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


                  BUILDING CONSUMER CONFIDENCE BY EMPOW-
                    ERING FDA TO IMPROVE COSMETIC SAFETY

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

                                HEARING

                               BEFORE THE

                         SUBCOMMITTEE ON HEALTH

                                 OF THE

                    COMMITTEE ON ENERGY AND COMMERCE
                        HOUSE OF REPRESENTATIVES

                     ONE HUNDRED SIXTEENTH CONGRESS

                             FIRST SESSION

                               __________

                            DECEMBER 4, 2019

                               __________

                           Serial No. 116-79
                           
 [GRAPHIC NOT AVAILABLE IN TIFF FORMAT]                          


      Printed for the use of the Committee on Energy and Commerce    
    
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                               __________

                    U.S. GOVERNMENT PUBLISHING OFFICE                    
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-----------------------------------------------------------------------------------                           
                        
                    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..............................     3
    Prepared statement...........................................     4
Hon. John Shimkus, a Representative in Congress from the State of 
  Illinois, prepared statement...................................     6
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................................   102

                               Witnesses

Susan T. Mayne, Ph.D., Director, Center for Food Safety and 
  Applied Nutrition, Food and Drug Administration................    12
    Prepared statement...........................................    14
    Answers to submitted questions...............................   124
S. Gregg Renfrew, Founder and Chief Executive Officer, 
  Beautycounter, LLC.............................................    55
    Prepared statement...........................................    58
    Answers to submitted questions...............................   127
Leigh O'Donnell, Executive Director, Handcrafted Soap and 
  Cosmetic Guild.................................................    64
    Prepared statement...........................................    66
    Answers to submitted questions...............................   129
M. Isabelle Chaudry, Senior Policy Manager, National Women's 
  Health Network.................................................    69
    Prepared statement...........................................    71
Scott Faber, Senior Vice President, Government Affairs, 
  Environmental Working Group....................................    79
    Prepared statement...........................................    81
    Answers to submitted questions...............................   130

                           Submitted Material

H.R. 4296, the Safe Cosmetics and Personal Care Products Act of 
  2019, submitted by Ms. Eshoo \1\
H.R. 5279, the Cosmetic Safety Enhancement Act of 2019, submitted 
  by Ms. Eshoo \1\
Article of April 9, 2019, ``As Baby Powder concerns mounted, J&J 
  focused marketing on minority, overweight women,'' by Chris 
  Kirkham and Lisa Girion, Reuters, submitted by Mr. Rush........   103
Letter of June 30, 2017, from Anna K. Abram, Deputy Commissioner 
  for Policy, Planning, Legislation and Analysis, Food and Drug 
  Administration, to Mr. Pallone, submitted by Ms. Eshoo.........   111

----------

\1\ The legislation has been retained in committee files and also is 
available at https://docs.house.gov/Committee/Calendar/
ByEvent.aspx?EventID=110300.
Letter of September 9, 2019, from Karen Gross, Associate 
  Commissioner for Legislative Affairs, Food and Drug 
  Administration, to Mr. Pallone, submitted by Ms. Eshoo.........   114
OMB Burden Statement for FDA Form 2511 and 2512, Food and Drug 
  Administration, September 30, 2020, submitted by Ms. Eshoo.....   117
Letter, undated, from Earthjustice, et al., to Mr. Pallone and 
  Mr. Walden, submitted by Ms. Eshoo.............................   118
Statement of the Natural Products Association by Daniel 
  Fabricant, Ph.D., Chief Executive Officer and President, 
  December 3, 2019, submitted by Ms. Eshoo.......................   119
Statement of Revlon, December 4, 2019, submitted by Ms. Eshoo....   121

 
  BUILDING CONSUMER CONFIDENCE BY EMPOWERING FDA TO IMPROVE COSMETIC 
                                 SAFETY

                              ----------                              


                      WEDNESDAY, DECEMBER 4, 2019

                  House of Representatives,
                            Subcommittee on Health,
                          Committee on Energy and Commerce,
                                                    Washington, DC.
    The subcommittee met, pursuant to call, at 10:03 a.m., in 
room 2322, Rayburn House Office Building, Hon. Anna G. Eshoo 
(chairwoman of the subcommittee) presiding.
    Members present: Representatives Eshoo, Engel, Matsui, 
Castor, Sarbanes, Schrader, Kennedy, Cardenas, Welch, Ruiz, 
Dingell, Kuster, Kelly, Barragan, Blunt Rochester, Rush, 
Pallone (ex officio), Burgess (subcommittee ranking member), 
Upton, Shimkus, Guthrie, Griffith, Bilirakis, Long, Bucshon, 
Brooks, Mullin, Hudson, Carter, Gianforte, and Walden (ex 
officio).
    Also present: Representative Schakowsky.
    Staff present: Jeffrey C. Carroll, Staff Director; Waverly 
Gordon, Deputy Chief Counsel; Megan Howard, FDA Detailee; Josh 
Krantz, Policy Analyst; Aisling McDonough, Policy Coordinator; 
Alivia Roberts, Press Assistant; Rebecca Tomilchik, Staff 
Assistant; Kimberlee Trzeciak, Chief Health Advisor; C.J. 
Young, Press Secretary; Margaret Tucker Fogarty, Minority 
Legislative Clerk/Press Assistant; Theresa Gambo, Minority 
Financial and Office Administrator; Tyler Greenberg, Minority 
Staff Assistant; Ryan Long, Minority Deputy Staff Director; 
Kate O'Connor, Minority Chief Counsel, Communications and 
Technology; Kristin Seum, Minority Counsel, Health.
    Ms. Eshoo. The Subcommittee on Health will now come to 
order.
    Good morning, colleagues. I hope you all had a wonderful 
Thanksgiving, come back refreshed.
    And welcome to our witness and to the audience that is in 
the room. Thank you.
    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

    Every day, Americans trust that the shampoo, the 
toothpaste, the deodorant, for some of us the makeup that is 
used, that this is all safe. Millions of Americans work in hair 
salons and nail salons and spas, trusting the products that 
they are constantly breathing and touching, and trusting that 
that too is safe.
    Most businesses in the $80 billion cosmetic industry argue 
that these ubiquitous products are safe and should be trusted. 
But that trust isn't based on independent reviews, ingredient 
lists, the threat of recall, or the public reporting of bad 
reactions. Instead, the only thing standing between Americans 
and a dangerous cosmetic product is an 80-year-old Federal law, 
the 30 employees at the FDA's Office of Cosmetics and Colors, 
and strongly worded letters from the FDA.
    To put it bluntly, we don't know what is in our cosmetics, 
and what we don't know could hurt us.
    An American child goes to the emergency department every 2 
hours due to harmful exposure to personal care and beauty 
products. Salon workers, often minority women, face serious 
health threats from potential toxins in cosmetics. Nail polish 
has been linked to serious health and respiratory problems for 
nail technicians. Epidemiological studies since the 1980s have 
found that hair stylists are at risk for skin and respiratory 
diseases, birth defects, and also miscarriages.
    With the lack of Federal authority, the cosmetic industry 
regulates itself. The Personal Care Products Council represents 
600 member companies and provides support to the industry to 
improve product safety, but the council faces potential 
conflicts as it tries to balance consumer safety with 
recommendations that could cut into its members' profits.
    Some States have stepped up to the challenge. My State, 
California, and independent health groups, like the California 
Healthy Nail Salon Collaborative, have had to fight to make 
sure nail salons offer products free of the toxic trio of 
formaldehyde, DBP, and toluene.
    This advocacy led to the California Safe Cosmetics Act, 
which was the first State law to regulate cosmetic 
manufacturers. The 2005 law requires manufacturers to supply 
health-related information about cosmetic ingredients and 
regulates the products used in salons.
    In California, Proposition 65--everyone in California knows 
what Prop 65 is--requires businesses to warn Californians about 
significant exposures to chemicals that cause cancer, birth 
defects, or other reproductive harm. Much of the Nation, 
however, is still unprotected.
    The FDA reports that it physically inspected only a few 
hundred of the nearly 3 million imported cosmetic shipments 
into our country. In its limited inspections, the FDA found I 
think some scary problems, including mold in Chinese eye shadow 
and mercury in skin cream.
    I think it is time to examine this, what I have just 
described, and that we look to strengthening the Federal 
standards to make sure the products used by virtually every 
American, every day, are safe, and I look forward to working 
with my colleagues on this issue.
    [The prepared statement of Ms. Eshoo follows:]

                Prepared Statement of Hon. Anna G. Eshoo

    Every day, Americans trust the shampoo, toothpaste, 
deodorant, and make-up they use are safe.
    Millions of Americans go to work in hair salons, nail 
salons, and spas trusting the products they're constantly 
breathing and touching are safe.
    Most businesses in the $80 billion dollar cosmetic industry 
argue that these ubiquitous products are safe and should be 
trusted.
    But that trust isn't based on independent reviews, 
ingredient lists, the threat of recall, or the public reporting 
of bad reactions.
    Instead, the only thing standing between Americans and a 
dangerous cosmetic product is an 80-year-old Federal law, the 
30 employees at the FDA's Office of Cosmetics and Colors, and 
strongly worded letters from the FDA.
    To put it bluntly: We don't know what's in our cosmetics. 
And what we don't know could hurt us.
    An American child goes to the emergency department every 2 
hours due to harmful exposure to personal care and beauty 
products.
    Salon workers, often minority women, face serious health 
threats from potential toxins in cosmetics.
    Nail polish has been linked to serious health and 
respiratory problems for nail technicians. Epidemiological 
studies since the 1980s have found that hair stylists are at 
risk for skin and respiratory diseases, birth defects, and 
miscarriages.
    With the lack of Federal authority, the cosmetic industry 
regulates itself.
    The Personal Care Products Council represents 600 member 
companies and provides support to the industry to improve 
product safety. However, the Personal Care Products Council 
faces potential conflicts as it tries to balance consumers' 
safety with recommendations that could cut into its members' 
profits.
    States have also stepped up to the challenge.
    In California, independent health groups like the 
California Healthy Nail Salon Collaborative have had to fight 
to make sure nail salons offer products free of the ``toxic 
trio'' of formaldehyde, DBP, and toluene.
    This advocacy led to the California Safe Cosmetics Act, 
which was the first State law to regulate cosmetics 
manufacturers. The 2005 law requires manufacturers to supply 
health-related information about cosmetic ingredients and 
regulates the products used in salons.
    Additionally, Prop 65 requires businesses to warn 
Californians about significant exposures to chemicals that 
cause cancer, birth defects, or other reproductive harm.
    Much of the Nation, however, is still unprotected.
    The FDA reports that it only physically inspected only a 
tenth of a percent of the nearly 3 million imported cosmetics 
shipments. In its limited inspections, the FDA has found scary 
problems, including mold in Chinese eyeshadow and mercury in 
skin cream.
    It's time to pass a strong Federal bill to make sure the 
products used by virtually every American each day are safe. I 
look forward to working with my colleagues to do so.

    Ms. Eshoo. The Chair now recognizes Dr. Burgess, the 
ranking member of the subcommittee, for his 5-minute 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. And we are convened 
here today to discuss the issue of cosmetics regulation by the 
Food and Drug Administration, a topic that Congress has debated 
over the course of the past several years.
    Chairman Pallone, your staff has been working with Mr. 
Shimkus and our committee staff to reach a bipartisan 
consensus. It is disappointing that this hearing today appears 
to be a partisan exercise. And I hope, moving forward, we can 
be accommodating to some remaining Republican concerns about 
the approaches to take.
    One of those concerns is that both the bills introduced by 
Chairman Pallone and Chairwoman Schakowsky, as currently 
drafted, do not adequately address the issue of harmonization 
between the States and the issue of Federal preemption. The 
Constitution has a supremacy clause, it has that for a reason. 
It states that Federal law is the supreme law of the land and 
supersedes conflicting State law. It is critical that the 
language in a bill that is marked up in this subcommittee and 
the full committee contain language stating that Federal laws 
preempt any State laws.
    This patchwork, which would inhibit harmonization of States 
regarding cosmetics, would be complicated and certainly, from 
the consumer standpoint, disruptive and confusing. Regulations 
would not enable competition, but discourage it, especially for 
small businesses.
    On that point, another concern that has been raised on this 
side of the dais is these bills do nothing to exempt small 
business from new FDA registration requirements. Cosmetics 
should be safe for consumers, but a retiree who makes cosmetics 
in his or her living room or home shop as a hobby, or someone 
who is trying to start a new cosmetics business to market on a 
small local scale, if this legislation is passed would have to 
register with the FDA.
    The number of products these individuals and small 
businesses are selling is virtually inconsequential when 
discussing the overall safety of a very large cosmetics 
industry. Ms. O'Donnell of the Handcrafted Soap and Cosmetic 
Guild will explain this in more detail on the second panel with 
her testimony.
    We can have conversations about what is a meaningful 
ingredient review process at the FDA. If there are ingredients 
that are proven to be unsafe, then it would be best for 
consumers that they not be included in cosmetics products. I am 
interested to hear from our witness what would be necessary to 
create a process that would be realistic for the FDA to conduct 
and helpful, not harmful, to the industry and to consumers.
    Additionally, I am concerned that H.R. 4296 outright bans 
some type of testing, animal testing, when there is currently 
no accepted alternative.
    Look, I live in a household with multiple pets. I 
understand the moral issues that many people have with animal 
testing. But I also have concerns about products coming on the 
market that have not been adequately tested. So we need to add 
to all of this the discussion as to whether or not we can 
substitute another kind of testing.
    So in conclusion, I am disappointed it is a partisan 
hearing. I hope that as this bill continues to move through the 
subcommittee and full committee that it can involve both sides 
of the dais.
    [The prepared statement of Mr. Burgess follows:]

             Prepared Statement of Hon. Michael C. Burgess

    Thank you, Madame Chair. We have convened today to discuss 
the issue of cosmetics regulation by the Food and Drug 
Administration, a topic that Congress has debated over the 
course of the past few years. Mr. Chairman, your staff has been 
working with Mr. Shimkus and our committee staff to reach 
bipartisan consensus. I am disappointed that this hearing today 
is a partisan exercise, and I hope that moving forward you will 
be accommodating to some remaining Republican concerns about 
the approach your bill has taken.
    One of those concerns is that both the Pallone bill and 
Schakowsky bill as currently drafted do not adequately address 
Federal preemption. The Constitution's Supremacy Clause states 
that Federal law is ``the supreme Law of the Land'' and 
therefore supersedes conflicting State law.
    It is critical that the language in a bill that is marked 
up in this subcommittee and the full committee contains 
language stating that Federal laws preempt any State laws. 
Having a patchwork of State laws regarding cosmetics would be 
complicated for cosmetics manufacturers to comply with and 
disruptive for consumers. Burdensome regulations would not 
enable competition, but hamper it, especially for small 
businesses.
    On that point, another concern that I, and many of the 
Republicans on this subcommittee, have is that these bills do 
nothing to exempt small business from these new FDA 
registration requirements. While cosmetics should be safe for 
consumers, a retiree who makes cosmetics in their living room 
or garage as a hobby, or someone who is trying to start a new 
cosmetics business to market on a small local scale, should not 
have to register with the FDA.
    The number of products these individuals and small 
businesses are selling are inconsequential when discussing the 
overall safety of the cosmetics industry. Ms. O'Donnell of the 
Handcrafted Soap and Cosmetic Guild will explain this in more 
detail in her testimony.
    We can have conversations about what a meaningful 
ingredient review process at the FDA would entail. If there are 
ingredients that are proven to be unsafe, then it would be best 
for consumers that they not be included in cosmetics products. 
I am interested to hear from our witnesses about what would be 
necessary to create a process that would be realistic for the 
FDA to conduct and helpful, not harmful, to industry and 
consumers.
    Additionally, I am concerned that H.R. 4296 outright bans 
animal testing when there is no currently accepted alternative.
    As an owner of multiple pets, I understand the moral issues 
that individuals have with animal testing, but we should not be 
in the business of banning this testing when we cannot 
substitute another kind of testing.
    In conclusion, I remain disappointed that this is a 
partisan hearing and hope that, should this bill continue to 
move through this subcommittee and the full committee, that it 
be a bipartisan product.
    Thank you, and I yield back.

    Mr. Burgess. I would like to yield the balance of my time 
to the chairman of the Environment Committee, Mr. Shimkus.
    Mr. Shimkus. Thank you, Mr. Ranking Member.
    And Chairman Pallone has been a champion of reform his 
entire political career. He recently joined with our former 
colleague, Leonard Lance, and now, unfortunately, it is my turn 
to be helpful in this.
    I want to thank Chairman Pallone for continuing to work 
with us to develop bipartisan product to create a uniform 
framework for cosmetic product regulation based upon science, 
in which both consumers and businesses can have confidence.
    I think businesses should have the certainty that legal 
products they manufacture for commerce in Illinois should be 
legal in New Jersey and every other State. That is the basis of 
the Interstate Commerce Clause, and that is our primary reason 
why we have this committee of jurisdiction, is the Interstate 
Commerce Clause. And I think American consumers want to know or 
already believe that someone is taking a look at these products 
to ensure safety.
    We engaged on a similar journey a few years ago to 
consolidate the responsibility for evaluating the safety of 
toxic substances through the enactment of the Frank R. 
Lautenberg Chemical Safety for the 21st Century Act. Given the 
desire of both industry and consumer reform of our Nation's 
cosmetic law, I am hopeful we can apply the same mentality and 
fortitude that proved to be a successful process for TSCA and 
implement legislation to recognize FDA as the most competent 
regulator when it comes to cosmetic products sold in the United 
States.
    And I yield back my time.
    [The prepared statement of Mr. Shimkus follows:]

                Prepared Statement of Hon. John Shimkus

    Thanks to Chairman Pallone for continuing to work with us 
to develop a bipartisan product to create a uniform framework 
for cosmetic product regulation based on science in which both 
consumers and businesses can have confidence. I think 
businesses should have certainty that legal products they 
manufacture for commerce in Illinois should be legal in New 
Jersey, and every other State.
    And I think American consumers want to know, or already 
believe, that someone is taking a look at these products to 
ensure safety. We engaged on a similar journey a few years ago 
to consolidate the responsibility for evaluating the safety of 
toxic substances through enactment of the Frank R. Lautenberg 
Chemical Safety For The 21st Act (TSCA).
    Given the desire of both industry and consumers to reform 
our Nation's cosmetics law, I'm hopeful we can apply the same 
mentality and fortitude that proved to be a successful process 
for TSCA, and implement legislation to recognize FDA as the 
most competent regulator when it comes to cosmetic products 
sold in the United States.

    Ms. Eshoo. The gentleman yields back.
    The Chair now recognizes Mr. Pallone, chairman of the full 
committee, for his 5-minute 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.
    I don't know why you said ``unfortunately.'' You are the 
obvious person to be dealing with this on a bipartisan basis 
after what you did with TSCA, and that is the only way we 
ultimately will get it done. So I appreciate your taking up the 
mantle, but I want you to be happy about it.
    Let me also mention that this committee has had a long 
history of bipartisan efforts on FDA reform. I don't know how 
many years ago, but a few years ago, between our chairman John 
Dingell and our chairman Henry Waxman and myself and others put 
forth a whole series of things on FDA reform, which we got 
accomplished. One was with prescription drugs. Another was with 
food safety. And it was bipartisan. They were signed into law. 
And this is really the only thing that remains, is cosmetics, 
in terms of that effort that started out with our two giants, 
Dingell and Waxman.
    And so we have two legislative proposals that empower the 
Food and Drug Administration to more effectively regulate 
cosmetic and personal care products, the one draft that I put 
out and the other that Jan Schakowsky has introduced as 
legislation.
    Consumers today assume that the cosmetic products they 
purchase are safe and appropriately regulated, but, 
unfortunately, that isn't always the case. The truth is that 
Congress has not updated FDA's authority to regulate the 
multibillion-dollar cosmetic industry in over 80 years. And 
this is especially concerning considering the industry's 
exponential growth.
    Today, we actually have a situation where the average 
American woman uses 12 personal care products a day, and nearly 
all Americans, male or female, use at least one personal care 
product daily. Yet under the current system FDA does not have 
the tools or the resources it needs to ensure these products 
are safe for consumers.
    For example, FDA does not have the authority to require 
companies to report adverse events associated with their 
products, it can't issue a mandatory recall for products if 
there are concerns that a product could be harmful to 
consumers, and it can't ensure foreign suppliers are complying 
with good manufacturing practices or using ingredients that are 
safe for cosmetic use. These are all giant gaps in consumer 
safety that we have to address.
    One particularly alarming example of the shortcomings of 
the current system involves asbestos-tainted product marketed 
to kids and teens. Earlier this year, FDA detected asbestos in 
products manufactured by both Claire's and Justice Retail, two 
chains that primarily market their products to kids and teens. 
And after FDA notified Claire's of its findings, it took nearly 
a week for the company to agree to take their asbestos-tainted 
products off the store shelves.
    I don't think that is acceptable, but unless we equip FDA 
with the tools and resources the agency needs, we are going to 
continue to see frightening issues with these products for 
years to come.
    So my bill seeks to update FDA's authority and provide the 
agency with the resources it needs to properly oversee the 
market. That bill, the Cosmetic Safety Enhancement Act, 
empowers FDA by giving it authority to issue mandatory product 
recalls, requires manufacturers to notify the agency about 
adverse events, compels manufacturers to register their 
cosmetic ingredients, and provides FDA with stable funding to 
conduct this new and important work.
    And while this legislation takes an important step forward, 
I recognize that we still have a lot of work to do. Over the 
past few weeks, I have worked in good faith with colleagues on 
both sides of the aisle, FDA, industry, and other stakeholders, 
to make changes to the ingredient review and user fee 
frameworks. I know that our work there is not done and, moving 
forward, I intend to continue to work to get this language 
right.
    I also understand that my colleagues and industry 
stakeholders still would like to see preemptive language added 
to the bill. I hope we can work together to draft language that 
will protect State laws, preserve the ability of individuals to 
hold industry accountable when they are harmed, and at the same 
time provide certainty to industry about the rules and 
requirements.
    [The prepared statement of Mr. Pallone follows:]

             Prepared Statement of Hon. Frank Pallone, Jr.

