[House Hearing, 116 Congress]
[From the U.S. Government Publishing Office]
EXAMINING THE PUBLIC HEALTH RISKS OF CARCINOGENS IN CONSUMER PRODUCTS
=======================================================================
HEARING
before the
SUBCOMMITTEE ON ECONOMIC AND CONSUMER POLICY
of the
COMMITTEE ON OVERSIGHT
AND REFORM
HOUSE OF REPRESENTATIVES
ONE HUNDRED SIXTEENTH CONGRESS
FIRST SESSION
__________
March 12, 2019
__________
Serial No. 116-08
__________
Printed for the use of the Committee on Oversight and Reform
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Available on: http://www.govinfo.gov
http://www.oversight.house.gov
http://www.house.docs.gov
_________
U.S. GOVERNMENT PUBLISHING OFFICE
36-060 PDF WASHINGTON : 2019
COMMITTEE ON OVERSIGHT AND REFORM
ELIJAH E. CUMMINGS, Maryland, Chairman
Carolyn B. Maloney, New York Jim Jordan, Ohio, Ranking Minority
Eleanor Holmes Norton, District of Member
Columbia Justin Amash, Michigan
Wm. Lacy Clay, Missouri Paul A. Gosar, Arizona
Stephen F. Lynch, Massachusetts Virginia Foxx, North Carolina
Jim Cooper, Tennessee Thomas Massie, Kentucky
Gerald E. Connolly, Virginia Mark Meadows, North Carolina
Raja Krishnamoorthi, Illinois Jody B. Hice, Georgia
Jamie Raskin, Maryland Glenn Grothman, Wisconsin
Harley Rouda, California James Comer, Kentucky
Katie Hill, California Michael Cloud, Texas
Debbie Wasserman Schultz, Florida Bob Gibbs, Ohio
John P. Sarbanes, Maryland Clay Higgins, Louisiana
Peter Welch, Vermont Ralph Norman, South Carolina
Jackie Speier, California Chip Roy, Texas
Robin L. Kelly, Illinois Carol D. Miller, West Virginia
Mark DeSaulnier, California Mark E. Green, Tennessee
Brenda L. Lawrence, Michigan Kelly Armstrong, North Dakota
Stacey E. Plaskett, Virgin Islands W. Gregory Steube, Florida
Ro Khanna, California
Jimmy Gomez, California
Alexandria Ocasio-Cortez, New York
Ayanna Pressley, Massachusetts
Rashida Tlaib, Michigan
David Rapallo, Staff Director
Susanne Sachsman Grooms, Deputy Staff Director and Chief Counsel
Elisa LaNier, Chief Clerk and Director of Operations
William Cunningham, Subcommittee Chief Counsel and Policy Advisor
Joshua Zucker, Assistant Clerk
Christopher Hixon, Minority Staff Director
Contact Number: 202-225-5051
------
Subcommittee on Economic and Consumer Policy
Raja Krishnamoorthi, Illinois, Chairman
Mark DeSaulnier, California, Michael Cloud, Texas, Ranking
Katie Hill, California Minority Member
Ro Khanna, California Glenn Grothman, Wisconsin
Ayanna Pressley, Massachusetts Chip Roy, Texas
Rashida Tlaib, Michigan Carol D. Miller, West Virginia
Gerald E. Connolly, Virginia
C O N T E N T S
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Page
Hearing held on March 12, 2019................................... 1
Witnesses
Anne McTiernan, MD, PhD, Member, Fred Hutchinson Cancer Research
Center
Oral Statement............................................... 5
Scott Faber, Senior Vice President for Government Affairs,
Environmental Working Group
Oral Statement............................................... 6
Marvin Salter, Son of Deceased Ovarian Cancer Patient
Oral Statement............................................... 7
The written statements for witnesses are available at the U.S.
House of Representatives Repository: https://docs.house.gov.
Appendix
Page
Johnson & Johnson Letter; submitted by Rep. Krishnamoorthi... 19
Felipe Aviles' Letter; submitted by Rep. Krishnamoorthi...... 23
Chicago Residents' Joint Letter;submitted by Rep.
Krishnamoorthi............................................. 26
Johnson & Johnson Memo; submitted by Rep. Pressley........... 30
Personal Care Products Council Documents; submitted by Rep.
Cloud...................................................... 32
EXAMINING THE PUBLIC HEALTH RISKS OF CARCINOGENS IN CONSUMER PRODUCTS
----------
Tuesday, March 12, 2019
House of Representatives
Committee on Oversight and Reform
Washington, D.C.
The subcommittee met, pursuant to notice, at 10:06 a.m., in
room 2154, Rayburn House Office Building, Hon. Raja
Krishnamoorthi presiding.
Present: Representatives Krishnamoorthi, DeSaulnier,
Khanna, Pressley, Tlaib, Connolly, Gomez, Cloud, Grothman, and
Miller.
Mr. Krishnamoorthi. Good morning. The subcommittee will
come to order.
Without objection, the Chair is authorized to declare a
recess of the committee at any time.
This hearing is entitled, ``Examining the Public Health
Risks of Carcinogens in Consumer Products.''
I now recognize myself for five minutes to give an opening
statement.
Today marks our subcommittee's first hearing. The
Subcommittee on Economic and Consumer Policy was created to
focus attention on the pocketbook issues that matter the most
to Americans, economic opportunity and fairness, consumer
health and safety, and the overall quality of life. We will do
this first and foremost by asking tough questions and following
the facts wherever they lead.
Today our focus is on a group of widely used personal care
consumer products that contain talc, a mineral that
manufacturers put in baby powder for infants, make-up for
teenage girls, and personal care products for people of all
ages.
Now, why is this issue important right now? First, recent
reports claim that Johnson & Johnson, a large maker of personal
care products, was aware for decades that its talc products
sometimes contained asbestos, a carcinogen that has killed
thousands of miners and shipyard workers. And separately, the
FDA recently issued advisories regarding cosmetics marketed by
Justice and Claire's to children, also containing asbestos.
