[House Hearing, 118 Congress]
[From the U.S. Government Publishing Office]





 
                       HEMP IN THE MODERN WORLD:


                   THE YEARSLONG WAIT FOR FDA ACTION

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

                                HEARING

                               before the

                      SUBCOMMITTEE ON HEALTH CARE
                         AND FINANCIAL SERVICES

                                 of the

                         COMMITTEE ON OVERSIGHT
                           AND ACCOUNTABILITY

                        HOUSE OF REPRESENTATIVES

                    ONE HUNDRED EIGHTEENTH CONGRESS

                             FIRST SESSION

                               __________

                             JULY 27, 2023

                               __________

                           Serial No. 118-57

                               __________

  Printed for the use of the Committee on Oversight and Accountability
  
  
  [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT] 
  


                       Available on: govinfo.gov
                         oversight.house.gov or
                             docs.house.gov
                                ______

             U.S. GOVERNMENT PUBLISHING OFFICE 
 53-026 PDF               WASHINGTON : 2023 
                             
                             
                             
               COMMITTEE ON OVERSIGHT AND ACCOUNTABILITY

                    JAMES COMER, Kentucky, Chairman

Jim Jordan, Ohio                     Jamie Raskin, Maryland, Ranking 
Mike Turner, Ohio                        Minority Member
Paul Gosar, Arizona                  Eleanor Holmes Norton, District of 
Virginia Foxx, North Carolina            Columbia
Glenn Grothman, Wisconsin            Stephen F. Lynch, Massachusetts
Gary Palmer, Alabama                 Gerald E. Connolly, Virginia
Clay Higgins, Louisiana              Raja Krishnamoorthi, Illinois
Pete Sessions, Texas                 Ro Khanna, California
Andy Biggs, Arizona                  Kweisi Mfume, Maryland
Nancy Mace, South Carolina           Alexandria Ocasio-Cortez, New York
Jake LaTurner, Kansas                Katie Porter, California
Pat Fallon, Texas                    Cori Bush, Missouri
Byron Donalds, Florida               Shontel Brown, Ohio
Kelly Armstrong, North Dakota        Jimmy Gomez, California
Scott Perry, Pennsylvania            Melanie Stansbury, New Mexico
William Timmons, South Carolina      Robert Garcia, California
Tim Burchett, Tennessee              Maxwell Frost, Florida
Marjorie Taylor Greene, Georgia      Summer Lee, Pennsylvania
Lisa McClain, Michigan               Greg Casar, Texas
Lauren Boebert, Colorado             Jasmine Crockett, Texas
Russell Fry, South Carolina          Dan Goldman, New York
Anna Paulina Luna, Florida           Jared Moskowitz, Florida
Chuck Edwards, North Carolina        Vacancy
Nick Langworthy, New York
Eric Burlison, Missouri

                       Mark Marin, Staff Director
       Jessica Donlon, Deputy Staff Director and General Counsel
                        Ryan Giachetti, Counsel
                Sarah Feeney, Professional Staff Member
                 Ben Tardif, Professional Staff Member
      Mallory Cogar, Deputy Director of Operations and Chief Clerk

                      Contact Number: 202-225-5074

                  Julie Tagen, Minority Staff Director

                      Contact Number: 202-225-5051
                                 ------                                

           Subcommittee on Health Care and Financial Services

                   Lisa McClain, Michigan, Chairwoman
Paul Gosar, Arizona                  Katie Porter, California Ranking 
Virginia Foxx, North Carolina            Minority Member
Glenn Grothman, Wisconsin            Alexandria Ocasio-Cortez, New York
Russell Fry, South Carolina          Jimmy Gomez, California
Anna Paulina Luna, Florida           Greg Casar, Texas
Nick Langworthy, New York            Summer Lee, Pennsylvania
Eric Burlison, Missouri              Jasmine Crockett, Texas
Vacancy                              Vacancy
                         C  O  N  T  E  N  T  S

                              ----------                              
                                                                   Page

Hearing held on July 27, 2023....................................     1

                               Witnesses

                              ----------                              

Mr. Jonathan S. Miller, General Counsel, U.S. Hemp Roundtable
Oral Statement...................................................     7

Dr. Rayetta G. Henderson, Senior Managing Scientist, 
  ToxStrategies, LLC
Oral Statement...................................................     8

Mr. Richard A. Badaracco, President-Elect, Kentucky Narcotic 
  Officers
  Association; (Retired) Assistant Special Agent in Charge, U.S. 
  Drug Enforcement Administration
Oral Statement...................................................    10

Dr. Gillian Schauer (Minority Witness), Executive Director, 
  Cannabis Regulators Association
Oral Statement...................................................    12

Written opening statements and statements for the witnesses are 
  available on the U.S. House of Representatives Document 
  Repository at: docs.house.gov.

                           Index of Documents

                              ----------                              

  * Statement for the Record, cbdMD; submitted by Chairman Comer.

  * Statement for the Record, Council for Responsible Nutrition; 
  submitted by Chairman Comer.

  * Statement for the Record, Dr. Kevin Sabet, PhD, Smart 
  Approaches to Marijuana (SAM); submitted by Rep. McClain.

  * Letter to Reps. McClain and Porter, July 25, 2023, from the 
  American Trade Association for Cannabis and Hemp (ATACH); 
  submitted by Rep. Porter.

  * Letter to Reps. Comer and Raskin, July 25, 2023, from the 
  Coalition for Access Now; submitted by Rep. Raskin.

  * Report, American Trade Association for Cannabis and Hemp 
  (ATACH), ``Toward Normalized Cannabinoid Regulation''; 
  submitted by Rep. Porter.

Documents are available at: docs.house.gov.


                       HEMP IN THE MODERN WORLD:



                   THE YEARSLONG WAIT FOR FDA ACTION

                              ----------                              


                        Thursday, July 27, 2023

                        House of Representatives

               Committee on Oversight and Accountability

           Subcommittee on Health Care And Financial Services

                                                   Washington, D.C.

