    [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

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

                                   __________

                        U.S. GOVERNMENT PUBLISHING OFFICE
    44-230 PDF                 WASHINGTON : 2022

    -----------------------------------------------------------------------------------

                        COMMITTEE ON ENERGY AND COMMERCE

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

                               Professional Staff

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

                           ANNA G. ESHOO, California
                                    Chairwoman
    ELIOT L. ENGEL, New York             MICHAEL C. BURGESS, Texas
    G. K. BUTTERFIELD, North Carolina,     Ranking Member
        Vice Chair                       FRED UPTON, Michigan
    DORIS O. MATSUI, California          JOHN SHIMKUS, Illinois
    KATHY CASTOR, Florida                BRETT GUTHRIE, Kentucky
    JOHN P. SARBANES, Maryland           H. MORGAN GRIFFITH, Virginia
    BEN RAY LUJAN, New Mexico            GUS M. BILIRAKIS, Florida
    KURT SCHRADER, Oregon                BILLY LONG, Missouri
    JOSEPH P. KENNEDY III,               LARRY BUCSHON, Indiana
        Massachusetts                    SUSAN W. BROOKS, Indiana
    TONY CARDENAS, California            MARKWAYNE MULLIN, Oklahoma
    PETER WELCH, Vermont                 RICHARD HUDSON, North Carolina
    RAUL RUIZ, California                EARL L. ``BUDDY'' CARTER, Georgia
    DEBBIE DINGELL, Michigan             GREG GIANFORTE, Montana
    ANN M. KUSTER, New Hampshire         GREG WALDEN, Oregon (ex officio)
    ROBIN L. KELLY, Illinois
    NANETTE DIAZ BARRAGAN, California
    LISA BLUNT ROCHESTER, Delaware
    BOBBY L. RUSH, Illinois
    FRANK PALLONE, Jr., New Jersey (ex
        officio)

                                C O N T E N T S

                                  ----------
                                                                       Page
    Hon. Anna G.Eshoo, a Representative in Congress from the State of
      California, opening statement..................................     1
        Prepared statement...........................................     3
    Hon. Michael C. Burgess, a Representative in Congress from the
      State of Texas, opening statement..............................     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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