Let's be clear: there is no question that exposure to
asbestos is hazardous to human health, and geologists know that
asbestos can be found in rock formations that also contain
talc. Yet, the FDA cannot order any manufacturers to recall
these personal care or cosmetics products that potentially
contain asbestos. The question is why?
Because a loophole in the statute that empowers the FDA to
regulate personal care products and cosmetics does not allow
the FDA to require necessary recalls. Thankfully, some
manufacturers like Claire's have volunteered to recall products
the FDA has found to contain asbestos, which I thoroughly
commend. But FDA authority generally remains weak. In fact,
product recalls, mandatory risk labeling, and adverse event
reports are just a few of the processes in which compliance
with FDA guidelines is entirely voluntary for the cosmetics
industry.
This is a statutory problem that needs reform, and I expect
the Energy and Commerce Committee, under the leadership of
Chairman Frank Pallone, will focus like a laser on that problem
to protect consumers. But juries across America are not waiting
for Congress to act. In fact, juries have awarded verdicts to
victims and survivors who have suffered or died from ovarian
cancer that was possibly caused by talcum baby powder. Many of
those juries have assessed punitive damages against
manufacturers for failing to warn consumers of talcum powder's
ovarian cancer risk.
Today we are joined by women and their families from across
the country who suffer from ovarian cancer which they attribute
to long-time use of talcum baby powder. One of these families
is the Browning family from my home state of Illinois. Anthony
and Elisa Browning, thank you both for being here today on
behalf of your mother, Gloria Browning. I extend my sincerest
condolences to you and your family.
Additionally, one of our witnesses today, Mr. Salter, is
the surviving son of a deceased ovarian cancer patient. He will
testify to what he and his mother's doctors believe caused his
mother's death. Mr. Salter, I extend our sympathies to you as
well, and I want to personally thank you for joining us here
today.
We will also hear from a distinguished epidemiologist, Dr.
Anne McTiernan, who has conducted extensive analyses of the
scientific data on talc and asbestos.
We will also hear from the Environmental Working Group,
which is devoted to consumer health and education, to help us
evaluate the problems in the Federal regulation of personal
care products.
We are also listening to what the largest maker of talcum
body powders, Johnson & Johnson, says about the safety of their
products. In preparing for this hearing, my staff has discussed
the company's detection methods, manufacturing and mining
processes, and the health risk data with senior executives and
their company, and we will continue to gather facts from them
as well.
The average adult uses nine personal care products daily in
this country, nine. Consumers use these products trusting that
they are safe and will not harm themselves or their families.
Today's hearing is just our first step in protecting consumers
from potentially carcinogenic products. The American people
deserve nothing less.
Now the Chair recognizes the ranking member, Mr. Cloud of
Texas, for five minutes for an opening statement.
Mr. Cloud?
Mr. Cloud. Thank you, Mr. Chairman.
Thank you, everyone, for being here.
Let me say at the outset congratulations, Chairman, on your
chairmanship and on this first meeting of the subcommittee. I
do look forward to working with you.
Mr. Krishnamoorthi. Thank you.
Mr. Cloud. I know we are just getting to know each other,
but I know enough about both of us to know that our most
important role is that of being a father, and because of that
we keep in mind our families and the families we represent, and
that is one of the things that makes this such an important
issue today.
The issue we are discussing today is particularly important
not only because of the potential harm for individuals but
because of how commonplace consumer products are. I am
confident that everyone in this room has used several consumer
products this morning, or at least I hope so----
[Laughter.]
Mr. Cloud [continuing]. the safety of which we largely take
for granted.
When a problem like the potential contamination of consumer
products with carcinogens becomes apparent, one of the first
questions that comes to mind is what is the Federal
Government's role in addressing it?
I think we can all agree on this: a company knowingly puts
contaminated products on the marketplace for consumers to buy
and use, that is a bad actor, and bad actors should be held
accountable.
The government should engage in fact-finding and determine
the level of risk posed to consumers by these contaminated
processes, which is a process I hope we begin today.
Any Federal Government action should be guided by the best
available science and based on real, quantifiable risk to
consumers, not by fear or desire to simply act. It should be
tailored to the problem at hand and designed to limit
unintended or secondary consequences.
We need only to look at recent history to find instances of
government regulation having the opposite effect from what was
intended. In our response to the 2008 financial crisis,
Congress took the expansive action and passed Dodd-Frank to
address banks that were too big to fail. But according to the
Wall Street Journal, the three largest U.S. banks by assets
have taken up more than $2.4 trillion of domestic deposits over
the last 10 years. That growth is more than the total assets
held by the eight largest banks in 2007, the year before the
crisis began. In other words, we took banks that were too big
to fail and we made them bigger.
Why does this happen? It happens because regulatory
complexity favors large, established companies who can better
absorb new compliance costs. It creates barriers to entry, so
there are fewer new companies being formed, and it drives
consolidation, concentrating risk into fewer institutions that
have bigger roles in the economy.
So as we work on this very real situation, I hope we can
keep in mind scalable solutions, as opposed to a one-size-fits-
all approach, and I do thank our witnesses for appearing before
this subcommittee today. I look forward to your testimony.
Thank you for being here.
Mr. Chairman, I yield back.
[Prepared Statement of Mr. Cloud follows:]
WRITTEN TESTIMONY OF RANKING MEMBER MICHAEL CLOUD COMMITTEE ON
OVERSIGHT AND REFORM SUBCOMMITTEE ON ECONOMIC AND CONSUMER
POLICYU.S. HOUSE OF REPRESENTATIVES
March 12, 2019
Thank you, Mr. Chairman, and thank you everyone for being
here for the first hearing of this subcom1nittee in the 116th Congress.
I look forward to working with you, Mr. Chairman, and all
Members of this subcommittee over the coming years to address issues
facing American consumers and our economy.