    The Subcommittee met, pursuant to notice, at 2:21 p.m., in 
room 2247, Rayburn House Office Building, Hon. Lisa C. McClain 
[Chairwoman of the Subcommittee] presiding.
    Present: Representatives McClain, Foxx, Grothman, Comer (ex 
officio), Porter, Lee, and Raskin (ex officio).
    Mrs. McClain. All right. I want to welcome everyone to 
today's hearing.
    We are here, yet again, to discuss the failures of the--oh, 
let me back up. Let me back up. Start over. Start over.
    The Subcommittee on Healthcare and Financial Services will 
come to order.
    Welcome, everyone.
    Without objection, the Chair may declare a recess at any 
time.
    I recognize myself for the purpose of making an opening 
statement. Here we go.
    I want to welcome everyone today. We are here, yet again, 
to discuss the failures of the Food and Drug Administration. 
Earlier this year, the Subcommittee learned how failures at the 
FDA led to the infant formula crisis. Now, we are learning of 
the FDA's failure to regulate hemp products.
    In both cases, the FDA's action or, quite frankly, lack 
thereof, have hurt families and children. The growth and sales 
of hemp and hemp-derived products, including CBD, was legalized 
in the 2018 Farm Bill.
    CBD was also removed from Schedule I status, which are 
drugs that have no currently accepted medical use and a high 
potential for abuse. It makes sense to remove CBD from Schedule 
I status. We know that CBD can have a medical use, because the 
FDA approved a prescription CBD drug that is used to treat 
children with severe forms of epilepsy. We also know that pure 
CBD does not have a high potential for abuse and cannot cause a 
high because it is not intoxicating. However, if you buy a CBD 
consumer product off the shelf today, in many cases, there are 
no way for the average consumer to verify its purity or even 
the amount of CBD in it, or rely on the FDA's enforcement of 
regulations.
    In fact, one study tested almost 3,000 CBD products, showed 
that only one-quarter of the brands tested their CBD products 
for purity and that only 16 percent of those products tested 
contained exclusively what was stated on their label. Sixteen 
percent. And that is because the FDA has not regulated CBD as a 
dietary supplement or food additive in the 5-years since hemp 
was legalized.
    It is also common for CBD products to contain contaminants, 
like heavy metals, mold, and THC, which is the intoxicating 
chemical in the cannabis plant. The widespread usage of CBD 
products that contain other unknown contaminants has led to 
children accidentally ingesting and overdosing on THC. This 
could be fixed if the FDA regulated CBD as a dietary 
supplement. That would mean that the FDA would have the 
enforcement authority to enforce labeling requirements and keep 
Americans safe and healthy.
    But instead of regulating hemp-derived products under its 
currently--currently existing authority, the FDA announced 
earlier this year that it needs a new regulatory framework for 
hemp and CBD. Translation: Give us more authority, give us more 
money, give us more staff, and only then will we actually do 
our duties under the law.
    This announcement has led to confusion and uncertainty in 
the market, which has suppressed the ability for good-faith 
manufacturers to sell CBD products. It only benefits bad actors 
who capitalize on the confusion and the flood of the market 
with potentially unsafe products.
    The FDA must do better and use their already existing 
authority to regulate hemp-derived products. You know, actually 
do the job they were signed up to do.
    I now recognize the Ranking Member of the Subcommittee, 
Ranking Member Porter, for her opening statement.
    Ms. Porter. Thank you very much, Chairwoman.
    I want to focus on doing the job that they are supposed to 
do as well. But I want to focus on a different body, not the 
FDA. I want to talk about Congress doing the job that it is 
supposed to do.
    Hemp-derived products may provide numerous health benefits, 
such as easing anxiety, insomnia, chronic pain, and addiction. 
That is why today, we have Members on both sides of the aisle 
who are interested in determining how we should regulate these 
products.
    Right now, as the Chairwoman said, you can buy CBD and 
other hemp-derived products in grocery stores, or you can order 
them online to be shipped anywhere. While this framework 
provides a great deal of accessibility, it also creates 
challenges.
    Because hemp-derived products are not federally regulated, 
they may include, not just CBD, but THC, an intoxicant. These 
products can be sold in packaging that makes them look like 
traditional snack foods. That can be confusing to adults and 
children alike, who may not want or intend to consume products 
with intoxicating levels of THC.
    This is a real problem. In fact, just a few weeks ago, the 
FDA and the Federal Trade Commission issued warning letters to 
six companies for illegally selling products containing THC. We 
should all be able to agree that the Federal Government needs 
to regulate hemp-derived products in a way that protects our 
constituents while also making safe products available to them.
    In fact, the FDA convened an internal working group to 
explore how the agency might go about regulating hemp-derived 
products. After its review, the FDA working group came back, 
and they said, we need a new regulatory pathway for hemp-
derived products. They even added that they would like to work 
with Congress--nobody wants to work with us--they would like to 
work with Congress to get that pathway set up through 
legislation.
    Today, Republicans have convened this hearing because they 
believe, apparently, that the FDA does not need any more 
authority from Congress to properly regulate hemp-derived 
products. The problem is that some of the same lawmakers who 
want to do oversight of the FDA for being cautious about its 
existing powers would turn around and blast the agency if they 
ever felt like it went too far beyond its legal authority.
    Look, we cannot have it both ways here. The FDA knows 
Congress will appropriately hold it accountable if the agency 
exceeds its authority. That is our job. So, the FDA is not 
going to take the risk of going too far. Why ask them to take 
that risk when we could just work together across the aisle on 
some commonsense legislation?
    Given the bipartisan interest, Members of Congress should 
have no problem rolling up our sleeves--hell, I do not even 
have any sleeves--and getting to work to establish the 
regulatory pathway that the FDA says it needs. Let us not jump 
to blaming the FDA until Congress has done everything it can to 
set it up for success.
    At this point, we should certainly evaluate how the FDA 
does. In the meantime, the better institution to exhort to do 
its job is us, Congress. We are the better oversight subject at 
this point.
    Thank you, and I yield back.
    Mrs. McClain. Thank you, Ms. Porter.
    The Chair now recognizes Chairman Comer for an opening 
statement.
    Mr. Comer. Well, I want to thank Chairwoman McClain for 
having this very important hearing today on this very important 
topic, and I want to thank our great witnesses who are here 
today.
    Five years ago, Congress passed the 2018 Farm Bill. That 
bill removed hemp and hemp-derived products, including CBD, 
from Schedule I status under the Controlled Substances Act. 
Since that time, farmers, manufacturers, researchers, and 
distributors have looked for various ways to grow the industry 
and provide hemp and CBD products to the American people.
    The U.S. Department of Agriculture's February 2022 National 
Hemp Report shows that over 54,000 acres of U.S. land is 
utilized for hemp farming. Clearly, hemp has so much potential 
for our American economy, from growers and manufacturers to 
businesses of all sizes and consumers of many backgrounds. And 
since 2018, scientific research and careful study has continued 
to shed light on both the efficiency and safety of these 
products, especially CBD.
    FDA continues to imply that adequate scientific data is not 
available to inform their decision-making around CBD and hemp-
derived products. But there is ample available data studying 
CBD and hemp-derived compounds. FDA is simply not being 
transparent with the industry stakeholders or Congress in what 
scientific studies it relies on, and often moves the goalpost 
for researchers attempting to satisfy the FDA's requirements 
through rigorous studies.
    So, even though we have more and more data available to 
regulators to make appropriate decisions about CBD in the 
marketplace, the FDA has taken no meaningful action to provide 
clear guidance and certainty in the market, refusing to 
regulate CBD products under existing lawful pathways. Without 
FDA regulations, the good-faith producers of these products are 
left with no path forward, and consumers are left in the dark. 
It is well past time for FDA to do its job and act.
    More than just a major obstacle to the economic prosperity 
of our great farmers and producers of these products, the FDA's 
inaction has also led to concerns for consumers. With no 
regulations, shelves have been flooded with products that make 
various claims about content and dosage that may or may not be 
accurate, while others may be mislabeled and actually contain 
