this area, do we fully understand the connection between 
marijuana and mental health and suicide?
    Dr. Volkow. Marijuana, if you take high-content THC, in 
almost any one of us, if the content of THC is high enough, it 
is going to make us paranoid, extremely anxious, and very, very 
afraid, if not fully psychotic. And that can explain and one 
could conceive why in those circumstances someone, if they feel 
threatened, may actually attack someone else or attack 
themselves.
    So in some people, that results in a chronic syndrome, and 
that is where we don't have sufficient knowledge of 
understanding why is it that in most cases it is just a very 
short limited psychotic episode and why is it that use of 
marijuana in some results in long-lasting effects; that we do 
not know yet.
    Mr. Gianforte. OK. So just to summarize--I appreciate your 
expert opinion--it is possible that cannabis could increase 
suicide rates. Is that correct?
    Dr. Volkow. The epidemiological data has given some 
evidence that it may. But I want to be cautious again. I think 
that one of the issues that we have been criticizing the whole 
field of marijuana is that people say you are exaggerating. How 
do you know that a person to start with was depressed and was 
suicidal thinking that put them at risk to take marijuana to 
auto-medicate? So how do you now it is really a causal as 
opposed to an auto-medication? That is what I want to----
    Mr. Gianforte. But it brings us back to the fact we just 
have to do the research.
    And with that, Madam Chair, I yield back.
    Ms. Eshoo. The gentleman yields back.
    A pleasure to recognize the gentlewoman from Delaware, Ms. 
Blunt Rochester, for her 5 minutes of questions.
    Ms. Blunt Rochester. Thank you, Madam Chairwoman, for this 
important hearing. And thank you to the witnesses.
    As you can tell, many of my colleagues, we are going over 
time on the time we have because there are so many questions 
that we have. And as I thought about this, it really is a 
multitude of issues that we are dealing with in this one 
hearing, both protecting and enhancing public health, providing 
economic opportunities but in a just way, restorative and 
criminal justice as well as public safety.
    I am encouraged at the inclusion of comprehensive 
legislation that addresses some of the social justice aspects 
of cannabis reform. Even a minor criminal record can lead to 
barriers in employment, housing, and education. It is also a 
significant drain on our national economy. That is why I have 
introduced bipartisan legislation, the Clean Slate Act, which 
would seal an individual's Federal record, criminal record for 
nonviolent or simple possession offenses involving cannabis.
    As Congress continues to evaluate our Nation's approach to 
cannabis, let us continue to include criminal justice reform as 
a critical part of the conversation.
    Dr. Throckmorton, as you mentioned in your testimony, the 
FDA has approved one cannabis derived product for medical 
treatment, Epidiolex, which is used to treat rare pediatric 
seizures. Can you walk us briefly, very briefly through how the 
FDA came to approve it?
    Dr. Throckmorton. Happy to very shortly. So we have a 
process that we have laid out in a variety of different ways, 
including small business assistance and things that basically 
gives a roadmap to drug developers, beginning with 
conversations with us, coming in and just basically saying I 
want to develop a drug to do the following and this is where I 
think I might get my drug, my active pharmaceutical ingredient 
so called. We walk them through a series of meetings leading 
to, if successful, a drug approval of the kind that we were 
able to do for Epidiolex.
    Ms. Blunt Rochester. So you have a roadmap that we can 
actually get a copy of?
    Dr. Throckmorton. Absolutely.
    Ms. Blunt Rochester. OK. So we will we request a copy of 
that roadmap. And also, what I would like to follow up on is 
what you have learned through the clinical trials from that as 
well.
    Since the 2018 farm bill, we have seen a massive expansion 
in commercially available CBD products, everything from CBD 
active wear to CBD toothpaste. Many of these products assert 
that they contain various wellness benefits like reduced levels 
of anxiety or better sleep. I want to continue on. The FDA has 
stated that many of these products are marketed with 
unsubstantiated therapeutic claims.
    Doctor, could you talk about what the FDA does to--what 
actions do you take for these bad actors? What are you 
currently doing?
    Dr. Throckmorton. Sure, thank you. And we would be happy to 
follow up with details too there. So, fundamentally, if someone 
makes a claim that their product treats, diagnoses, mitigates, 
or prevents a disease, they are a drug. And if they are doing 
that without approval from the Food and Drug Administration, 
they are an unapproved drug, the subject to our enforcement 
actions. You know, they are making claims that they don't have 
any substantiated evidence for, we take an enforcement strategy 
that focuses on the high-risk things, the really egregious 
claims.
    Ms. Blunt Rochester. So can you just give us some examples 
of what you did, who you targeted, what you did?
    Dr. Throckmorton. So the egregious claims that we have--
recently we took an action, we sent 15 warning letters out, 
identifying specific products that made those kinds of claims 
or in some other way violated the Food, Drug, and Cosmetics 
Act. We called on them to stop whatever the violation was that 
they were committing. Most of them had to do with labeling, and 
gave them steps that they needed to take in order to come back 
into compliance.
    Ms. Blunt Rochester. Just so I am clear, the warning letter 
went to the person who is the bad actor.
    Dr. Throckmorton. Manufacturer.
    Ms. Blunt Rochester. The manufacturer. How is the public 
informed of that to be aware?
    Dr. Throckmorton. So those letters are public. You can go 
on to our Web site and see the series of warning letters. This 
is actually I think the third time we have done this that we 
put out. And then we obviously have a follow-up plan for each 
of those companies to make sure that they come into compliance.
    Ms. Blunt Rochester. One of the areas I didn't, when I ran 
through all of those intersections, I didn't run through 
consumer protection, and I think that is another big area. I 
know if I go into a store, I am not likely to then go on your 
Web site to figure out, is this dangerous for me or not. And so 
I think this is something else that we need to follow up, as we 
look at research and other issues, how to best protect the 
consumer.