The issue we are discussing today is particularly
important. Not only because of the potential for harm to individuals,
but because of how co1n1nonplace consu1ner products are.
I am confident that everyone in this room has used
several consumer products this morning,the safety of which we largely
take for granted.
When a problem like the potential contamination of
consumer products with carcinogens becomes apparent, one of the first
questions that comes to mind is what the Federal Government should do
about it.
There are those of us who prefer the government to take
an active role in responding to a problem such as this, while others
prefer a 1nore limited role.
But I think we can all agree on this: If a company
knowingly puts contaminated products out in the marketplace for
consumers to buy and use, that is a bad actor and bad actors should be
held accountable.
The government should engage in factfinding and determine
the level of risk posed to consumers by these contaminated products,
which is a process I hope we begin today.
If allegations of wrongdoing are substantiated, the
government should act in a measured and responsible manner.
Any Federal Government action should be guided by the
best-available science and based on real and quantifiable risks to
consumers, not by fear or a desire simply to act.
It should be tailored to the problem at hand and designed
to limit unintended or secondary consequences.
We need only look at our recent history to find instances
of government regulation having the opposite effect from what was
intended.
In response to the 2008 financial crisis, Congress took
expansive action and passed Dodd-Frank to address banks that were ``too
big to fail.''
But according to the Wall Street Journal, the three
largest U.S. banks by assets have taken in more than $2.4 trillion of
domestic deposits over the past 10 years.1A\1\
---------------------------------------------------------------------------
\1\ Rachel Louis Ensign, Biggest Three Banks Gobble Up $2.4
Trillion in New Deposits Since Crisis, WALL STREET J.(Mar. 22, 2018),
https://www.wsj.com/articles/biggest-three-banks-gobble-up-2-4-
trillion-in-new-deposits-since-crisis-152171001.
That growth is more than the total assets held by the
---------------------------------------------------------------------------
eight largest banks in 2007, the year before the crisis began. \2\
\2\ Id.
---------------------------------------------------------------------------
In other words, we took the banks that were already too
big to fail, and we made them much larger.
Why? Because regulatory complexity favors large,
established companies who can better absorb new compliance costs.
It creates barriers to entry, so there are fewer new
companies being formed, and it drives consolidation, concentrating risk
into fewer institutions who have bigger roles in the economy.
We 1nust avoid falling into the same trap if Congress is
to act in response to the proble1n before us today.
I thank our witnesses for appearing before our
subcommittee today and I look forward to their testimony.
Mr. Chairman, I yield back.
Mr. Krishnamoorthi. Thank you, Mr. Cloud.
Now I want to welcome our witnesses: Dr. Anne McTiernan, M.D.,
Ph.D., a member of the Fred Hutchinson Cancer Research Center; Scott
Faber, the Vice President of Government Affairs at the Environmental
Working Group; and Marvin Salter, who is the son of a deceased ovarian
cancer patient.
If the witnesses will please rise, I will begin by swearing you in.
If you could put up your right hand, please?
[Witnesses sworn.]
Mr. Krishnamoorthi. Let the record show that the witnesses answered
in the affirmative.
You may put your right hands down.
Let the record show that the witnesses have answered in the
affirmative. Thank you, and please be seated.
The microphones are sensitive, so please speak directly into them.
There is a timing system here. Counting down from five, you start
with the green light, and then you go to yellow light and red light.
But unlike with stop lights, you have to speed up when you see yellow,
not slow down.
Without objection, your written statements will be made part of the
record.
With that, Dr. McTiernan, you are now recognized to give an oral
presentation of your testimony for five minutes.
STATEMENT OF ANNE McTIERNAN, M.D., PH.D.
Dr. McTiernan. Chairman Krishnamoorthi, Ranking Member Cloud, and
members of the subcommittee, good morning and thank you for inviting
me. My name is Dr. Anne McTiernan. I am a cancer prevention researcher
in the Epidemiology Program, Division of Public Health Sciences, at the
Fred Hutchinson Cancer Research Center in Seattle, Washington. I am
also a Research Professor in the University of Washington Schools of
Public Health and Medicine. I am not representing the Fred Hutchinson
or the University of Washington in my presentation of testimony this
morning to the subcommittee.
I am an internal medicine physician and an epidemiologist. My
research focuses on cancer epidemiology and prevention, particularly
cancers in women. I was asked to give testimony today because I have
conducted a thorough and systematic review of the science linking use
of talcum powder products with risk for ovarian cancer. As part of this
review, I prepared an expert report on behalf of consumers for an
ongoing multi-district litigation on talcum powder products as causes
of ovarian cancer.
My scientific review focused primarily on the epidemiologic
research. Epidemiologists look at large groups of people with a disease
and compare them to people without that disease to look for what might
be causing the disease.
The American Cancer Society and the U.S. National Cancer Institute
estimate that in 2019, over 22,000 women will receive a diagnosis of
ovarian cancer, and over 13,000 will die of ovarian cancer. There is no
established method for screening for ovarian cancer. As a result, most
women are diagnosed at an advanced, less treatable stage. There is also
no method established for preventing ovarian cancer other than surgical
removal of the ovaries. Therefore, it is critical to identify causes of
ovarian cancer in order to prevent this serious disease.
My review identified 38 high-quality epidemiologic studies
conducted over the past 40 years. These studies asked women about their
use of talcum powder products in the genital area and tested
associations with risk of ovarian cancer. Together, these studies
included over 14,000 women with ovarian cancer, and particularly
epithelial cancer, which is the most common type, and an even greater
number of women without ovarian cancer. Most of these studies were
conducted in the United States.
Ovarian cancer is thought to develop over years. Therefore, a
woman's experience in her younger and middle years can affect her risk
of ovarian cancer decades later. Women have reported use of talcum
powder products on sanitary napkins, underwear, and directly to the
genital area. In some studies, over 4 in 10 women report ever regularly
using these products in the genital area.