intoxicating variants of the cannabis plant, like delta-8 or 
delta-9 THC.
    Consumers are often unaware that the CBD product that they 
are ingesting is not only going to assist them with joint pain 
and other relief, but could be adulterated with other 
compounds. The American people need to know what is in their 
products, and the FDA has the power to enforce reasonable 
regulations by regulating CBD as a dietary supplement or food 
additive--and I repeat that--regulate it as a dietary 
supplement or food additive. But still they have not acted.
    I am also concerned about the availability of potentially 
dangerous products making their way into the hands of children. 
Hemp-derived products like CBD and others intended for human 
consumption should be clearly labeled with an accurate 
accounting of their contents and available to responsible 
adults who are aware of any side effects and risks associated 
with those products.
    I have said this before at Oversight hearings, but I take 
hemp-derived CBD--hemp-derived CBD from labs in my 
congressional district in Kentucky that I have seen and have 
confidence in. I think we all agree that it is beneficial for 
the industry and consumers alike when our shelves are stocked 
with products that contain what they say contain, while 
limiting the ability of irresponsible and bad-faith actors to 
mislead consumers.
    If CBD were regulated as a dietary supplement, the FDA 
would have enforcement power to make this a reality. The hemp 
industry would prosper. Consumers would have choice in the 
market and ability to rely on accurate labeling. It would be a 
win for our economy, a win for industry, and a win for the 
American consumer. But instead of doing its job here, the FDA 
has refused to act and use this as an opportunity for a power 
grab, asking Congress for even more authorities and more money. 
Let me be clear. Further bloating the Federal bureaucracy is 
not the answer.
    I look forward to hearing from the witnesses today to 
obtain an accurate understanding of the issues here. I hope 
there is bipartisan support on this issue, and I look forward 
to ways we can work across the aisle to bring about positive 
changes for the hemp industry, the Americans who rely on that 
industry for their livelihood, as well as American consumers 
demanding hemp products.
    Thank you, Madam Chair, and I yield back.
    Mrs. McClain. Thank you, Mr. Chairman.
    The Chair now recognizes Ranking Member Raskin for an 
opening statement.
    Mr. Raskin. Well, thank you kindly, Chairwoman McClain, and 
Chairman Comer also, for being here for this important hearing.
    While the hearing itself is focused on hemp, I do think it 
is part of a sweeping rethinking of cannabis policy that is 
going on across the country. And earlier today, I am proud to 
say that Congresswoman Mace and I introduced our bipartisan 
Cannabis Users Restoration of Eligibility Act, or the so-called 
CURE Act, or at least we hope people will call it the CURE Act.
    Our bill would remove prior marijuana use as an obstacle to 
people getting hired in the Federal Government or passing the 
Federal security clearance process, and so it would allow for 
people who have been denied security clearance on the sole 
basis that they had once used marijuana, either legally as part 
of a medical marijuana or recreational marijuana state, or 
unlawfully in college or whatever, that these people would be 
able to get their security clearance reviewed again, and that 
no longer could be used to nullify their opportunity to be 
hired in the Federal Government.
    This change is imperative, and it is long overdue. I 
learned of the problem because of a constituent who is a 
distinguished scientist and doctor who was about to get hired 
to a sub-Cabinet-level post in the Biden Administration, but 
who failed the security clearance because he accurately and 
faithfully reported on his security clearance form that he had 
used medical marijuana because of a chronic back condition, and 
then he was immediately disqualified. Even though they had 
already told him they were going to offer him the job, he was 
told he could no longer get the job because he had told the 
truth about having used medical marijuana to treat a medical 
condition.
    And then, when we began to look into this, there are, well, 
hundreds of thousands, if not millions, of people who are 
disqualified from even being even able to apply for positions 
they are qualified to hold. And thousands of people that we 
know of who have actually gone through the process and then 
suddenly run into the professional guillotine of a marijuana 
question on the security clearance form.
    So--but I want to thank Ms. Mace for her collaboration and 
cooperation on this bill. We look forward to moving it through 
this Committee with the help, I hope, of Chairman Comer, who I 
know has asked some good questions about it. But I am hoping 
that we will be able to arrive at a good, commonsense bill that 
all Americans would be able to get behind.
    Now, turning back to the Federal rules related to hemp and 
its derivatives, it is important here again that we take a 
commonsense approach to these regulations. The FDA released a 
statement earlier this year explaining that current regulatory 
frameworks for foods and supplements are not appropriate for 
cannabidiol, or CBD, one of the biggest hemp derivatives. The 
FDA explained that the regulatory frameworks may not be 
sufficient for managing risk in conducting appropriate 
oversight for CBD products.
    And I agree with my colleagues that we need reasonable 
regulation of the hemp and hemp-derivative marketplace to 
protect consumers and to ensure that good actors in the hemp 
industry can grow their businesses and we can have a legitimate 
and flourishing market in hemp, but we need to make sure that 
the regulations make sense.
    A vast world of hemp derivatives is flourishing beyond just 
CBD. Among them are newly developed synthetic cannabinoids, 
including delta-8 THC, which can have intoxicating effects when 
consumed. Without regulation, companies can synthesize these 
intoxicants from legal hemp and evade regulatory scrutiny and 
Federal marijuana laws, sending products to market without 
proper testing, labeling, or other safety precautions.
    Hemp-derivative products can come in all sorts of different 
forms. They cannot be easily or always categorized simply as 
food or supplements. These products can be oils, tinctures, 
vape pens and cigarettes, and even cosmetics and skin care. The 
FDA realistically cannot regulate the entire world of hemp and 
its derivatives without additional research authority and 
resources.
    So, I hope we can work with our colleagues to figure out 
the proper path forward, and with the assistance of today's 
expert witnesses, on regulating hemp and its derivatives so 
that we can protect the American people and provide a more 
effective framework for the regulation of a potentially strong 
industry.
    I thank you, Madam Chair, and I yield back to you.
    Mrs. McClain. Thank you, Mr. Raskin.
    I am pleased to introduce our witness panel today.
    Jonathan Miller is a longtime advocate for the hemp 
industry in the United States. He currently serves as the 
general counsel for the U.S. Hemp Roundtable, which advocates 
for the broader hemp industry, including agriculture, oil, 
seed, fiber, and extracts like CBD. Welcome.
    Dr. Rayetta Henderson is a toxicologist and senior managing 
scientist at ToxStrategies. She is the lead author of several 
peer-reviewed publications relating to the safety assessment 
and toxicology testing of CBD as a dietary ingredient.
    Richard Badaracco--did I say that right? Look at me--is the 
incoming president of the Kentucky Narcotic Officers 
Association, who brings four decades of experience as a 
professional law enforcement officer. Among other law 
enforcement roles, he brings special expertise as a retired 
Assistant Special Agent In Charge at the U.S. Drug Enforcement 
Administration. Thank you, sir, for your service.
    And, finally, Dr. Gillian Schauer is an Executive Director 
of the Cannabis Regulators Association, where she leads a 
nonpartisan association agency involved in cannabis and hemp 
regulation across 45 states and U.S. territories. Welcome.
    Pursuant to Committee Rule 9, the witnesses will please 
stand and raise their right hands.
    Thank you.
    Do you solemnly swear or affirm that the testimony that you 
are about to give is the truth, the whole truth, and nothing 
but the truth, so help you God?
    Let the record show that the witnesses all answered in the 
affirmative.
    We appreciate all of you being here today and look forward 
to your testimony.
    Let me remind the witnesses that we have read your written 
statements, and they will appear in full in the hearing record. 
Please limit your oral statements to 5 minutes. As a reminder, 
please press the button on the microphone in front of you so 
that it is on, and the Members can hear you. When you begin to 
speak, the light in front of you will turn green. After 4 
minutes, the light will turn yellow. When the red light comes 
on, your 5 minutes has expired, and we would ask you to please 
wrap up.
    I now recognize Mr. Miller to please begin his opening 
statement.