    Thank you so much, Madam Chairwoman, for this very 
important hearing, and I look forward to the next one. And I 
yield back the balance of my time.
    Ms. Eshoo. And thank you for your important work as well. 
The gentlewoman yields back.
    A pleasure to recognize the only pharmacist in the 
Congress, Mr. Carter of Georgia, you are recognized.
    Mr. Carter. Thank you, Madam Chair.
    Mr. Strait, I am going to start with you. Dr. Burgess asked 
you earlier in this hearing about changing a drug from one 
schedule to another. And I wanted to expound upon that and ask 
you, you mentioned that it can be initiated a number of 
different ways. When was--what initiated the change from 
hydrocodone from a C-III to a C-II? Do you know?
    Mr. Strait. Yes, that was a petition from a doctor.
    Mr. Carter. From a doctor. Why did it take so long? The 
opioid epidemic started in the early 1990s, lasted--and 
arguably the epitome of it was in 2006 to 2010, and yet it took 
you until 2014 to initiate that--or to complete it. Excuse me.
    Mr. Strait. Yes, to complete it. So I believe that petition 
came in----
    Mr. Carter. Why did you have to wait on a petition?
    Mr. Strait. I am sorry?
    Mr. Carter. Why did you have to wait on the petition?
    Mr. Strait. We don't have to wait on a petition.
    Mr. Carter. Then why, with the opioid epidemic being as bad 
as it is, did it take the DEA until 2014 to reschedule 
hydrocodone from a C-III to a C-II?
    Mr. Strait. Well, actually, back when that petition came 
in, I would argue that a lot of folks in the medical community 
were actually concerned about access to opioids. And so a 
petition to reschedule marijuana, despite its potential for 
abuse and its actual abuse, kind of ran contrary to some of 
those other broader concerns by the medical community.
    Mr. Carter. I--OK. Dr. Volkow, you and I have worked 
together for many years now, and I have great admiration for 
your work and great respect. You were asked earlier, I believe 
it was from Representative Castro, if marijuana is a gateway 
drug. And I have to be quite honest with you, you gave a very 
scientific response, something about sensitivity.
    Is marijuana a gateway drug, in your opinion? And I ask you 
that as a psychiatrist. You understand we have had, in this 
subcommittee here, we have had panels of parents, of loved ones 
who have lost loved ones to opioid addiction, who have all said 
that it started with experimenting with marijuana.
    Dr. Volkow. Indeed, they all--most of the epidemiological 
studies show that the first drug of initiation is marijuana. 
And because of that, that is another big argument for saying 
why it is a gateway drug. The counter argument and why it is 
not so simple is that it states that if you have the 
vulnerability for drug taking, it is much more likely as you 
are a teenager that you will encounter marijuana, then heroin. 
And, ergo, you start with marijuana and then you go into other 
drugs.
    That is why it is not such a simple and that is why I 
basically say, overall, I would state, based on stories, not 
just in epidemiology or in laboratory animals, that if you 
expose them early on, they are more sensitive to other drugs 
that it----
    Mr. Carter. Wouldn't you agree that the psychological 
effects of experimenting with marijuana lead to experimenting 
with other drugs, which leads to more addiction? No question 
about it. That has been proven time and time again.
    Dr. Volkow. But the same thing pertains to nicotine. So 
nicotine is another one----
    Mr. Carter. And what have we done with nicotine? We put 
limitations on it.
    And I want to cut to the chase. If you want to see time 
fly, wait until you get up here for 5 minutes, but I want to 
cut to the chase. Everyone up here has expressed the same 
concern: We need more research. Tell us what we need to do.
    Mr. Strait, what do you need? Do you need a schedule I-A 
that is not going to have anything in it except for marijuana? 
That is fine with me. I will create it.I will legislate that. 
But tell me what it is going to take. I don't--please.
    Mr. Strait. Two things. We have seen a 150 percent increase 
in the number of schedule I marijuana--manufacture--researchers 
in the United States in the last five years. We are making 
progress. We want to do more, for sure.
    What do we need in terms of improving access to research? I 
feel as if this interagency group of folks here have worked 
collaboratively on a proposal that would actually do just that.
    Mr. Carter. And is that the proposal you mentioned earlier 
about Fentanyl?
    Mr. Strait. Correct. Absolutely. Yes. It is within the 
context of fentanyl----
    Mr. Carter. Can you make sure we get a copy of that? 
Because I want to see it, because we invite your input. We want 
to do the right thing.
    You know, I saw an article just here recently that said 
that there is actually the--the use of new research found 
opioids were prescribed less often in States where marijuana 
had been legalized for medicinal or recreational use. You know, 
as a practicing pharmacist for many years, I have always said 
that the only thing worse for me than filling a prescription 
for someone who doesn't need it is not filling a prescription 
for someone who does need it.
    If marijuana truly does have medicinal benefit, I want to 
use it. I am adamantly opposed to the recreational use of it. I 
think it is a gateway drug, and it should not be used 
recreationally. But if there are benefits to it, I want it to 
be used. All we want here, everyone has expressed the same 
thing throughout this whole hearing. Tell us how we can get 
this research done. Tell us how we can find out.
    It is the epitome of ineptitude that the Federal Government 
has this scheduled as a schedule I drug and 11 States have 
approved it recreationally. Embarrassing.
    Thank you, and I yield back.
    Ms. Eshoo. So there.
    OK. The gentleman from California is recognized, Mr. 
Cardenas, for his 5 minutes of questioning.
    Mr. Cardenas. Thank you very much, Chairwoman Eshoo and 
also Ranking Member Burgess, for having this important hearing 
in this committee, in this committee where it belongs, the 
Health Subcommittee of the Energy and Commerce Committee.