Summarizing data from all of the published studies consistently
shows that women who had ever used talcum powder products in the
genital area had a statistically significant 22 to 31 percent increased
risk of developing epithelial ovarian cancer compared with women who
had never used them. Evidence suggests that these associations hold
across diverse race and ethnic groups.
These combined analyses also showed that increasing exposure to
these products was associated with increasing risk of ovarian cancer.
We know from laboratory and clinical studies as well as in humans
that talc can migrate from the genital area up to the area of the
ovaries and the fallopian tubes. Talc has been shown to cause
inflammatory responses in the human body. We know that elevated levels
of inflammation are associated with increased risk of ovarian cancer.
And all of this provides a biologically plausible pathway by which
talcum powder products can cause ovarian cancer.
So given the frequency with which asbestos has been found in
cosmetic and personal talc products, I reviewed the literature in
asbestos as well, and in 2012 the International Agency for Research on
Cancer stated that a causal association between asbestos and cancer of
the ovary was clearly established. That agency has also classified
fibrous talc as a Class 1 carcinogen, the most dangerous type of
carcinogen.
Given the high prevalence of use of talcum powder products, this
level of increase can have profound effects on clinical events and
public health. Women need to know about the risks of using talcum
powder products in their genital areas. All consumers need to be warned
about the contents of these products, including asbestos and fibrous
talc, so they can make informed decisions about use.
Thank you for the opportunity to provide this testimony. I would be
happy to answer any questions you may have.
[Prepared Statement of Dr. McTiernan available on:https://
oversight.house.gov/sites/democrats.oversight.house.gov/files/
McTiernan-Statement.pdf]
Mr. Krishnamoorthi. Thank you, Dr. McTiernan.
Now, Mr. Faber?
STATEMENT OF SCOTT FABER
Mr. Faber. Thank you, Mr. Chairman, Ranking Member Cloud, and
members of the committee. Let me start by thanking you for holding this
hearing, and let me thank the people sitting behind me who have been
personally impacted and who are willing to share their stories.
The recent news that asbestos was found in facial powders marketed
to teens is something that should concern all of us. Unfortunately,
cosmetics purchased at stores like Claire's and Justice are not the
only products that are likely to contain asbestos. There is always some
risk that the products produced with talc will contain this dangerous
carcinogen.
EWG has found more than 2,000 cosmetics and other personal care
products that contain talc, including more than 1,000 loose powders or
pressed powders that could pose a risk of being inhaled or absorbed.
Even small amounts of asbestos and talc can cause mesothelioma or other
diseases many years after exposure.
It is not a secret that talc can contain asbestos. Companies have
known of this risk since at least the 1950's. Nevertheless, as
Commissioner Gottlieb said last week, cosmetic companies have no duty
to test for products made with talc for asbestos or to share those test
results with FDA, and have no duty to warn consumers of this potential
risk.
Asbestos is not the only contaminant or chemical of concern in
personal care products. Since 2009, cosmetics manufacturers themselves
have reported using 88 chemicals linked to cancer, birth defects, or
reproductive harm in both men and women. Nevertheless, the FDA is not
now required to review and regulate, if necessary, these chemicals, and
has very limited authority to do so.
While Congress has given the FDA the authority to review and
regulate chemicals in food, in colors, in pesticides, Congress has not
given the FDA the same power or the resources necessary to address
chemicals of concern in cosmetics.
As a result, cosmetics have largely fallen into a regulatory black
hole. While the FDA has only banned or restricted nine chemicals in
cosmetics for safety reasons, more than 40 other nations have banned or
restricted more than 1,400 chemicals in cosmetics and other personal
care products.
While other categories subject to FDA oversight, categories like
drugs, medical devices or food, must register with the FDA, must report
ingredients, must report adverse events, cosmetics manufacturers do not
have to register with the FDA, do not have to report ingredients, do
not have to report adverse events. When products in other categories
subject to FDA oversight harm consumers, FDA can stop their production
and order a recall. But as we learned last week, FDA can only ask a
cosmetics company to recall contaminated products.
Since the 1950's, Congress has tried to give FDA the power to
oversee the safety of these everyday products but has so far been
stymied, but that may be changing now that cosmetics companies, large
and small, have endorsed bipartisan legislation to give FDA these basic
powers.
All of us use personal care products every day. Women use on
average 12 products that contain 168 unique chemicals. Men use on
average six products that contain 85 different chemicals. Most
Americans assume that these everyday products are safe, but they would
be wrong. That is why I am so grateful, Mr. Chairman, that you are
holding this hearing today.
Thank you. I am happy to take your questions.
[Prepared Statement of Mr. Faber is available on:https://
oversight.house.gov/sites/democrats.oversight.house.gov/files/
Scott%20Faber-Testimony.pdf]
Mr. Krishnamoorthi. Thank you, Mr. Faber.
Mr. Salter, could you present your testimony?
STATEMENT OF MARVIN SALTER
Mr. Salter. Good morning, Chairman Krishnamoorthi, Ranking Member
Cloud, and members of the subcommittee. It is a great honor for me to
address this subcommittee on behalf of my mother, the late Jacqueline
Salter Fox. My mother departed this life on October 6, 2015. Her death
came suddenly. At that time, she was doing well. She felt at that point
in her battle against ovarian cancer that she was winning. Her exact
words were: ``God wasn't done with me yet.'' But as we came to learn,
like many women who suffer from this deadly disease, victories can be
short-lived, and celebrations are often cut short. Her disease recurred
with a vengeance, and my mom lost that fight.
My mother had me when she was 16 years old, and we were all we had.
In many ways, we grew up together. We saw hard times, but we always
weathered the storm together. Her illness and eventual death was a
storm neither of us were ready for and one from which I remain
devastated.
I sincerely believe that Johnson & Johnson took my mother's life.