    Today, we will discuss two legislative proposals that 
empower the Food and Drug Administration (FDA) to more 
effectively regulate cosmetic and personal care products.
    Consumers today assume that the cosmetic products they 
purchase are safe and appropriately regulated, but 
unfortunately that isn't always the case. The truth is that 
Congress has not updated FDA's authority to regulate the 
multibillion-dollar cosmetic industry in over 80 years. Can you 
imagine that? This is especially concerning considering the 
industry's exponential growth. Today, the average American 
woman uses 12 personal care products a day and nearly all 
Americans use at least one personal care product daily.
    Yet, under the current system, FDA does not have the tools 
or the resources it needs to ensure these products are safe for 
consumers. For example, FDA does not have the authority to 
require companies to report adverse events associated with 
their products. It cannot issue a mandatory recall for products 
if there are concerns the product could be harmful to 
consumers. And it cannot ensure foreign suppliers are complying 
with good manufacturing practices or using ingredients that are 
safe for cosmetic use. These are all giant gaps in consumer 
safety that we must address.
    One particularly alarming example of the shortcomings of 
the current system involves asbestos-tainted products marketed 
to kids and teens. Earlier this year, FDA detected asbestos in 
products manufactured by both Claire's and Justice Retail--two 
chains that primarily market their products to kids and teens. 
After FDA notified Claire's of its findings, it took nearly a 
week for the company to agree to take their asbestos-tainted 
products off the store shelves.
    That's unacceptable, but unless we equip FDA with the tools 
and resources the agency needs, we're going to continue to see 
frightening issues with these products for years to come.
    That's why I've introduced comprehensive legislation to 
update FDA's authority over cosmetics and to provide the agency 
with the resources it needs to properly oversee the market and 
protect consumers.
    The Cosmetic Safety Enhancement Act empowers FDA by giving 
it the authority to issue mandatory product recalls, requires 
manufacturers to notify the agency about adverse events, 
compels manufacturers to register their cosmetic ingredients, 
and provides FDA with stable funding to conduct this new and 
important work.
    While this legislation takes an important step forward, I 
recognize that we still have more work to do. Over the past few 
weeks I have worked in good faith with colleagues on both sides 
of the aisle, FDA, industry and other stakeholders to make 
changes to the ingredient review and user fee frameworks. I 
know that our work there is not done, and moving forward I 
intend to continue to work to get this language right.
    I also understand that my colleagues and industry 
stakeholders still would like to see preemption language added 
to this legislation. I hope that we can work together to draft 
language that will protect State laws, preserve the ability of 
individuals to hold industry accountable when they are harmed, 
and, at the same time, provide certainty to industry about the 
rules and requirements they must comply with.
    I thank my colleagues for their commitment to working 
together to come to a bipartisan agreement and I look forward 
to continuing that work as we move through the legislative 
process.
    As this industry continues to grow, it is more important 
than ever that we ensure consumers are safe and have confidence 
in the products they use every day.
    I'd like to yield the remainder of my time to Ms. 
Schakowsky.

    Mr. Pallone. I have more, but I want to stop now, because I 
want to yield the remainder of my time to Ms. Schakowsky, who 
has taken a leadership on this as well.
    Ms. Schakowsky. Thank you, Mr. Chairman.
    Cosmetics are one of the most used and yet least regulated 
consumer products on the market. The $84 billion cosmetic 
industry uses roughly 12,500 unique chemical ingredients in 
their products with almost no oversight. These chemicals 
include formaldehyde and PFAS. The average woman uses about 12 
personal care products, men about 6.
    But it was also found that a product that is marketed 
mostly to young Black girls is a shampoo called Just for Me 
that is the most toxic product that is on the market right now, 
and these exposures are linked to cancer and fertility, asthma.
    I am out of time. I wanted to just say that both the 
chairman and myself do have legislation.
    It is time to act. It is the legislation that has a name 
that is regulated and yet it is not regulated, and we need to 
move aggressively right now to protect. There is no question 
that unregulated cosmetic industry is a public health hazard.
    And I yield back.
    Mr. Pallone. And I yield, Chair.
    Ms. Eshoo. The Chair is pleased to recognize the ranking 
member of the full committee, Mr. Walden, for his 5 minutes.

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

    Mr. Walden. Good morning, Madam Chair, and to our witnesses 
and guests and colleagues.
    Today's hearing is a really important opportunity to hear 
from the FDA as well as interested stakeholders about what 
actions are currently being taken and whether more needs to be 
done to ensure the safety of cosmetics and personal care 
products.
    This is a big industry--our numbers show upwards of $488 
billion global industry--which includes hundreds of products, 
from makeup to deodorant to shampoo and shaving cream, products 
that both men and women use every day. Personal care products 
are regulated either as cosmetics or over-the-counter drugs, 
depending on whether the products change the structure or 
function of the body.
    Federal regulation of cosmetics balances the low-risk 
nature of these products and ensures their safety. Apart from 
color additives, the FDA does not require premarket approval of 
the chemicals used in cosmetic products, as we have heard. 
However, the FDA does have regulatory authority to prohibit or 
restrict the use of ingredients if there are safety concerns.
    The FDA also has the authority to take certain enforcement 
action, such as seizures, injunctions, and criminal penalties, 
against adulterated or misbranded cosmetic products. FDA may 
also conduct inspections of cosmetic facilities and 
manufacturers and prohibit imports of cosmetics that violate 
the Federal Food, Drug, and Cosmetic Act.
    Now, in addition to these authorities, the FDA also 
regulates cosmetics labeling under the Fair Packaging and 
Labeling Act, which requires that ingredients and warning 
statements, among other information, must be included in the 
labeling. There are also labeling restrictions, such as 
prohibition on therapeutic claims or statements claiming a 
product is FDA approved.
    While there are no mandatory reporting requirements under 
current law, the FDA does maintain a Voluntary Cosmetic 
Registration Program. These voluntary submissions do provide 
the FDA with information about cosmetic products and 
ingredients, their frequency of use, and businesses engaged in 
manufacturing.
    The information collected through the database is also used 
to inform the Cosmetic Ingredient Review, an independent 
industry-funded panel of scientific experts whose purpose is to 
review certain ingredients and determine if there is a 
reasonable certainty that the ingredient is safe under its 
conditions of use.
    Now, ensuring consumer safety is a priority for this 
committee and the FDA. We should strive to enact legislation 
that provides the agency with the tools necessary to protect 
the public health, while being careful not to overregulate an 
industry that has generally posed relatively minimal risk to 
human health.
    I know getting this policy right is a top priority of 
Chairman Pallone and others on the committee. I appreciate his 
efforts and commitment to reaching out in a bipartisan way to 
achieve consensus on workable cosmetics legislation, but I do 
believe, as he mentioned, there is additional work we have to 
achieve.
    I am concerned that significant regulatory burden, while 
manageable for larger, more established manufacturers, could 
threaten the existence of some small businesses, who have fewer 
resources to expend on regulatory compliance, and the ability 
for new entrepreneurs to enter the market.
    As we will hear today, legislation to regulate the 
cosmetics industry will not only impact large companies whose 
products we see on drugstore shelves or advertised on 
television, but also individuals back at home who are simply 
trying to bring in a little extra income to support their 
families. An individual who makes handcrafted soap out of their 
home to sell at the local farmers market may not warrant the 
same regulatory requirements as larger companies.
    Additionally, some States have passed or are considering 
legislation that would restrict or dictate which ingredients 
can be in cosmetics products, which, if continued, will lead to 
an unworkable patchwork of differing product requirements. So, 
if FDA determines after a thorough scientific-based review that 
an ingredient is safe, States should not be able to decide 
otherwise and impose additional requirements or restrictions on 
such an ingredient.
    To provide FDA with new authorities and the ability to make 
determinations on ingredient safety while allowing States to 
continue to impose new requirements would not only undermine 
the Federal legislation, but it also could put FDA's 
determinations in dispute and lead, frankly, to a lot of 
consumer confusion.
    Currently, both bills being considered today lack strong 
national standards language. I hope to continue to work with 
the chairman to find a path forward on this issue.
    Finally, I want to note that, while we do have some 
industry representation on the panel today, we will, 
unfortunately, not have the opportunity to hear the full range 
of industry perspectives. I think it is critical we hear from 
the full spectrum of affected stakeholders when considering 
legislation that will impose expansive regulation and user fees 
on industries. So I trust the chairman will continue to engage 
with those groups as discussions on legislation move forward.
    With that, Madam Chair, I yield back the balance of my 
time, with the notation that we have another subcommittee 
hearing I have to go off to.
    Ms. Eshoo. I understand that.
    Mr. Walden. But this is an important one, and we appreciate 
your leadership on it.
    [The prepared statement of Mr. Walden follows:]

                 Prepared Statement of Hon. Greg Walden

    Today's hearing is an opportunity to hear from the Food and 
Drug Administration (FDA), as well as interested stakeholders, 
about what actions are currently being taken, and whether more 
needs to be done, to ensure the safety of cosmetics and 
personal care products.
    Personal care products, a $488 billion global industry, 
includes hundreds of products from make-up to deodorant, 
shampoo, and shaving cream--products that both men and women 
use every day. Personal care products are regulated either as 
cosmetics or over the counter drugs depending on whether the 
products change the structure or function of the body.
    Federal regulation of cosmetics balances the low risk 
nature of these products and ensuring their safety. Apart from 
color additives, the FDA does not require premarket approval of 
the chemicals used in cosmetic products. However, FDA does have 
regulatory authority to prohibit or restrict the use of 
ingredients if there are safety concerns.
    FDA also has the authority to take certain enforcement 
actions--such as seizures, injunctions, and criminal 
penalties--against adulterated or misbranded cosmetic products. 
FDA may also conduct inspections of cosmetic manufacturers and 
prohibit imports of cosmetics that violate the Federal Food, 
Drug, and Cosmetic Act (FFDCA).
    In addition to these authorities, FDA also regulates 
cosmetics labeling under the Fair Packaging and Labeling Act. 
This law requires that ingredients and warning statements, 
among other information, must be included in the labeling. 
There are also labeling restrictions, such as a prohibition on 
therapeutic claims or statements claiming a product is ``FDA 
Approved.''
    While there are no mandatory reporting requirements under 
current law, FDA does maintain a Voluntary Cosmetic 
Registration Program. These voluntary submissions provide FDA 
with information about cosmetic products and ingredients, their 
frequency of use, and businesses engaged in manufacturing. The 
information collected through this database is also used to 
inform the Cosmetic Ingredient Review (CIR), an independent, 
industry-funded panel of scientific experts whose purpose is to 
review certain ingredients and determine if there is a 
reasonable certainty that the ingredient is safe under its 
conditions of use.
    Ensuring consumer safety is a priority for this committee 
and FDA. We should strive to enact legislation that provides 
the agency with the tools necessary to protect the public 
health, while being careful not to overregulate an industry 
that has generally posed relatively minimal risk to human 
health.
    I know getting this policy right is a top priority for the 
chairman and I appreciate his efforts and commitment to 
reaching a bipartisan consensus on cosmetics legislation, but I 
believe additional work remains.
    I am concerned that significant regulatory burden, while 
manageable for larger and more established manufacturers, could 
threaten the existence of small businesses, who have fewer 
resources to expend on regulatory compliance, and the ability 
for new entrepreneurs to enter the market.
    As we will hear later today, legislation to regulate the 
cosmetics industry will not only impact large companies whose 
products we see on drug store shelves or advertised on 
television, but also individuals back at home who are simply 
trying to bring in a little extra income to support their 
families. An individual who makes handcrafted soap out of their 
home to sell at the local farmer's market may not warrant the 
same regulatory requirements as larger companies.
    Additionally, some States have passed or are considering 
legislation that would restrict or dictate which ingredients 
can be in cosmetics products which if continued, will lead to 
an unworkable patchwork of differing product requirements. If 
FDA determines, after a thorough scientific-based review, that 
an ingredient is safe, States should not be able to decide 
otherwise and impose additional requirements or restrictions on 
such ingredient. To provide FDA with new authorities and the 
ability to make determinations on ingredient safety, while 
allowing States to continue to impose new requirements would 
not only undermine Federal legislation, but it could also put 
FDA's determinations in dispute and lead to consumer confusion.
    Currently, both bills being considered today lack strong 
national standard language. I hope to continue to work with the 
chairman to find a path forward on this issue.
    Finally, I want to note that while we do have some industry 
representation on the witness panel today, we will 
unfortunately not have the opportunity to hear the full range 
of industry perspectives. I think it is critical that we hear 
from the full spectrum of affected stakeholders when 
considering legislation that will impose expansive regulation 
and user fees on industry. I trust that the chairman will 
continue to engage with these groups as discussions on 
legislation move forward.
    Thank you, I yield back.

    Ms. Eshoo. I appreciate Members that have to go downstairs 
and come back up again or came here first, and it shows your 
commitment to the subcommittee, and I think that that says a 
lot. I always like that.
    So the gentleman yields back. The Chair wants to remind 
Members that, pursuant to committee rules, all Members' written 
opening statements shall be made part of the record.
    I now would like to introduce our first witness for today's 
hearing, Dr. Susan Mayne. She is the Director of the FDA Center 
for Food Safety and Applied Nutrition.
    We thank you, Dr. Mayne, for joining us today, and we look 
forward to your testimony.
    Do you understand the lights?
    Dr. Mayne. Yes.
    Ms. Eshoo. It will be green for a while. When it turns 
yellow, red is on the heels of yellow.
    So welcome, and you are recognized for your 5 minutes of 
testimony.

 STATEMENT OF SUSAN T. MAYNE, Ph.D., DIRECTOR, CENTER FOR FOOD 
   SAFETY AND APPLIED NUTRITION, FOOD AND DRUG ADMINISTRATION

    Dr. Mayne. Thank you.
    Good morning, Chairwoman Eshoo, Ranking Member Burgess, and 
members of the subcommittee. I am Dr. Susan Mayne, and I am the 
Director of the Center for Food Safety and Applied Nutrition, 
also called CFSAN, at the Food and Drug Administration. Thank 
you for the opportunity to appear before you today to discuss 
the regulation of cosmetics.
    Cosmetic products are used to cleanse and beautify, often 
on sensitive areas of the body, such as the lips and eyelids. 
American consumers have an expectation that cosmetic products 
are safe, and we believe that most cosmetic products on the 
market today in the United States are, indeed, safe.
    However, FDA's cosmetics authorities were established in 
1938. It is important that we recognize that since 1938 the 
cosmetics industry has grown significantly in its size and in 
the variety and complexity of products now available to 
consumers.
    These changes help bring new opportunities and choices to 
consumers. However, the industry now relies on a global supply 
chain, and when problems or questions arise, we may need to 
trace cosmetics and cosmetic ingredients across the globe.
    We now regularly see cosmetics imported each year from up 
to 180 different countries. Yet, other than a discrete set of 
authorities covering color additives, our authorities have not 
been modernized in more than 80 years.
    FDA's cosmetic program has remained small and receives 
about 3 percent of CFSAN's total budget. In recent years, we 
have had the resources to conduct fewer than 100 domestic and 4 
foreign inspections per year. Of the more than 2.7 million 
lines of cosmetics imported in fiscal year 2018 from more than 
30,000 foreign firms, we are able to physically examine around 
0.2 percent of imported lines.
    While it will be up to Congress whether to provide the FDA 
with additional authorities and/or resources to regulate 
cosmetics, it is important that the subcommittee and the 
American public understand the scope of the current cosmetics 
program.
    Under our authority, cosmetics must not be adulterated or 
misbranded. However, with the exception of color additives, 
cosmetics and their ingredients are not subject to premarket 
approval requirements or FDA safety review. Therefore, we don't 
know whether cosmetic ingredients have gone through adequate, 
if any, safety testing.
    We encourage cosmetic manufacturers to voluntarily register 
products and list their ingredients with the FDA before 
marketing products to American consumers. But, because 
registration and product listing are voluntary, FDA does not 
have a complete picture of what cosmetic products are on the 
market or what ingredients they contain.
    Cosmetics firms can voluntarily decide whether to notify 
FDA of adverse events associated with their products or whether 
they will provide FDA access to records during an inspection. 
However, it is not required that firms report adverse events or 
provide records access to FDA.
    FDA has issued a draft guidance on good manufacturing 
practices for cosmetic products, though firms are not required 
to follow good manufacturing practices. FDA works with firms to 
voluntarily recall a product when we identify a safety issue, 
as we have been doing with talc-containing cosmetic products 
contaminated with asbestos. However, we do not have mandatory 
recall authority for cosmetic products.
    It is FDA's experience that most firms are responsible 
actors. They care about consumer safety and the reputations of 
their brands. When a safety problem occurs, however, FDA is 
reliant on a company's willingness to voluntarily provide us 
with information to aid in our inquiry. In our experience, we 
are not always able to compel companies to give us all the 
information we request to aid in our investigation, and we have 
limited recourse to address the problem.
    While Congress continues to explore modernizing the 
regulation of cosmetics, the committee should keep in mind the 
basic elements of a modern regulatory framework to protect 
public health: mandatory registration and listing of products 
and their ingredients so the agency knows who is making the 
regulated products and what is in them; explicit authority to 
establish good manufacturing practice regulations; mandatory 
company reporting of adverse events; access to records during 
routine or for-cause inspections; mandatory recall authority; 
mandatory disclosure of known cosmetic allergens on a product's 
label; and sufficient additional resources to implement these 
public health protections. And if an ingredient review program 
is a priority for the committee, the program should be 
meaningful and workable.
    Thank you again for the opportunity to testify before the 
subcommittee. I look forward to answering any questions.
    [The prepared statement of Dr. Mayne follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
    