    Too often we either talk about cannabis as either a 
criminal justice issue or a medical issue. The reality is that 
we cannot pull them apart. Research has shown that for youth, 
in particular, incarceration is tied to poor physical and 
mental health outcomes later on in life. Compared to those not 
incarcerated, children and adolescents in the system for more 
than a year were three times more likely to have functional 
limitations, over four times more likely to have symptoms of 
depression, and over two times more likely to have suicidal 
effects into adulthood.
    Now, I am not talking about the use of cannabis. I am 
talking about incarceration. Let me make that clear.
    Nearly 75 percent of all of the people arrested for 
cannabis-related offenses are under the age of 30, and one in 
four--one-fourth are under the age of 18. That is almost a 
quarter of a million teenagers arrested for these types of 
offenses each year in the United States of America.
    Given that we know being arrested for possession, growing 
or selling cannabis, can lead to incarceration, and we know 
that incarceration has adverse health consequences, we can 
establish that, at a minimum, cannabis criminalization causes 
some negative public health consequences. So the question then 
turns to balancing these public health concerns. We also know 
that a conviction for a controlled substance can lead to 
difficulty with job prospects, which could lead to both 
unemployment and underemployment, which has potentially adverse 
public health consequences. Similarly, a drug conviction means 
a currently enrolled college student receiving Federal student 
loan money would have their financial assistance terminated. 
This can harm the future employment, earnings, and ultimately, 
health prospects of that youth.
    Examining the public health harms created by 
criminalization of cannabis is the type of research that could 
be conducted without having to expand the research supply.
    I think it is really important for us to understand that 
calling cannabis a gateway drug in an anecdotal fashion is 
unfair to the American people and it is really not the proper 
dialogue that policymakers and/or researchers and/or medical 
experts should be having. And the reason why I say that is 
because, if we are going to have that discussion, we should 
have the discussion and the question, is alcohol a gateway 
product or substance? Is nicotine a gateway product or 
substance?
    So to think that cannabis is in and of itself a category I, 
an evildoer to all that touch it, is something that should not 
be the subject of dialogue when it comes to true policymaking 
and also when it comes to real honest research, not anecdotal 
answers and questions.
    What I have--I think one of the main things that we need to 
understand as policymakers is that the inception of the United 
States Congress calling cannabis a class I drug, I would 
encourage everybody in this room and everybody in this country 
to look at the footage on the floor of the United States 
Congress and the nonresearched derogatory statements that were 
being made specifically about a certain community and how using 
cannabis would lead to rape and murder of women and citizens of 
this country. I am cleaning it up a little bit because I think 
it is unfortunate that we have that stain on the United States 
Congress. And so far, we haven't had the will to actually 
correct it.
    The United States Congress made a mistake, and every 
Congress since has not had honest hearings and honest dialogue 
and has not allowed, truly allowed, the researchers in this 
great country to do the true research that needs to be done for 
us to properly categorize cannabis in this country. And as a 
result of that, we have millions of individuals in this 
country, as I outlined earlier, who have been subjected to 
incarceration and a criminal record that otherwise they would 
have a much more productive and better life, and that society 
would be much better off, including the taxpayers, if we were 
to actually get this right.
    So hopefully we will have the opportunity to do that in 
future hearings of the United States Congress so we can get it 
right and we can get the research done and we can end this 
anecdotal discussion and have a real, real discussion about the 
facts.
    With that, I yield back.
    Ms. Eshoo. The gentleman yields back.
    The gentleman from Illinois, Mr. Shimkus.
    Mr. Shimkus. Thank you, Madam Chairman.
    Ms. Eshoo. My partner in all things 911.
    Mr. Shimkus. Oh, yes, that is right.
    Thank you all for being here. It is been a long day for you 
all. And I didn't have to sit through all of it, at least in 
the hearing room. So I appreciate that you have had to do that. 
And so I am going to try to be fairly brief.
    And this one is to Dr. Volkow first. Are you familiar with 
the most recent article that came out of The Lancet Psychiatry 
about the risk of drug-induced psychosis converting to full 
schizophrenia?
    Dr. Volkow. That is correct.
    Mr. Shimkus. Can you comment on--I mean, I have got the 
stats and stuff. Can you tell me--I mean, summarize that report 
and maybe comment on your observations of that.
    Dr. Volkow. This report is consistent with a concern that 
the use of marijuana, particularly high THC, can produce 
chronic psychosis. Overall, the statement, as I have made, is 
that most cases are of the use of marijuana trigger an acute 
psychosis that by itself will go away. What this study does is 
it shows that those individuals that went into an emergency 
department for an acute psychotic episode associated with the 
use of cannabis were much more likely to subsequently go into a 
chronic psychosis.
    So this study links the use of marijuana, not just with 
acute psychosis, but provides evidence that it increases your 
risk of transitioning into a chronic psychotic episode, as is 
the case of schizophrenia.
    Mr. Shimkus. OK, thank you. Let me--because I have been--
mental illness, mental health, early use, what we call when 
they--a lot of people self-medicate through drugs based upon 
psychosis. And I think a lot of us may have had personal 
experiences with family members or friends and neighbors that 
have kind of fallen into this trap. And I think part of it is 
early drug use at an early age.
    Let me go to this other subject that we have been dealing 
with.And this will be back to you, Dr. Volkow, and to I think 
Mr. Strait, and it really deals with this vaping and the THC 
and also the vitamin E acetate issue. So the question is, first 
of all, is it possible for scientists with a schedule I license 
to conduct federally funded research on THC oil in these vaping 
products?
    Mr. Strait. Are we talking about the stuff that is actually 
being consumed illegally, I presume, as opposed to----
    Mr. Shimkus. Right.
    Mr. Strait [continuing]. Creating a THC extract that could 
then somehow be tested?
    Mr. Shimkus. Yes. I think part of--that is the direction, 
yes, sir.