We believed in the company, and in that product specifically. My mother
was a true fan. It was a staple in our house and a necessary part of
our hygienic routine. It was as natural for her as brushing her teeth
every single day. Baby powder was always in our bathroom cabinets or on
our bedroom dressers. It was wherever we were getting dressed. We never
realized that what we were using could possibly be harmful. Had we
known then what we know now, we never would have brought this into our
household.
Prior to her diagnosis my mother, like so many other women, had no
symptoms whatsoever. She was diagnosed with late-stage ovarian cancer
in April 2013. It was a rough time for us, but my mother was the type
of woman who never let bad news overtake her joy. She was confident she
would beat this disease. She approached her treatment with a positive
attitude and a big smile. She smiled through her surgery. She smiled
through her chemotherapy and even the hair loss that it caused. She
cheered up the other patients, even though her own body was wracked
with pain and fatigue. She spent her time just as she had spent her
life, serving and caring for others. Her spirit was never broken,
despite what was happening to her body. She smiled through it all.
At some point she learned that her over 30 years of use of baby
powder could have been responsible for her disease. I was not involved
in her decision to file a lawsuit, but I supported my mother fully. She
told me it was important for her to bring awareness to women about the
risk of cancer. She did not want any more women going through what she
did. Unfortunately, she did not make her trial. Because I knew how
important it was for her, it was important for me to continue that
fight. I wanted to make sure that her voice was heard, and I wanted
Johnson & Johnson to know her name. I wanted them to know what a
wonderful woman she was and how unfair it was that she was no longer
with her family.
The trial was eye-opening. The evidence put forth against Johnson &
Johnson was substantial. They lied to us all. They knew the cancer
risks associated with their products but chose to cover it up instead.
They protected their products and profits while putting innocent lives
at risk. Each day revealed new details about exactly how much they knew
and when they knew it.
Testing of my mother's tissue revealed the presence of talc. I
learned how talc migrates up the female pelvic system and causes
chronic inflammation at the surface of the ovaries. I learned how talc
particles can infiltrate the lymphatic system and spread throughout the
body. I learned that talc is a mineral often found with heavy metals
and asbestos, which are known to be cancer-causing.
In the end, the jury saw things as we did. Despite having passed,
my mom accomplished her goal of helping educate women everywhere that
baby powder is a serious threat to all women.
There have been more trials since my mother's. More juries have
seen all the evidence. More news outlets have reported on this issue.
The truth is finally coming out, but justice has not been served.
Johnson & Johnson has yet to take ownership for what they have done,
and they have yet to take one step to make amends to all of us whose
lives have been turned upside down because we trusted in this company
when they said their product was safe. Johnson & Johnson continues to
market and sell a product they know to be harmful, and they continue to
lie and cover up the truth about its safety. It is past time for
Johnson & Johnson to do the right thing.
All my mother wanted is for women to know the risks of using baby
powder. Johnson & Johnson could voluntarily add a warning to their
product today, or better yet, stop selling it altogether. After all
this time, it is safe to assume that Johnson & Johnson will not do what
needs to be done to protect the public.
I ask that this body use whatever power in its disposal to assist
in bringing about justice for my mother and for all women and families
who have been adversely affected by ovarian cancer caused by Johnson &
Johnson's baby powder.
Thank you.
[Prepared Statement of Mr. Salter is available on:https://
oversight.house.gov/sites/democrats.oversight.house.gov/files/
Marvin%20Salter-Testimony.pdf]
Mr. Krishnamoorthi. Thank you, Mr. Salter.
I now will begin the questioning. I recognize myself for five
minutes for questions.
Dr. McTiernan, I would like to kind of unpack some of what you had
to say with regard to the link between talcum powder use and cancer.
Could you explain a little bit about the process by which talcum
powder would lead to ovarian cancer?
Dr. McTiernan. We know from studies in humans that women who use
these products have a higher risk of developing cancer. So the question
is how could this be occurring?
One possible way is we know that talc can migrate to the fallopian
tubes or ovaries, both of which can initiate the cancer cell
developing.
One plausible mechanism is inflammation because talc has been shown
to cause an inflammation when it is inside the human body, including in
various parts of the body, and that inflammation can induce
carcinogenesis. So that is one possible mechanism. But other studies,
cell studies where talc has been applied to cells shows that there are
some other mechanisms that could also be working.
Mr. Krishnamoorthi. How frequently would one have to use talcum
powder for cancer-related inflammation to begin to occur? I think you
called it carcinogenesis.
Dr. McTiernan. It is really not clear how frequently somebody would
need to use this product. Theoretically, if one dose is in the
particular area and causes an inflammation, that could be sufficient.
But when you have more doses, when a person has used this more often
and longer, the likelihood of that being introduced into the peritoneal
area around the fallopian tubes or ovaries, that likelihood increases.
We do not know. There is no particular threshold. There is nothing that
says this amount is safe, this amount is not safe.
Mr. Krishnamoorthi. I would like to point to a statement that
Johnson & Johnson submitted to us yesterday. They said, ``Decades of
independent scientific testing has confirmed that Johnson & Johnson's
cosmetic talc and Johnson's baby powder are safe, are not contaminated
with asbestos, and do not cause cancer.''
Without objection, I would like to enter this letter into the
record.
[The information referred to is in the Appendix section.]
Mr. Krishnamoorthi. Dr. McTiernan, do you agree with the statement
that I just made, quoting from Johnson & Johnson's letter to us?
Dr. McTiernan. I do not agree in the science aspect of it. I have
not seen any of the particular data they are talking about. They are
probably talking about two things. One is the epidemiologic studies. I
interpret those data that the use of these products increases risk of
ovarian cancer, as do many of the very large combined studies.
The other part of that statement I believe had to do with testing
the product, and while I have not conducted those sorts of tests
myself, I saw when I was doing my expert report, I saw both published
data and information from the companies that suggested that some of
those products could have asbestos or other substances that could be
carcinogenic, as well as the talc itself.
Mr. Krishnamoorthi. Thank you.