                    STATEMENT OF JONATHAN S. MILLER

                            GENERAL COUNSEL

                          U.S. HEMP ROUNDTABLE

    Mr. Miller. Madam Chairwoman, Ranking Member Porter, I am 
grateful for the opportunity to testify before your Committee 
today.
    Chairman Comer, I am grateful for your presence today, but, 
more importantly, for your decade-long leadership on behalf of 
Kentucky and U.S. hemp farmers. You and I started on this 
journey in 2012 and worked across the aisle to secure hemp's 
legalization in the Bluegrass state.
    Indeed, hemp's policy success has always been a bipartisan 
hallmark. Unfortunately, the U.S. hemp industry has been 
struggling considerably in the last few years, and this turmoil 
is due, in large part, to decisions made by FDA.
    When Congress passed the 2018 Farm Bill, it explicitly 
legalized the sale of hemp and its derivatives, such as CBD. 
Farmers across the Nation relied on this and invested 
considerable resources to grow and market commercial hemp 
crops, particularly for the product for which there was 
immediate processing, infrastructure, and consumer demand: CBD 
and cannabinoids.
    But just a few hours after the Farm Bill was signed into 
law, FDA asserted its opinion that it was illegal to market CBD 
as a dietary supplement or to use as a food additive. Beyond 
warning letters that mostly targeted illegal disease claims, 
the agency has not engaged in meaningful enforcement. This 
position, coupled with lack of action, has cast a cloud over 
the industry.
    FDA has swung back and forth with contradictory positions. 
First, the agency affirmed its ability to regulate CBD under 
current law. We agreed. But then, in the intervening 4 years, 
FDA stalled, even ignoring congressional appropriations report 
directives to take expedited action.
    Finally, this January, the agency concluded that it could 
not regulate CBD under existing regulatory pathways. It stated 
a concern over the substance's safety. But in so doing, the FDA 
relied on a narrow set of research focused on super-high-dosage 
CBD isolate formulations, while refusing to acknowledge a range 
of studies that demonstrate the safety of various CBD 
formulations at much, much lower dosage levels, such as those 
typically found in products sold at retail. A summary of these 
studies appears in my written testimony.
    Lack of a Federal framework has led to the proliferation of 
unregulated products, some of which raise significant quality 
and safety concerns. Surplus hemp CBD biomass is being 
chemically converted into impairing products, such as delta-8 
THC, which are being sold unregulated, sometimes to minors.
    These products serve as a lifeline to U.S. farmers, and 
when manufactured properly, can be of considerable value to 
adult consumers. We oppose their ban or criminalization, but 
they need to be strictly regulated for safety and kept out of 
the hands of children.
    Meanwhile, Federal regulatory uncertainty severely impacted 
the hemp and CBD market, with reduced manufacturing demand 
resulting in a more than 90 percent commodity price decline, 
crushing farming opportunities.
    Please see this chart behind me. In all but one category, 
prices have collapsed due to FDA inaction. The one exception in 
green, that line represents the price of hemp flour, which 
recovered when it started being widely used for delta-8 THC.
    It is clearly time for Congress to act. We support 
legislation that has been introduced by a bipartisan coalition. 
H.R. 1628 would provide a regulatory pathway for CBD as a food 
and beverage additive. H.R. 1629 would ensure that hemp 
ingredients could be lawfully marketed as dietary supplements. 
In the Senate, S. 2451 and its companion House bill, H.R. 4849, 
would provide both regulatory paths.
    All of these would require compliance with the entire 
existing comprehensive regulatory frameworks for dietary 
supplements and food, which help ensure products are safe, 
properly labeled, and produced under good manufacturing 
practices.
    While we disagree with FDA's opinion that a new regulatory 
regime is needed, especially given the length of time this 
would require, we are certainly open to stricter regulation of 
CBD and other cannabinoid products on top of the existing 
frameworks.
    In the absence of FDA action, the hemp industry has 
established the U.S. Hemp Authority, a self-regulatory 
organization to promote high standards and best practices. 
States have stepped in, but a patchwork of inconsistent law has 
emerged.
    Without a Federal regulatory pathway for requiring such 
standards, economic opportunities for U.S. hemp farmers will be 
diminished, and consumers will not have access to safe, quality 
products. Legislation is necessary to protect consumers, help 
stabilize hemp markets, open up a promising economic 
opportunity for U.S. agriculture, and honor the commitment made 
to growers in the 2018 Farm Bill.
    Madam Chairwoman, the hemp industry may be unique in that 
we are coming to Congress to ask: Please regulate us.
    We appreciate your consideration.
    Mrs. McClain. Thank you, Mr. Miller.
    The Chair now recognizes Dr. Henderson.