    Mr. Strait. Yes. So as we had said earlier, the challenge, 
of course, with that is we certainly understand that 
researchers want access to that material. Under the Controlled 
Substances Act, researchers generally or have to obtain a 
controlled substance from another DEA registrant. This is 
something that Dr. Volkow has mentioned it. A failure to do so 
might impact their ability to keep their Federal funding for 
their program. So some of them have expressed some concerns 
about that.
    Mr. Shimkus. And then let me just follow up. Would you 
agree that, with the CDC, that the scheduling status for 
cannabis makes it challenging for the epidemiological testing 
of these vaping products?
    Dr. Volkow, you are shaking your head yes. Do you want to 
elaborate?
    Dr. Volkow. Yes. Yes, it is, because you want to, when you 
start to see, for example, these emergency room admissions 
occurring in different States or communities, you would like to 
be able for researchers to go in and try to understand what is 
it in those products that is accounting for the rise in these 
cases, and that is not--currently not possible, if you want to 
use funding from Federal agencies like ours.
    Mr. Shimkus. Great. Thank you. And I want to yield my last 
minute to Morgan.
    Mr. Griffith. I appreciate the gentleman very much.
    Earlier, Mr. Strait, we were talking about the applicants 
that are already in place. So 33 applicants who grow marijuana 
for research are out there. Y' all are changing the rules. I 
asked if they would be able to amend their petition. You said, 
well, yes, we did this before. We refunded their money. I don't 
think they want their money refunded. They want to be able to 
not have to go back and start all over again with their 
application.
    So can they just amend their application? Wouldn't that 
make sense?
    Mr. Strait. Thanks for giving me the opportunity to 
clarify. What I meant and what I said and meant was for--
because the applications had come in prior to passage of the 
farm bill and that some of these applicants may have actually 
applied to produce things that now are no longer controlled 
under the CSA, we gave them the opportunity to withdraw their 
application for purposes of no longer needing it. Those that 
have applied, they are in the queue and they will not have to 
reapply. We will be adjudicating every single application.
    Mr. Griffith. I appreciate that. Thank you. That makes more 
sense than what I thought I heard. I appreciate the 
clarification.
    Mr. Strait. You bet.
    Mr. Griffith. I yield back.
    Ms. Eshoo. The gentleman yields back.
    The Chair recognizes the gentleman from Illinois, Mr. Rush, 
for his 5 minutes of questions.
    And we have--we don't have very many members left, and it 
is my understanding that votes are going to be called shortly, 
so I think that we will be on time.
    Mr. Rush, you are recognized.
    Mr. Rush. I want to thank you, Madam Chair, for holding 
this hearing.
    And this hearing is particularly timely and more and more 
States are loosening their restrictions around marijuana, 
including my home State of Illinois, which just legalized 
recreational marijuana beginning the first of January of this 
year. As such, I believe more than ever that it is important 
that we prioritize the research upon, not only the benefits, 
but also on the risk of marijuana.
    I worry, Madam Chairman, that too little is known about 
when and how marijuana can be harmful, particularly after 
frequent and long-term use. And that said, it seems to me that 
many States, including mine, are stampeding to legalize both 
medicinal and recreational use of cannabis, particularly 
because there is a budgetary crisis that these States are 
confronting. And the revenues from increased marijuana sales 
and legalized marijuana, particularly at the recreational 
level, is meant to help correct the budgetary issues that they 
are facing.
    And I want to ask Dr. Volkow a question. Would you please 
expand on the possible health risk and implication for 
citizens, both on adults and adolescents of these States, which 
are exhibiting what I call a mob marijuana mentality and who 
are engaged in what I would refer to as a marijuana mania, that 
really exists in my State and in some of the situated States 
across the Nation?
    Dr. Volkow. Yes. And I like you way you call it the 
marijuana mania, because it is actually a change in belief 
without the fact that there hasn't been any evidence to make us 
think that it is safe. And I don't want to negate the 
possibility that, in some instances, cannabis can have 
therapeutic benefits, but we cannot deny the fact it has some 
very untoward effects. That does not negate the possibility 
that we can come up with indications that can--where marijuana 
can be used safely for therapeutic purposes. These things are 
not exclusive.
    But it is clear, the evidence is clear that use of 
marijuana is associated with negative effects. And we are 
already seeing it by the significant increase in emergency 
department admissions that are being observed in the States 
that are legalizing marijuana, as well as hospital admissions. 
This is happening.
    By changing the culture, by legalizing it, by creating a 
sense that it is a safe drug, more people are being exposed to 
it. And as a result of that, that otherwise they wouldn't have 
because they wouldn't want to do something illicit. The more 
people get exposed to it, the greater the likelihood that we 
are going to see adverse effects, which is what we are 
observing.
    So the data is clear that it can have adverse effects and 
why--I mean, and at the same time where we are leading as a 
country, which is quite amazing, is how rapidly the perception 
of risks disappear among the public. And we need to actually 
create the balance that brings evidence of really what 
marijuana can do, so that the individuals that want to take it 
know the positives and the negatives and they don't do it 
blindly, which is what we are observing happening.
    Mr. Rush. Another area that I am really concerned about, 
along with this mania that exists is this empty excuse of--or 
this expungement of records. It is OK, all right, but the cause 
of those records is being ignored.
    Is there a nexus between marijuana--the offense of 
marijuana, smoking marijuana or ingesting marijuana, and 
abhorrent social behavior which creates a law enforcement issue 
which, in my theory, is that led to mass incarceration? I don't 
know whether or not you can make the connection, but can you 
make that connection?
    Dr. Volkow. Well, I think at the point of incarceration and 
incarceration of individuals with a substance use disorder, 
when you do the studies, it has clearly showed that not only it 
does not in any way benefit or protect anyone; it actually 
makes them much more vulnerable to relapsing and drug taking 
and other adverse mental consequences. So incarceration has an 
adverse effect on those that are suffering.