    Ms. Eshoo. Thank you very much, Dr. Mayne.
    We are now going to move to Member questions, and each 
Member knows that they will have 5 minutes to ask questions of 
Dr. Mayne, and I will start by recognizing myself for 5 
minutes.
    I read your testimony, Dr. Mayne, and now listened to it, 
and I can't help but begin by just making a statement. This 
sounds like a division or a part of FDA that is kind of a name 
only; 0.2 percent of inspections, I consider that pretty darn 
close to zero. You don't have the authorities or the dollars to 
do anything. Everything is voluntary.
    So it seems to me that the subcommittee is going to have to 
consider how to build this out and what we want, because there 
really isn't--there is very little in place. I don't even know 
what the little is.
    But I want to ask some questions of you, and a simple yes 
or no is fine.
    The FDA's authority over the safety of baby lotion. First, 
can the FDA require a review of baby lotion for safety before 
it comes to market?
    Dr. Mayne. No, we cannot.
    Ms. Eshoo. Can the FDA require the manufacturer not to use 
a toxic ingredient, for example formaldehyde, in its baby 
lotion?
    Dr. Mayne. No.
    Ms. Eshoo. Is the manufacturer required to register with 
the FDA before selling its baby lotion?
    Dr. Mayne. No.
    Ms. Eshoo. I think my first statement is becoming truer.
    Once the baby lotion comes to market, can the FDA require 
safety information about the baby lotion?
    Dr. Mayne. No.
    Ms. Eshoo. If the baby lotion has caused bad reactions in 
the babies, can the FDA require a recall?
    Dr. Mayne. No.
    Ms. Eshoo. If the manufacturer is aware of the babies' bad 
reactions, would the manufacturer be required to report that to 
the FDA?
    Dr. Mayne. No.
    Ms. Eshoo. Well, I think everybody is paying rapt attention 
here.
    In our country today, could cosmetic products for sale to 
use on children or infants with unknown ingredients and no 
safety review, if the product is dangerous, the FDA would not 
be able to require a recall. You already said that. And, 
obviously, we need to, I think, empower the FDA to do more to 
protect Americans. I mean, given all the noes that you just 
answered, I think we have a real problem on our hands.
    I want to divide for a moment the U.S. industry and what is 
imported into the country. How would you characterize what is 
imported?
    Dr. Mayne. Well, I think the whole host of cosmetic 
products are imported into this country that we also see in the 
domestic setting. As I indicated, it is about 2.7 million lines 
that are imported from approximately 30,000 foreign firms, and 
it covers the whole gamut of cosmetic products.
    Ms. Eshoo. Now, do a lot of U.S. firms manufacture 
overseas?
    Dr. Mayne. I don't have that information. I just know 
that----
    Ms. Eshoo. Can you get that information for us, do you 
know? Would the agency have it?
    Dr. Mayne. We would be happy to provide what information we 
have available. I don't know if we have that information, but 
we are happy to provide whatever we can.
    Ms. Eshoo. What would you, if you were to request of 
Congress fill in the blank--I know, going back to 2015, there 
was a request of the FDA during the Obama administration for 
user fees. Did you ask for expanded inspections? And, if so, 
what was the standard that you were moving to? Was there 
anything else that you requested? Because there really is 
nothing going on now. We are about at zero.
    Dr. Mayne. So I would say in this case we are happy to work 
with the committee on the legislation. It is important to us, 
if we do get these new authorities, that it be appropriately 
resourced.
    Ms. Eshoo. Well, no, we understand that. We understand. 
Every agency says that. We understand that. But were there any 
other requests that you have made of the Congress 2015 forward?
    Dr. Mayne. I would say, again, the important things from 
our perspective are the modern elements of the regulatory 
framework that I alluded to in my statement. Those are the 
important things for us to be able to regulate in a modern 
regulatory----
    Ms. Eshoo. And you asked for that, or you are saying you 
agree with the bill?
    I want to know if FDA--maybe this is a better way to ask. 
Has FDA been proactive in asking for certain authorities, given 
the experience that you have had and the inability to respond 
to whatever is happening in the country, whether it is imported 
or whether it is domestic?
    Dr. Mayne. I can't speak to what happened in 2015, but what 
I can say is we are committed and eager to work with the 
committee and moving forward with a modernized regulatory 
framework.
    Ms. Eshoo. It is a nonanswer. Thank you.
    All right. My time is up. The Chair will now recognize Dr. 
Burgess for his 5 minutes to ask questions.
    Mr. Burgess. Thank you.
    And, Dr. Mayne, thank you for being here. Welcome to our 
humble subcommittee. Congratulations to the FDA, by the way. 
Your Administrator designate apparently cleared a hurdle in the 
other body, and that is good news. I look forward to his 
tenure. Being a fellow Texan, I think any time we get a Texan 
in charge of a Federal agency, that is a good day for me.
    So we just heard a litany of questions on baby lotion. So 
can I just ask you, under current law, what is the process for 
informing and advising consumers of an identified health risk?
    Dr. Mayne. So we would use our authorities if we had 
concerns about a product. For example, we may get some adverse 
event reports. That may lead to an inspection of a facility, 
that may lead to some product sampling, and that may lead to 
some concerning findings.
    If we do find concerning findings in a product, we would 
typically go to the firm, ask for a voluntary recall of that 
product. If the firm did not agree to do the recall, we would 
put a consumer safety advisory out. And so we would use our 
authorities to inform consumers about any health concerns that 
we had, based upon that process.
    Mr. Burgess. Well, thank you for clarifying, because the 
end result of that series of questions was that the FDA, your 
part of the FDA, would not do anything, but that is not 
actually the case. You would take several actions.
    And a company that, say, manufactured a baby lotion would 
want to not receive that designation that you ended up with. Is 
that correct? Is there aversion from the industry itself to 
getting that negative designation from your branch of the FDA?
    Dr. Mayne. I mean, I can only assume that they would want 
to protect their brand.
    Mr. Burgess. Yes, I think so, too.
    Other than the baby lotion example, are there any other 
examples that you can think of quickly as to other types of 
health risks that have been identified and dealt with?
    Dr. Mayne. Well, so what we have alluded to are some of the 
more acute health risks, and that would be, for example, where 
a consumer used a product, experienced an acute effect in the 
short term, and then could report that to the FDA. So that 
would be the type of safety information that we may have 
information available about.
    What we would not have information about would be potential 
long-term safety risks, because those are not going to come to 
us through an adverse event reporting type of system.
    Mr. Burgess. And when you do issue or recommend a voluntary 
recall, as a practical matter, is that something that is 
complied with, or do you meet resistance?
    Dr. Mayne. I would say most companies have worked with the 
FDA and have been cooperative and have initiated voluntary 
recalls. However, we have certainly had examples where 
companies have refused to do that, including in the cosmetics 
space.
    Mr. Burgess. And I wonder if it would be in order if I 
could ask you to perhaps provide us a list--you don't need to 
do it right now--but provide that in writing for our questions 
for the record.
    So in your testimony you state that most cosmetic firms are 
responsible, and I believe you are correct, they are concerned 
about consumer safety and the reputation of their brands. H.R. 
4296 and the draft bill that we have in front of us require 
various forms of registration, reporting, disclosure be issued 
to the Food and Drug Administration, the public, or both.
    So do you have an idea of what type of burden this would 
place on all of the businesses that are acting in good faith 
that must now register and report all of this information?
    Dr. Mayne. So we would be happy to work with the committee 
in terms of whatever version of the legislation. Certainly, our 
goal is to protect consumers while minimizing the regulatory 
burden. And we are always willing to consider flexibility and 
options to address some of the issues you flagged with regard 
to small businesses.
    So we are happy to work with the committee to get the 
public health goals that we all want while not having 
unnecessary regulatory burdens.
    Mr. Burgess. I appreciate that. May I just--would it be out 
of place for me to ask if you have the resources to accomplish 
these goals?
    Dr. Mayne. Our current resources would be completely 
insufficient to accomplish what is envisioned in the 
legislation. So the importance in my statement is that we would 
need to be adequately resourced to carry out those activities.
    Mr. Burgess. As you know, just the observation that we are 
into our second continuing resolution. The fiscal year expired 
September 30. And it is really hard from an agency perspective 
to be flexible and embark on anything new or different when you 
are only funded at last year's levels for last year's problems. 
So I do urge our counterparts on the Agriculture Appropriations 
Subcommittee to do their work.
    You brought up the issue of talc, and let me just ask you, 
can you explain FDA's recent actions and the ongoing efforts to 
address talc? And further, has that investigation been 
concluded, or is it still underway?
    Dr. Mayne. So we are aware that talc is mined from areas 
where there can be asbestos also collocated in the same area. 
So we have been testing cosmetic products that contain talc in 
order to see if there is the presence of asbestos.
    We did some testing in 2009-2010. We tested 34 different 
products, different types of cosmetics. We found none of those 
products contained any asbestos from that testing.
    Mr. Burgess. I am sorry, how many?
    Dr. Mayne. Zero out of 34 in our 2009-2010 testing. We did 
another round of testing starting in 2017, going up until the 
current time. We sampled, collected 50 different samples of 
cosmetic products.
    In that particular testing, we did find the evidence of 
asbestos in certain products that I think you are all aware of. 
We immediately pursued the approaches I described earlier, 
notifying the company, asking for voluntary recall, notifying 
consumers that we were concerned about the safety of those 
products.
    Mr. Burgess. And was the voluntary recall complied with?
    Dr. Mayne. The voluntary recalls were complied with in most 
circumstances. Again, there was one circumstance involving a 
company where they did not comply with the voluntary recall, so 
we went with a consumer safety advisory.
    Mr. Burgess. Very well. Thank you. I have additional 
questions. I will submit them for the record.
    Ms. Eshoo. I thank the ranking member. His time is expired.
    It is a pleasure to recognize the gentlewoman from 
California, Ms. Matsui.
    Ms. Matsui. Thank you very much, Madam Chair. And I want to 
thank the witness for appearing here today.
    You know, I am really pleased that we are taking much-
needed steps to bring FDA's oversight of cosmetics into the 
21st century. Consumers really deserve the confidence that 
everyday personal products won't harm them or their families.
    Now, as Americans, we assume that the products we buy are 
safe, and most cosmetics are safe, but we must be scrupulous in 
exposing bad actors.
    You know, I am highly concerned that product recalls, 
mandatory risk labeling, and adverse event reporting are 
entirely voluntary measures for the cosmetics industry. The 
issue we are discussing today is particularly important to my 
home State where, absent Federal regulation, California has 
been a leader in taking aggressive steps to ensure consumer 
safety for cosmetics.
    California Safe Cosmetics Program requires that companies 
disclose to the Department of Public Health chemical 
ingredients intentionally added to their products that are 
known or suspected to cause cancer, birth defects, or other 
reproductive harm.
    Since 2009, over 600 cosmetic companies have reported to 
the Safe Cosmetics Program on the sale of more than 75,000 
beauty and personal care products in California. We have built 
a robust ingredients database through which numerous tests have 
confirmed that lead and asbestos frequently contaminate certain 
cosmetics.
    Aside from some labeling requirements, cosmetics at the 
Federal level are largely self-regulated when it comes to 
demonstrating safety and disclosing ingredients. You mentioned 
in your testimony that only one-third of cosmetic manufacturers 
voluntarily file cosmetic product ingredient statements. Are 
there specific chemicals, like those included in California's 
Prop 65 list, that must be disclosed to FDA?
    Dr. Mayne. The ingredients in a product must be disclosed 
on the label of the product. So we have access to what the 
ingredient labels indicate on those products, as do consumers. 
The exceptions are fragrances and flavors, where the actual 
ingredients do not have to be disclosed.
    Ms. Matsui. So these ingredient statements are made 
available to the public, all of them?
    Dr. Mayne. The required labeling is that the ingredients in 
cosmetic products be displayed on the label, with the exception 
of fragrances and flavors.
    Ms. Matsui. OK. So for nonreporting manufacturers, does FDA 
proactively seek any information on hazardous and potentially 
hazardous ingredients in these products?
    Dr. Mayne. And by nonreporting, you mean nonregistered with 
the FDA?
    Ms. Matsui. Uh-huh.
    Dr. Mayne. No, we do not.
    Ms. Matsui. The California Safe Cosmetics Program requires 
manufacturers to disclose potentially harmful ingredients and 
makes this information publicly available.
    You have discussed limitations in FDA's authority and 
resources. From your perspective, would a Federal ingredients 
disclosure standard like California's law help alleviate 
challenges to protecting consumer health?
    Dr. Mayne. So I assume something would be like a warning 
label. In our experience, we tend to use warning labels to help 
consumers know how they can safely use a product or to inform 
consumers about ingredients such as allergens. But if a product 
cannot be safely used by a consumer, that labeling would not be 
the approach we would use. Rather, we would prefer to not have 
that product on the market.
    Ms. Matsui. OK. So a critical tool for monitoring the 
safety of cosmetic products is adequate, timely surveillance of 
adverse event and product complaint reports. I would like to 
get a better understanding of how the agency uses the existing 
Adverse Event Reporting System to monitor cosmetic safety.
    Reporting of adverse events and product complaints is 
voluntary in the U.S. for cosmetic products who are responsible 
for reporting adverse events to the FDA. What types of adverse 
events are typically included in these reports?
    Dr. Mayne. We get a number of different ones, ranging from 
more mild situations, such as rashes, to more severe. In our 
CFSAN Adverse Event Reporting System, approximately 30 percent 
of the adverse events we get reported for cosmetics are the 
more serious or severe types. Seventy percent are more mild.
    Ms. Matsui. So, after receiving this report, what triggers 
the FDA to evaluate an adverse event for real safety concerns?
    Dr. Mayne. So that is a signal for us. We look at the 
trends over time. We look to see if we are seeing something 
new. We obviously prioritize the severe ones that we would want 
to investigate. So we look at the trends, and that is used as a 
signal that would then potentially trigger further 
investigation.
    Ms. Matsui. So what steps will you take to protect the 
public after identifying this?
    Dr. Mayne. So one example is we had an unusual number of 
adverse events involving a hair loss. We had over a thousand 
adverse events reported. In that case, we went to the 
manufacturer. We had some concerns. We did an inspection. At 
the time of the inspection, we learned that the manufacturer 
had received 21,000 adverse event reports. We requested those 
reports and their details, and they were not provided to the 
agency.
    Ms. Matsui. OK. Well, I know this adverse event report data 
has its limitations, and I think it would be useful if the 
reporting process would be strengthened in the FDA oversight of 
cosmetic products.
    And with that, I yield back. Thank you.
    Ms. Eshoo. Those 21,000 reports, what did FDA do? Did you 
put out an alert?
    Dr. Mayne. Yes. We notified consumers that we had concerns 
about the safety of these products.
    Ms. Eshoo. And how do you do that? Is it online? Is it on 
your website? How do you do it?
    Dr. Mayne. We use social media. We issue press statements. 
We use all available tools to notify consumers.
    Ms. Eshoo. Thank you.
    The gentleman from Illinois, Mr. Shimkus, is recognized.
    Mr. Shimkus. Thank you, Madam Chair.
    For all the reasons we have heard so far, that is why we 
are trying to get to a place where we can be supportive in a 
bipartisan manner. So let me go down a list of questions of the 
challenges that we are having.
    Dr. Mayne, many businesses have developed proprietary 
information that provides a competitive advantage because it is 
not known to others. As the United States continues its shift 
to a knowledge- and services-based economy, the strength of 
competitiveness of domestic firms increasingly depends on their 
know-how and intangible assets.
    Trade secrets are the form of intellectual property that 
protects this sort of confidential information. I think it is 
critical that any bill reforming the cosmetic industry protects 
confidential business information from misappropriation by 
others, and we know that a trade secret is misappropriated when 
it is obtained through the abuse of a confidential relationship 
or improper means of acquisition.
    Can you describe the process FDA currently employs to 
ensure that information garnered as a result of an FDA 
inspection or other access to proprietary records remains 
confidential?
    Dr. Mayne. I would say in the case of cosmetics we look at 
what ingredient information is available. We don't have access 
to formulations or commercial confidential information.
    We think for the importance of disclosure to consumers, for 
example, if the fragrances that they are using, which may be 
commercial confidential information, if those fragrances 
contain something that we know to be allergenic, that we ask 
that that be disclosed on the label.
    Mr. Shimkus. So what about this draft that we are 
considering today, how would it deal with confidential business 
information?
    Dr. Mayne. We would be happy to work with the committee on 
how to deal with some of those issues. And our experience, as I 
said, the importance to us is that a consumer knows what the 
ingredients are.
    Mr. Shimkus. OK. A witness on our next panel submitted 
written testimony suggesting FDA review as many ingredients as 
possible every year. How many ingredients do you think FDA 
would be able to inspect annually once the program is fully 
operational?
    Dr. Mayne. I think it would depend upon the resources 
available, and we would be happy to provide technical 
assistance in terms of the resources and the number of 
ingredients that could be managed at a given point in time.
    Mr. Shimkus. Going back to TSCA, we know that well 
intentions are well intentions. But even with resourcing, it is 
still a challenge. If you are really using the scientific 
method to evaluate this, it just takes a long time.
    How would FDA go about selecting new ingredients to review 
once the initial lists laid out in the draft are complete?
    Dr. Mayne. I think we would want to work with the committee 
in terms of a process that would lay out how we would do that. 
I would assume that would be a public process where people 
could nominate ingredients for review and provide information 
to the agency that would help lead to the selection of the next 
priority.
    Mr. Shimkus. Given some of the challenges and consumer 
confusion resulting from insufficient data findings at the FDA, 
what steps might the agency take to evaluate the likelihood 
that sufficient data exists to make a safety determination 
before initiating a review of that ingredient?
    Dr. Mayne. I think there are ways we could handle that. It 
is a key point that we want to make sure that there are 
sufficient data, and as you alluded, some of these safety 
reviews can take significant time because we need to make sure 
that we do have that data.
    And I think a potential analogy is what we do with our food 
additive petition process. When people come to us with a food 
additive petition, we work with the company to make sure that 
we have sufficient data available to do that safety 
determination.
    The fact that we are doing the petition is public. At the 
conclusion, our determination is public. But in the interim, we 
work with the company to make sure that we have the data we 
need to conclude that process.
    Mr. Shimkus. And, as you know, this committee has advanced 
legislation in the past to establish user fees for over-the-
counter products. We have done PDUFA, Prescription Drug User 
Fee Act. We have done AGDUFA. You have heard it here first. Now 
we have got CSUFA, right, Cosmetic User Fee Act, and I am going 
to brand that myself.
    Can you discuss the challenges associated with collecting 
fees for cosmetic products that are also regulated as over-the-
counter products, so-called cosmeceuticals?
    Dr. Mayne. We would work with the committee to make sure 
that there is no redundancy there. I mean, we are very 
committed to making sure that whatever we arrive at would be 
streamlined and that there would not be redundancies.
    Mr. Shimkus. And how do we ensure that the products are not 
cross-subsidizing each other?
    Dr. Mayne. Again, I think that would be a commitment we 
would pledge to work with the committee.
    Mr. Shimkus. So, Madam Chairwoman, and for the chairman of 
the full committee, I think there are ways that we can go to 
get there. I think we are raising appropriate questions to make 
sure. And I look forward to working with you as we move 
forward.
    And I yield back.
    Ms. Eshoo. The gentleman yields back.
    I agree with you. And this is a--it is just an area that is 
wide open, and it really requires protocols, new laws, and all 
of that. And we thank the gentleman for the work that he has 
done on it.
    A pleasure to recognize the gentlewoman from Florida, Ms. 
Castor, for her 5 minutes of questions.
    Ms. Castor. Well, thank you, Madam Chair, for holding this 
important hearing today on the cosmetic products that American 
families use every day. And I want to thank Chairman Pallone 
and Chairwoman Schakowsky for their ongoing leadership on this 
issue.
    Cosmetics are broader than makeup and perfume. They include 
toothpaste, deodorant, and shampoo, the products that everyone 
uses every day. So we should be concerned about the safety of 
these products.
    Dr. Mayne, I was struck in your testimony by the estimate 
that the current cosmetic industry may be larger than $80 
billion in annual sales. You also noted in your testimony that 
over 2.7 million cosmetic products were imported into the U.S., 
yet only 68,000 cosmetic products have ingredient statements on 
file with the agency.
    There appears to be some discrepancy among these figures. 
Does FDA have reliable data on how many cosmetic products are 
being sold and distributed in the United States today?
    Dr. Mayne. We do not. And that is one of the reasons in any 
legislative bill that we need to get the opportunity in the 
early years to get the registration ingredient listing put into 
place so that we would, in fact, have that reliable data.
    It would also mean that, if there is a user fee provision, 
that we need to have the ability to potentially adapt some of 
those user fee information based upon the data that we would 
get in the first years of the program, because we do not have 
reliable data on what is out there.
    Ms. Castor. So there have been cosmetic ingredient 
statements filed for over 68,000 products, which you believe 
represents participation from only one-third of manufacturers 
today. Will you discuss what information is included in the 
cosmetic ingredient statements and why they are important to 
the agency's work?
    Dr. Mayne. I think that the real importance is knowing what 
is out there in terms of ingredients. So, if we have concerns 
about an ingredient based upon the processes that I described, 
we have no way of essentially knowing how widely that is used 
in the marketplace or even how to notify manufacturers that 
they may be using an ingredient that we have concerns about.
    So it would be important to know who they are, where they 
are located, what they are producing and what ingredients are 
in current use. That would be helpful in terms of a modernized 
framework.
    Ms. Castor. Now, one of the witnesses on the second panel 
is opposed to ingredient reporting to the agency, noting that 
it would be burdensome, saying that it would result in hundreds 
to thousands of reports to FDA per company per year and would 
not improve consumer safety.
    Does FDA agree with this assessment? And does the agency 
have an estimate of the length of time it takes for entities to 
file cosmetic ingredient statements today?
    Dr. Mayne. So the companies that have currently voluntarily 
registered are primarily the larger companies. And so that 
information is already in the database for the numerous 
products. As you indicated, 68,000 products are already in the 
database.
    If smaller companies are coming in, we anticipate it would 
be a fairly brief registration, to include information about 
who they are, where they are located, as well as the products 
that they have.
    So we anticipate this would be a fairly light regulatory 
burden, and once it is in the database it would prepopulate for 
annual updates. We assume at that point it would be extremely 
minimal.
    Ms. Castor. And registration is different from premarket 
review. Is that correct?
    Dr. Mayne. Correct.
    Ms. Castor. Would you explain the difference?
    Dr. Mayne. So, in a premarket review, a company would come 
to us with a new ingredient, whatever that may be, some new 
technology, some nano material, whatever it may be, they would 
come to us in a premarket way and say: Is it safe for inclusion 
in cosmetics? We do not have that authority.
    Instead, what we have is a postmarket one, which is after 
it has been introduced into the market we may have a concern 
about its safety, and then we would act. So it is not 
preventing. It is, rather, acting once we see evidence of harm.
    Ms. Castor. Well, it strikes me as common sense that FDA 
should have greater information regarding the cosmetic products 
that Americans use every day, including the ingredients in 
these products, especially since so many are now imported from 
countries outside of the United States. So I look forward to 
continuing to work with the agency on moving this legislation 
forward.
    Thank you, and I yield back, Madam Chair.
    Ms. Eshoo. The gentlewoman yields back.
    It is a pleasure to recognize the gentleman from Missouri, 
Mr. Long, for his 5 minutes of questions.
    Mr. Long. Thank you, Madam Chair.
    Dr. Mayne, if Congress provides the FDA with additional 
authority to regulate cosmetics, it is important to ensure that 
those authorities and any safety determinations made by the 
agency stand nationwide, as this committee has done in other 
areas. We are starting to see a patchwork of inconsistent State 
and local requirements for cosmetics that is not helpful for 
consumers or businesses to operate.
    Do you think that it is helpful here to establish a 
national standard for cosmetic regulation at the FDA?
    Dr. Mayne. So I think what you are getting at is the issue 
of preemption. And the agency doesn't take a position on 
preemption. Rather, we leave such decisions to Congress to 
decide that.
    Mr. Long. What type of data information will FDA want to 
see when reviewing ingredients for safety?
    Dr. Mayne. So let me be clear that the ingredients we would 
be looking at for safety would be only those that rise to the 
level of being concerns. So it is not the full gamut of 
ingredients that are in those products, it is the ones we have 
concerns about.
    And, in that case, depending upon how they are used, what 
the usage would be, what we know about those particular 
compounds, the type of data would vary. But we want to be 
confident that both for short-term as well as long-term safety 
that we have the evidence to substantiate the safety.
    Mr. Long. So how does one rise to the level of becoming a 
concern?
    Dr. Mayne. There are a number of chemicals that many people 
have expressed concerns about. You have heard that many of the 
States have generated their own list. Certainly, there are a 
number of compounds that have been flagged. And so we would go 
through a process working with the committee to identify the 
ones that we should prioritize for review.
    Mr. Long. So that is kind of like the cart before the horse 
to me. I mean, how do you determine? If a new product comes 
online that it is out there in service until someone complains 
about it?
    Dr. Mayne. This is a postmarket regulatory framework. We do 
not have premarket authority.
    Mr. Long. Right. OK. Is there data already available for 
many ingredients that may be of concern? If not, how long would 
it take to generate data sufficient to determine if an 
ingredient is safe, unsafe, or safe under specific conditions?
    Dr. Mayne. We know that there is data out there that have 
signaled concerns about many of these ingredients. In terms of 
what data exist to substantiate the safety, we don't have that 
information, because industry is not required to give that 
information to FDA.
    Mr. Long. In 2018, according to my research, over 2.5 
million lines of cosmetic products were imported into the 
U.S.--2.5 million different lines imported into the U.S., which 
is an increase of more than 1 million product lines over the 
last 10 years.
    Could you speak to FDA's ability to monitor imports of 
cosmetic products, especially given the huge increase that we 
have seen over the last decade?
    Dr. Mayne. So, when we look at the safety of imported 
products, we typically use many tools to try to do that, for 
example in the food space. So we have things where we look at 
products that are coming across the border. We electronically 
look at every single one of those, and we prioritize the ones 
that we have concerns about for additional followup, sampling, 
testing, for example.
    In the proposed legislation, there is a provision for 
Foreign Supplier Verification Program. That is another tool 
that could be used to help assure the safety of imported 
products. The other tool that we use is foreign inspections. 
But, as you heard, that is a very costly way for the agency to 
try to get at the safety of imported products.
    Mr. Long. What additional resources do you think the FDA 
needs to effectively monitor cosmetic imports?
    Dr. Mayne. We would be happy to work with the committee. 
And in some cases, it depends, that some of the provisions work 
together. So, for example, with regard to the Foreign Supplier 
Verification Program, if that was going to be looking at the 
safety of fully finished cosmetic products coming into the 
market, that would need to be accompanied by a GMP-type, Good 
Manufacturing Practice, provision so that ingredients that are 
coming in would be safe as addressed through the GMP process. 
So the provisions would work together in combination to help 
assure the safety of imported products.
    Mr. Long. There is a radio station at home, and they are 
doing a deal right now, you go take an angel off the tree and 
underprivileged kids will put, like, their top three picks for 
their Christmas gifts, what they want to receive for Christmas.
    So Christmas is coming. I don't know if you have been to 
see Santa Claus yet or not. But can you give me your top three 
things that you would like to get from this committee, from 
Congress, that would help you?
    Dr. Mayne. I think what we would like is the committee to 
engage with us on those authorities. Should the committee 
decide to give us those new authorities, we want to make sure 
that that is appropriately resourced. That is a really key 
provision for us. I think those are the real two, is that we 
engage in the process on those new authorities and that it be 
appropriately resourced.
    Mr. Long. OK. You got one extra you are not going to use. 
OK.
    All right. Thank you. I yield back.
    Ms. Eshoo. The gentleman yields back.
    I now would like to recognize the gentleman from Oregon, 
Mr. Schrader, for his 5 minutes of questions.
    Mr. Schrader. Thank you, Madam Chair, I appreciate it.
    Thank you, Dr. Mayne, for coming.
    You talked about the one authority you really do have, 
which is dealing with color additives in the cosmetics space. 
And wondered if you--if that included tattooing? If you have 
authority over tattooing?
    Dr. Mayne. We do. We do have authority over tattooing 
through the color additive petition process. As you may be 
aware, historically we have not used that authority over time 
in terms of regulating the safety of tattooing. Rather, where 
we have been on the safety of tattooing, we have been 
prioritizing the resources that we have to areas where we had 
concern. And so, some of those concerns we have had are, for 
example, adverse events where people have had tattoos and then 
experienced infections or skin reactions that has led us to do 
some inspections of tattooing manufacturers, that has led to 
some product testing. What we have found is we have had some 
concerning levels of microbial contamination in tattooing that 
has led to recall consumer notification.
    So that has been our priority right now, has been focusing 
on those acute effects that we have seen. However, we do note 
that we have the color additive authority for tattooings. And 
we are engaged with the tattoo industry, encouraging them to 
consider submitting color additive petition processes to go 
through that process with us with regard to the tattooings.
    Mr. Schrader. There are some really good actors in that 
industry, and there are some that are a little more sketchy. 
And I think I would encourage you to work closely with those 
good actors to make sure we get it right. Not--it seems to be a 
burgeoning cosmetic approach, one that I worried for years 
about my daughters, the guys now too, so I want to make sure it 
is done right.
    Switching gears a little bit, ingredient reviews can be 
lengthy. I guess there is a reason for that, to make sure we 
get it right, taxpayer dollars being well-utilized. How best 
can we ensure that we are adequately reviewing the ingredients 
of concern?
    Dr. Mayne. Yes. So you noted that they can be lengthy. And 
from our perspective, the biggest piece of that length of time 
is getting the adequate data in hand. It is not actually the 
review of the data, but it is getting the data in to make sure 
that we have all the information we need.
    I think, again, important for us is that at the conclusion 
of that, if we have to make a statement that the data are 
inadequate to substantiate the safety, one of the things that 
would be helpful is to know, with clarity, what would we do 
with that information? Does the product then remain on the 
market, or is it going to be an adulterated product under new 
legislation? If inadequate data translates into it and it stays 
on the market, then it is essentially the circumstance where we 
are in today, where we may have inadequate data on the 
products, even if they contain ingredients of concern, remain 
