[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
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COMMITTEE ON ENERGY AND COMMERCE
FRANK PALLONE, Jr., New Jersey
Chairman
BOBBY L. RUSH, Illinois GREG WALDEN, Oregon
ANNA G. ESHOO, California Ranking Member
ELIOT L. ENGEL, New York FRED UPTON, Michigan
DIANA DeGETTE, Colorado JOHN SHIMKUS, Illinois
MIKE DOYLE, Pennsylvania MICHAEL C. BURGESS, Texas
JAN SCHAKOWSKY, Illinois STEVE SCALISE, Louisiana
G. K. BUTTERFIELD, North Carolina ROBERT E. LATTA, Ohio
DORIS O. MATSUI, California CATHY McMORRIS RODGERS, Washington
KATHY CASTOR, Florida BRETT GUTHRIE, Kentucky
JOHN P. SARBANES, Maryland PETE OLSON, Texas
JERRY McNERNEY, California DAVID B. McKINLEY, West Virginia
PETER WELCH, Vermont ADAM KINZINGER, Illinois
BEN RAY LUJAN, New Mexico H. MORGAN GRIFFITH, Virginia
PAUL TONKO, New York GUS M. BILIRAKIS, Florida
YVETTE D. CLARKE, New York, Vice BILL JOHNSON, Ohio
Chair BILLY LONG, Missouri
DAVID LOEBSACK, Iowa LARRY BUCSHON, Indiana
KURT SCHRADER, Oregon BILL FLORES, Texas
JOSEPH P. KENNEDY III, SUSAN W. BROOKS, Indiana
Massachusetts MARKWAYNE MULLIN, Oklahoma
TONY CARDENAS, California RICHARD HUDSON, North Carolina
RAUL RUIZ, California TIM WALBERG, Michigan
SCOTT H. PETERS, California EARL L. ``BUDDY'' CARTER, Georgia
DEBBIE DINGELL, Michigan JEFF DUNCAN, South Carolina
MARC A. VEASEY, Texas GREG GIANFORTE, Montana
ANN M. KUSTER, New Hampshire
ROBIN L. KELLY, Illinois
NANETTE DIAZ BARRAGAN, California
A. DONALD McEACHIN, Virginia
LISA BLUNT ROCHESTER, Delaware
DARREN SOTO, Florida
TOM O'HALLERAN, Arizona
------
Professional Staff
JEFFREY C. CARROLL, Staff Director
TIFFANY GUARASCIO, Deputy Staff Director
MIKE BLOOMQUIST, Minority Staff Director
Subcommittee on Health
ANNA G. ESHOO, California
Chairwoman
ELIOT L. ENGEL, New York MICHAEL C. BURGESS, Texas
G. K. BUTTERFIELD, North Carolina, Ranking Member
Vice Chair FRED UPTON, Michigan
DORIS O. MATSUI, California JOHN SHIMKUS, Illinois
KATHY CASTOR, Florida BRETT GUTHRIE, Kentucky
JOHN P. SARBANES, Maryland H. MORGAN GRIFFITH, Virginia
BEN RAY LUJAN, New Mexico GUS M. BILIRAKIS, Florida
KURT SCHRADER, Oregon BILLY LONG, Missouri
JOSEPH P. KENNEDY III, LARRY BUCSHON, Indiana
Massachusetts SUSAN W. BROOKS, Indiana
TONY CARDENAS, California MARKWAYNE MULLIN, Oklahoma
PETER WELCH, Vermont RICHARD HUDSON, North Carolina
RAUL RUIZ, California EARL L. ``BUDDY'' CARTER, Georgia
DEBBIE DINGELL, Michigan GREG GIANFORTE, Montana
ANN M. KUSTER, New Hampshire GREG WALDEN, Oregon (ex officio)
ROBIN L. KELLY, Illinois
NANETTE DIAZ BARRAGAN, California
LISA BLUNT ROCHESTER, Delaware
BOBBY L. RUSH, Illinois
FRANK PALLONE, Jr., New Jersey (ex
officio)
C O N T E N T S
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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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