    Mr. Rush. I want to thank you, Madam Chair. I yield back.
    Ms. Eshoo. The gentleman's time has expired.
    It is a pleasure to recognize the gentlewoman from--so we 
are going to go to Ms. Barragan for her 5 minutes of 
questioning. And we have two members that are waiving on to the 
committee. And I sure hope we will be able to take your 5 
minutes of questions as well.
    Ms. Barragan, you are at bat.
    Ms. Barragan. Thank you.
    Ms. Eshoo. Five minutes.
    Ms. Barragan. Great. Thank you.
    And thank you all for being here today and providing 
informative information. I thought it was pretty powerful, and 
the most powerful was to hear from Congressman Griffith and his 
story. It is the personal stories that are the most impactful.
    When I was very young, my father had Parkinson's disease, 
and he had it pretty much all of my life. And I remember when I 
would see him in pain, I would just ask is there anything that 
could be done for him. I don't care if it is legal or not. And 
it was more of the sense of, you know, you are a child and 
seeing your parent suffer and you want to give them something 
to make that pain go away. And so I am firmly in the same boat 
of supporting efforts to make sure that we are providing things 
like marijuana for medical purposes to make sure patients are 
having access to what they need to help give them some comfort, 
especially when they are near the end of their life. There is 
no reason that people need to be suffering. And so his story 
was pretty compelling for me.
    I am wondering if anybody on the panel today supports any 
of the bills, any of the legislation that is before us today. 
Does anybody want to comment on any support on any of the 
bills?
    Dr. Volkow. We have been asked that question, and I 
actually was asked more specifically which one I favor, and I 
said I favor actually the advancing of science and the ability 
to do things in a way that can help us accelerate research. But 
specifically which is the best bill, I think that that is more 
on the side of you who are actually the ones that are creating 
them. But my colleagues may--I may put them on the spot.
    Ms. Barragan. And I am not asking for the best bill. I am 
asking for, you know, these are the three bills I would support 
that I think would be helpful or that I think would be 
beneficial.
    Dr. Volkow. And the one that I had--have gone on the record 
for these that are basically--and we have been working with my 
colleagues at the FDA and the DEA that are favored is the 
creation of a subcategory for schedule I substances that would 
allow us to do research expeditiously. And it is not just for 
marijuana, it is in general schedule I substances, so that 
researchers don't--don't have to go through all of the 
obstacles and the delay process. That is what we have been--
actually one of the things that we are very specifically tried 
to achieve.
    Ms. Barragan. Gentlemen, any----
    Dr. Throckmorton. I would be happy to provide comment on 
any particular bill that you wanted us to help you with, 
obviously. I think Dr. Volkow said it very well before. The 
goal needs to be kept in mind. So whatever the vehicle, 
decontrol or other approaches that are suggested and that are 
included in some of those legislations, we need to think about 
the goals in mind. And in particular, from the FDA's 
perspective, the outcome needs to keep in mind the need for 
continued drug development and appropriate scientific study.
    Mr. Strait. And from the Department of Justice side, none 
of these bills have actually been reviewed by the 
administration, so there is actually no official position in 
terms of any of the proposals. But as we are all talking about 
today and as I think we all have kind of mutually agreed upon, 
the key is science and having the access to the data to support 
sound decisionmaking, whether that be legislative or within the 
executive branch absent legislation.
    Ms. Barragan. Right. So I want to shift for a moment on the 
issue of sickle cell and the impact it has had on African 
Americans. I think in some States they have a list of medical 
marijuana uses, and I have talked to patients--I have seen what 
sickle cell has done to patients and the pain that they have 
suffered, and many sickle cell patients use marijuana to 
address acute pain that is a symptom of the disease. And some 
of the States currently have medical marijuana laws but have 
chosen not to include sickle cell disease on the list of 
conditions that would qualify a patient to receive the 
medication.
    Dr. Throckmorton, is there a way we can assure that States 
that allow for medical marijuana have a comprehensive list of 
conditions that would qualify for the medication so that those 
who would potentially benefit from its effects are not 
excluded?RPTR GIORDANOEDTR SECKMAN[12:59 p.m.]
    Dr. Throckmorton. So which medications are you talking 
about? So----
    Ms. Barragan. We are talking about the use of marijuana for 
sickle cell.
    Dr. Throckmorton. OK. Yes. So the medications for sickle 
cell disease that I would advocate for are the ones that we 
have had the good fortune to be able to approve in recent 
years.
    Ms. Barragan. Well, no. I am asking----
    Dr. Throckmorton. They are not for pains. And those 
medications, we can and do work with providers to make certain 
that they understand they are available. We hope to include 
them--make them available----
    Ms. Barragan. Right. That was not the question. The 
question was that the States that provide the lists where 
people can use medical marijuana, like how do we ensure that 
some of these diseases are included. So----
    Dr. Throckmorton. I am happy to talk with you offline.
    Ms. Barragan. OK.
    Dr. Throckmorton. Those States are making those choices 
without Federal input, so----
    Ms. Barragan. OK. Thank you. I yield back.
    Ms. Eshoo. The gentlewoman yields back.
    Pleasure to recognize the gentleman from California, Dr. 
Ruiz, for his 5 minutes of questions.
    Mr. Ruiz. Thank you, and thank you all for being here. Dr. 
Volkow, you say in your written testimony that, quote, CBD is 
ubiquitous, and it is possible to purchase CBD extracts as well 
as food, drinks, cosmetics, and other CBD- containing products 
which are sometimes marketed with health and wellness claims 
that are not backed by science, unquote.
    It is also worth noting that, while more than 30 States 
allow for comprehensive medical use of cannabis and the FDA has 
approved some derived and cannabis-related drug products, 
cannabis does not have the FDA approval for any indication.