                STATEMENT OF RAYETTA G. HENDERSON, PH.D.

                       SENIOR MANAGING SCIENTIST

                           TOXSTRATEGIES, LLC

    Ms. Henderson. Chairwoman McClain, Ranking Member Porter, 
Chairman Comer, Ranking Member Raskin, and Members of the 
Subcommittee, thank you for inviting me to participate in 
today's hearing. I appreciate the opportunity to talk about our 
research and its utility in an overall evaluation of CBD to 
support its safe use as a dietary ingredient.
    I am a toxicologist and senior managing scientist at 
ToxStrategies, a scientific consulting firm that provides 
support for clients in the public and private sectors. I have 
experience in the safety assessment of ingredients that are 
often used in food, supplements, and/or feed. And since the 
2018 Farm Bill, I have been actively involved in the safety 
assessment of CBD and other hemp-derived products.
    I am here today to present our recently published 
preclinical safety studies that provide key information needed 
to conduct robust science-based assessments to evaluate the 
safety of CBD as a dietary ingredient. These studies, in 
combination with other available data, provide a sufficient 
basis from which to determine safe levels of CBD for oral 
consumer use.
    To ensure consumer protection, dietary ingredients must 
meet the relevant prescribed safety standards for their 
intended use, such as those established for new dietary 
ingredients. We have conducted a safety testing program to 
specifically address gaps identified for a CBD product that 
would be expected to be filled as part of regulatory 
compliance. The need for these studies was determined based on 
standard practices typically employed in the safety evaluation 
of dietary ingredients.
    Before I present the outcome of these studies, it is 
important to provide some background on how they are designed 
and used to support safety. A fundamental concept in any safety 
assessment is that the finding of a potential adverse effect 
does not automatically mean there is a risk of that effect 
occurring. Preclinical toxicology studies are intentionally 
designed to be conducted at high enough exposure levels to 
identify potential adverse effects. This is an important 
distinction because exposure levels associated with human 
consumption may be very different from exposure levels tested 
in toxicology studies.
    Substances considered to be beneficial and even necessary 
for health can be toxic if consumed in large enough amounts. 
Understanding the levels at which these effects might occur 
provides the information necessary to determine levels of 
consumption that are unlikely to be associated with such 
effects.
    When sufficient data are available for an ingredient, a 
risk assessment can be performed based on information from 
safety studies and exposure levels and consumers to evaluate 
whether a sufficiently protective margin of safety exists and 
determine a safe level of intake for consumers.
    Our program included six preclinical toxicity studies on a 
hemp-derived CBD isolate. All studies were performed according 
to the highest standards available and involved a collaboration 
and oversight of scientists from multiple disciplines and 
research organizations. In addition, three manuscripts 
summarizing these studies have undergone an independent peer-
review process and are now publicly available in scientific 
journals. A copy of each is provided as an appendix to my 
written statement.
    First, CBD did not cause DNA or chromosomal damage in our 
testing program. This is critical, as a genotoxic finding would 
have precluded its use as a dietary ingredient. Next, our 
studies demonstrated that CBD was well-tolerated following 
repeated consumption in animal models up to the highest dose 
tested of 140 milligrams per kilogram body weight for 90 days.
    In our reproductive study, exposure up to 100 milligrams 
per kilogram body weight a day did not cause adverse effects on 
fertility or reproduction in female animals, nor did it cause 
any developmental effects in offspring. For context, when 
converted to milligrams a day based on body weight, this value 
would be 100fold higher than a dietary supplement product 
containing 70 milligrams of CBD.
    Finally, no adverse effects on male reproductive parameters 
were observed up to the highest dose tested of 300 milligrams 
per kilogram body weight a day.
    Together, this suite of studies provides the baseline data 
that are typically required to evaluate use of a dietary 
ingredient.
    Providing the science to do safety and risk assessment for 
dietary ingredients is expressly in line with the objective of 
protecting the health and well-being of the American consumer. 
We have conducted core safety studies that add to an already 
extensive body of science for CBD, which includes human 
clinical trials and studies in animal models.
    Based on my experience performing similar evaluations, the 
data available are sufficient for conducting a safety 
assessment of hemp-derived CBD isolate. The process would 
follow the same principles that we as risk assessors apply when 
evaluating any ingredient for dietary use.
    Recommendations for safe use, such as exposure levels, will 
depend on a number of factors, including the data available for 
review by the assessors and the population of interest for the 
product. Recommendations for safe use could be refined as 
necessary as new data continue to become available.
    I thank the Subcommittee and its Members for your interest, 
and look forward to answering any questions you may have.
    Mrs. McClain. Thank you, Dr. Henderson.
    The Chair now recognizes Mr. Badaracco.

                   STATEMENT OF RICHARD A. BADARACCO

                            PRESIDENT-ELECT

                 KENTUCKY NARCOTIC OFFICERS ASSOCIATION

              (RETIRED) ASSISTANT SPECIAL AGENT IN CHARGE

                  U.S. DRUG ENFORCEMENT ADMINISTRATION

    Mr. Badaracco. Chairman Comer, Chairwoman McClain, Ranking 
Member Porter, and esteemed Members of the Subcommittee, I am 
grateful for the opportunity to testify before your Committee 
today.
    My testimony today focuses on the absence of a Federal 
regulatory structure to govern the marketing of CBD and other 
hemp-derived products. Mr. Miller testified earlier that the 
collapse of hemp and CBD led many farmers and businesses to 
chemically convert CBD biomass into intoxicating compounds, 
most prominently, delta-8 THC.
    The passage of the Agricultural Improvement Act of 2018 and 
the deregulation of hemp did not specifically address delta-8 
THC, but effectively legalized the sale of hemp-derived delta-8 
THC products with no oversight. Its popularity has grown 
dramatically since 2020, gaining the attention of consumers and 
market stakeholders alike throughout the country.
    Hemp and marijuana are primarily the same plant and often 
are not visually distinguishable. Each contain many 
cannabinoids. The two well-known compounds naturally produced 
in the cannabis plant are tetrahydrocannabinol, THC, both 8 and 
9, and cannabidiol, CBD.
    Mostly, the distinction between hemp and marijuana is the 
concentration of delta-9 THC in the two plants. Hemp, by 
definition, must contain no more than 0.3 delta-9 THC. 
Marijuana plants usually contain anywhere from 5 to 30 percent 
delta-9 THC. It is this substance that produces the 
intoxicating effects of the marijuana plant.
    CBD is a much more prevalent compound in the hemp plant, so 
the standard method of creating delta-8 THC involves chemically 
extracting CBD from hemp and converting it into delta-8 THC. 
Delta-8 THC has psychoactive and intoxicating effects like 
delta-9, having about half of the intoxicating effects of 
delta-9.
    In many states, including Kentucky, most delta-8 THC 
products are sold throughout unregulated market sources, like 
convenience stores, grocery stores, smoke/vape shops, gas 
stations, and can even be ordered online. These products are 
not reliably tested and have been found to contain many 
impurities.
    In addressing these issues, Congress and regulators may 
choose to work with the U.S. Hemp Authority, the hemp 
industry's self-regulating organization. In the absence of FDA 
regulations, the Hemp Authority encourages manufacturers to 
participate in the program to use best practices and high 
standards in preparing their products. The standards are based 
largely on FDA's regulatory regime concerning dietary 
supplements in food and beverage additives and is enforced by 
third-party auditors.
    However, self-regulation is not sufficient. Federal 
regulation is necessary to ensure that all products on the 
marketplace maintain the highest safety standards. These 
products and their abuse have become a concern for law 
enforcement in many instances.
    However, Congress, law enforcement, and state legislators 
can, right now address some of the complex issues surrounding 
these substances, such as enact legislation regulating the 
manufacturing, sale, and distribution of products containing a 
hemp-derived cannabinoid, including licensing resale--
retailers.
    Enact legislation enabling testing requirements of all 
products containing hemp-derived cannabinoids and create rules 
specifying pass-fail action levels for safety and toxicity.
    Establish child safety packaging and labeling requirements 
along with restrictions to advertising which may appeal to 
minors.
    Regulate the hemp industry so products contain only the 
legal limit of 0.3 percent or less of a concentration of THC.
    Mandatory reporting to a government entity when ingestion 
of these substances led to an adverse reaction. Law enforcement 
believes these events are underreported.
    Seek state or Federal funding for forensic lab 
infrastructure that could assist and help with the development 
of improved hemp and marijuana differential methods.
    And training for law enforcement officers concerning these 
substances and navigating the possible implications of 
arresting and prosecuting individuals under the influence.
    In closing, I want to thank the Committee for examining 
this important topic, and I look forward to your questions.
    Mrs. McClain. Thank you, Mr. Badaracco.
    The Chair now recognizes Dr. Schauer for her opening 
statement.