Before my next question, without objection, I want to enter into
the record a letter from Felipe Aviles from Palatine, Illinois, who
states that his daughter Jeannette regularly used talcum powder in her
hygienic routine.
Without objection, I would like to enter her statement into the
record, or her father's statement into the record.
[The information referred to is in the Appendix section.]
Mr. Krishnamoorthi. ``This past December, Jeannette felt severe
abdominal pain. She then got a biopsy and discovered that she had
mesothelioma. On January 18th, 2019, Jeannette was admitted to the
University of Chicago Hospital. She never left and passed away on
February 4th, 2019. She was sick, diagnosed, and gone all within a few
months.''
Without objection, I am also entering into the record a joint
letter from 10 additional Chicago residents who are relatives of
individuals whose lives have been taken or whose health has suffered
after years of talcum powder.
[The information referred to is in the Appendix section.]
Mr. Krishnamoorthi. I see that my time is about to expire, so I
would like to yield back and I would like to call--I am going to ask
Mr. Grothman if you have questions.
Mr. Grothman. Okay. This is a question for any one of the three of
you. It was prompted by Mr. Salter's testimony.
You say all along Johnson & Johnson knew the connections between
talc and cancer. Is that true? You said all along that Johnson &
Johnson knew the connection between talc or baby powder and cancer. Is
that true?
Mr. Salter. Yes, I would say that is correct. Obviously, we had our
trial back in 2016, so I was privy to a lot of the evidence that was
put forth that showed that they knew about it as early as the `80's.
Mr. Grothman. Could you expand a little bit on that, like what type
of testing, or they knew there was correlation between their product
and cancer?
Mr. Salter. I am not familiar with exactly what type of testing was
done, but I was only a witness to some of the documents that were
presented during trial.
Mr. Grothman. Okay. Does either Dr. McTiernan or Mr. Faber know a
little bit how much they were covering up, what they were covering up,
and how long they were covering up?
Mr. Faber. Thank you for the question, Mr. Grothman. As Mr. Salter
mentioned, there is a great deal of documentary evidence showing that a
number of companies, including Johnson & Johnson, found positive test
results of their talc for the presence of asbestos fibers going back to
the late 1960's and early 1970's. I am happy to share those results
with you.
Mr. Grothman. That is fine. They did not care? Any followup studies
that maybe we ought to reduce that in the product?
Mr. Faber. So, at the time, these results were shared by a number
of parties with FDA. FDA considered whether or not to regulate talc or
to come up with a system to ensure that talc was free of asbestos, and
ultimately in 1976, under pressure from industry, FDA agreed to allow
industry to self-regulate provided they used a particular testing
method that could detect some but not all of the asbestos that might be
present in talc.
Mr. Grothman. And you think asbestos is what causes the cancer?
Mr. Faber. There is no doubt whatsoever that asbestos can
contribute to mesothelioma and other forms of cancer and disease. That
is why, beginning in 1972, OSHA set standards for asbestos. That is why
more than 50 other nations, although not yet the United States, have
banned the use of asbestos.
Mr. Grothman. Johnson & Johnson also makes pharmaceuticals?
Mr. Faber. That is correct.
Mr. Grothman. Is there any reason you would think they would be any
more careful with pharmaceuticals than they are with these other
products?
Mr. Faber. That is a great question.
Mr. Grothman. Does that morality spread throughout the company?
Mr. Faber. So, as I am sure you know, Mr. Grothman, pharmaceutical
drugs are subject to premarket review by FDA. By contrast, personal
care products like talc are not. So we essentially rely on an honor
system. We trust companies to monitor or to test for the presence of
asbestos. We trust companies to test the products that are sent to them
for asbestos. We trust these companies to conduct marketplace
surveillance. But they have no need to do those tests or----
Mr. Grothman. Would common sense--and I hate to say this, but would
common sense tell you that when you are putting something on your skin,
that there is the potential over time to have something bad happen?
Mr. Faber. Mr. Grothman, most consumers assume, and there has been
a lot of research done on this question, that FDA has actually reviewed
these products for safety before we put them on our bodies every day. I
think if you walked outside the Rayburn Building and asked anyone on
the street, they would assume that shampoos, soaps, lotions have been
tested and regulated by the FDA.
Mr. Grothman. To you and Dr. McTiernan, one more general question.
Juries can always reach conclusions that are wrong, I suppose. But in
both of your opinions, is there any doubt in your mind that the baby
powder that was sold by Johnson & Johnson has a connection to cancer? I
mean, do you feel, after looking at the evidence, that that is
something that is subject to debate?
Dr. McTiernan. I can answer from my review of the scientific
literature. I believe that talcum powder products do cause ovarian
cancer, yes. It is clear. There have been 24 case-control studies that
have been conducted over the last 40 years. Over 14,000 women with
ovarian cancer have been interviewed for these studies and have given
information, and even more women without ovarian cancer, and the
results are really consistent. So I do believe, yes, that those
products----
Mr. Grothman. Is it off the market now?
Dr. McTiernan. Pardon?
Mr. Grothman. Is it off the market now? The product, is it off the
market now?
Dr. McTiernan. No, this is still on the market.
Mr. Grothman. It is still on the market as almost a proven
carcinogen?
Mr. Faber. There are now at least 2,000 products that contain talc
that are available for sale today, of which more than 1,000 are loose
powders or pressed powders, therefore posing the risk of--things that
are used around the nose and mouth that might be inhaled. It only takes
one fiber lodged in the lung to contribute to mesothelioma decades
later, and that is why many organizations and, frankly, many countries
have required some sort of warning label, especially for children under
the age of 3, when using these products that contain talc.
Mr. Krishnamoorthi. Thank you. Your time has expired, Mr. Grothman.
I would just say that I do not think that common sense would
dictate that when people apply things to their skin, that they would
ever expect cancer. I just do not see that happening.
Anyway, the next person up is Ms. Tlaib. You have five minutes.
Ms. Tlaib. Thank you, Chairman.