    We have seen that cannabis can be used to treat certain 
ailments, such as for children with particular seizure 
disorders that are refractory to other treatments; as an 
appetite stimulant for patients suffering from AIDS or 
receiving chemotherapy; as an adjunct to other therapies in the 
treatment of chronic pain syndromes, which is of particular 
interest during the current opioid epidemic. Pain and 
spasticity in multiple sclerosis is another use. However, there 
is evidence show that chronic use is not without its 
consequence: for example, cannabinoid hyperemesis syndrome, a 
syndrome of cyclic intractable vomiting and chronic abdominal 
pain; disadvantaged attention, learning, and processing speed 
among teens who use marijuana regularly.
    These neurobehavioral changes can even be seen on brain 
MRIs of these patients. These changes can be permanent. Earlier 
onset, as you had mentioned earlier, of schizophrenia and 
bipolar disorders in young users of marijuana.
    So it is clear that more research need to be done to better 
understand the risks and benefits.
    Dr. Throckmorton, it seems the FDA has found therapeutic 
value in marijuana-related compounds, but for limited and 
specific uses. Can you discuss what factors went into approving 
these drugs for medical use for these specific populations?
    Dr. Throckmorton. Sure. It began with the basic science 
work that groups like NIDA does, so it began with supporting 
the kinds of research that NIDA supports to identify compounds 
and targets--therapeutic targets of interest; so suggesting 
from animal models or other places that the drugs had use in 
those areas.
    And then something called translational science needs to 
happen, which is a drug manufacturer or a drug developer picks 
up that idea and comes and talks to us and says:We believe this 
is a product that we can turn into a drug. What are the 
pathways--what do we need to do? What are the next steps?
    Typically that includes additional clinical studies, 
sometimes additional non-clinical studies, and the result is 
something called the new drug application, chosen--the 
therapeutic area then is chosen by the individual company. They 
are choosing to invest in pain, or they are choosing to invest 
in--you know--I do not know--infectious diseases, or whatever 
else it is, with a particular product. Our job is to make sure 
that that assessment occurs, occurs quickly and efficiently, 
and is scientifically driven, and results--you know, if the 
data are what they need to be, and then approval of a drug for 
a specific condition with an understanding of its safety and 
effectiveness.
    Mr. Ruiz. And, based on this approval process, can FDA 
extrapolate the safety of CBD for other products?
    Dr. Throckmorton. Extrapolation for effectiveness is very 
hard to do, and we have done it in very limited spaces. It is 
probably something we could talk about in more detail offline.
    Safety is something that we are sometimes able to do more 
readily. A drug in a class that has an adverse effect, we will 
worry about does that same adverse effect occur in other drugs 
in the class? We have discovered over the years that very small 
differences in molecules have very large impacts in terms of 
effectiveness.
    THC and CBD are very close to one another at a molecular 
level and yet have extraordinarily different patterns of use.
    Mr. Ruiz. So your comments earlier said that CBD does not 
come without its risks. That is what we have all been talking 
about here. Your testimony outlines some of these risks. Can 
you elaborate more about what you know about CBD so far and 
what questions the agency may still have related to other uses?
    Dr. Throckmorton. And now you are talking about safety, or 
are you talking about effectiveness?
    Mr. Ruiz. Safety in other uses.
    Dr. Throckmorton. So safety, I think, as you said, my 
testimony outlines, I would say, several buckets: one, adverse 
effects that we have observed in the clinical trials leading to 
the approval of Epidiolex; two, unknowns, things that we 
believe we need to have additional information about. I would 
put in that category particularly things like----
    Mr. Ruiz. Right.
    Dr. Throckmorton [continuing]. The liver injury and 
testicular injury.
    Mr. Ruiz. I only have seven minutes, and I just want to 
make a very important statement here, that, as you conduct your 
data collections, you have got to ensure that you have a 
diverse sample of populations. Too many research is done on men 
and non-Hispanics and non-African-Americans in the medical 
world, and I believe that, in all categories of research, you 
need more women, and you need more people of color. OK?
    Dr. Throckmorton. Agreed.
    Mr. Ruiz. All right. Thank you.
    I yield back.
    Ms. Eshoo. The gentleman yields back.
    The Chair now recognizes Ms. Schakowsky of Illinois, 
waiving onto the subcommittee, for her 5 minutes.
    Ms. Schakowsky. Thank you, Madam Chair, and I appreciate 
being able to waive onto the committee.
    I am a proud original cosponsor of Representative Jeffries' 
Marijuana Freedom and Opportunity Act and a cosponsor of 
Representative Nadler's MORE Act, which would both remove 
cannabis from regulatory Controlled Substances Act and add the 
criminal justice and mass incarceration address-it issue that 
we have been perpetually backing, and so that would get rid of 
that.
    Here is what--I want to focus on research, too. Everybody 
has, it seems, or most people. On January 1st, Illinois 
legalized recreational cannabis across our State, and 
dispensaries sold more than $19.7 million in cannabis over the 
first 12 days.
    However, research at Northwestern University, which is in 
my district and is a leading research institution, have no way 
of accessing the cannabis that is sold in these dispensaries. 
And instead Northwestern scientists often face extreme 
difficulty in securing and maintaining cannabis and Federal 
funding for the research.
    So I am glad that there is strong bipartisan support, at 
least for most of H.R. 3797, Representative Blumenauer's 
Medical Marijuana Research Act of 2019. The bill would 
streamline the cannabis research process to ensure that our 
academic institutions remain at the cutting edge, et cetera.
    Dr. Volkow and Dr. Throckmorton, how can we establish a 
process by which researchers in a State like Illinois, where 
recreational marijuana has been legalized and several different 
strains of cannabis are now widely available--how could 
Illinois acquire the research supply through local 
dispensaries?