on the market.
    Mr. Schrader. So certain timeframes would be helpful to you 
to decide when they should be getting this stuff in, and your 
response time also, to be fair. And then the consumer hopefully 
will have some reasonable expectation of this is going to be 
done in a timely manner and they--whether a product is safe or 
unsafe, and the manufacturer would have that same opportunity.
    Dr. Mayne. Yes. And we would be happy to provide assistance 
on what types of timelines would be appropriate.
    Mr. Schrader. Also concerned about the process being 
slightly unclear as to what happens if an ingredient is deemed 
unsafe, you know. How long should companies have to comply? 
What criteria do you use to declare an ingredient unsafe?
    Dr. Mayne. Yes. So the criteria obviously is a scientific 
determination, and the objective that we would use, it would be 
based upon what is ever in the legislation. In the proposed 
legislation that we have seen, it is the reasonable certainty 
of no harm standard. So that is the criteria we would use, is 
the scientific data would need to support that there is a 
reasonable certainty of no harm. So that is the standard that 
we would use.
    In terms of how long a product could remain on the market, 
I think one of the things we would want to be clear about is 
these are cosmetic products. These are not, for example, like a 
drug product where there is a clear benefit to a consumer. And 
so that would factor into any decisions we would have about 
timelines. These are voluntarily used, and so, if we had a 
concerning ingredient, we would want that product off the 
market pretty quickly.
    Mr. Schrader. I guess a followup statement from my point 
would be that there is science, and then there is science. 
There are a lot of groups out there that are well-intentioned, 
but some of the scientific rigor peer-reviewed research declare 
something safe, or unsafe, or toxic. I want to make sure that 
we are using good science to go down that route. Because it 
could mean big problems for companies, big problems for 
consumers when things are inadvertently taken off the 
marketplace that really are not posing a serious or significant 
risk. And also label it appropriate, especially in the cosmetic 
space where to some the--an infant's susceptibility or 
sensitivities would be very different than an adult's. I hope 
that as we go forward we would be discriminatory.
    Dr. Mayne. Yes, we are a science-based regulatory agency, 
so we are always committed to doing the best science. And I 
think some of your comments allude to the importance of an 
independent scientific review.
    Mr. Schrader. Thank you. I yield back.
    Ms. Eshoo. The gentleman yields back. Pleasure to recognize 
the gentleman from Indiana, Dr. Bucshon.
    Mr. Bucshon. Thank you, Madam Chairwoman.
    Dr. Mayne, one issue that is often talked about in the 
cosmetic space that we have not touched on today is sunscreen. 
As a doctor, I was looking for a medical nexus for the hearing. 
I think this may very well be it.
    While I believe sunscreen in the U.S. is safe and 
effective, I know that it has been reported at other places 
around the world, including Europe, have outperformed some of 
the sunscreens that we have here, particularly in the UVA area, 
the UVA rays as it relates to skin cancer risk. Could you talk 
about the U.S. standards and how they apply to sunscreen in the 
U.S., and compare how they are different than maybe we see in 
Europe? Briefly, because I have got a couple of other 
questions.
    Dr. Mayne. With regard to sunscreens, they are actually not 
cosmetic.
    Mr. Bucshon. Well, they are in Europe. And I am aware of 
the fact they classify them as cosmetics in Europe, in the 
United States they are considered over-the-counter drugs.
    Dr. Mayne. Yes. So that is not my center. That is a 
different part of the FDA. I would be happy to work with you 
and have those staff work with you to answer your questions.
    Mr. Bucshon. So you are not going to be able to answer any 
questions then?
    Dr. Mayne. No.
    Mr. Bucshon. Yes, all right. Well, that is too bad. I am 
going to put it on the record anyway. In February, the FDA did 
put a proposed rule out to establish a final monograph 
regulations for the over-the-counter products, and the agency 
had proposed to strengthen that standard for UVA protection, so 
that is a good thing. So you are obviously not going to go be 
able to provide an update on what they have done there.
    So with that, I yield back.
    Ms. Eshoo. Would the gentleman yield just 10 seconds to me?
    Mr. Bucshon. I yield 3 minutes and 25 seconds.
    Ms. Eshoo. I thank Dr. Bucshon. I can't help but recall, 
Dr. Mayne, a recent conversation we had, and it was relative to 
something that many people in our country have an allergy to, 
it is sesame seeds. We had that conversation. We are trying to 
make a determination as to whether we went forward 
administratively with the FDA to make the changes or 
legislative. What you are describing in terms of a pathway to 
Members on how you would do this, the authorities that you 
need, how you would do it, and it has come up in different 
questions in your answers. Your answer to me on the previous 
issue was it would take 7 years to do the rule and have it 
implemented. How long would it take to set up protocols that 
you would like to have FDA set up and implement?
    Dr. Mayne. So I think, if you are talking about labeling on 
allergens in the cosmetics framework, is there is required 
labeling on allergens and cosmetics. What would be helpful is a 
framework how to add new allergens to that. Under the food 
labeling, the FLSA legislation----
    Ms. Eshoo. No, I don't want to know about the food, though. 
There is--there are bad things in some of these products.
    Dr. Mayne. Correct.
    Ms. Eshoo. So you are going to go have to write a rule for 
it. Is that going to take 7 years?
    Dr. Mayne. I think the legislation could certainly mandate, 
as they did in FLSA, which allergens needed to be declared and 
then could lay out a regulatory pathway for FDA to add new 
allergens.
    Ms. Eshoo. Is formaldehyde an allergen?
    Dr. Mayne. I am not sure whether formaldehyde is an 
allergen.
    Ms. Eshoo. I don't know. I am just asking. Does anyone 
know?
    Dr. Bucshon, do you know?
    Mr. Bucshon. Yes, it can be in some people. I mean, 
anything that touches your skin----
    Dr. Mayne. I know it is an irritant.
    Mr. Bucshon [continuing]. Could be an irritant or an 
allergen, of course, it is possible, yes.
    Ms. Eshoo. I appreciate the gentleman yielding. I couldn't 
help but think of that 7 years.
    Mr. Bucshon. Yes. I am going to reclaim the last minute 
because I came up with something else I can ask.
    Ms. Eshoo. Your time.
    Mr. Bucshon. No. I mean, I had this on here, but I didn't 
touch on it. I mean, one of the things I--in medicine as it 
relates to the FDA, it may not relate to you particularly as 
frustrating is that sometimes the requirements for studies, 
scientific studies, to prove things before approving products, 
whether it is cosmetics or other medical devices or other 
things, when there is already studies that have been done in 
Europe, extensive studies, or other countries, and the FDA 
doesn't really utilize those. Can you comment some on, maybe in 
this space, where some maybe in this space--some maybe, how you 
might use European data or standards to help craft what you do 
here in the U.S.?
    Dr. Mayne. So we are informed by the global scientific data 
available, so we look at any studies regardless of where they 
come from. We are also informed by what other regulatory 
agencies may do. That doesn't necessarily mean we will come to 
the same conclusions, because we have different authorities----
    Mr. Bucshon. I understand.
    Dr. Mayne [continuing]. But we are informed by all the 
information from foreign regulators.
    Mr. Bucshon. Yes, because in the medical space, at least, a 
lot of times the FDA will say, Well, we don't have good U.S. 
studies to back that up so we don't accept it. And that is very 
frustrating when that happens. I usually find it is just when 
the FDA doesn't want to act, and so they use that as a crutch, 
but that is not--not you particularly, but that is just my 
opinion on what happens. And sometimes, that delays products 
getting to the U.S. consumers that could otherwise be 
beneficial.
    Thank you. I yield back.
    Ms. Eshoo. The gentleman yields back.
    I recognize the gentlewoman from California, Ms. Barragan, 
for her 5 minutes.
    Ms. Barragan. Thank you.
    Thank you, Dr. Mayne, for being here today and the work you 
are doing and the interest you have in collaborating with 
government and private sector to making sure that we are 
protecting consumers and addressing concerns. I have been 
hearing more and more concerns, and making me concerned about 
when I am using, whether it is nail polish, different cosmetic 
products, and whether it is safe to do so. You mentioned that 
ingredients have to be listed many, many times. Even if 
ingredients are listed, people don't even know what they mean. 
What is this? Is this safe? Is this not safe?
    I am in a congressional district that is majority minority, 
very working class. And so I am not sure how often, you know, 
we, in my district, read the labels and wouldn't know what it 
is, so that certainly is a concern.
    You know, the American Cancer Society estimates that 22,280 
women in the United States will be diagnosed with ovarian 
cancer this year, and that about 14,240 women will die of it 
just this year. Expert epidemiologists have estimated that 
about 10 percent, or 1,424, of those who will die of ovarian 
cancer also have a history of talc use.
    Internal documents from one talcum powder manufacturer, 
Johnson & Johnson, showed that the company knew of the health 
risk of talc and spent approximately 30 years hiding it from 
the public. In fact, I have one of the memos here from Johnson 
& Johnson, that is dated April 15th, 1969. The notes that the 
asbestos in the product should be kept to a, quote, ``absolute 
minimum,'' unquote, because of the disease hazard, and the 
company anticipated litigation if it became known that its talc 
contained asbestos. Does the FDA have the authority to force 
manufacturers to remove their products off the shelves if they 
are contaminated with asbestos?
    Dr. Mayne. Yes. And we can't force, we can ask for a 
voluntary recall, which is what we have done with the other 
situations where we found asbestos in talc. So, if we test it 
and we find asbestos, we would seek a voluntary recall, as I 
have indicated in most cases, including with Johnson & Johnson, 
they complied with a voluntary recall.
    Ms. Barragan. So there has never been an instance where the 
FDA has actually been able to force----
    Dr. Mayne. No. We don't have mandatory recall authority.
    Ms. Barragan. And isn't it true that, after the FDA 
privately requested that Claire's recall products marketed to 
young girls containing asbestos, Claire's, Beauty Plus, and 
Justice all refused to comply with the request?
    Dr. Mayne. I don't think that is correct. I believe there 
was one company that refused, but not all three.
    Ms. Barragan. Do you know which company that was?
    Dr. Mayne. My recollection is that Claire's did not agree 
to the voluntary recall.
    Ms. Barragan. Thank you. I was disappointed to see, like, 
with many other issues that there are substantial racial 
disparities when it comes to the dangers associated with the 
cosmetic products. A study by the environmental working group 
found that African-American women used products at a higher 
rate than White women, and what they used was proportionately 
less safe, testing 1,177 products targeted for sale to African-
American women, the results showed that one out of 12 products 
were rated highly hazardous to human health. Potential dangers 
connected to product ingredients include cancer, hormone 
disruption, developmental and reproductive damage, allergies 
and other adverse health effects. This data is particularly 
concerning to me, because I have a district that is nearly 90 
percent Latino and African-American.
    Dr. Mayne, what more can be done to address these racial 
disparities in cosmetics? And will any of the bills today help?
    Dr. Mayne. I think that the goal we all share is making 
sure that these cosmetic products are safe for all consumers. 
And some of the new authorities that are contemplated in the 
legislation would certainly be helpful to that.
    At the same time, I want to commit that we are always 
concerned about vulnerable populations, populations who may 
have heightened disease risk. At the FDA, we have an Office of 
Women's Health, we have an Office of Minority Health. We are 
sensitive to those issues, and we are happy to work with any 
individual communities that may have a disproportionate risk, 
or need additional safety information. That includes, in some 
circumstances, language translation, safety advisories can go 
out in both English and in Spanish. So we are always sensitive 
to the needs of specific populations.
    Ms. Barragan. Is there any tracking that is done from 
reports of products that impact communities of color?
    Dr. Mayne. Again, we don't even know at this point who 
manufactures these products, or whether they are in the market.
    Ms. Barragan. Great. Thank you.
    I yield back.
    Ms. Eshoo. The gentlewoman yields back.
    Pleasure to recognize the gentlewoman from Indiana, Mrs. 
Brooks.
    Mrs. Brooks. Thank you, Madam Chairwoman. And thank you so 
much for hosting this really important hearing. And I 
apologize, I am one of those Members that is between hearings, 
so I apologize that I have not heard all of your testimony.
    But I want to thank you for your work. We know that much 
more needs to be done. And, in fact, what you were just talking 
about with the fact that we don't have so many products that 
register.
    Do you have any idea, Dr. Mayne, what percentage of 
cosmetics or personal care products currently sold in the 
United States are imported from overseas?
    Dr. Mayne. I do not know that number right off the top of 
my head. We can certainly go back and take it back and see what 
numbers we can get available for you. It has consistently 
increased over time, as you heard before, dramatic increases in 
imported cosmetics coming in from other countries.
    Mrs. Brooks. OK. Thank you. We probably would request and 
will submit a question for the record to try and get that 
information.
    On the products manufactured in the United States, do you 
have any sense what percentage of those products contain--are 
made up of components imported from overseas?
    Dr. Mayne. I do not have that information. We do not even 
know what those ingredients are, let alone where they are 
sourced from. So we don't have information on the supply 
chains.
    Mrs. Brooks. Are there any particular components that are 
of a particular concern from overseas?
    Dr. Mayne. I think we look at the holistic problem of 
products coming in, whether they are imported or whether they 
are from domestic. I will note that we have had more products 
intercepted at the border from certain countries rather than 
others, and that factors into our prioritization which products 
we will look at more carefully at the borders.
    Mrs. Brooks. When you say you have more products 
intercepted, that is the work that the FDA is doing. Is that 
correct?
    Dr. Mayne. That is what we are doing. That is where we 
electronically screen all imports that come in, and then we 
prioritize, based upon algorithms, based upon data that we have 
about potential risk. We sample and test the highest priority 
products based upon a risk perspective. And then of those, 
approximately 20 percent or so are found to be violative and 
not allowed to enter into interstate commerce.
    Mrs. Brooks. One of the things we are talking about 
downstairs in the Health Subcommittee hearing is actually 
influenza and vaccines. And I have been really involved, along 
with the chair of this committee, in insuring we got PAHPA 
reauthorized earlier this year and signed into law. Given our 
focus on biohazard preparedness and the fact that we, as you 
have said, we see an increasing volume of cosmetic products 
coming from oversees, has--does the FDA, and your inspectors, 
and your organization focus at all on the fact that an overseas 
adversary could potentially poison the products intentionally? 
And that is something I don't think many people ever 
contemplate, that cosmetics could potentially be a weapon of 
some sort, but can you talk a little bit about discussions at 
the FDA about that?
    Dr. Mayne. What I would say is that we have broad concerns 
about the problems of any intentional adulteration, whether it 
be a food, whether it be a dietary supplement, whether it be a 
cosmetic. I think we would use any and all information that we 
would have available to try to survey for that. But it is a 
concern, obviously, intentional adulteration of any commodity 
that the FDA regulates.
    Mrs. Brooks. Can you talk a little bit in the time I have 
left about how well-equipped FDA is to deal with those 
adulterations of cosmetic products? And could you just tell us 
whether it is a surveillance system that is happening overseas, 
or--and maybe a bit on--and I apologize if you have already 
been asked--the screening that is done at our borders?
    Dr. Mayne. I think I would have to take that back and find 
out what tools they are using for this particular issue, which 
is the intentional adulteration, rather than the traditional 
safety where we are looking for things like mercury-containing 
compounds, products, things like that.
    Mrs. Brooks. Thank you. I yield back.
    Ms. Eshoo. The gentlewoman yields back.
    Pleasure to recognize the gentlewoman from Delaware, Ms. 
Blunt Rochester.
    Ms. Blunt Rochester. Thank you, Madam Chairwoman. And I 
would also like to thank Dr. Mayne for joining us today.
    I think we can all agree that we should be working together 
to help achieve the FDA's mission of protecting and advancing 
public health. It has been 80 years since our Nation's cosmetic 
laws were updated. And I look forward to working with my 
colleagues to find the best legislative pathway forward.
    I am especially grateful that today we are examining the 
issue of cosmetic safety. A lot of people don't realize how 
broad that covers, and it is not just the makeup that we put on 
our face. And I have long believed that the FDA's authority in 
this area is woefully inadequate to keep up with an industry 
that has evolved considerably since Congress has last 
legislated in this space.
    I am concerned that, increasingly, the increasingly global 
market that FDA has is--you are not equipped to properly 
oversee the safety of cosmetic and personal care products. And, 
in fact, maybe hamstrung to move swiftly if there is a risk to 
consumers.
    So, Dr. Mayne, in your testimony you noted that cosmetic 
products and ingredients are not subject to premarket approval 
and premarket notification. You also said it in your testimony. 
And further, that manufacturers may use any ingredient in a 
cosmetic, as long as it doesn't adulterate the finished 
cosmetic product and the product is labeled properly. Other 
than color additives, has FDA reviewed the safety of any 
cosmetic ingredients? And if so, how many has FDA reviewed?
    Dr. Mayne. So I would say our review is not the official 
type of Cosmetic Ingredient Review that is envisioned in the 
legislation, but, of course, if we have some safety concerns, 
if we are seeing adverse events, we will try to find out 
whenever we can about the safety and what may have caused that 
particular adverse event.
    So our goal is to use whatever information and whatever 
tools we currently have available. But we have not done any 
type of an official review as envisioned in the legislation 
through the Cosmetic Ingredient Review program.
    Ms. Blunt Rochester. And I recognize that cosmetic products 
may not pose the same risks as other products that the agency 
regulates, but I believe that the FDA should be empowered to 
establish an ingredient review program to help establish the 
safety of cosmetic ingredients in appropriate conditions for 
their use.
    Would you describe what a workable and meaningful 
ingredient review program at FDA for cosmetics might look like?
    Dr. Mayne. So I think what it could look like is, first, a 
public process to help prioritize the ingredients that would go 
in at the front end, like which ones are we most concerned 
about? Do we have the greatest concern we want to prioritize 
for that review? Then we would need to work with industry that 
is using those particular ingredients to find out what data 
they have to substantiate the safety standard that would be 
defined in the legislation. We would then need to make sure 
that we have time to get that data available. There may be an 
iterative process back and forth with industry. We would then 
conclude that review. And we would make a public announcement 
of what our conclusion is. The one thing, again, we want to 
caution against is a conclusion at the end of that process, 
that there is inadequate data to substantiate the safety, and 
then that product would remain on the market. And so, as we 
would hope not to be in the situation that we are in right now, 
at the end of that type of a process with inadequate data. So 
that is the importance of having time to work with industry to 
get that data to the FDA for review.
    Ms. Blunt Rochester. There seems to be a hesitation from 
some in industry about establishing an ingredient review 
program at FDA, given the recent experience with sunscreen 
ingredients. If FDA were to find that there is not adequate 
scientific data, as you talked about, or information to 
establish a safe use of a cosmetic ingredient, how would FDA 
communicate that to industry and consumers? And what actions 
would be required of manufacturers? And we have a minute.
    Dr. Mayne. Yes. So I think the first part of that is, at 
the beginning of that process, we would get the data in. If the 
data were inadequate, we could use a process like we use with 
our food additives petitions, where we are working with the 
industry to say, What information do we need to substantiate?
    I will note that some of these studies may take significant 
time if they do not have the data available. And so, obviously, 
nuances of these processes we would be happy to work with the 
committee on. But we could envision something like that, where 
working with the industry at the very, very end of it, if we 
still don't have that data, we would have to say the data are 
inadequate. And the question is, then, would we have the 
ability to say because the data are not available to 
substantiate the safety, that ingredient needs to be removed 
from the market?
    Ms. Blunt Rochester. Thank you.
    I just want to close by saying that, again, many people 
think already that somebody is checking these things for them. 
And so we want to make sure that one of the things you said is 
that you--in addition to the authorities, you need the 
resources. And so, as a followup, we can hopefully figure out 
what specifically you mean by the resources that you need.
    So thank you so much for your testimony, and thank you, 
Madam Chairwoman.
    Ms. Eshoo. It is called as much money as possible.
    The Chair is delighted to recognize the gentleman from 
Georgia, Mr. Carter.
    Mr. Carter. Thank you, Madam Chair. And thank you, Dr. 
Mayne, for being here. I appreciate it very much.
    Let me ask you, for many years, I was a practicing 
pharmacist, and I owned my own business, and we sold many 
products. I was in somewhat of a rural area, so we had a lot of 
home remedies, if you will. And I am just wondering what your 
intent is on how far you want to carry this. For instance, one 
of things that we sold a lot of, just tons of, was soap made 
out of goat's milk. Is that the kind of thing you are talking 
about here or----
    Dr. Mayne. So I would say we would leave that to the 
committee to make those decisions about what would be 
incorporated from our perspective. Things like good 
manufacturing practices can----
    Mr. Carter. Well, this was made in somebody's barn. I mean, 
it was--
    Dr. Mayne. Then one of the concerns we may have, and we 
have seen evidence, is whether it is made in somebody's barn or 
somewhere else, it needs to be a sanitary condition. And we 
have had circumstances where we have had products manufactured 
in facilities with rodent intrusion, rodent droppings. We have 
had products that are contaminated----
    Mr. Carter. These were good practices, but it wasn't a 
manufacturing plant by any stretch of the imagination. But, I 
mean, we sold tons of it. And----
    Dr. Mayne. And I don't think any GMP would envision that it 
would need to be done in a manufacturing plant. But 
nonetheless, there are important sanitation considerations that 
we would hope all manufacturers would be utilizing already 
right now.
    Mr. Carter. And see, that is one of concerns that I have 
got. Now granted, I was not here, and I am not trying to 
compare apples and oranges here, but I want to go to the Drug 
Quality Security Act, because DQSA--again, granted, I was not 
here when it was passed, but I think that FDA has taken it to a 
level that the legislative intent was never intended for it to 
go to. So that is my concern here. And again, I know we are 
talking about drug quality as opposed to cosmetics. And I am 
not trying to downplay the importance of cosmetics. I 
understand it, and I get it. But, at the same time, with DQSA, 
it has resulted in a number of patients not being able to get 
medications that they need as a result of what I think is the 
misinterpretation of the legislative intent of what DQSA was.
    Dr. Mayne. And I would say, with regard to small 
businesses, small manufacturers, we are always open to 
flexibility for how we can take that into consideration. In the 
setting of good manufacturing practices, of course, there could 
be modified requirements for small businesses. But as I would 
indicate, probably most of these people are following GMPs 
today, in terms of sanitation control. But this is to make sure 
that they all are doing that to protect consumers.
    Mr. Carter. And we all want that, but what has resulted in 
the case of DQSA is that patients aren't able to get some of 
the medications they need, some of the compounding medications 
they need, because of the interpretation of FDA of the rule. So 
that is my concern here. I just--you know, we in the Federal 
Government don't have tendency to overreact, we do overreact. 
And that is just my concern.
    Dr. Mayne. And I can't speak to the drug side of FDA, 
because that is not where I am working.
    Mr. Carter. I understand
    Dr. Mayne. But we are happy to have folks come back and 
engage with you if you have questions about----
    Mr. Carter. OK. Well, let me ask you something. I can 
understand when you are looking at ingredients that are using 
these products, the immediate reaction to the product. But how 
do you ascertain the long-term effects of these products, and 
how are you going to be able--these ingredients--and how are 
you going to be able to ascertain that in a short period of 
time?
    Dr. Mayne. I mean, the review of the data does not take 
that long. The question is the data itself. In terms of how we 
review the long-term safety, we use the same scientific 
techniques and tools that are used across the agency. So we 
want to make sure, for example, that a compound doesn't cause 
genotoxic damage that might be indicating long-term 
carcinogenicity risk. So there are standard toxicity tests that 
can be looked at to prevent long-term toxicity, not just the 
acute setting, which is where we currently have prioritized and 
focused our efforts.
    Mr. Carter. Can you give me an example of one of the trends 
that you see now that concerns you in the way of cosmetics?
    Dr. Mayne. I think, as I said before, most cosmetics are 
safe, but we do see adverse events. We do see microbial 
contamination of cosmetics that are injected into the skin. We 
do see asbestos contamination, asbestos is a known carcinogen. 
So there is no safe level of asbestos in talc products.
    So we do see these trends. We have been very public when we 
find that type of information. We have requested recalls and we 
notified consumers. But while the vast majority are safe, we 
are trying to protect against the adverse events that we do 
see.
    Mr. Carter. One last question. I used the example earlier 
about the soap made out of goat's milk. Is it going to be FDA 
will be addressing the manufacturer, not the retailer who is 
selling it, or both?
    Dr. Mayne. So our authority would presumably be at the 
manufacturer level. The retailer may be distributing a product. 
And if we have to do a recall, then we may be invoking the 
retailers, but it is typically the manufacturer that is 
responsible for the safety of their products.
    Mr. Carter. I understand. And I know I am out of time, but 
I am just very concerned about an overreaction here, and that 
we are going to be putting people out of business and getting 
people that are really depending on these products not being 
able to get them.
    Thank you, Madam Chair. And I yield back.
    Ms. Eshoo. The gentleman yields back.
    I just got a catalogue that I was taking a look at at home 
yesterday, and it was advertising goat soap.
    Mr. Carter. Yes.
    Ms. Eshoo. So beware, Dr. Mayne, you never know what the 
FDA will find in a catalogue.
    I would like to recognize the chairman of the full 
committee, Mr. Pallone, for his 5 minutes of questions.
    Mr. Pallone. Thank you, Madam Chair.
    Dr. Mayne, I want to thank you for being here today to 
discuss cosmetics reform and the need to modernize the FDA's 
authorities. As you know, the agency was first given 
authorities over cosmetics in 1938, and the industry has grown 
dramatically since then.
    Your testimony outlines several gaps in FDA's authorities, 
many of which I believe works to address in the legislation 
that I brought forth yesterday. And I want to focus on one area 
that continues to concern me, and that is imported cosmetics. 
In the past decade, the volume of imported cosmetics has 
increased to more than 1 million lines to nearly 3 million per 
year. For example, you note in your testimony there were 2.7 
million import lines in fiscal year 2018. Yet FDA has shared 
with me that the agency physically examined only 5,564 of them. 
That is less than 1 percent. And of those inspected and 
sampled, almost 23 percent had adverse findings, including 
illegal color additives and microbial contamination.
    So my question is, the cosmetics program is one of the 
smallest programs at the agency. Recognizing that this program 
is not going to have the financial or staff resources to 
physically examine every import line, in order to inspect every 
foreign facility, I included a requirement that importers 
verify that the cosmetic product or cosmetic ingredient that 
they are bringing into the U.S. is safe and has been made in 
compliance with good manufacturing practices. But do you 
believe this type of requirement would help the agency to 
ensure the safety of imported cosmetics? And if so, would you 
explain further why you believe that is the case?
    Dr. Mayne. So we have some experience with this type of 
requirement through the FSMA legislation that we received and 
as a foreign supplier verification program. And what we found 
is that it is very useful in order to make sure that the 
importer, the person who is importing those products, is 
responsible for assuring that those products have been made 
according to the same good manufacturing practices that we have 
in the United States. So it helps to assure parity between 
domestic and foreign importers. And we would envision a similar 
type of program in the cosmetic setting where an importer would 
be responsible for making sure that finished cosmetics products 
that came into the U.S. were manufactured under the same types 
of conditions that domestic manufacturers would be held to.
    Mr. Pallone. I was going to ask about the foods program, 
but you are saying that you like what the foods program 
currently has as a similar requirement.
    Dr. Mayne. The FSVB program requirement under FSMA has been 
very helpful to add to the tools that we have.
    Mr. Pallone. All right. Well, then, my question would be, 
would you not just use it for finished products, but also maybe 
for ingredients and things that are before the finished 
product?
    Dr. Mayne. So we feel if there is a GMP, a good 
manufacturing practice, part of the legislation as well, that 
those ingredients would not necessarily have to go through an 
FSVP-type process. Rather, under the GMPs used by domestic 
manufacturers, they could make sure that those ingredients are 
safe and meet the standards. So you would not need to do that 
for the ingredients as long as you have a GMP provision as part 
of the bill.
    Mr. Pallone. So do you think that--is there anything else 
that you would have a structure as a requirement for cosmetics 
industry based on what we learned in the food space?
    Dr. Mayne. I think we have learned a lot in the food space, 
and we would certainly be happy to provide any additional 
technical assistance from some of the new authorities that we 
have had in the food space. One in particular I can comment on 
is mandatory recall authority. That was a new authority that 
came in to us as part of the FSMA regulations, and we have 
found it very useful.
    And while we have not had to invoke it very often because 
we simply--folks know that we have the authority, and it 
encourages people to do the recall voluntarily, which is the 
quickest way to get a product off the market. It is really--it 
is appropriate, and we have had to invoke it occasionally when 
we have requested voluntary recall in the food space for an 
unsafe product and manufacturers have refused to do it, we have 
invoked mandatory recall.
    Mr. Pallone. All right. Well, I appreciate willingness to 
continue to work with us on that. And I would definitely like 
for you to do so. And it is sort of the interesting too because 
I started out today talking about how years ago, with 
Congressmen Dingell, John Dingell, and Waxman, we had this all-
in-one bill that covered food, cosmetics, drugs, and 
everything. Of course, we separated them out. But there is, you 
know, in many ways, we can use the lessons from those other 
things.
    Thank you so much. Thank you, Madam Chair.
    Ms. Eshoo. The gentleman yields back.
    Mr. Mullin is recognized from Oklahoma for your 5 minutes 
of questions.
    Mr. Mullin. Thank you, Madam Chair.
    Ma'am, how would the FDA implement the ingredient-reporting 
requirements under both these bills?
    Dr. Mayne. So, in terms of the reporting requirements, I 
think what you are alluding to is the registration program?
    Mr. Mullin. Right.
    Dr. Mayne. So we would augment the online database that we 
have available right now, where first a company would register 
with information about who they are, where they are located, 
what products do they manufacture. And then the second piece of 
that is the ingredients that are in those products. So it would 
list the products and the ingredients that are included.
    Once the information is put up into the database, 
presumably it could be updated on some basis that was 
specified. For example, on an annual basis, the information 
would remain in existence and any updates that would be needed 
could be made to the database so that FDA would have 
information on the ingredients they are using.
    Mr. Mullin. So, when they are looking to bring a new 
product to line, this would have to go through this process 
every time, or would it just be just 1 year, and then they 
wouldn't have to do it unless they changed an ingredient to the 
product?
    Dr. Mayne. Certainly we would be happy to provide technical 
assistance on how that could work. But yes, that would be 
presumably how it would be envisioned if once it is up, it 
would be up there and that they need to update any changes that 
were made if they were producing new products or making 