And thank you, all three of you, so much.
Mr. Salter, thank you so much. My father had cancer, and he passed
on at 67 of cardiac arrest, but I was very, very much appreciative of
your honesty and your testimony, and I thank her so much for bringing
attention to this. This will truly always be her legacy, to be able to
at least protect other women.
Today's hearing is significant. I think people are not realizing
corporate greed is a type of cancer in our democracy right now, and it
is true. People are questioning the science, questioning real, actual
data that says exposure to these products hurts our families, our
residents.
Just last week, the Food and Drug Administration issued a safety
alert confirming that asbestos was found in make-up product samples
from stores like Claire's and Justice, which are the stores that my
residents go to, working folks, working families. They do not go to the
bourgeois Macy's counter. I am being serious. These are targeting
working-class people, companies that manufacture and sell these make-up
products to young girls, many of them of color.
The FDA safety alert states, and I quote, ``The FDA requested that
Claire's recall their products because they should not be used by
consumers. Claire's has refused to comply with the FDA's request, and
the agency does not have authority to mandate a recall.'' However,
later on after that, Claire's has since voluntarily complied.
But even reading that just now, it shook me. And I know I am new,
but before I came here I honestly thought FDA has got it covered, EPA
has got it covered. I see what happened in Flint, in Michigan.
So being here, the products mentioned and the safety alerts include
eye shadows. I mean, these are things that I see my nieces--the younger
girls are starting to put all kinds of stuff on their face. I was not
allowed to wear make-up until I was 18, but it is true, it is changing
because they are really focusing on our young girls.
So, Mr. Faber, your organization has devoted so much to helping
consumers make right decisions. I know the Ecology Center in Michigan,
I sat on their board for years testing car seats that had toxins in
them, kids' car seats.
Corporate greed is so dangerous. It makes us look blindly at the
science, at real data and information. It is not like we do not want
you--we want you to do well. We support--who does not? But we do not
want it in exchange for people dying.
So in the context of makers of talcum baby powder and so forth, if
you were to make a decision, if you were in my spot, what are some of
the specific things? I mean, you had mentioned 40 other countries had
1,400 restricted already? And I think--what is ours? How many you said?
Mr. Faber. Nine.
Ms. Tlaib. Nine, and you just said 2,000 products are on the market
right now. What would you ask us to do on behalf of our residents right
now at this point?
Mr. Faber. Well, the good news is that Chairman Pallone, Chairman
of the Energy and Commerce Committee, is now working with Congressman
Shimkus to craft legislation that would give the FDA these basic powers
to order a recall if a product is contaminated, to review ingredients
if the ingredients have been linked to cancer or reproductive harm.
The other good news is that many of the companies that in the `70's
fought giving FDA this power now support bipartisan legislation like
the kind being developed by Mr. Pallone and Mr. Shimkus to give FDA
these basic powers, the ability to know whether or not something is
contaminated, to order a recall, to stop the production of contaminated
products, all powers that FDA has for other categories but does not
have today for cosmetics.
Ms. Tlaib. I read--and I do not know if my colleagues know this,
but I believe that this is a $62 billion industry in America right now,
and they cannot just put a disclaimer, anything, any information out
there right now, education on what these products are. But to think
that asbestos, asbestos, which is living, breathing in your body--it
takes a while; it is like a slow death--is in these products is
unbelievable.
I want to ask maybe afterwards if we can talk. I really want to put
these products on my congressional website. I want to see if my
colleagues will not let me do that, because I want to put it on my
website and provide this information to these young girls and try to
increase education, because I cannot wait for this legislation to pass
for people to stop dying.
Thank you so much.
Mr. Krishnamoorthi. Thank you, Ms. Tlaib.
Mrs. Miller, you have five minutes.
Mrs. Miller. Thank you, Chairman Krishnamoorthi and Ranking Member
Cloud. And thank you to all of you all for being here today.
Mr. Salter, I grieve with you. I understand the tight bonds there
are between a mother and a son. I also held my mother-in-law when she
lost her 34-year-old son, and I grieve with you. It is very sad.
Like many of my colleagues here today, I am troubled by the
findings and the experiences that we have heard. For years, consumers
have utilized products that contain talc without so much as a second
thought. We have used it ourselves. I have bought products from both
Claire's and used baby powder for years and years, and used it on my
children as well.
It is even more concerning that people have known about these
carcinogens in the products and have put them on store shelves
regardless.
Mr. Faber, I agree that we need oversight to ensure that products
put on store shelves are safe. However, we must also ensure that
regulations placed on these companies are not so stringent that they
may halt production altogether. It is such a fine line to walk.
How would you suggest that we ensure more testing is done without
stifling the research and the innovation that it takes?
Mr. Faber. Thank you for the question. We work very closely with
companies like J&J, Proctor & Gamble, Revlon, Estee Lauder and L'Oreal,
as well as many small companies who are the real innovators in this
industry, to craft legislation that would give FDA the power to review
and, if necessary, regulate contaminants linked to cancer, birth
defects, or reproductive harm, but would recognize the differences
between very large companies like Proctor & Gamble and very small
companies that are going to provide the most innovative products in our
economy.
I think the evidence that FDA can provide this oversight is all of
the success we already see in the drug sector, the medical device
sector, among food companies. I do not think it is hard to imagine
striking a balance where FDA can ensure that these everyday products do
not contain ingredients linked to cancer or reproductive harm, and that
we continue to have many of these everyday products in our homes.
There is certainly going to be cases where chemicals or
contaminants are so dangerous that they should not be allowed in these
everyday products. But there are literally thousands and thousands of
ingredients available to formulators, and companies make products every
day that do not include many of the chemicals and contaminants that I
have mentioned in my testimony.
Mrs. Miller. Is there a way to ensure that companies institute
stringent testing procedures rather than relying upon the FDA?