                STATEMENT OF GILLIAN SCHAUER, PH.D., MPH

                           EXECUTIVE DIRECTOR

                    CANNABIS REGULATORS ASSOCIATION

    Ms. Schauer. Thank you, Chairman McClain, Ranking Member 
Porter, Chairman Comer, and Members of the Subcommittee. Thank 
you for inviting me to testify today.
    My name is Gillian Schauer. I am the Executive Director of 
the Cannabis Regulators Association, referred to as CANNRA. 
CANNRA is a nonpartisan association of government agencies 
implementing cannabis and hemp regulation across 45 states and 
U.S. territories.
    Prior to serving as the first Executive Director of CANNRA, 
I spent more than a decade working with Federal, state, and 
municipal agencies on cannabis-related policy, research, and 
public health. I have a Ph.D. in behavioral science and a 
master's in public health.
    Thank you for holding this hearing. This is the No. 1 issue 
facing my members, cannabis and hemp regulators. Because of a 
broad definition of hemp in the 2018 Farm Bill, we have seen an 
explosion of hemp-derived products that are intoxicating, that 
are not regulated to be safe for consumers, and that can appeal 
to and be accessed by youth. Red states, blue states, every 
state is grappling with this issue.
    Intoxicating hemp-derived cannabinoids, including delta-8, 
HHC, THC-O-acetate, H4CBD, are being made chemically using CBD 
as a source material. Many of these compounds have not been 
studied for safety. People consuming them are literally the 
test case for their safety. And yet they are widely available 
across all states in gas stations, grocery stores, and online.
    Farm bill-compliant cannabinoid hemp products can also 
contain far more delta-9 THC than is legal in state-regulated 
marijuana markets, and yet still be under the 0.3 percent 
delta-9 THC threshold. They can contain high levels of THCA, 
which readily converts to delta-9 THC when heated in products. 
And products marketed as full-spectrum or whole-plant CBD that 
contain all of the compounds found in the hemp plant can also 
have enough delta-9 THC to be intoxicating.
    Hemp and marijuana come from the same plant and have the 
same compounds. Whether delta-9 THC comes from what we call 
hemp or marijuana, it works the same in the body, yet the 
Federal legality of it differs based on the source.
    The Farm Bill did not create a Federal regulatory structure 
to adequately protect consumers. Cannabinoid hemp products are 
sold to anyone, anywhere, without any standards or Federal 
regulations. These products, whether intoxicating or not, have 
no required testing for contaminants, pesticides, heavy metals. 
They are not regulated federally for ingredients or additives, 
particularly those that could be harmful when smoked or vaped. 
They have no required packaging and labeling to tell consumers 
what is in the product and whether they are intoxicating. There 
are no Federal restrictions on products that mimic commercial 
food and candy, and kids can access intoxicating hemp products 
because there are no Federal age restrictions.
    This is in stark contrast to state-regulated marijuana 
markets, which are highly regulated for consumer safety and 
youth prevention. s have seen a range of public health and 
safety issues directly linked to intoxicating cannabinoid 
products, including accidental ingestion by young kids 
resulting in hospitalization, overconsumption by teenagers 
resulting in hospitalization, and unexpected impairment by 
adults who thought they were purchasing something 
nonintoxicating.
    With no Federal regulation in place, state legislatures are 
enacting policies state by state. Policy differs, but, 
increasingly, states are bringing intoxicating hemp products 
under the purview of the marijuana regulator, where the same 
cannabinoids, but derived from marijuana, are being regulated. 
Without Federal minimum standards, we are creating a patchwork 
of regulation that creates consumer safety and market 
challenges and leaves regulatory gaps that cannot be covered by 
states alone, including in online markets and through 
interstate commerce.
    As an association of state regulators, CANNRA is not 
encouraging the recriminalization of cannabinoid hemp products 
but, rather, comprehensive regulation that protects consumers 
and public health across a range of available products.
    We have an opportunity to learn from the approaches that 
states have taken to set thoughtful and comprehensive Federal 
regulatory policy. A Federal regulatory agency with a focus on 
public health and safety, like FDA, needs to be authorized and 
funded with a specific timeframe in which to implement a 
regulatory framework for these products.
    And that framework cannot just focus on CBD. It must 
contend with the breadth of hemp-derived cannabinoids we see on 
the market today, both intoxicating and non, and it must 
account for those products we do not yet know about. It must 
consider the many ways cannabinoid hemp products are consumed: 
as foods, as beverages, vaped products, smoked products. It 
must also require contaminant testing and compliance and 
enforcement. These essential components of a regulatory 
framework for cannabinoid hemp extend beyond traditional food 
and dietary supplement pathways.
    These issues are far more nuanced and detailed than what I 
have been able to cover with you in these opening remarks. My 
written testimony provides additional information.
    I would encourage all of you to reach out to CANNRA, to 
connect with your state cannabis or hemp regulator, to hear 
firsthand from them what this issue looks like on the ground in 
your state, in your jurisdiction.
    Thank you for your time and attention, and thank you for 
including a regulatory perspective on this hearing about 
regulation. I welcome your questions today and your continued 
engagement moving forward.
    Mrs. McClain. Thank you--thank you, Dr. Schauer.
    The Chair now recognizes Chairman Comer for questions, 5 
minutes.
    Mr. Comer. Thank you, Madam Chair.
    Mr. Miller, hemp products, including CBD, were removed from 
Schedule I status in the 2018 Farm Bill. Is that correct?
    Mr. Miller. Yes.
    Mr. Comer. Since the 2018 Farm Bill, have private companies 
attempted to enter the market with hemp and CBD products for 
the American people?
    Mr. Miller. Absolutely.
    Mr. Comer. Do you have any data on the size of the CBD 
market?
    Mr. Miller. There is--there is considerable data in my 
written testimony that--that----
    Mr. Comer. OK.
    Mr. Miller. [continuing]. We have shared with the 
Committee.
    Mr. Comer. The FDA has not regulated hemp-derived products, 
including CBD, in the 5 years since the 2018 Farm Bill was 
passed. Has the FDA's lack of action impacted the hemp 
industry?
    Mr. Miller. Yes. No. As I mentioned earlier, the lack of 
action has cast a shadow over the industry. There have been--it 
has kept a lot of big box stores from carrying products that 
they otherwise would. It has kept a lot of big food and 
beverage companies from adding CBD to their mixes. And as a 
result, there was a decrease in demand when the supply went way 
up. And as you have seen, economics 101, by the chart I shared 
earlier----
    Mr. Comer. Uh-huh.
    Mr. Miller [continuing]. The prices collapsed----
    Mr. Comer. Yes.
    Mr. Miller [continuing]. And the farmers are bearing the 
burden.
    Mr. Comer. That is right. It has affected farmers too.
    Mr. Miller. The farmers, worst of all.
    Mr. Comer. In a bad way.
    Mr. Miller. Yes.
    Mr. Comer. So, Dr. Henderson, you are the lead toxicologist 
at three published scientific papers analyzing data from 
studies of CBD isolate. Is that correct?
    Ms. Henderson. Yes, that is correct.
    Mr. Comer. Your studies were designed to determine the 
levels of CBD at which you would observe adverse effects?
    Ms. Henderson. That is correct. Yes.
    Mr. Comer. In addition to your research, are you also aware 
of other scientific studies on CBD that would be available to 
FDA regulators?
    Ms. Henderson. Yes, I am. Data on CBD specifically are 
plentiful. CBD has been evaluated as a drug, as we know--
Epidiolex--and so FDA has access to the clinical and 
nonclinical data packages submitted as part of that review.
    It is also my understanding that FDA has commissioned and 
has been conducting their own targeted safety studies on CBD. 
There are other human clinical trials outside of Epidiolex, 
with other CBD formulations, across a wide range of 
populations. And in addition to our studies, there are other 
studies that have been conducted by stakeholders that are not 
published yet. And then there are other preclinical safety 
related studies that are published.
    So, there are a lot of data that we typically do not have 
access to when reviewing an ingredient as a dietary supplement.
    Mr. Comer. All right. So, Mr. Miller, given the 
availability of scientific data related to CBD, would you agree 
that the FDA is not doing its job here by saying there is not 
enough data to proceed?
    Mr. Miller. Correct. They--there is enough data to pursue a 
regulatory pathway for dietary supplements and food and 
beverage additives.
    Mr. Comer. So, has the FDA at least been transparent with 
stakeholders as to what it needs to move forward with 
regulating CBD? And, if not, how so?
    Mr. Miller. Well, as I mentioned in my testimony, we do not 
think a new regulatory pathway is needed, but we would be happy 
to entertain or--so even support additional regulatory 
safeguards above what is currently under law. But the FDA has 
not specified those in a way that has allowed Members of 
Congress to draft legislation to accommodate that.
    Mr. Comer. All right. Mr. Badaracco, I am very concerned 
with--that without FDA regulations, products mislabeled as CBD 
that are adulterated with other substances will continue to be 
available and potentially present a danger to the public and 
even children.
    Can you describe some of what you are hearing in the law 
enforcement community about the dangers consumers may face?
    Mr. Badaracco. Well, I have--when I knew that I was 
testifying at this hearing, I had caused a solicitation email 
out to the members of KNOA, which is 400 members within the 
state of Kentucky, to give firsthand or anecdotal reports of 
these intoxicants being ingested by middle school children or 
high school children and what the adverse--what the adverse--
what the adverse, if I will, results were.
    Mr. Comer. Right, right.
    Mr. Badaracco. And it--I am continuing to get reports from 
across the state----
    Mr. Comer. Right.
    Mr. Badaracco [continuing]. From--I know in far eastern 
Kentucky, there is a police department, there has been so many 
of these instances----
    Mr. Comer. Uh-huh.
    Mr. Badaracco [continuing]. That that is their No. 1 
priority----
    Mr. Comer. Right.
    Mr. Badaracco [continuing]. With these substances.
    Mr. Comer. Right.
    Mr. Badaracco. I have got two physicians from two hospital 
ERs. I have not talked to them yet, but they want to talk to 
me----
    Mr. Comer. OK.
    Mr. Miller [continuing]. As well as far as what they are 
seeing.
    Mr. Comer. Yes. So, it is a huge problem. We see that 
everywhere. We have seen that in other products that claim to 
contain CBD, and there is no regulatory body to regulate that. 
And very seldom do I, as a typical Republican, advocate for 
regulations, but what you have in the hemp industry, you have a 
lot of credible actors that are doing the right thing, and then 
there are a lot of bad actors.
    And when I say it needs to be regulated like a 
nutraceutical or the vitamins or things like that, you go in, 
and the bottle of supplements--let us use as an example--it 
says how many milligrams of this and what is in the supplement. 
The FDA, to make sure that what the label advertises is what 