modifications to ingredients.
    Mr. Mullin. So what would the timeframe be added to then, 
to bring a product to the market?
    Dr. Mayne. I think that would need to be considered in the 
legislation itself, and FDA working with that.
    Mr. Mullin. Do you currently have the capacity to be able 
to handle all the new requirements?
    Dr. Mayne. Well, we currently have a database that covers 
approximately one-third of all manufacturers, so we would need 
to augment that database, and we would then simply work through 
that, with the committee.
    Mr. Mullin. Have you guys tried to figure out what the cost 
would be to businesses, especially small businesses?
    Dr. Mayne. I would have to take that back to our folks on 
the budget side. I think industry is probably better able to 
address that. What I can say is that our goal, especially in 
the small business, would be to make this as the least 
burdensome as possible. Simply entering the manufacturing 
information should take minutes, depending upon the number of 
products. Putting the ingredients into a database could take 
minutes as well. So our goal is to keep it minimally 
burdensome, but get the information that we need about what is 
in the cosmetics marketplace.
    Mr. Mullin. At the beginning of the hearing, I think the 
chairwoman said that--if I am not mistaken--said there was 
roughly, on average, a person uses 12 cosmetic products?
    Dr. Mayne. Those are personal care products, not all of 
which are cosmetic.
    Mr. Mullin. So what is considered cosmetic? You have got to 
forgive me for that, because I am just not someone who puts on 
makeup every day.
    Dr. Mayne. Yes. Some of the things in the personal care 
products space would include some of the over-the-counter 
drugs. So if there is, for example, modifying structure 
function like reducing wrinkles versus simply improving the 
appearance.
    Mr. Mullin. So that would be lotion?
    Dr. Mayne. Some--lotions are certainly in the cosmetic 
space, shampoos you have heard about many of them here today.
    Mr. Mullin. Deodorants.
    Dr. Mayne. Deodorants would be cosmetic, correct.
    Mr. Mullin. That is three for me so far. What about gel 
hair products?
    Dr. Mayne. That would be a cosmetic as well.
    Mr. Mullin. I'm up to four. I don't think I am going to 
meet 12, though.
    Ms. Eshoo. We are going to get mascara on you before we are 
finished here.
    Mr. Mullin. Just when I have a black eye and trying I am to 
cover something up.
    My biggest concern on this whole thing is just the cost to 
small business. Of course, we want everyone safe. We want the 
safest products out. But at the same time, 50 percent of our 
economy in the United States is driven by small businesses. And 
the threshold to enter business anyway is tough. The failure 
rate is way too high. And any cost, added cost and added 
requirements we have prohibits the next generation of inventors 
coming forward. And what we see is, is the industry 
consolidating more and more. We already see that in the 
pharmaceutical businesses. We don't want to see that in the 
cosmetic industry.
    And so, moving forward, my biggest concern in this whole 
thing is, what will the cost be to the small businesses? What 
are the implementations for it, and is that threshold 
achievable? So, while I like the idea where we are headed, I 
just want to be careful that we don't--we are not slapping the 
hand that feeds our economy.
    So with that, I yield back.
    Ms. Eshoo. The gentleman yields back.
    Pleasure to recognize the gentleman from California, Mr. 
Cardenas.
    Mr. Cardenas. Thank you very much, Madam Chair, for having 
this very important hearing.
    Dr. Mayne, thank you so much for coming forth and answering 
our questions with your expertise and knowledge. I am sure you 
are aware that there is a lot of interest in our conversations 
around cosmetics reform as it relates to tattoo ink, 
manufacturers and tattoo artists. For some of us, it might seem 
a bit surprising that any aspect of tattooing would be 
regulated as a cosmetic product, but as I understand it, the 
Food and Drug Administration has said that the agency considers 
the pigment in tattoo inks to be a color additive, and the 
agency treats finished tattoo inks as cosmetic products.
    In recent years, there have been examples of certain 
manufacturers selling contaminated inks. Despite these few bad 
actors, the industry, at large, is focused on safety of their 
products and is willing to work with the FDA to ensure that 
their products meet reasonable safety standards. Given the 
continuous growth of the tattoo industry and the past concerns 
about contaminated tattoo inks, I want to focus on what we can 
do to balance the need for safe tattooings with the robust 
market demand of the 45 million Americans who already have 
tattoos on their bodies.
    First, I would like to ask you, Doctor, can you tell me a 
little bit about the FDA's history with the tattoo industry?
    Dr. Mayne. Yes. So the engagement we have had has been 
around areas where we have had safety concerns in trying to 
work with the industry to make sure to help them make a safer 
product. That has been the engagement we have had. That has 
largely concentrated around those products that we have found 
to be microbially contaminated, as you alluded to. So we had 
meetings with the sectors of the industry to make them aware of 
that and help them understand what to do in order to make sure 
that those products are as safe as possible.
    You also mentioned the color additive petition process. We 
are engaging in dialogue with the industry about potentially 
submitting some color additive petitions to FDA. So we are 
working in partnership with that industry to help assure the 
safety of those products, and it is obvious that is something 
we care about. I am a parent to one of those many million 
heavily tattooed individuals out there.
    Mr. Cardenas. Yes, I am a parent of at least one that I am 
aware of. He finally took his shirt off one day during the 
summer, it was too hot. And I said, ``What's that?'' So I know 
what some families are going through.
    So the FDA has an involvement in regulating tattoo inks, 
and what does that look like today?
    Dr. Mayne. What we have done is we have prioritized the 
resources that we have, again, where we have the greatest risk 
and the greatest concern, and that has been the microbial 
areas. But at the same time, we want to continue to work with 
industry to make sure that the inks that are used are as safe 
as possible, and the color additive petition process is one 
pathway we can do that.
    Mr. Cardenas. How many pigments have the tattoo industry 
manufacturers submitted to FDA for review and color additive 
products as well?
    Dr. Mayne. At that point, we don't have any color additive 
petitions that have been submitted from the tattoo industry.
    Mr. Cardenas. Zero, huh? OK.
    As you know, the legislation offered by Chairman Pallone 
would give the FDA the authority and responsibility to 
establish a review framework for cosmetic ingredients. Does the 
FDA believe it would be appropriate to review tattooings under 
this new framework, or would the agency continue reviewing the 
pigment in tattooings under the color additive review process?
    Dr. Mayne. As you know, we do have the authority right now 
under the color additive petition review process to review 
those inks. But it is an interesting question whether they 
could also be considered as candidates to go into the cosmetic 
ingredient review program, and we would be happy to engage with 
the committee on which path may be a more appropriate path for 
moving forward with regard to the safety reviews on tattoo 
inks.
    Mr. Cardenas. The FDA has tremendous amounts of 
responsibility currently. Of those responsibilities at the FDA 
that you are aware of has already identified to make our world 
safer for consumers and producers of products, does the FDA 
currently have all the resources necessary to move forward and 
address all of those needs?
    Dr. Mayne. Are you speaking across all areas?
    Mr. Cardenas. Yep. I think I know the answer.
    Dr. Mayne. I mean, what I would say is we make the most of 
the authorities that we have. We can always do more with more. 
We have specific budgetary outfit that we put forward on areas 
where we could potentially use more resources.
    Mr. Cardenas. So you are not here to ask for more 
resources, but I just wanted the public to recognize that it is 
Congress' responsibility to make sure that the resources are 
made available to every government, Federal Government, entity 
that we put those responsibilities on, just like the 
legislation that Chairman Pallone is carrying, which I support. 
And I think it is very important that we understand that we 
have a partnership in this. And part of that partnership is to 
give you the resources necessary to keep our consumers safe and 
make sure that our manufacturers understand the rules and 
regulations of the road.
    I yield back. Thank you.
    Ms. Eshoo. The gentleman yields back.
    The Chair recognizes the gentleman from Illinois, Mr. Rush.
    Mr. Rush. I want to thank you, Madam Chair, for holding 
this historic hearing. And I don't know whether or not you are 
aware of it, but this is only the second time in the last 40 
years that this committee, subcommittee, has had a hearing on 
personal care product safety. So I want to thank you, Madam 
Chair, for the second hearing in 40 years.
    Dr. Mayne, I really appreciate you being here and listened 
intently at your testimony. While cosmetics and personal care 
products are important for all Americans, African-American 
women, yet again, are most at risk, according to the 
Environmental Working Group, whose senior vice president will 
testify later today. I quote her and she says, ``Black women 
appear to buy and use more personal care products, and fewer 
than 25 percent of products marketed to Black women are 
considered to be low in potentially hazardous ingredients, 
compared to about 40 percent of the items marketed to the 
general public.''
    While there are many products that are targeted to African 
Americans, including concealers and foundation, we do not 
currently have safe alternatives. There are three specific 
products that have recently gotten increased news coverage and 
are particularly troubling: talcum powder sold by Johnson & 
Johnson, which the FDA has found to contain asbestos; skin 
lightener, which was found to contain high doses of mercury; 
and hair straightener products that contain formaldehyde, which 
the National Toxicology Program has linked to cancer. Are there 
any safe alternatives for talcum powder, skin lighteners, and 
hair relaxers?
    Dr. Mayne. So I can't speak to the alternatives issue, 
because part of what you are getting at is the efficacy, and we 
don't review cosmetics for efficacy, we review them for safety, 
so I can't get at that issue. What I can tell you is that we 
share your commitment in terms of making sure those products 
are safe. The reason we know about some of these issues, 
including asbestos in talc, is because we have invested 
resources to sample talc-containing products and test those 
products. As we noted, we have tested 50 in our most recent 
batch. We will continue to test talc-containing products for 
asbestos going forward. So we are utilizing our resources to 
try to address those issues.
    Similarly, the problem of mercury in skin lighteners is 
well-known. Those are the types of products that are going to 
be scrutinized at the border especially, and also in our 
sampling, because we have a history of problems with those 
types of products. And those are the kinds of things where we 
are prioritizing our resources.
    If there are education and outreach opportunities to reach 
special targeted populations, we would be happy to partner with 
you. We do a significant amount of consumer outreach and 
education. We would be happy to partner with you on those.
    Mr. Rush. Well, can anything be done in the instance that--
Madam Chair, I do have a news article I would like unanimous 
consent to be entered into the record. It is a special report, 
``As Baby Powder concerns mounted, J&J focused marketing on 
minority, overweight women.''
    Ms. Eshoo. So ordered.
    [The information appears at the conclusion of the hearing.]
    Mr. Rush. Dr. Mayne, I am concerned in the case of baby 
powder that African-American women and girls were targeted 
through free samples and promotional offers, which were handed 
out at churches, beauty salons and barbershops. And, according 
to the article that I just indicated, 100,000 gift bags 
containing baby powder, Johnson's baby powder, were distributed 
in African-American and Hispanic neighborhoods in Chicago. 
Today, there are over 12,000 lawsuits against Johnson & Johnson 
claiming that this baby powder caused ovarian cancer and 
mesothelioma, both extremely deadly forms of cancer.
    And I just want to ask you, do you need more authority from 
Congress in order to deal with incidents where companies are 
targeting vulnerable communities with these dangerous products?
    Dr. Mayne. Sir, FDA is not responsible for the marketing 
part of these products. We are responsible for the safety, and 
that is why we are here to talk today about some of the new 
authorities that we would have in that area. In the meantime, 
we will continue to test talc products to try to make sure that 
they are as safe as possible for consumers. That is one of our 
commitments.
    Mr. Rush. And you mentioned that you would be willing to 
work with this committee and the Congress to provide a broad-
based----
    I yield back.
    Dr. Mayne. I didn't hear the finish of the question. We are 
willing to work with the committee on----
    Ms. Eshoo. The gentleman can submit it in his written 
questions.
    The Chair now recognizes the gentlewoman from Illinois, Ms. 
Kelly, for her 5 minutes of questions.
    Ms. Kelly. Thank you, Madam Chair. And thank you, Dr. 
Mayne, for being here.
    I am very concerned about the unknown impact of 
unsubstantiated cosmetic ingredients on women and girls across 
the country. I have heard that women use 12 personal care 
products on average. I was trying to count on my own self. And 
some surveys have suggested that girls as young as age 14 are 
using 14 products. Surveys have also shown that women believe 
that the products they are using, of course, are safe and that 
the FDA cleared these products for marketing, as some of my 
colleagues have said.
    Further, as the witness on our second panel pointed out in 
her written testimony, vulnerable and underserved women and 
girls may be disproportionately impacted by exposure to 
chemicals, including the ingredients used in their personal 
care products. In fact, she pointed out that reproductive-age 
women of color have higher levels of endocrine-disrupting 
chemicals than do White women of reproductive age.
    I understand that there could be a variety of factors that 
contribute to the disparity, but I am concerned that cosmetic 
products is one such factor. It is my understanding that we 
know relatively little about the full impact of endocrine 
disruption on women and girls. But I also understand that the 
science is advancing. I would like to know what tools FDA 
requires to better protect women from these harmful chemicals. 
So can you give us a sense of the state of the science 
regarding the effects of endocrine disruption?
    Dr. Mayne. I think with our current authorities, we would 
need to demonstrate that the inclusion of those compounds that 
have those activities renders the product adulterated, 
injurious, harmful to humans.
    What is envisioned in this legislation is a cosmetic review 
program that would have a safety standard reasonable certainty 
of no harm. And so you could imagine that some of the compounds 
that we hear about a lot today which have potential endocrine-
disrupting activity, those might be the types of chemicals that 
would be prioritized for review in this program under that 
safety standard.
    So we would look at that current science that is available 
in this area of endocrine disruption in order to make that 
safety determination based upon the data that are available at 
that time. And as you note, it is an emerging area. There is 
additional science that comes in all the time. So we would look 
at that scientific basis.
    Ms. Kelly. I was going to say, how much do we actually know 
about the possible linkage between low-level exposure to 
certain chemicals, and then certain adverse health 
consequences, such as cancer?
    Dr. Mayne. Yes, that would be our experts, those would be 
our scientific experts who would be doing those reviews who 
would be familiar with the state of science on that, and that 
would be the way the cosmetic ingredient review process would 
work.
    Ms. Kelly. Are there many validated nonanimal-tested 
methods to determine if ingredients are causing endocrine 
disruption?
    Dr. Mayne. So I am aware that there are in vitro tests to 
look at things like estrogenic, androgenic activity that you 
could apply to compounds. Whether or not those would be 
validated for use as end points, we would have to take that 
back to our scientific experts to have them address that 
question.
    Ms. Kelly. And then, finally, I understand that the 
legislation we are considering today would direct FDA to 
evaluate the safety of cosmetic ingredients. Should such an 
evaluation take into account the potential long-term effects of 
ingredients used, such as the endocrine disruption or 
possibility of adverse health consequences for women and girls?
    Dr. Mayne. I would say, absolutely. That is one of most 
important features, because with our current authorities we 
find out about short-term effects, if they get reported through 
the adverse of that reporting system. But the importance of 
cosmetic ingredient review is to really look at that potential 
for long-term effects through some of the mechanisms that you 
just spoke about.
    Ms. Kelly. And as some of my colleagues--someone asked you 
what your Christmas list was, and some of my colleagues said 
that we need to make sure that we are giving you the necessary 
tools so that you can carry out your work. And I certainly vote 
in favor of that.
    Thank you.
    Dr. Mayne. Thank you.
    Ms. Eshoo. The Chair is pleased to recognize the 
gentlewoman from New Hampshire, Ms. Kuster, for her 5 minutes.
    Ms. Kuster. Thank you very much for being with us today. I 
appreciate it, and I find it unbelievable that for 80 years the 
FDA has lacked the appropriate resources and tools to ensure 
the safety of cosmetic and personal care products. Lotions, 
fragrances, makeup, shampoo, all of these products we use 
directly on our skin on a daily basis. So just 2 weeks ago, 
this committee passed legislation on PFAS chemicals that are 
contaminating our environment and jeopardizing human health. 
Across the country, in my home State of New Hampshire, 
communities and families are dealing with the proliferation of 
toxic PFAS and PFOA chemicals.
    In fact, there is rarely a day where we don't open our 
newspaper and read yet another story about a town, a school, a 
community faced with unsafe drinking water, or a household that 
must rely on bottled water because of PFAS contamination.
    So you can imagine how shocking it was to me to see listed 
as the first ingredient on a cosmetic product, PTFE. The 
average consumer might overlook this as just another acronym, 
but I am quite certain that they would recognize the trademark 
name for PTFE, best known as Teflon. The number one ingredient 
in nonstick frying pans is also an ingredient in our cosmetics 
and our personal care products. It turns out PFAS chemicals are 
added to cosmetics for various reasons, including oil and water 
repellency. Waterproof mascara and eyeliners, for example, are 
common makeup items that may use PFAS chemicals. We don't know 
how our exposure to these chemicals is affecting our health, 
and that is exactly why we are here today, to better understand 
the potential health impacts of these products. So I want to 
thank you for appearing with us.
    I want to ask the question: To what extent are PFAS being 
used in cosmetics and personal care products, if you would?
    Dr. Mayne. So we are aware of the issue of PFAS being added 
to cosmetics products as ingredients. We have queried the 
Voluntary Cosmetic Registration Program and ingredient database 
that we have, and so we are aware that there are compounds that 
are being added to cosmetics. What we don't have information on 
is quantities, exposures. We also don't have good information 
available about potential health effects of many of those 
compounds, which you know is an emerging area of science more 
broadly on the PFAS.
    So we are engaging in dialogue with industry as well to 
better understand what is being added to cosmetics, what the 
exposures may be, and, again, any potential health concerns. It 
is an area that we are deeply engaged in at the FDA, not just 
in the cosmetic space, but more broadly.
    Ms. Kuster. And are there any restrictions at all at this 
point in time on including PFAS as an ingredient in cosmetics?
    Dr. Mayne. There are not. Again, there are no banned 
ingredients involving PFAS in cosmetics at this point in time.
    Ms. Kuster. And when products contain harmful chemicals 
known to be linked to cancer and reproductive health, is there 
a way that consumers would know this information?
    Dr. Mayne. Under the current laws, cosmetic ingredients 
need to be declared on the labels, and so that would be the 
only way that a consumer would potentially have that 
information available, is by reading the ingredient list on 
products that are currently on the market.
    Ms. Kuster. And could you outline, under the legislation 
that we are considering, what would be different in your 
authority and in the consumer receiving this information?
    Dr. Mayne. I think we would be happy to work with the 
committee to address any thoughts that you may have on how that 
ingredient, you know, listing could be implemented to address 
some of your concerns. We would be happy to work with you.
    Ms. Kuster. Great. Well, thank you very much. I 
appreciate--I think this is an important area, and I know my 
constituents will be as shocked as I was to see that as 
literally the number one ingredient, that PFAS is just such a 
big issue for us right now. People can't drink their water. 
They have to have bottled water. We had a scare recently in a 
school, a new school in my district, PFAS, very high levels in 
the water.
    And so, the idea that we are literally putting products on 
our face every day, paying good money for it, and the 
testimony, I think, previously about young girls being involved 
with this without having any idea, families not knowing. So I 
appreciate the work you are doing and I thank you, Madam Chair, 
for holding this important hearing.
    And I yield back.
    Ms. Eshoo. The gentlewoman yields back.
    Just an FYI. The European Union has banned 1,400 chemicals, 
the United States has 11. So we have got work to do.
    The gentleman from Maryland, Mr. Sarbanes, is recognized.
    Mr. Sarbanes. Thank you very much, Madam Chair.
    I actually was going to ask you some questions about PFAS, 
but my colleague from New Hampshire did a really good job of 
that. So another question I had is, I am just curious, how do 
we get to where all of these products have somehow fallen out 
of the purview, or the regulation, the oversight of the FDA? 
Was there some point along the way as FDA was gathering to it 
and having Congress assigned to it the responsibility of 
transparency and accountability with respect to chemicals and 
products and so forth that can pose a harm to health that this 
category of products somehow dropped out of the discussion, or 
off the radar screen, or never got into the discussion?
    It is sort of striking how unpoliced this area is. And I 
don't know if you have a historical perspective on that that 
could explain it, or maybe it is just some--you know, it is a 
problem here in Congress that we can attribute it to.
    Dr. Mayne. I can't speak to the history as to why there has 
not been a previous attempt to try to modernize the authorities 
in cosmetics, as there has been in many other product areas 
that we regulate. So cosmetics is notably lacking in many of 
the authorities that we do have in the other areas at FDA. So I 
can say that. But in terms of why, I can't speak to that.
    Mr. Sarbanes. And does the FDA--I mean, how constrained are 
you by the lack of, sort of, statutory oversight to even--I 
mean, for example, you get these consumer complaints that come 
at you, even though there is no obligation on the industry to 
report adverse incidents, et cetera.
    So when those come at you, do you find that your hands are 
just really tied in terms of how you can respond to it, or if 
there is some way for you to respond, do you encounter even in 
that resistance from the industry that is palpable? Can you 
speak to that?
    Dr. Mayne. As I said earlier, I think most industry is 
cooperative and works with FDA when we identify a safety 
concern. But when we have industry that doesn't want to 
disclose information to us, even though we request it and we 
may request it in writing and they fail to disclose that 
information to us, we have little recourse. That does hinder 
our investigations. The type of information we could use to 
better understand the cause of some of the adverse effects that 
we see hinges on the data that we would like to get from some 
of those companies and from some of that industry.
    So we have to use alternative methods to try to get that 
information and that data, using our own resources rather than 
relying on the information that the companies may, in fact, 
hold but fail to disclose to us in those unusual circumstances 
where a company doesn't want to work with the FDA.
    Mr. Sarbanes. I remember when we had hearings a couple 
years back on updating the Toxic Substances Control Act, and 
the observation of a number of us on the committee was that the 
average member of the public would never imagine that, in that 
instance, there were so many toxic chemicals that were flowing 
through the stream of commerce without any basic knowledge of 
the harm they might pose.
    And I will make the same observation here. For any consumer 
who is out there watching this, I think they would be shocked 
to hear that there is so little oversight and transparency with 
respect to cosmetics and some of the potential adverse effects 
that they can pose. And obviously, it is our responsibility 
here in this committee to rectify that situation and create 
that transparency, and we have proposals before us that would 
do that, and your testimony is going to be very helpful.
    So thank you, and I yield back.
    Dr. Mayne. Thank you.
    Ms. Eshoo. The gentleman yields back.
    Now, I would like to recognize the gentlewoman from 
Illinois, Ms. Schakowsky, for 5 minutes.
    Ms. Schakowsky. Thank you so much, Madam Chair, for once 
again allowing me to waive on to this subcommittee.
    I did introduce in 2010 legislation, so there has been at 
least some discussion, and yet, very little action. Nineteen 
thirty-eight is a long time ago for the Food, Drug, and 
Cosmetics Act. And I know that many others have said, I think 
there is an assumption by consumers on all kinds of products, 
including cosmetics, that someone somewhere, that the 
government is protecting them, and so far from true.
    So we have a largely unregulated industry right now that is 
so prevalent in all of our lives. I wanted to just review some 
of that. So you have no authority, is it true, to have 
registration of cosmetics companies?
    Dr. Mayne. That is correct. It is voluntary.
    Ms. Schakowsky. Do we know how many--so you don't know what 
you don't know, right?
    Dr. Mayne. Our best guess is approximately a third of 
manufacturers have registered in our voluntary program.
    Ms. Schakowsky. And there is no mandatory recall. Is that 
correct?
    Dr. Mayne. That is correct.
    Ms. Schakowsky. And are they required to report serious 
adverse events?
    Dr. Mayne. They are not.
    Ms. Schakowsky. And I just want to point out, in 2018, 
there were 2,727,848 lines of cosmetics that were imported from 
177 countries. Is it true that only 289 were actually sampled?
    Dr. Mayne. What I have is a percentage. We examined 0.2 
percent of imported lines, less than 1 percent.
    Ms. Schakowsky. So I wanted to also quote, and I think you 
were just repeating that earlier, that you testified that, 
quote, ``Cosmetics firms, are responsible for the safety of 
their products and ingredients,'' and, quote, ``In our 
experience, most firms are responsible actors,'' unquote. How 
do you know that?
    Dr. Mayne. I mean, when we have had concerns, we have had 
companies that have worked with us. But I think your point is 
well-taken in that we don't have access to the safety data, so 
we really do not know what safety data exists out there to 
substantiate that.
    But, given our experience in the market, we are not aware 
of adverse events with the vast majority of cosmetic products.
    Ms. Schakowsky. Are you aware--I was trying to get at, and 
I didn't do it very well--that in 2018 there was a study by the 
Breast Cancer Prevention Partners and found that the most toxic 
product it tested was a shampoo called Just for Me that is 
marketed to young Black girls? Are you aware of that?
    Dr. Mayne. I have heard the report of that study, correct.
    Ms. Schakowsky. And so, what authority do you have to act 
on that?
    Dr. Mayne. So, again, the burden would be on FDA to 
demonstrate that the inclusion of whatever compounds they were 
defining as being toxic in that product, the burden would be on 
us to demonstrate that that renders the product injurious to 
humans.
    So it is a safety burden on the FDA to prove that data. We 
would need to create our own data, because we cannot rely on 
industry's data necessarily, because they don't need to provide 
that data to us.
    Ms. Schakowsky. But do you have the authority to examine 
all ingredients that are in cosmetics?
    Dr. Mayne. To examine all ingredients in cosmetics would be 
daunting. As you noted, there are literally tens of thousands 
of ingredients. What we do is we prioritize the ones where we 
have safety concerns that come to our attention. We utilize our 
authorities wherever possible to try to protect consumers.
    Ms. Schakowsky. Before my time runs out, the chairwoman 
just gave an example of other countries that actually have 
banned these products. Is that not calling it to our attention?
    Dr. Mayne. Certainly, that has raised the visibility and 
the issue with regard to the cosmetics regulatory framework we 
have in the United States today.
    Ms. Schakowsky. Well, let me just, in the last couple 
minutes--we need to work with you to come up with legislation 
that actually does fulfill the expectations of consumers right 
now, who are not only spending a lot of money, but endangering 
their own health because of the lack of regulation.
    And I yield back.
    Ms. Eshoo. The gentlewoman yields back. And we thank her 
for the legislation that she has on the table here. There is a 
lot of work to do on this. I agree with you. I think just about 
everyone assumes that someone is reviewing what is being sold, 
and that it is safe. And we are just wide open.
    I agree that there are good people in all of this, but I 
don't think we know how many are. I don't know if we know how 
many American companies--great labels, labels we have never 
heard of--do they do their manufacturing here? Do they do it 
abroad? I mean, we are finding a tainted drug supply coming 
into the country. Well, if a drug supply can be tainted and 
there is subpar manufacturing, God knows what is in this stuff. 
And I think FDA could be encyclopedic at this point, given the 
EU, given California. So we have a lot to draw from.
    Mr. Shimkus. If the lady would yield.
    Ms. Eshoo. Sure, I would be glad to.
    Mr. Shimkus. Just to weigh in. And we are kind of where we 
started on this. To move quickly and get something across the 
finish line would require working together and getting 
something through the Senate and to the President's desk that 
he will sign, and we are all in willing to do that. I think the 
hearing so far has identified a need, a gap. So let's continue 
to work on it.
    Ms. Eshoo. Good. Well, we are going to depend on you, 
because you, Ms. Schakowsky, Mr. Pallone are in the lead on it. 
And we will all be the beneficiary.
    So that concludes our first panel, our one and only. Dr. 
Mayne, thank you for the work that you do at the FDA. Was it my 
understanding that you suggested that there be timeframes 
relative to rulemaking in legislation, that FDA supports that?
    Dr. Mayne. No, I don't think that that would be possible, 
but we can certainly give you--when we spoke earlier, we gave 
you the typical timeframes for doing notice and comment 
rulemaking, which involves, obviously, like the----
    Ms. Eshoo. But we are really going to have a problem here, 
as far as I am concerned, if it is going to be 7 years. I mean, 
it is an 80-year-old law. Now, Congress finally is rising up. 
It is not going to be easy. Nothing ever is around here. But I 
have confidence that--this is bipartisan. Everyone is 
interested in this, has a stake in it. But if it is going to 
take FDA 7 years, then I don't even know what to say about 
that. Let me just say, I am not for that, how is that, all 
right?
    Dr. Mayne. The 7 years was a unique situation where we both 
had to create a scientific regulatory framework for the issue 
that you and I discussed----
    Ms. Eshoo. But that is why I asked about it, though.
    Dr. Mayne [continuing]. And then subsequent to that, engage 
in notice and comment rulemaking. And so that was a different 
scenario than what we have here today.
    Ms. Eshoo. But you are starting from scratch on this.
    Dr. Mayne. But things like GMPs we are not starting from 
scratch on.
    Ms. Eshoo. That is a small part of it.
    Dr. Mayne. GMP regulations, those are things that could be 
done much more expeditiously, because we have experience----
    Ms. Eshoo. So you don't want Congress to lean in on 
timeframes?
    Dr. Mayne. We could certainly get back to you in our 
dialogue.
    Mr. Shimkus. If the gentlelady would yield.
    It is the same problem we have in doing the real science. 
It is multigenerational. So that is the challenge. That is the 
rat studies, right? You do multiple generations of the rat 
studies, or maybe we don't have to do that. We got rid of that 
in TSCA, for the most part. Other processes of doing, you know, 
the animal testing versus--but that is the problem with some of 
this stuff.
    Ms. Eshoo. The headline here: ``Congress Gets Rid of the 
Rats.'' OK.
    Mr. Shimkus. They won't believe that.
    Ms. Eshoo. I know. I know. I know.
    Well, thank you, Dr. Mayne. And we appreciate your being 
here and the time that you spent answering the questions. And 
you are going to be front and center working with both sides of 
the aisle on this.
    So I would ask the staff to prepare the witness table for 
the next panel so we can take their testimony.
    [Discussion off the record.]
    Ms. Eshoo. The witnesses, you can take your places at the 
table, please.
    OK. We are now going to hear from the second panel of 
witnesses on this important issue, and the witnesses include 
Isabelle Chaudry. Is Isabelle here? Oh, she is not here. All 
right. Was she here?
    Ms. O'Donnell. Yes. I think she just stepped out.
    Ms. Eshoo. All right. Mr. Scott Faber, welcome, Senior Vice 
President, Government Affairs, the Environmental Working Group. 
Leigh O'Donnell--Leigh, welcome. It is lovely that you are 
here, Executive Director of the Handcrafted Soap and Cosmetic 
Guild. Ms. Gregg Renfrew, founder and CEO of Beautycounter. 
Welcome to you. And we will welcome Ms. Chaudry when she takes 
her seat.
    So why don't we begin with Ms. Renfrew. You are recognized 
for 5 minutes, and thank you again for being here today and 
your patience in waiting, but I am sure you found it 
interesting in the exchange between Members and the witness' 
testimony. So you are recognized for 5 minutes.