    Ms. Volkow. And this is a question that we have been 
discussing it, and DEA is the one that is actually on the 
process of identifying additional sources of marijuana so that 
researchers can investigate marijuana from different 
dispensaries. So that is ongoing, and so--but that is regulated 
by the DEA.
    Ms. Schakowsky. And can we look forward to some change 
there?
    Mr. Strait. As we have previously discussed, I think one of 
the challenges is unfortunately the fact that, for your 
purposes, a researcher who is procuring a controlled substance 
for research purposes is obligated under the Controlled 
Substances Act to procure that substance from another Federal 
DEA register----
    Ms. Schakowsky. Right.
    Mr. Strait [continuing]. To research it.
    Ms. Schakowsky. Right.
    Mr. Strait. So none of these dispensaries are applying for 
a registration. None of them are registered with the DEA, and, 
therefore, they are unable to distribute to researchers.
    Ms. Schakowsky. So we would have to get marijuana off the 
Controlled Substances Act--out of it in order to do the 
research that we absolutely need to do on what is being sold 
right now, and millions and millions of dollars being spent on 
it, and many, many users?
    Mr. Strait. Well, certainly that is your discretion and 
Congress' discretion as one way to solve that issue. I do not 
know at the end of the day where this administration would come 
down on that approach.
    Ms. Schakowsky. Is that the only way?
    Mr. Strait. No. I think there are other legislative means 
by which Congress could propose to change that specific 
requirement, but I do believe that it would require some 
legislative changes to the Controlled Substances Act.
    Ms. Schakowsky. I did want to say about that piece of 
legislation, H.R. 3797, that I do have a concern that DOJ would 
have the ability to deny medical marijuana licenses based on 
even minor past drug convictions, and I hope that we can also 
remedy that. Though I know that we do not all agree on 
deregulation and descheduling, we, I think, at the very least, 
should be able to work together to ensure adequate research is 
able to be conducted so that we know the consequences of what 
people are using right this very minute in the State of 
Illinois and many other States.
    And I yield back.
    Ms. Eshoo. The gentlewoman yields back. Votes have been 
called, and I recognize the gentlewoman from the State of 
Washington, Ms. McMorris-Rodgers, for 5 minutes.
    Mrs. Rodgers. Thank you.
    Thank you, Madam Chair, and I also want to recognize the 
ranking member and all the committee members. I appreciate this 
committee being engaged on this public health and consumer 
safety topic around cannabis. I get asked about this a lot in 
Washington State. We legalized both recreational and medicinal 
marijuana the same year as Colorado. I believe we were the 
first two States.
    I am a cosponsor of Blumenauer's Research Act because I do 
think that we need more research. I also represent Washington 
State University, and it is in the same situation as Ms. 
Schakowsky's university around wanting to do more research 
around the issue.
    Since we have legalized marijuana, the number of cannabis 
products available on the marketplace has exploded over the 
years, and so have the marketing tactics that promise cannabis 
is a miracle for your health. A quick search promises you 
cannabis products will help you sleep, relieve your pain, calm 
your anxiety, shrink tumors, cure diseases, and a whole lot 
more.
    The concern is that these claims are not yet backed by 
scientific research or clinical trials. I am concerned about 
manufacturers who are ignoring all the unknowns of cannabis and 
spending health promises to fuel an industry that is projected 
to be nearly $2 billion by 2022.
    I do believe that this industry, like with the FDA- 
approved CBD oral solution for epilepsy--and others have 
mentioned this--is on the verge of major breakthroughs that can 
improve people's lives, and we should be encouraging these 
developments. Like other cures and treatments, cannabis 
products should be held to a standard that people can trust so 
that the bad actors cannot spin to make a quick buck.
    Bottom line: this is a public health and a consumer safety 
issue. Those priorities should be at the forefront as we unlock 
the mysteries of cannabis.
    Dr. Throckmorton, I wanted to ask--and others have been on 
this topic also, but, as I mentioned earlier, the FDA has 
approved only one CBD product, a prescription drug product to 
treat epilepsy.
    That being said, all sorts of CBD products are being 
marketed and sold throughout the country. We have no idea what 
the health implications may be.
    So what is the solution to this? How should it be handled?
    Dr. Throckmorton. So not one solution; that shouldn't be a 
surprise, right? I personally believed one really important 
element is to encourage the development of a mature industry 
using these products--an industry used to manufacturing 
standards; industry used to packaging standards, labeling 
standards; an industry of the kind that you see when you go 
into Walmart and Costco and places like that. Those products 
are being manufactured to a standard, as you said, which I 
think is very valuable.
    I hope that, by the recent increase in interest in doing 
research using these products, behind that will be a growth of 
an industry that wants to do the right thing, that wants to be 
science-driven, appropriately labeled, manufacturing to a high-
quality standard. I think that is one important element, among 
other things.
    I also think it is terribly important that we lay out a 
pathway for nondrug products containing compounds from hemp so 
that there is a clear path that developers can follow to find a 
way forward as far as developing those products and making them 
appropriately available.
    Mrs. Rodgers. Do you see that happening at the State level 
in any of the States where marijuana has been legalized?
    Dr. Throckmorton. Yes, I do.
    Mrs. Rodgers. Either for the industry or the nondrug 
products?
    Dr. Throckmorton. We have really benefited from talking 
with the states. I would say your State has been particularly 
helpful to us as we talked to them about their experiences 
because you have had to deal with all of these things.
    The States are all taking different approaches, but many of 
them--and I would say including your state--I know are 
grappling with these issues around labeling and dosing and 
manufacturing quality and things like that, and we are trying 
to learn from those experiences as we try to formulate a policy 
at the Federal level.
    Mrs. Rodgers. Another big concern is the increase in 
traffic accidents and traffic fatalities around the use of 
these products, and we have seen some pretty dramatic increase 
in numbers around accidents, at the very time that we are 
working here diligently to make our roads safer, and now also 
the number of fatality accidents that involve one of these 
products.