actual--what the actual product is that the consumer gets.
    And that is what we are asking for here. Right now, there 
is no one to determine whether or not someone selling CBD is 
being factual when they advertise what is on the bottle, and 
that is a threat, not just to the industry, but to consumers as 
well.
    So, hopefully, the FDA will do that.
    Madam Chair, thank you, and I yield back.
    Ms. Porter. Madam Chair, I would like to enter into the 
record a letter from the American Trade Association for 
Cannabis and Hemp and a report titled, ``Toward Normalized 
Cannabinoid Regulation.''
    Mrs. McClain. Without objection.
    Mrs. McClain. The Chair now recognizes Ms. Lee for 5 
minutes.
    Ms. Lee. Thank you, Madam Chairwoman. I literally was about 
to get up and go to vote, so I appreciate being called on.
    So, yes, we are here today because the Food and Drug 
Administration has committed to using science and data as a 
basis for making policy decisions to protect public health and 
safety. FDA has publicly and repeatedly stated that it had a 
roster of important questions about hemp-derived products that 
needed answers before it could regulate these products.
    They have questions about how much hemp-derived product an 
individual could safely consume in a day, whether this amount 
varies depending on the form taken, potential negative 
interactions with other drugs or substances, effects on special 
populations like children or the elderly, and the risk of long-
term exposure.
    To be clear, I am glad we have extended hemp and CBD into 
our marketplace. However, anecdotal evidence and marketing 
claims are not the same as rigorous scientific research.
    Dr. Schauer, what is the problem with using online 
calculators or trusting product manufacturers regarding an 
appropriate dose of CBD?
    Ms. Schauer. Well, I think state hemp and cannabis 
regulators would tell you that we need academic data, we need 
nonpartisan data sources, and we need pathways that account for 
what we are seeing in the field. So, we are not just seeing 
dietary supplements in the field. We are seeing inhalables and 
combustible products as well. We need data on those products. 
Those products do not fit neatly into a regulatory pathway that 
FDA currently has and need to be studied.
    These novel cannabinoids that are coming out as well, being 
converted from CBD, we need data to understand those. And, 
increasingly, very few products are just CBD. The products 
contain CBD and many other cannabinoids. We need to understand 
how those cannabinoids interact, what their effects are on 
humans. And we need not to be using humans as the test case for 
that. We really do need science to create thoughtful 
regulation.
    Ms. Lee. So, would regulating industry through the existing 
food and dietary supplemental regulatory pathway address these 
concerns with the safety of CBD products? Yes or no?
    Ms. Schauer. I do not believe that it will. If I can take a 
second, there are three main reasons, I think, for that. One is 
we have inhalable and combusted products that do not fit into a 
food or dietary supplement pathway.
    Two, dietary supplements usually follow GMP practices. 
Every state is trying to use testing. We really need to know 
what contaminants are in the products, and that is not a 
traditional part of the dietary supplement pathway.
    And then, finally, we need specific warnings and labeling 
based on the route of administration, which, again, is not just 
food or dietary supplement; it includes other pathways.
    Ms. Lee. So, the FDA believes it needs additional 
scientific studies and new authorities to balance consumer 
access with appropriate safeguards and oversight. This 
Subcommittee should understand the need for careful oversight, 
and we should work with the FDA to achieve it.
    In addition to protecting public health, we also need to 
ensure we encourage diversity and inclusion in this growing 
industry. I have worked hard in this Congress to promote 
diversity, both in and out of committee hearings. In my role on 
Science, Space, and Technology Committee, I will be sending a 
letter to the Chair addressing the need for more diverse 
witnesses.
    Mr. Miller, can you tell us about the purpose of the U.S. 
Hemp Roundtable's Minority Empowerment Committee?
    Mr. Miller. Yes. As you are all too aware, cannabis has a 
very sad history when it comes to disparate treatment of people 
of color, and there has been structural racism that has 
pervaded Federal farm programs. And so that is why our 
organization, and I think the industry at large, has really 
engaged in an effort to promote diversity and equity in our 
ranks.
    Ms. Lee. Thank you. Effective oversight and a dedication to 
science and evidence are the best way to move forward with hemp 
and CBD. However, I also want to be sure that we are deliberate 
in our approach to regulation and do not follow the path of 
overcriminalization. I am encouraged by the potential benefits 
of these products and look forward to continuing to learn and 
work on this issue.
    With that, thank you so much, and I yield back.
    Mrs. McClain. Thank you.
    Pursuant to the previous order, the Chair declares the 
Committee in recess, subject to the call of the Chair.
    We will plan to reconvene rather quickly right after votes. 
We just need to go vote, and we will come right back. Thank 
you.
    So, the Committee stands in recess.
    [Recess.]
    Mrs. McClain. The Subcommittee on Healthcare and Financial 
Services will come to order, and we will reconvene.
    The Chair now recognizes Mr. Grothman for 5 minutes.
    Mr. Grothman. Mr. Miller, if CBD is regulated as a food 
supplement or additive by the FDA, what would the economic 
consequences be?
    Mr. Miller. There would be enormous economic consequences. 
I laid this out in my written testimony, but there are 
independent studies. The Brightfield Group is one of those 
economic groups that claim that that difference could be a $5 
billion a year difference if these avenues are--these 
regulatory pathways are made clear.
    Mr. Grothman. OK. Other countries like U.K., Australia, 
have regulated CBD. How is our--and they found it safe. How is 
our market different than theirs?
    Mr. Miller. It is not at all different. I think that we can 
look at Australia and Great Britain and Canada for good 
examples of how CBD could be regulated.
    Mr. Grothman. OK. What do you think we should do with CBD 
in this year's farm bill?
    Mr. Miller. I would love to see the legislation like 1628, 
1629 attached to this year's farm bill. I understand that there 
are jurisdictional issues with the House Agriculture Committee, 
but I am hopeful that those can be resolved. And perhaps, if it 
has to be added in conference committee, we would be very 
supportive.
    Mr. Grothman. OK. What percentage of hemp farming is 
dedicated to CBD and other extracts?
    Mr. Miller. It used to be about 90 percent. That was the 
last study I have seen. That was a couple years ago. I do think 
it has declined a bit. There has been a growth in the fiber 
side, but it certainly is still an overwhelming part of the 
hemp industry.
    Mr. Grothman. OK. So, we do not know. It has probably 
dropped, though?
    Mr. Miller. Yes.
    Mr. Grothman. OK. What does action look like from Congress 
so that we do not interfere with the FDA's authority?
    Mr. Miller. Pass H.R. 1628, 1629. Congressman, you have 
been a strong supporter of both of those bills in the last 
Congress as well. We really appreciate that. But if we are able 
to affirmatively direct FDA to regulate CBD as a dietary 
supplement and food beverage additive, even if we are going to 
add additional regulatory oversight on top of that, we are open 
to that as well.
    Mr. Grothman. OK. Mr. Badaracco, in your estimate, is it 
legal to ship delta-8 THC products derived from CBD across 
state lines?
    Mr. Badaracco. It really depends on the state, I think, and 
it is kind of a mixed bag, if you will, between----
    Mr. Grothman. There is not a norm you can cite?
    Mr. Badaracco. I am sorry?
    Mr. Grothman. There is not a norm that you can cite?
    Mr. Badaracco. No. No. I mean, you have states that 
decriminalized marijuana. You have states that have 
criminalized delta-8 products. You have states that have 
medicinal only, states that have recreational and medicinal. 
So, it is really a mixed bag across the country.
    Mr. Grothman. OK. Can it be ordered on the internet?
    Mr. Badaracco. Yes.
    Mr. Grothman. OK. Why do you think some companies feel that 
they can do this?
    Mr. Badaracco. You know, it is without regulation--I mean, 
there is two ways, and they are using the 2018 hemp bill to do 
this. You know, I think it was an unintended consequence, 
because they can extract--CBD and hemp is infinitesimal. I 
mean, it is less--1 percent or even less. But there is 
plentiful CBD in hemp, so they will extract the CBD, chemically 
convert it into delta-8 THC, and then use that to make a 
variety of retail products, whether that be hemp flowers and 
they treat it with delta-8 for smoking, capsules, ingestibles 
which is candy, brownies, other ingestibles.
    Mr. Grothman. Does anybody have the idea of the size of 
this so-called problem or problem?
    Mr. Badaracco. I can only speak anecdotally from the 
response I am getting from the memberships from the Kentucky 
Narcotic Officers Association. I am getting more and more 
firsthand, as well as anecdotal reports of these substances 
being consumed by middle school and high school kids and having 
adverse reaction. I am also----
    Mr. Grothman. You think they are ordering it on the 
internet?
    Mr. Badaracco. I am sorry?
    Mr. Grothman. You think they are ordering it on the 
internet?
    Mr. Badaracco. We do not know. We do not--we really do not 
know. There are ongoing investigations concerning that, but at 
this point, I do not know.
    Mr. Grothman. Mr. Miller, are there any hard numbers on 
this you know?
    Mr. Miller. No. It has been gathered on a state-by-state 
basis, but it is clear that kids have been getting it. Vape 
stores, convenience stores, those are other places where you 
will find that kind of commerce.
    Mr. Grothman. OK. Thank you.
    Mrs. McClain. Thank you, Mr. Grothman.
    The Chair now recognizes the gentlelady from North 
Carolina, Dr. Foxx.
    Ms. Foxx. Thank you, Madam Chairwoman.
    And I will follow up on Mr. Grothman's comments. Mr. 
Badaracco, what are the dangers of problems associated with 
consuming CBD products that may contain widely varying levels 
of intoxicants?
    Mr. Badaracco. I mean, with children having to go to the 
emergency room--which there is reports that I referenced to 
that we are starting to get now--it can add to agitation, 
increased heart rate, nauseous, unconsciousness, things of that 
nature. There was a report just yesterday from Covington, 
Kentucky, of a 10-year-old, I think was the age of the 
individual, who bought a gummy bear which turned out to be a 
THC delta-8 gummy bear treated, and it had 10 dosages in it. 
And the child consumed it and, of course, went to the ER and 
was experiencing many of those symptoms that I had just 
described. And I am finding this across the state.
    Ms. Foxx. I was going to follow up about children, so thank 
you for covering that in your answer.
    Why doesn't the Drug Enforcement Agency go after 
intoxicating CBD products that are synthesized from legally 
grown hemp?
    Mr. Badaracco. Well, I think it is--you are seeing kind of 
a mixed bag from the court system. I know the Ninth Circuit 
said that delta-8 is the derivative of hemp, so therefore it is 
illegal. A Kentucky court has also expressed that opinion as 
well, legalizing delta-8 in the state of Kentucky. But it is--
other than that, there is really no direction or regulatory 
framework to use, because under 2018--the Farm Bill under 2018 