  STATEMENTS OF S. GREGG RENFREW, FOUNDER AND CHIEF EXECUTIVE 
    OFFICER, BEAUTYCOUNTER, LLC; LEIGH O'DONNELL, EXECUTIVE 
  DIRECTOR, HANDCRAFTED SOAP AND COSMETIC GUILD; M. ISABELLE 
    CHAUDRY, SENIOR POLICY MANAGER, NATIONAL WOMEN'S HEALTH 
  NETWORK; AND SCOTT FABER, SENIOR VICE PRESIDENT, GOVERNMENT 
              AFFAIRS, ENVIRONMENTAL WORKING GROUP

                 STATEMENT OF S. GREGG RENFREW

    Ms. Renfrew. Thank you. Chairman Eshoo, Ranking Member 
Burgess, and members of the Energy and Commerce subcommittee, 
thank you for holding this important hearing and for inviting 
me to participate.
    My name is Gregg Renfrew, and I am the founder and CEO of 
Beautycounter, a company with a mission to get safer products 
into the hands of everyone. Beautycounter is the result of a 
personal journey where I found the connection between our 
environment, what we put in our bodies, and what we put on 
them. I have seen, firsthand, health impacts on friends and 
family, and I was compelled to change the personal care 
industry.
    In addressing the need for clean beauty laws, the business 
opportunity also became apparent. The clean beauty industry 
continues its impressive growth, on track to reach a value of 
nearly $22 billion by the year 2024. But one company, even with 
the combined efforts of others, cannot fix this problem alone. 
And so, in that spirit, today I will focus my testimony on what 
I believe is critical to creating cosmetic safety laws that 
protect consumers while simultaneously advancing the beauty 
industry.
    First, we need a health protective safety standard. The 
current absence of Federal safety regulations in our industry 
forces businesses like Beautycounter to make their own 
decisions about the safety of ingredients. A uniform safety 
standard is paramount to gain consumer trust. We believe that 
how Congress defines what is safe is one of the most important 
elements of reform.
    By creating a strong safety standard in this bill, Congress 
has the opportunity to protect the health of American families 
while making sure that our business community is keeping up 
with international markets.
    Beautycounter supports a safety standard where the FDA has 
the tools to adequately assess both short- and long-term 
impacts of ingredients. We believe that reasonable certainty of 
no harm best reflects a public health approach that consumers 
can trust.
    Second, we encourage timely ingredient review, based on the 
best available science. We support legislation that reviews as 
many ingredients as possible each year. The sooner that safety 
determinations can be made on ingredients, the faster 
manufacturers like ourselves can bring products to the market.
    Additionally, we encourage you to allow the FDA to review 
classes of ingredients, where relevant, to conserve agency 
resources, while noting that determinations must be made on 
individual chemicals. Reflecting on Beautycounter's early days, 
we would have benefited from a Federal program that allowed us 
to either avoid or use ingredients based on a comprehensive 
review of available scientific literature. I have no doubt that 
many other companies feel the same way.
    Third, we support a user fee system that fully funds the 
FDA. As the CEO of a company that started with just a handful 
of employees, I understand how the notion of fees can seem 
daunting. Through this experience, we have gained an 
appreciation for the need to make reasonable accommodations for 
small- to mid-size businesses. That is why we support a sliding 
scale user fee program that takes into account both large and 
small businesses. As the company grows, we believe the 
responsibility should increase accordingly.
    Fourth, Federal law must account for existing State 
protections. Given the lack of Federal laws on cosmetics and 
personal care products, many States were forced to take action. 
Beautycounter supports a State preemption approach that 
preserves existing State laws while creating a strong Federal 
program that will negate the need for new laws to be passed. At 
Beautycounter, we refer to the concept of progress versus 
perfection, and I believe that sentiment also holds true for 
the legislative process.
    We are encouraged by the key elements reflected in 
proposals before the committee, including setting mandatory 
good manufacturing practices, granting the FDA the ability to 
recall harmful products, increasing ingredient transparency, 
and requiring the disclosure of fragrance allergens.
    I believe that this committee can and must come together to 
pass bipartisan legislation, as you have done many times 
before. But I am not asking you to do this alone. I, on behalf 
of Beautycounter, our advocates, and our clean beauty movement, 
commit to mobilizing our community of millions to support this 
important public health issue.
    In closing today, I am asking you to act. Act to protect 
the mother trying to find safer products for herself and her 
family. Act to empower companies, large and small, across 
America. Act to meet the consumer demand for greater 
transparency. When you pass legislation that will protect the 
health of American families, you are not only responding to a 
growing, passionate, and bipartisan electorate eager for 
reform, but you are also protecting the health of American 
families, now and forever.
    Thank you for your time today and for your leadership on 
this important issue.
    [The prepared statement of Ms. Renfrew follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
    
    Ms. Eshoo. Thank you, Ms. Renfrew.
    Next the Chair recognizes Ms. Leigh O'Donnell, and thank 
you for being here. I look forward to your testimony. You can 
proceed.