    What needs to happen in that regard to make sure that we 
are safe on the roads?
    Dr. Throckmorton. So it is one of the unknowns we have 
identified for cannabidiol. We have studied it in children. We 
never did those kinds of studies because children don't drive, 
but we understand we need to understand the effects of CBD on 
driving impairment. We need to have that--those data as soon as 
we can.
    Mrs. Rodgers. OK. Well, there is a lot more to explore 
here. Thank you all for being here.
    Thank you, Madam Chair.
    Ms. Eshoo. The gentlewoman yields back, and we thank her 
for participating in our hearing.
    So let me, on behalf of all of the members of the 
subcommittee, thank our witnesses. This is a long hearing. I 
might add it is the very first hearing on cannabis in the 
history of the Energy and Commerce Committee, which is the 
oldest committee in the Congress.
    So it has been a long hearing, but I think a highly--excuse 
the expression--instructive one because of the participation of 
all of the members, and we will have another hearing from other 
stakeholders that are not agency stakeholders. So thank you 
again to each one of the witnesses.
    Where you weren't instructive, it was instructive to us, 
and so much of your testimony was. We learned from you. And we 
have, I believe, the vehicles to develop a roadmap to address 
this lack of really substantive research that is absolutely 
needed. That is foundational to what--you know, so many of our 
undertakings.
    So I want to submit the following statements for the 
record, and I also want to remind members--of course they are 
not here--that, pursuant to committee rules, they have ten 
business days to submit additional questions for the record to 
be answered by the witnesses or to whomever questions are 
submitted. We count on our witnesses to respond promptly to any 
of the questions that you may receive, and I trust that you 
will do that.
    So I request anonymous consent to enter into the record the 
following documents: the statement from the Greenwich--from 
Greenwich Biosciences; a statement from the American College of 
Occupational and Environmental Medicine; a statement from the 
National Safety Council; a letter from the National Consumers 
League; a statement from Doctors for Cannabis Regulation; 
testimony of Aaron Smith, executive director of the National 
Cannabis Industry Association; a letter from over 100 
organizations in support of H.R. 3884; a letter from five 
organizations representing State legal cannabis businesses; a 
statement from the California Cannabis Industry Association; 
the testimony of Congressman Hakeem Jeffries in support of H.R. 
2843; a statement from Kris Krane, president of 4--the number 4 
and the word ``Front''--Ventures; a statement from Americans 
for Safe Access; a report from the National Cannabis Industry 
Association entitled ``Adapting a Regulatory Framework for the 
Emerging Cannabis Industry''; a statement from the American 
Property Casualty Insurance Association; the testimony of Paul 
Armentano, deputy director of the National Organization for the 
Reform of Marijuana Laws; a response letter from FDA/NIH to 
Senator Schatz; a letter from the minority requesting a hearing 
on cannabis, and here we are, and I said yes; a letter from the 
American Academy of Neurology in support of H.R. 171; a letter 
from the American Academy of Neurology in support of H.R. 601; 
a Bloomberg News article entitled ``Pot Imports Grow as U.S. 
Stalls on Medical Research''--quite timely; a collection of six 
letters from organizational supporters of H.R. 3797; a 
statement from the Biopharmaceutical Research Company; a letter 
from Smart Approaches to Marijuana; a letter from the Michael 
J. Fox Foundation in support of H.R. 601; a statement from the 
Consumer Brands Association; a letter from the DEA in reply to 
an application to grow marijuana for research purposes; and 
slides created by NIH entitled ``Effects of Cannabis on the 
Human Brain.''
    Without objection, so ordered.
    [Material submitted for inclusion in the record follows:]
    Ms. Eshoo. Does the ranking member have anything he wishes 
to submit?
    Mr. Burgess. I would not do anything to prolong the 
hearing.
    Ms. Eshoo. All right. So, on that happy note, thank you to 
each one of our witnesses again.
    To everyone that remained in the hearing room, thank you 
for your attentiveness.
    And, to the reporters, the press, thank you for your 
interest.
    At this time, the subcommittee is adjourned.
    [Whereupon, at 1:22 p.m., the subcommittee was adjourned.]

               Prepared Statement of Hon. Eliot L. Engel

    Thank you Chairwoman Eshoo and Chairman Pallone for holding 
today's important hearing on legislative proposals to modernize 
federal policies on cannabis.
    As an advocate for legalizing cannabis, I have been 
supportive of state laws to legalize cannabis, including 
marijuana. As this sea change has occurred, federal laws have 
begun to catch up. In 2018, I served as a Conferee to the 
Agriculture Improvement Act, better known as the Farm Bill, 
which took a step forward in legalizing cannabis by allowing 
the cultivation of hemp. This past June, I voted for an 
appropriations amendment that would prohibit the Department of 
Justice from interfering in state cannabis programs, including 
those involving marijuana.
    Many of the proposals under consideration today would help 
us move closer to the complete legalization of cannabis. The 
Marijuana Freedom and Opportunity Act, introduced by New York 
Congressman Hakeem Jeffries, would decriminalize marijuana and 
THC by removing it from the list of Schedule I substances. It 
would also provide states with the necessary resources to 
expunge marijuana convictions, which have had a 
disproportionate impact on minority communities. Congressman 
Jeffries' legislation, which I have cosponsored, would provide 
commonsense reforms to our nation's antiquated cannabis laws.
    It is also critical that we streamline the federal process 
for medical research on cannabis. Currently, a number of 
regulatory and legal barriers dissuade promising research into 
cannabis. The bipartisan Medical Marijuana Research Act would 
alleviate many of these barriers and open the door into 
cannabis research.
    I look forward to working with my colleagues, on both sides 
of the aisle, on advancing cannabis policies that are in tune 
with this new decade.

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