where it is a derivative of hemp, it is being treated as legal.
    Ms. Foxx. So, can the average person tell with any 
confidence if a CBD product contains intoxicants?
    Mr. Badaracco. Not really, no. Not right now. Not without 
having a specific labeling of what exactly is in the 
substances. Part of the--how should I say? You know, part of 
the chemical process, you know, CBD is in large quantities from 
the hemp plant, and it is extracted chemically to make delta-8 
THC. And they use syrup--many, many manufacturers will use 
solvents to make that conversion and acids to convert it as 
well.
    Ms. Foxx. Thank you.
    Mr. Miller, we know the FDA has not been regulating hemp-
derived products, but has the FDA engaged in any meaningful 
enforcement?
    Mr. Miller. No. The only enforcement actions they have 
taken so far are sending warning letters. Most of those warning 
letters have been to companies that have been making outrageous 
medical claims, like this CBD is going to cure cancer or it is 
going to cure COVID. But to date, they have not been seizing 
anything off the shelves or taken any other more direct 
enforcement action.
    Ms. Foxx. Mr. Miller, do you believe that delta-8 THC and 
other compounds derived from CBD that can be intoxicants are 
legal to produce and sell under Federal law?
    Mr. Miller. You know, it is still an open question, but as 
Rich mentioned earlier, the Ninth Circuit has weighed in and 
says that they are legal. A number of state courts have said 
the same thing. However, in certain states, we have seen them 
be declared illegal. New York is one of those, for example. So, 
it is really a mixed bag and really a reason why FDA--we need 
to have a Federal approach. And as we argue, let us not ban 
them, let us not criminalize them, but let us strictly regulate 
them and keep these intoxicating compounds out of the hands of 
children.
    Ms. Foxx. So, mention was made already of the 2018 Farm 
Bill. With the passage of that bill, did Congress intend to 
allow for the sale of intoxicants?
    Mr. Miller. You know, when we were lobbying up on the Hill 
for the 2018 Farm Bill, in 2014, for that matter, we said hemp 
is not marijuana. Hemp is not intoxicating. And so, I do not 
believe that that was the intent of Congress. But the language 
got written as it was, and this loophole was found. And 
frankly, as I mentioned earlier, it has really been a lifesaver 
for many farmers who have struggled because of CBD lack of 
regulation. We just need to get a hold of it. We need to 
regulate it. We need to get it out of the hands of kids.
    Ms. Foxx. So, do you believe intoxicants should be sold 
under the farm bill?
    Mr. Miller. I would like to see new legislation that would 
put intoxicating cannabinoids under a stricter regulatory 
regime, whether that be at FDA or, potentially, the TTB is 
another possibility. But we look to Congress to try to make 
sure that they are regulated in a way that will help keep them 
away from kids.
    Ms. Foxx. Thank you. And thank you, Madam Chair.
    Mrs. McClain. Thank you.
    I recognize myself for 5 minutes.
    Thank you all again for being here. I really appreciate it.
    I want to understand a little bit about regulation. Am I 
assuming, Mr. Miller, without regulation from the FDA right 
now, is there any way for the average consumer to verify the 
ingredients?
    Mr. Miller. As both Rich and I mentioned in our testimony, 
there is a self-regulating organization called the U.S. Hemp 
Authority that provides a certificate for manufacturers who go 
through an intensive process of good manufacturing practices, 
truth in labeling, and they put on the label----
    Mrs. McClain. So, as consumers, we should look for that, so 
that would be----
    Mr. Miller. Yes, I would look for the U.S. Hemp Authority 
label. Some states have also stepped into the breach and have 
come up with good regulatory structure.
    Mrs. McClain. If there is a consequence, meaning I have a 
CBD product and I say it is X and it is less than X or, 
unfortunately, more than X, whatever it may be, is there any 
consequence to my action if I falsify what is in the 
ingredients?
    Mr. Miller. In some states, there is some regulatory 
ability to do that, but the vast majority of products, there is 
no enforcement.
    Mrs. McClain. Not real enforcement, so to speak?
    Mr. Miller. No.
    Mrs. McClain. OK. I am curious how this has affected the 
private sector's ability to participate in marketing a product 
that was legalized in the 2018 Farm Bill.
    Mr. Miller. I mean, it has devastated our industry, and it 
has imposed tremendous burdens because of this lack of 
regulatory authority.
    Mrs. McClain. Hence, you showed us that slide at the very 
beginning of the opening.
    Mr. Miller. Right.
    Mrs. McClain. The only one I think you said that was 
profitable was the flower?
    Mr. Miller. Yes. The flower that is converted into delta-8 
THC, which we mentioned----
    Mrs. McClain. And that is very dangerous, right?
    Mr. Miller. It can be dangerous. Certainly, if it is 
manufactured improperly and if it is sold to children.
    Mrs. McClain. And there is no regulation on that as of 
current?
    Mr. Miller. No. No, regulation at all.
    Mrs. McClain. OK. Has the FDA been receptive to efforts 
from private sectors to have their products regulated?
    Mr. Miller. No. The FDA meets with us--the industry about 
once a year. They are always listening sessions, so we do the 
talking and they do the listening.
    Mrs. McClain. So, just to be clear, this is private 
industry petitioning for more regulation?
    Mr. Miller. Yes.
    Mrs. McClain. I mean, that is like cats and dogs living 
together.
    Mr. Miller. I know. We are begging. We are begging.
    Mrs. McClain. OK. Can you explain why regulations in this 
instance would not help industry? If we did not regulate it, 
would it help industry?
    Mr. Miller. No, no. Regulation will help industry because 
it would help stabilize the markets. These big box stores and 
big food companies would start carrying their products, the 
prices would go up, and it would give consumers a lot more 
confidence that these products are safe. Right now, they are 
taking a risk in buying them. So, regulation would be really 
good for business, which----
    Mrs. McClain. OK. So, it is good for business. It helps 
protect children. It was instituted in the 2018 Farm Bill, yet 
the FDA has slow-walked, maybe, not even at all, done any sort 
of regulation on this?
    Mr. Miller. Yes. They--oh, go ahead.
    Mrs. McClain. Correct?
    Mr. Miller. Correct.
    Mrs. McClain. I just find that ironic that we give this 
agency money, authority, and they cannot do their job. I would 
love to come into work and say, you know what, if you just paid 
me a little bit more, I will go to a few more hearings, I will 
take a few more votes. It just does not work like that, right? 
I am sure the average American would love to do that.
    Do the job you were signed up to do. I mean, I am almost on 
the opposite. I think we should start rescinding dollars until 
people actually start doing the job they signed up to do, and 
stop with the excuses. It drives me crazy.
    I often wonder, Mr. Miller, I am just curious, it is my 
understanding, and I could be wrong, that the FDA has not 
returned to its pre-pandemic telework policy. Is that correct?
    Mr. Miller. I am unaware of their policies.
    Mrs. McClain. Anybody have any data on that?
    The data I show is they have not returned back to work a 
hundred percent.
    Do you believe that the failure to work in person may be 
contributing to this?
    Mr. Miller. Yes, I would not comment because this has been 
a running problem since before the pandemic hit.
    Mrs. McClain. Yes. Perhaps if we just went back to work, we 
would have more hours in the day to do the job that we signed 
up to do.
    What are the concrete steps that the FDA can immediately do 
to engage--to take this more seriously? If you could have a 
wish list, what could the FDA do right now?
    Mr. Miller. Well, the first thing is they could immediately 
start regulating these products as dietary supplements and food 
and beverage additives.
    Mrs. McClain. And they have the authority to do that?
    Mr. Miller. We believe they have the authority to do that.
    Mrs. McClain. I do too.
    Mr. Miller. Now, they would like to have an additional set 
of regulations on top of those, and we are not opposed to that. 
And so, the next best thing they can do is to define, very 
specifically, what that regulatory structure would look like, 
so to aid Congress in developing a regulatory regime.
    Mrs. McClain. Very good. Thank you, again. And I thank each 
of you for being here today. I appreciate your insightful 
testimony and expertise. Unfortunately, the government 
bureaucracy appears to have gotten in the way of the American 
hemp industry and consumer safety, the actual opposite of what 
they were supposed to do.
    To be clear, the industry wants regulation to inject 
certainty into the market so good-faith businesses can prosper 
and deliver high demand products to consumers. And we want this 
opportunity to happen right here in the United s to benefit 
growers and everyone else up and down the supply chain, all the 
way to the end of consumers who consume the hemp product. It is 
interesting to note that, even though the FDA has not approved 
CBD products as dietary supplements or food additives 5 years 
after the passage of the 2018 Farm Bill.
    Mr. Miller, as he indicated in his testimony, the FDA also 
has not engaged really in any meaningful enforcement actions 
either. Again, wouldn't it be nice to just pick and choose what 
you get to do every day? I would love that, just love it.
    The FDA has not always been transparent or consistent in 
their decision-making with the hemp industry either, and that 
is unfortunate. And although FDA claims to have the available 
safety data, it is limited. The fact is, is that there is data 
available to regulators to actually make informed decisions 
about labeling requirements, dosages, and other measures 
necessary to actually ensure public safety.
    There is rigorous scientific process that goes into the 
toxicology testing and research that scientists like Dr. 
Henderson and others have conducted. On top of that, the 
research is peer-reviewed before it is published. FDA has 
research data available to them to make appropriate decisions 
under their existing authorities.
    We have also heard from law enforcement professionals with 
years of experience, like Mr. Badaracco, about the difficulties 
consumers face in an unregulated market. Lack of FDA action has 
left a market where dangers lurk for consumers who may receive 
products altered with unlabeled substances or with wildly 
inconsistent dosages.
    And finally, Dr. Schauer enlightened us as to how it is 
likely just the first step for the FDA. CBD is just one of many 
derivatives of the cannabis plant, and the public needs the FDA 
not to just start doing its job with respect to CBD, but 
continue to be engaged in this emerging market for the benefit 
of industry and consumers alike.
    The pathway already exists. Congress spoke in 2018. The FDA 
just needs to do the job that the American taxpayer is paying 
them for. And if they cannot do their job, maybe we should stop 
funding them or funding them at reduced levels. Again, the 
pathway already exists.
    Once again, I truly want to thank you all for being here 
today.
    And with that, without objection, all Members will have 5 
legislative days within which to submit materials, to submit 
additional written questions for the witnesses which will be 
forwarded to the witnesses for their responses.
    If there is no further business, without objection, the 
Subcommittee stands adjourned. And again, thank you, and have a 
nice recess.
    [Whereupon, at 3:50 p.m., the Subcommittee was adjourned.]