                  STATEMENT OF LEIGH O'DONNELL

    Ms. O'Donnell. Good afternoon, Chairman Pallone, Ranking 
Member Walden, and members of the Energy and Commerce 
Committee's Subcommittee on Health, Chairwoman Eshoo, and 
Ranking Member Burgess. Thank you for this opportunity today. I 
am honored to offer this testimony on behalf of the handcrafted 
soap and cosmetic industry.
    My name is Leigh O'Donnell. I am the executive director of 
the Handcrafted Soap and Cosmetic Guild, a registered nonprofit 
trade association representing the handcrafted industry in the 
United States. The HSCG has been representing the businesses of 
the handcrafted soap and cosmetic industry since 1998 by 
providing business services, legal compliance training, 
certification, education and industry conference, and more.
    By using data from our industry suppliers, we estimate that 
there are over 350,000 small businesses making and selling 
handcrafted soap and cosmetics in the United States. A large 
majority of these businesses are women- or minority-owned and 
operated.
    The handcrafted industry supports updating the Food, Drug, 
and Cosmetic Act of 1938 and supports FDA's oversight of 
cosmetics ingredients. We support FDA having recall authority 
and mandatory adverse event reporting.
    The handcrafted industry supports the FDA identifying 
ingredients of concern. If an ingredient is deemed unsafe, the 
handcrafted industry does not want to use it in the products 
that they make. Most importantly, the industry supports safe 
cosmetics, truth in labeling, and protecting consumers of 
personal care products.
    What makes the handcrafted industry unique is the hands-on 
procedures that are used to produce some of the safest soaps 
and cosmetics on the market. Many handcrafters that start 
making these products do so to use and highlight high-quality, 
expensive ingredients like olive oil, coconut oil, avocado oil, 
and more.
    Batches of handcrafted soap and cosmetics are not measured 
in the millions, or even in the hundreds. Rather, a typical 
size batch is around 20 units. Handcrafters thrive on their 
ability to change ingredients to meet a customer's needs, make 
the products seasonal, or react to changes in the availability 
and the cost of ingredients. The final product is labeled by 
hand in accordance with current labeling laws, boxed or bagged 
and sold at local farmers markets, craft shows, small 
storefronts, and online.
    The handcrafted industry does not support ingredient and 
batch reporting for small businesses with annual gross sales of 
less than $1 million. Requiring handcrafters to register and 
report all ingredients or batches would result in hundreds to 
thousands of reports to FDA about mostly food grade ingredients 
per company per year. The handcrafted industry does not support 
mandatory external testing on products that are made in 
compliance with regulation, good manufacturing practices, and 
suggested usage rates for cosmetic ingredients.
    The handcrafted industry does not support assessing a user 
fee on small businesses below $1 million in annual gross sales. 
With over 350,000 small handcrafted businesses in the United 
States, even a nominal fee of $250 would mean a 
disproportionate share of the user fees would be from the 
sector of the industry with the smallest market share of total 
cosmetic sales.
    Furthermore, every dollar counts to a small business. They 
operate under very tight margins for the first several years of 
existence. Overreaching and burdensome regulations on this 
industry would devastate the businesses by forcing them to 
close and deterring others from starting.
    In order to give you some practical information and 
demonstrate how proposed provisions would affect handcrafters, 
I highlighted some stories of handcrafted businesses in my 
written testimony. I would be happy also to introduce you to 
small businesses in each of your districts.
    The handcrafted industry supports having meaningful small 
business provisions to allow small businesses to enter the 
industry, grow, and thrive. To protect the handcrafted 
industry, we must have meaningful thresholds for exemption. A 
small business that has grown to the level of achieving $1 
million in annual gross sales has employees to assist in new 
compliance requirements, and is no longer operating out of a 
personal residence. Businesses under this threshold should be 
exempted from burdensome registration requirements, batch 
reporting, ingredient reporting, mandatory external product 
testing, and user fees.
    FDA has supported exemptions for small business with other 
regulations that have been recently enacted. For example, the 
Food Safety Modernization Act contains an exemption for small 
businesses with less than $1 million in annual gross sales. The 
handcrafted soap and cosmetic industry should be afforded the 
same level.
    Thank you, again, for inviting me to testify on behalf of 
the handcrafted soap and cosmetic industry. It has been a 
privilege and an honor.
    [The prepared statement of Ms. O'Donnell follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
    
    Ms. Eshoo. Thank you, Ms. O'Donnell.
    It is a pleasure to recognize Ms. Chaudry, and you have 5 
minutes for your testimony. Welcome, and thank you for your 
patience today.

                STATEMENT OF M. ISABELLE CHAUDRY

    Ms. Chaudry. Good afternoon, and thank you for allowing me 
to testify before the Subcommittee on Health of the Energy and 
Commerce Committee. My name is Isabelle Chaudry, and I am the 
senior policy manager at the National Women's Health Network, a 
DC-based women's health advocacy organization. We are supported 
by a national network of individual members and do not accept 
financial support from drug or device makers or personal care 
product manufacturers.
    Critical loopholes in Federal cosmetic regulation currently 
allow manufacturers to use dangerous ingredients in products, 
evade fully disclosing the chemicals contained in those 
products, and then sell the products to the American public, 
all of which put consumers' health at risk. Among other issues, 
unsafe ingredients and contaminants can increase women's risk 
of infertility, pregnancy loss, reproductive health diseases, 
cancer and early death.
    National representative data of U.S. reproductive-age women 
suggests that women of color have higher levels of certain 
endocrine-disrupting chemicals, such as phthalates and 
parabens, within their body as compared with white women. 
Racial and ethnic differences are not explained by 
socioeconomic status. Research shows that even small exposure 
to toxic chemicals during critical periods of development, such 
as pregnancy, can trigger adverse health consequences.
    The Federation of Obstetrics and Gynecology recommends, and 
I quote, the following: ``Policies to address toxic chemicals 
must shift the burden of proof of safety of chemicals from the 
individual healthcare provider, the patient, and the public to 
manufacturers before they are released into the environment.''
    Under current law, dangerous chemicals that are used in 
personal care products are still not banned, restricted, or 
even required to be studied for their safety. Take, for 
instance, talc, which can be contaminated with asbestos and 
linked to cancer. Over the past few years, independent testing 
has uncovered possible asbestos contamination in several 
products sold and marketed to girls and women. Black women are 
disproportionately impacted. The insatiable appetite for profit 
in the cosmetic industry, bolstered often by fantastical narrow 
notions of beauty, have targeted Black women. This combination 
is dangerous, and it impacts the health of Black women, Afro-
descendent women, as well as poor women and other women of 
color, causing reproductive health issues, cancer, and even 
death.
    In 2016, a University of Virginia study found that African-
American women who used talcum powder for feminine hygiene had 
more than a 40 percent risk of increased cancer. We know that 
in many cases, companies actively targeted and marketed talc-
based products contaminated with asbestos to Black and Latino 
women.
    But the heightened risks for Black women and other women of 
color are not limited to talc. The cosmetic and personal care 
products marketed and sold to them often contain the most 
harmful ingredients, even as these women are most impacted by a 
range of reproductive health and comprehensive care barriers 
and related adverse maternal health risks and outcomes. In one 
study done by the Environmental Working Group, we know that 1 
in about 12 products--about 1 in 12 products marketed to Black 
women were ranked highly hazardous.
    Workers in the beauty industry are also predominantly women 
of color and immigrant women. They can face occupational health 
hazards from chemicals in professional cosmetic products. For 
example, salon workers. They face disproportionate incidences 
of cancer, neurological diseases, and other diseases that are 
at issue.
    Just as we, the National Women's Health Network, stated in 
our June 20, 2019, letter to the Energy and Commerce Committee, 
signed by over 40 national, State, and local organizations, we 
urge you to include the strongest possible safeguards to 
protect women's health in cosmetic legislation.
    We thank you, Chairman Pallone, for your efforts to 
modernize cosmetic law, and we stand ready to work with the 
committee to pass meaningful legislation which is protective of 
the public health.
    [The prepared statement of Ms. Chaudry follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
    
    Ms. Eshoo. Thank you very much, Ms. Chaudry.
    It is a pleasure to recognize Mr. Faber. Welcome. Thank you 
for your patience today as well. And you have 5 minutes to 
present your testimony.

                    STATEMENT OF SCOTT FABER

    Mr. Faber. Great. Thank you, Madam Chair, Ranking Member 
Shimkus. Thank you, Mrs. Schakowsky, for your longtime 
leadership on this issue. And I would like to thank all of you 
for the time you have invested in this issue and the time your 
staff have already invested in this issue. And I think we are 
very close to finally updating this law after now 81 years of 
waiting.
    As we have heard many times today, these are products we 
use every day. Women use, on average, 12 products a day. As you 
mentioned, teenage girls use, on average, 14 products every 
day. And the reason we are concerned about this issue is 
because of this repeat use. These are products we rub on our 
bodies every day, and it is the question of whether or not we 
are passing some threshold of risk that is unacceptable that we 
need FDA to help us examine and, if warranted, regulate.
    And as you have also heard, cosmetic companies can put just 
about any chemical in any amount into these products, including 
chemicals linked to cancer, like formaldehyde, or chemicals 
linked to reproductive harm, like phthalates. Cosmetic 
companies have told regulators that they now use 93 different 
chemicals linked to cancer, reproductive harm, or developmental 
harm.
    And while companies are required by a 1975 rule to 
substantiate the safety of their products, they don't have to 
share those substantiation records with anyone, including the 
FDA. And many of the studies that these companies rely upon are 
not independent studies, but are, instead, studies conducted by 
the industry's own review program, which is funded by and 
housed in the industry's trade association.
    So suffice it to say, this situation does not inspire a lot 
of confidence among consumers, or, I think, lawmakers. And, 
even if skeptical consumers did want to shop around this 
problem, they can't, because literally thousands of these 
chemicals can be hidden behind the word ``fragrance.''
    So, just to sort of summarize, these companies can pretty 
much add anything they want to these products in any amount. 
They can rely on their own studies to substantiate the safety 
of those products. They can refuse to disclose those studies to 
the public and to FDA, as we heard from Dr. Mayne this morning. 
And they can refuse to disclose whether some dangerous 
chemicals are in the products on the label.
    And what is more, as we have heard, companies don't have 
to--although many do, and most do, I expect--don't have to 
produce these products in a safe and clean environment. And, 
when things do go wrong and products are contaminated, cosmetic 
companies don't have to tell anyone about that either, 
including the FDA.
    And, even when their products are hurting people--for 
example, when facial powders marketed to teen girls are 
contaminated with asbestos--FDA cannot order a mandatory 
recall. In other words, FDA has no way to know when things go 
wrong and no power to act when they do.
    So I think we can all agree that it is time to fix this 
system, and in particular I think we can agree on six things.
    First, I think we can all agree that FDA should be required 
to review the most dangerous chemicals in personal care 
products.
    I think we can all agree that consumers should have the 
right to know whether these products have chemicals of concern.
    I think we can all agree that FDA should have access to 
safety records and be notified when products are so 
contaminated, or so dangerous, that people are literally losing 
their hair, as thousands of women and girls did recently after 
using a popular shampoo.
    Fourth, to avoid contamination, I think we can all agree 
that companies should adopt good manufacturing practices and be 
forced to police their supply chains, especially their foreign 
supply chains.
    Fifth, I think it is clear that FDA should have the power 
to act if people are getting hurt and a company is not acting 
responsibly.
    And last, I will just mention that I think it is clear that 
Congress has to recognize the difference between big companies 
like Revlon and Procter & Gamble, and the small entrepreneurs 
who are just getting into this business.
    A lot has changed since 1938. Congress has decided to 
regulate chemicals in food, chemicals in colors. We have chosen 
to regulate pesticides, to reduce the risk from repeat 
exposures. We recently modernized TSCA to properly review 
industrial chemicals. But, despite the enormous growth of the 
cosmetics industry, we are still relying on a law that is badly 
out of date.
    The last thing I will just mention is that retailers and 
manufacturers have demonstrated that we don't need many of 
these chemicals to make products that are safe and that fulfill 
the expectations of consumers. Big manufacturers and small 
manufacturers, retailers, have already begun to produce 
products without many of these chemicals of concern, really 
demonstrating that these chemicals are really no longer 
necessary to provide products that consumers want.
    So, Madam Chair, thank you again for holding this historic 
hearing, and I am happy to take your questions.
    [The prepared statement of Mr. Faber follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
    
    Ms. Eshoo. Thank you to each one of the witnesses. I am 
just so struck by how old the law is, how much updating needs 
to be done. I hear ``labeling'' and, honestly, I read labels 
all the time, but I don't even recognize the words. I can't 
even pronounce them. So I think if we are going to talk about 
labeling, we have got to use plain English.
    But I do think that there are some things that, if they are 
carcinogens, they should just be banned. What, are we going to 
start splitting hairs and saying that, you know, this can cause 
cancer, but a little bit of cancer, not a lot of cancer, you 
know, use 10 times, not 20 times? So we are going to have to 
get some very clear lanes on this.
    I want to walk through, with each one of you, your support 
in a cosmetic reform bill, so if you can just keep your answers 
to a simple yes or no. I will begin left to right.
    Dr. Renfrew, starting with you, do each of you--or do you 
support requiring manufacturers to notify the FDA of adverse 
events?
    Ms. Renfrew. We do.
    Ms. Eshoo. You do, OK.
    Ms. O'Donnell. Yes.
    Ms. Chaudry. Yes.
    Mr. Faber. Yes.
    Ms. Eshoo. Softball. Do you support the FDA being able to 
require recalls of a dangerous product?
    Ms. Renfrew. Yes.
    Ms. O'Donnell. Yes.
    Ms. Chaudry. Yes.
    Mr. Faber. Yes.
    Ms. Eshoo. Do you support the FDA being able to identify 
and ban dangerous or unsafe ingredients?
    Ms. Renfrew. Yes.
    Ms. O'Donnell. Yes.
    Ms. Chaudry. Yes.
    Mr. Faber. Yes.
    Ms. Eshoo. Do you support requiring cosmetic manufacturers 
to list all ingredients on their products' labels, including 
fragrances?
    Ms. Renfrew. Yes.
    Ms. Eshoo. You may not have a label that is large enough 
for all the ingredients, but go ahead and answer.
    Ms. O'Donnell. Yes.
    Ms. Chaudry. Yes, that would be the best possible outcome.
    Mr. Faber. And I will just note that big manufacturers, 
including P&G and Unilever, are already disclosing almost all 
of their fragrance ingredients, through their websites and 
other digital means.
    Ms. Eshoo. What is bad in fragrances? I want to know if I 
am spraying something on myself that smells fabulous, but is--
--
    Ms. Renfrew. Don't spray.
    Ms. Eshoo [continuing]. Maybe doing me in. Don't spray?
    Mr. Faber. So, thankfully, Women's Voices for the Earth did 
an exhaustive review of the 3,000 chemicals that can be used in 
fragrance, and they did find seven of those chemicals, so not 
all of them, but seven of them are known carcinogens, 15 of 
them have been banned in more than 40 countries around the 
world.
    So there are certainly chemicals in fragrance that are 
linked to serious health effects and don't have to be 
disclosed. So consumers can't simply shop around them.
    Ms. Eshoo. Well, it seems as if you are all in agreement on 
major portions of the legislation that we are considering 
today.
    So, Mr. Faber, what is your recommendation on how Federal 
law, cosmetic law, should treat State laws, both present and 
future?
    Mr. Faber. So States have been an important partner.
    Ms. Eshoo. Oh, I know. I am a Californian.
    Mr. Faber. California has a review program.
    Ms. Eshoo. I mean, we worship at the altar of Prop 65.
    Mr. Faber. And it is important to know that the safe harbor 
limits that are associated with Prop 65 have driven a lot of 
reformulation so companies don't have to carry the warning, 
which is something that doesn't get very much attention.
    But other States, including Maine, Washington, Minnesota, 
Oregon, and others, have also stepped forward to require 
reporting of dangerous cosmetic chemicals and review in some 
cases. So----
    Ms. Eshoo. Ms. Chaudry, do you agree with Mr. Faber?
    Ms. Chaudry. I do agree. We know that in California, there 
has been really protective legislation that has been passed for 
consumers, and so we think that it is important to preserve the 
work that has already been done.
    Ms. Eshoo. And, Ms. Renfrew, what is your recommendation?
    Ms. Renfrew. I agree. We believe that the work that has 
been done, we don't want to go backwards.
    Ms. Eshoo. I don't want to leave you out, Ms. O'Donnell. 
What do you think? Tell us what you think.
    Ms. O'Donnell. As the only manufacturer witness, I would 
say it is easier for businesses to comply with one Federal 
standard rather than a patchwork of laws. So we would, you 
know, defer to the committee on how that would be worked out. 
By it is easier for a manufacturer to be able to comply with 
Federal standards.
    Ms. Eshoo. I think my colleague here has something that 
smells wonderful. I don't know, it came from his district, I am 
sure, right?
    Mr. Shimkus. No.
    Ms. Eshoo. It didn't?
    Mr. Shimkus. No.
    Ms. Eshoo. It didn't? Well, I am going to now recognize the 
ranking member of the committee, and I want to thank all the 
witnesses again. I think you are a terrific and important 
panel.
    Mr. Shimkus. Thank you, Madam Chairman. Being the very 
aromatic Congressman John Shimkus from southern Illinois.
    Ms. Eshoo. Let's not get carried away.
    Mr. Shimkus. Well, when I open this box up, you will know 
it is.
    So I am going to talk to Ms. O'Donnell. But I looked up the 
definition, so we can put things in perspective, 
``handcrafted,'' and the definition is to make something by 
manual skill, made by using the hands rather than a machine, 
basically. So when we talk about big versus small, we are 
talking about handcrafted. Someone is making soap in a barrel, 
right, and mixing stuff.
    So, listen, I met Sister Kathleen from Monastery Creations, 
and I am not going to cross her. I am not crossing Sister 
Kathleen. And I think, you know, the issue is, let's make sure 
we don't harm these handcrafters.
    So, Ms. O'Donnell, can you talk about the activities your 
association engages in to make sure your members are 
knowledgeable about the ingredients and processes they are 
using?
    Ms. O'Donnell. Absolutely. We are lucky enough to have very 
good industry suppliers, and those suppliers, they actually 
encompass a lot--they don't just sell the raw ingredients to 
these people. They also provide video training, some of them. 
They provide training via articles and things like that. But 
they also provide for every ingredient that they sell MSDS 
sheets, certificates of authenticity for the ingredients, and 
safe usage requirements for whatever product, whether it be a 
soap or a lotion or whatever product it is going to be.
    At the HSCG too, we disseminate information that is 
beneficial as well about safe manufacturing, good manufacturing 
practices, how to properly label your products, and how to be 
compliant with current regulation.
    Mr. Shimkus. So this also includes the fragrance debate 
that we are having, the fragrances that handcrafters are using?
    Ms. O'Donnell. I am sorry, could you repeat that?
    Mr. Shimkus. The fragrance inclusions of what you have just 
described about the ingredients and the suppliers, does that 
include the fragrance aspect?
    Ms. O'Donnell. It does. And handcrafters choose between 
using essential oils, which are derived from plant material in 
different ways, or fragrance oils, which are more man-made. But 
both of those come with safe usage rates, MSDS sheets. There 
are also recommendations from IFRA, you know, for safe usage 
rates in each product that is made, whether it is a topical 
product or a wash-off product like a soap.
    Mr. Shimkus. So Mr. Faber testified that fragrance 
allergens should be disclosed on a label. What do your members 
do?
    Ms. O'Donnell. Right now, they comply with current 
regulation, which is to list it as either a fragrance or--you 
know, fragrance or flavor. They don't have access, our members 
do not have access to what the constituent--what the 
ingredients are in a fragrance, like a synthetic fragrance. 
That is not something that is known to us or disclosed to us.
    Mr. Shimkus. OK, thank you.
    And let me go to Scott. In your testimony, you actually did 
a little history about where we have been and the battles you 
fought and where we are at today, and I think it is 
instructional. You tiptoed around it in your opening statement, 
I appreciate that.
    You described something of a recent evolution, in terms of 
working with industry on some of the reforms we are discussing 
today. In a lot of ways, it sounds like an opportune time to be 
having this debate. So I am curious what you view as the major 
hurdles moving forward, and what can the Environmental Working 
Group and what are you prepared to do to help us get this thing 
across the plate, not the finish line, to keep it in baseball 
terms?
    Mr. Faber. That is right, another baseball fan.
    So thank you for the question. Many companies, large and 
small, have supported similar legislation as the bills that we 
are considering today in the Senate, legislation that has been 
introduced by Senator Collins and Senator Feinstein. And that 
includes companies like Estee Lauder, L'Oreal, Procter & 
Gamble, Unilever, as well as companies like Beautycounter, and 
I believe all three trade associations representing handmade 
soap makers.
    So there is a consensus that--among industry and NGOs, that 
we should give FDA more power to review these chemicals and to 
conduct basic oversight. Providing some regulatory certainty is 
obviously very important to industry. But I think one good 
development is that industry, by and large, has agreed that we 
need to provide some sort of registration fee so that we don't 
set FDA up for failure. And I think we all heard repeatedly 
from Dr. Mayne the need to provide FDA adequate resources. I am 
grateful that industry has agreed to support fees of some kind 
to help make sure that FDA can get the job done.
    Mr. Shimkus. Madam Chairman, I am done with my time. I 
yield back.
    Ms. Eshoo. I thank the gentleman.
    I now would like to recognize the gentlewoman from 
Delaware, Ms. Blunt Rochester, a wonderful member of our 
subcommittee.
    Ms. Blunt Rochester. Thank you, and I love our 
subcommittee. I am glad to be here.
    Ms. Eshoo. I do, too.
    Ms. Blunt Rochester. This is really an important hearing. 
And I want to thank the panel as well for your testimony. The 
Environmental Working Group estimates that women use an average 
of 12 products a day. Between shampoos, conditioners, face 
washes, deodorant, hair spray and makeup, the EWG estimates 
that is an exposure to 168 different chemicals. And for the 
average teen, it is close to 20 products a day. And in sampling 
a teen's blood and urine, the EWG found 16 hormone-altering 
chemicals.
    The safety of our personal care and cosmetic products is 
critically important for women and girls, because of the impact 
on their reproductive health and health throughout the 
lifespan.
    And so my first question is for you, Ms.--is it Chaudry or 
Chodry?
    Ms. Chaudry. Chaudry.
    Ms. Blunt Rochester. Chaudry. Thank you, Ms. Chaudry.
    In your testimony, you mentioned that vulnerable and 
underserved women and girls are disproportionately affected by 
environmental chemical exposures.
    Why are women of color more likely to have higher levels of 
certain endocrine-disrupting chemicals, and can you elaborate 
on how these racial and ethnic differences are not explained by 
socioeconomic status?
    Ms. Chaudry. Yes. Thank you for your question. So the issue 
is twofold, I think. One, we know that there is just a general 
lack of care for the formulation of the products that are 
marketed and sold to Black women and other women of color.
    But then, also, I have a document that I included in my 
testimony, and it is a report that was done on environmental 
justice in the beauty industry. And one of the tables in the 
report highlights external factors that I think answers your 
question about why it is not related to socioeconomic status. 
External factors include colorism, they include hair texture 
preferences, odor discrimination, and these issues are then 
linked to the products being formulated in different ways.
    So, if I just take, for example, colorism, the vulnerable 
populations there are dark-skinned Black women. And as a 
result, the chemical exposure is mercury. And then we know that 
mercury can lead to poisoning, kidney damage, and other issues.
    And so, the products that are marketed to us, studies have 
shown that they are more dangerous, they are more highly 
hazardous. And so that is one of the issues. The other issue, 
like I just mentioned, are external factors that are out of our 
control.
    Ms. Blunt Rochester. And I guess just to even put a fine 
point on that, so whether you are rich, poor, middle class, if 
you are an African-American woman and you go to a cosmetic 
counter, you are not asking, ``Is there something dangerous in 
this product?'' You are assuming that it has been tested and 
things are OK. In their marketing, it is across the board. So 
it goes to any kind of woman.
    And I guess it also harkens back to a hearing we had before 
on maternal mortality. And, if you could talk a little bit 
about the impact of the chemicals in these products on maternal 
mortality, because that was something that we hadn't even 
thought about in our hearing.
    Ms. Chaudry. Yes. So I went to a briefing on maternal 
mortality earlier, I would say a few months back, and there 
were, I think, over 20 panelists discussing solutions to 
address the issue. And none of the panelists mentioned 
cosmetics or how the ingredients that are used in cosmetics 
impact our health, but we know that there are ingredients of 
concern that are in hair relaxers that Black women usually use, 
chemicals like parabens, formaldehyde.
    We know that parabens have been linked to reproductive 
issues. We know that they have been linked to specifically 
uterine fibroid tumors, premature puberty and endocrine 
disruption. And so there are definitely chemicals of concern 
that have been highlighted in different research that show that 
the products that Black women use have these chemicals.
    And I think it is important that we study the long-term 
usage of these products, because girls are using these. And so, 
you know, you are using them for years and they eventually have 
an impact on your reproductive health.
    Ms. Blunt Rochester. Thank you so much for all of your 
testimony. I have additional questions that we will submit to 
you in writing, but thank you so much for your work.
    And I yield back.
    Ms. Eshoo. The gentlewoman yields back.
    The Chair recognizes the gentleman from Virginia, Mr. 
Griffith.
    Mr. Griffith. Thank you very much, Madam Chairman.
    Ms. O'Donnell, we heard some testimony earlier about 
registration fees. How does your organization feel about that?
    Ms. O'Donnell. We feel that the registration fees should 
be--that small businesses under $1 million in annual gross 
sales should be exempted, because there are so many of them. 
Just by the nature of the industry, there are people getting in 
and out every day. So it makes sense to allow a business to get 
up to that level.
    Mr. Griffith. And, Mr. Faber, you brought up registration 
fees, and I saw you nodding over there. You are in agreement 
with that? You had said something earlier about having a 
difference between the big companies and the little companies.
    Mr. Faber. We agree that the registration fee should not 
apply to companies with sales below $1 million, and that is how 
the fee provision in Mr. Pallone's bill is drafted.
    Mr. Griffith. So the $1 million, everybody seems to think 
that is OK?
    Ms. O'Donnell. Yes.
    Mr. Griffith. Ms. Renfrew, we were talking about earlier, 
and the chairwoman said something about she would spray 
something on or how would she know it was bad or whatever, and 
you said, ``Don't spray.'' Do you want to explain that?
    Ms. Renfrew. Well, you were asking the question of whether 
or not there were harmful ingredients in fragrance. And one of 
the things that we know is--we always say to people, if you are 
going to wear fragrance, maybe put it on your clothes, not on 
your body, because phthalates, which is one of the classes of 
the chemicals that are most harmful to health, are used to bind 
the fragrance to your skin.
    So it may not be the actual fragrance, but what is being 
used to bind it to your skin. And so yes, I would avoid--there 
are a lot of harmful ingredients in fragrance, as we have all 
discussed.
    Mr. Griffith. And you weren't making any comment then about 
just using sprays in general?
    Ms. Renfrew. I was not making comments about using sprays 
in general. I was speaking to the fact that I would avoid 
spraying it on your body if you can.
    Mr. Griffith. And the reason I ask is my wife uses sprays 
from time to time, and they drive me crazy because I will be 
walking by and----
    Ms. Renfrew. Well, I don't want to get into a fight with 
your wife.
    Mr. Griffith. Yes, I get a blast of whatever it is. All 
right.
    I do think it is important that we look at some of this, 
but I also have concerns, because sometimes when we give 
authority to a regulatory agency, they get carried away. And I 
have people who sell it to farmers markets. I represent a 
fairly rural district, 29 jurisdictions. And they sell goat 
soap and goat hand cream, that they raise their own goats and 
they milk the goats and then they make it themselves.
    They are right up your alley. I am not sure they are even 
members of an association, but they are making small batches. 
And, you know, if you go in--as you indicated, Ms. O'Donnell, 
in your testimony--if you happen to be at the farmers market 
and you say, ``Well, I want fragrance free,'' they say, ``Well, 
I will be back next week with some of that for you.''
    Ms. O'Donnell. That is right.
    Mr. Griffith. Or if you ask for a particular type. So one 
of the things I am curious about is if we can have--because I 
had this situation with suckers in a different world, where 
they were taking an over-the-counter, FDA-approved cough syrup 
and mixing it in with the candy, and FDA came in and said, 
``No, you can't do that anymore.''
    And they walked away from a 50-year--it was a part of their 
candy business. They just said, ``We can't hire three people 
and build a lab for this sucker product,'' and basically put 
that one employee of that small company in Bristol, Virginia, 
the Helms Candy Company, just put him out of doing that kind of 
work. They just quit.
    And so that is my concern. Is that your concern as well, 
Ms. O'Donnell, that they might get carried away? And could we 
come up with some kind of language that protects if you are 
buying from the big company, something that has already been 
approved that you can use it in your handcrafted product or in 
your small company to then sell without you having to worry 
about having studies or tests, et cetera?
    Ms. O'Donnell. Absolutely. I think that we have to be 
careful what burdens we put on small businesses, both for not 
only the money that they have to spend to comply but also their 
time, because time to a small business is money, you know.
    So we definitely, looking at, you know, consumer safety, it 
has to make sense for consumer safety, but it also has to make 
sense to allow the small business to keep operating. Having--
for example, in the GMP guidelines, you know, the voluntary 
guidelines that are out now, there is a requirement to have a 
chemist on staff, and that is not something that a small 
business obviously can comply with. So it just has to be 
meaningful regulation that they can comply with.
    Mr. Griffith. And that is very similar to what happened to 
this small candy company. For that one little area, they were 
required to have people on staff to test something that they 
had never had a problem with. It never had a bad reaction. They 
had been mixing up the same formula for 50 years, and all of a 
sudden they are told, ``You can't do that unless you have 
chemists or people who are going to test this on every batch 
every day,'' and they couldn't afford it.
    Ms. O'Donnell. Right.
    Mr. Griffith. So that is what I want to make sure we are 
not doing.
    I thank you, Madam Chair, and I yield back.
    Ms. Eshoo. We thank the gentleman. He yields back.
    Pleasure to recognize the gentlewoman from California, Ms. 
Matsui.
    Ms. Matsui. Thank you, Madam Chair. I want to thank the 
witnesses for being here today. And I learned something today. 
I am always spraying stuff on myself. Got to watch it now. My 
goodness.
    But anyway, there is a fair loophole in the Fair Packaging 
and Labeling Act that requires manufacturers to disclose all 
the ingredients in a finished cosmetic product, with the 
exception of fragrances, flavors, and colorants. This loophole 
allows dozens, sometimes even hundreds, of chemicals to hide 
under the word fragrance, parfum, flavor on the product label, 
some of which have been linked to cancer, reproductive harm, 
endocrine disruption, and asthma.
    The California legislature is considering a bill that would 
require disclosure of fragrance and flavor ingredients in 
cosmetics sold in the State that are linked to harming human 
health or the environment. I believe that we should even 
consider closing the same labeling loophole at the Federal 
level.
    Mr. Faber, California has a new fragrance law that applies 
to cleaning products. Is there overlap between the fragrance 
ingredients used in cleaning and cosmetic products? In your 
perspective, should fragrance transparency only apply to 
cleaning products?
    Mr. Faber. Thank you for the question. There are many 
chemicals that are used in cleaners that are also used in 
cosmetics. I am glad you mentioned California's new law, 
because industry supported a requirement that we expose the 
chemicals of greatest concern, either on the package or through 
online or digital disclosure. So I can't understand why we 
wouldn't have a similar requirement for the chemicals of 
concern, hazardous chemical allergens, and so on, in cosmetics.
    Ms. Matsui. OK. Some companies are voluntarily disclosing 
most of their fragrance chemicals. Doesn't this demonstrate the 
disclosure of fragrance chemicals does not threaten their 
ability to protect trade secrets?
    Mr. Faber. I agree. Many companies are fully disclosing 
their fragrances. Many big companies are disclosing all of 
their fragrance chemicals so long as they are not less than .01 
percent of the total product formulation. So, clearly, big 
companies, small companies are able to disclose most or all of 
these chemicals without risking trade secret protections.
    Ms. Matsui. OK. Since many fragrance ingredients of concern 
are not included on a cosmetic product label, is it possible 
for a savvy customer to shop their way around potential 
chemical lists?
    Mr. Faber. There are literally thousands of chemicals that 
can be hidden behind the word ``fragrance.'' So, unless you are 
a chemist and you can test the product yourself, there is no 
way to shop around the problem.
    Ms. Matsui. Yes, I believe that too. To achieve efficient--
effective transparency that benefits the maximum number of 
people, how should Congress consider applying a Federal 
fragrance disclosure requirement?
    Mr. Faber. At a minimum, we should be requiring the 
disclosure of allergens and chemicals linked to cancer and 
reproductive harm on the package. More broadly, we should be 
requiring much greater fragrance disclosure at a minimum 
through online disclosure, as we have done in California for 
cleaning products.
    Ms. Matsui. Thank you, Mr. Faber. I think it is clear when 
everyone has this right to know.
    While cosmetics products sold in the United States are 
largely unregulated, more than 40 other nations, and even 
retailers, have proactively prohibited or restricted the use of 
hundreds to thousands of cosmetic ingredients. California is 
currently considering legislation that would prohibit the sale 
of cosmetic products containing 11 highly toxic chemicals which 
are banned by the European Union.
    Mr. Faber, in your opinion, why are some chemicals banned 
as cosmetic ingredients in the EU and not here?
    Mr. Faber. Thank you for the question. More than 40 
countries around the world--the EU, southeast Asia, South 
America, Canada--have now banned or restricted more than 1,600 
chemicals. So clearly, the problem isn't with our ability to do 
the toxicology and make decisions, it's that we simply haven't 
updated the law governing cosmetics since 1938.
    Ms. Matsui. That is a long time ago, yes.
    Mr. Faber, as you look to update Federal cosmetic 
regulations, what role do you see State regulations and 
programs like California's having in the national oversight of 
cosmetic safety?
    Mr. Faber. We have talked about before, it is important not 
to go backwards. We should preserve the laws that have 
protected people by restricting, in some cases, formaldehyde, 
mercury, lead, cadmium, other chemicals, especially laws that 
have protected children's products, that required the removal 
of some of those ingredients from children's products.
    Ms. Matsui. Thank you very much. I appreciate your 
viewpoint. It is my viewpoint also.
    Thank you, and I yield back.
    Ms. Eshoo. The gentlewoman yields back.
    The Chair recognizes the gentlewoman from Illinois, Ms. 
Kelly. Surprise.
    Ms. Kelly. Thank you, Madam Chair. I thank all of you for 
your testimonies today.
    In addition to my role on this committee, I serve as the 
chair of the Congressional Black Caucus Health Braintrust and 
the cofounder and cochair of the Caucus on Black Women and 
Girls. Because of this, I am invested in working to reduce 
health disparities of vulnerable and minority populations, 
especially women and girls.
    Ms.--Chawdry?
    Ms. Chaudry. Chaudry.
    Ms. Kelly. Chaudry. I am sorry.
    I want to thank you for your testimony. As an advocate for 
the health of women and girls, I was concerned to read your 
testimony about the chemicals used in some cosmetic products, 
and that cosmetic and personal care products are 
disproportionately large sources of chemical exposure for women 
and girls in this country.
    I was especially concerned to learn that with all the 
personal care products used by young women each day--and now 
that I sit here, I have been trying to think of what I use 
myself--these products may contain chemicals that cause 
endocrine disruption, or reproductive harm. While I understand 
that much of the science is evolving as we speak, so we cannot 
quantify the exact impact of these chemicals on women, I would 
like to know more about these disparities that you mentioned in 
your testimony.
    You mentioned that women of color exposed to more 
endocrine-disrupting chemicals than White women. Can you speak 
a bit more about the specific risks to vulnerable populations?
    Ms. Chaudry. Yes. Thank you for your question. And so, we 
know that there have been at least 93 chemicals that have been 
linked to cancer, reproductive harm, developmental harm. And 
then we also know that Black women and women of color are 
particularly at risk because the cosmetics products sold to 
them are often the most harmful. And so, studies like the 
Breast Cancer Prevention Partner study that found, after 
reviewing over 20 different products, that the most toxic 
product was a product marketed to Black girls called Just for 
Me, which had endocrine-disrupting hormones. The one hormone or 
chemical in the study that was of concern was formaldehyde, 
which is a releasing preservative.
    And the product, Just for Me hair shampoo, was even more 
dangerous than some of the cleaning products that were tested. 
And so, as young Black girls and other girls of color grow up 
using these products over the years, they become more at risk 
to fibroids, to endometriosis, and to other health disparities 
and health issues that can later impact their ability to 
conceive, and even just carry a pregnancy to term.
    Ms. Kelly. I have a question. You mentioned that one 
product, but what about--and you might have said this and I 
missed it--when people go to the beauty salon and the products 
they use, are they under any restriction or----
    Ms. Chaudry. Yes. So we know that salon workers are also 
vulnerable populations, and so salon workers are in constant 
contact with these products on a daily basis, or whenever they 
work. And so we at the National Women's Health Network think it 
is important for any kind of legislation around this issue to 
include labels that warn consumers, as well as professionals 
who use these products, about the risks.
    Ms. Kelly. And any of you can answer this: Do you think the 
legislation that we are considering here today will help to 
make cosmetic industries and products safer? And if you do, 
great. But what else can we do? How can we be more helpful? 
Anybody.
    Ms. Renfrew. I think it is time for the Congress to take 
action. I think that would be one way, and thank you for asking 
the question. I think in terms of having Federal safety 
standards that everyone has to uphold will make, inevitably 
make the products that we are using on women, and children, and 
men across the country much, much safer.
    And I think having those standards will allow companies not 
only the opportunity to comply with the standards but also to 
formulate products that work just as well, but with much safer 
ingredients, which is an opportunity for businesses around this 
country and also protects the health of Americans.
    Ms. Kelly. Anybody else?
    Mr. Faber. I will just add, like Congressman Shimkus, we 
are all in. And the staff have already done a fantastic job of 
trying to figure out how do you come up with a review system 
that doesn't set FDA up for failure, it doesn't leave us with 
questions we can't answer when there isn't enough science to 
make a good decision, ensures that FDA does have the resources 
necessary to get the job done, and then make sure that we 
strike the right balance between the role of FDA and the role 
of the State.
    So I am--I think we are closer than we have ever been in 81 
years to finally updating this law.
    Ms. Kelly. Thank you. I know my time is up.
    Ms. Eshoo. The gentlewoman yields back.
    And I want to thank the gentlewoman from Illinois because 
she wears many hats, but she weaves them together. It really 
makes a difference in girls' and women's lives, so I would like 
to say that.
    The last person to question is Ms. Schakowsky from 
Illinois.
    Ms. Schakowsky. Thank you, Madam Chairman, for the 
opportunity to ask these questions.
    Ms. Renfrew, I want to say how grateful I am to 
Beautycounter for endorsing my Safe Cosmetics and Personal Care 
Products Act, H.R. 4296, this year along with dozens of other 
clean cosmetics companies. I just want to mention, I want to 
ask some questions, but I want to mention on my bill that it 
does not allow preemption for States who have already taken 
bold action. We have discussed that a little bit. And it does 
ban from the get-go 12 known toxins. And then, of course, 
allows for the testing of others, and hopefully others simply 
banned. But from the get-go, we do that for 12 of them.
    I have introduced this bill since 2010, so we have tried to 
get this conversation going. And I think it really is going 
right now. But Ms. Renfrew, there does seem to be a split 
between companies like Beautycounter who are supportive of 
comprehensive cosmetic reform that focuses on consumer 
protection, and then some other manufacturers who may support 
some more modest proposals, but some of those companies 
actually were invited but did not come, would not come today. 
So I am wondering if you could explain why, as a for-profit 
company--you have revenues over $200 million--that you have 
decided to speak out so strongly in favor of cosmetic reform.
    Ms. Renfrew. Thank you for the question. When I started 
Beautycounter, I set out with a mission of getting safer 
products into the hands of everyone. As I said in my testimony, 
I was looking at the health impacts of certain chemicals on 
friends and family and everyone around me. So we have always 
been a mission-based but for-profit entity.
    I think where you see discrepancy in the industry is, first 
of all, many of the incumbents have decided to participate in 
cosmetic reform and applaud efforts of Congress to try to move 
legislation forward. I do think it is complicated with existing 
manufacturing processes, the lack of consistency in terms of 
safety standards, holding their contract manufacturing partners 
accountable for certain sets of standards to allow them to 
uphold their brand promise to the consumer, and, of course, the 
requirements of the capital markets and the desire of 
stakeholders and shareholders to be constantly rewarded for 
investments that they make.
    But we have been able to prove at Beautycounter that you 
can create a company that can be very successful financially 
while simultaneously doing the right thing. So I think the 
future of commerce in this country is to look under that guise 
of how do we do things that are both good for the consumer and 
also good for business. And I do think many of the larger 
companies are coming around to this issue, but it does take 
time.
    Ms. Schakowsky. Well, I think you are a great example that 
you can do well and do good at the same time, and protect 
consumers. I thank you for that.
    I do want to talk about fragrances. Starting when I was in 
the State legislature, I introduced a bill that was brought to 
me by a constituent who is very, very sensitive to various 
fragrances. We had a bill, I can't even remember what the 
acronym stood for, but it was the SNIFF Act. It seemed to work 
out. And we know now that Unilever and Procter & Gamble, two 
very large companies, have recently started disclosing all the 
fragrances and chemicals that are part of their products. And 
my bill would require complete ingredient disclosure.
    And why do you think, Mr. Faber, that this is so important? 
That it not just be disclosed to the FDA, but it be disclosed 
to consumers?
    Mr. Faber. At a minimum, the ingredients that are linked to 
cancer or reproductive harm, serious health effects ought to be 
disclosed, in part, because as we have heard, FDA won't be able 
to get this review program up and running for some time, unless 
we have deadlines. We don't know when those reviews will be 
completed. Until then, consumers are going to have to continue 
to rely on their own wits to shop around chemicals of concern. 
And I think what Unilever and Procter & Gamble and others have 
made clear, and that is certainly true under California's new 
cleaners disclosure law, that you can disclose the most 
dangerous ingredients through digital without jeopardizing the 
secret sauce, without jeopardizing the trade secret protections 
that fragrance formulators are worried about.
    And another bill that moved through this committee a few 
years ago has really laid the groundwork for this. It was the 
GMO disclosure law that allowed companies to make their GMO 
disclosure through digital. That is now being fully 
implemented. All the food companies are disclosing the presence 
of GMOs in their food through SmartLabel, and the world has not 
ended. So I think that is a good model for how we can provide 
more information while we are waiting for FDA to build this new 
capacity.
    Ms. Schakowsky. And you, Ms. Renfrew, have not lost trade 
secrets, and you disclose.
    I am sorry.
    Ms. Renfrew. We disclose everything. At Beautycounter, we 
disclose all ingredients that go into our products. We believe 
the consumer should be informed and be able to make purchasing 
decisions with information.
    Ms. Eshoo. The gentlewoman yields back.
    Thank you to each one of you. You have been a terrific 
panel of witnesses. You have put forward a lot of very 
important information to us.
    I have learned a lot, and that is what is so marvelous 
about hearings. And I thank you, again, for your patience too, 
because you had to wait for the first panel, the panel of one, 
to complete her testimony. We had a lot of Members asking 
questions. But that is important because it is going to help 
shape the legislation.
    So I would like to submit the following statements for the 
record: a letter from the FDA regarding the safety of imported 
cosmetics, 2017; a letter from FDA regarding safety of imported 
cosmetics, 2019; a statement of OMB burden for FDA forms 2511 
and 2512; a letter from Public Citizen, et al., regarding 
chemicals in cosmetics; a statement from the Natural Products 
Association; and a statement from Revlon, Inc. And so hearing 
no objections, I am going to place these documents in the 
record.
    [The information appears at the conclusion of the hearing.]
    Ms. Eshoo. And, again--well, there is only one, one Member 
here. Just the two of us, John.
    Mr. Shimkus. We went the distance.
    Ms. Eshoo. That we went the distance. That, pursuant to 
committee rules, Members have 10 business days to submit 
additional questions for the record, to be answered by the 
witnesses who have appeared today. And we always ask the 
witnesses to be as prompt and timely as possible when you get 
questions, to answer them in a timely way. And I am sure that 
you will.
    So at this time, I close with my gratitude to all of you 
and to those that stayed in the hearing room from 10 a.m. on. 
You are great cosmetic heroes. How is that?
    Thank you, everyone, and the committee is adjourned.
    [Whereupon, at 1:25 p.m., the subcommittee was adjourned.]
    [Material submitted for inclusion in the record follows:]

               Prepared Statement of Hon. Eliot L. Engel

    Chairman Pallone and Chairwoman Eshoo thank you for holding 
today's hearing on modernizing FDA regulations for cosmetics 
and personal care products.
    Every day, millions of Americans use these products. 
According to the Environmental Working Group, women on a daily 
basis use 12 products containing 168 unique ingredients while 
men use six products with 85 different ingredients. Even with 
the widespread use of these products, FDA has been given 
limited tools and resources to oversee this nearly $80 billion 
industry.
    The absence of FDA regulation has led to egregious cases of 
consumer harm. In June of this year, a retailer specializing in 
cosmetics and personal care products for young women recalled 
three makeup products because they contained asbestos fibers. 
Similarly, a large manufacturer recently recalled its baby 
powder after the FDA found asbestos in it. According to the 
Centers for Disease Control and Prevention, asbestos exposure 
can lead to lung diseases and pulmonary cancers.
    It is unacceptable that our Nation's children are exposed 
to chemicals that have a well-documented history of causing 
adverse health events. Furthermore, these cases underscore the 
dire need for modernizing Federal oversight of cosmetic and 
personal care products.
    I commend Chairman Pallone and Congresswoman Jan Schakowsky 
for their work on legislation to reform our Nation's broken 
regulatory system.

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