Mr. Faber. We have relied on self-regulation now for more than 60
years. When Congress first began to consider whether or not to give
these powers to FDA in the 1950's, and when Congress gave FDA the power
to regulate chemicals in food in 1958 and chemicals in colors in 1960,
we instead chose to rely on industry self-regulation with regards to
cosmetics.
I think today's testimony and the support of so many cosmetic
companies for more regulation is evidence that relying on self-
regulation no longer makes sense.
Mrs. Miller. What steps can Congress take to help empower companies
and the FDA to utilize safe products?
Mr. Faber. The first step is giving FDA the power to identify those
ingredients that have been linked to cancer or birth defects and
reproductive harms and making an assessment of whether or not, first
and foremost, those ingredients and contaminants should be in these
products at all, or whether they should be restricted to other levels,
as more than 40 other countries have done.
For the most part, most countries, when they look at these
questions of the safety of these ingredients, have decided to restrict
them to levels at which they would not pose any harm. That is certainly
not the case for a contaminant like asbestos. There is simply no safe
level of asbestos. If we cannot sell products that are free from
asbestos, they should not be sold at all. But for most of the
ingredients that have been regulated around the globe, countries like
Canada, countries in Europe, countries in Southeast Asia, Korea, Japan,
Australia, have generally taken the step of restricting chemicals to
certain amounts so that we are not exposed to so much of that chemical
that we would be at an increased risk of cancer or other serious harms.
Mrs. Miller. Thank you. I yield back the rest of my time.
Mr. Krishnamoorthi. Thank you, Mrs. Miller.
Ms. Pressley, you have five minutes.
Ms. Pressley. I want to thank all of the witnesses for joining us
again today. Mr. Salter, I echo the sentiments of my colleagues. Death
is a certainty of life. However, her death was premature and could have
been avoided, and evidence supports that there was what I would
consider to be predatory marketing, and understanding that black women
are, I think, the number-one consumers of beauty products, and
specifically of this powder. So I thank you for turning your pain into
activism and to making sure that no other family knows the pain that
you do.
It is important to note that amongst the hundreds of thousands, if
not millions of women that have used Johnson & Johnson talcum powder,
the product was particularly popular with women of color. Johnson &
Johnson tailored their marketing strategy to women of color almost 30
years ago. An internal memo that I would like to enter into the record,
dated August 5th, 1992, entitled ``Johnson's Baby Powder: Major
Opportunity,'' shows a usage of 52 percent among African Americans, and
37.6 percent usage rate among Hispanics. This memo also details a plan
to implement an Hispanic media program and to launch a black print
media marketing effort accordingly.
Mr. Chair, I would like to submit this memo into the record.
Dr. McTiernan, in your meta-analysis, you surveyed the landscape of
studies conducted on the safety of Johnson & Johnson's talcum powder.
Is that correct?
Dr. McTiernan. Yes, that is correct.
Ms. Pressley. Do any studies prior to the 1992 memo which I just
submitted confirm the link between the use of talcum powder and ovarian
cancer?
Dr. McTiernan. Yes, definitely. Studies as early as 1982 found an
increased risk, up to two times increased risk of ovarian cancer in
women who were using these products.
Ms. Pressley. And is that for any use, and were black women
disproportionately at risk? I think that report that you are
referencing indicated that black women were three times more likely to
develop ovarian cancer based upon their usage. Is that correct?
Dr. McTiernan. That study did not have enough black women to make
specific comments on them in that paper. There were some later studies,
in 2016, 2015. One focused only on black women, and they did find
increased risk of at least 50 percent for ever use of talcum powder
products and risk of ovarian cancer. Another study was able to look at
both black and Latino women, as well as white women, and found similar
increased risk.
So it really seems, at least for these ethnic groups, for blacks,
Latinas, and white women, it has been shown to increase risk.
Ms. Pressley. So anyone was at risk that was using talcum powder in
their genital peritoneal, but women of color were seen at a higher risk
because the studies indicated that they used it more.
Dr. McTiernan. Definitely. The study that focused on them, at least
50 percent were using those regularly.
Ms. Pressley. Okay. So for well over half-a-century, tests confirm
instances in which Johnson & Johnson's talcum powder was contaminated,
and yet the company moved forward with aggressively marketing its
potentially dangerous product to women of color despite these
consequences.
Furthermore, a study by George Washington University even found
that black women in particular again used talcum powders in the genital
area at higher rates than the rest of the population. From Johnson &
Johnson's documented early `90's marketing acumen, I must assume that
they did know this, Okay?
So how could talcum powder use in the genital area over an extended
time period lead to ovarian cancer? Why specifically?
Dr. McTiernan. The exact mechanism still needs to be studied, but
we have several potential. One is inflammation, that talc or the other
constituents in it can get in around the fallopian tubes and ovaries,
can cause inflammation, and we know that inflammation can cause cancer.
There are some other potential mechanisms that have been studied in
ovarian cancer cells or in ovarian cells, and these look like many of
the hallmarks of cancer that can occur from application of talc.
Ms. Pressley. And just for the record I would like to state that
every consumer wants to be respected for their purchasing power and
marketed to, but nobody wants to be harmed and hurt by companies
pedaling dangerous products in the process. It is really just
inexcusable, and I look forward to continuing to work with my
colleagues and the subcommittee to lead the charge and to make sure
that companies are held accountable in this regard.
Mr. Salter, were there any warning labels placed on any of the talc
products your mother used, warning of the increased risk of ovarian
cancer?
Mr. Salter. No, not one single one. Obviously, we used it from
generation to generation, my grandmother, and my grandmother's
grandmother, my mom. So obviously, in the African American community,
it is a staple for usage for hygienic freshness, and not one single
time has there been any label that stated or highlighted the risk of
using this product whatsoever.
Ms. Pressley. And do you believe that women have the right to know
the facts about the cancer risks associated with talcum powder
products?
Mr. Salter. Oh, without a doubt. You know, I feel that if we had
known that, my mother may still be here among countless other women who
are battling this disease right now. They could have at least been
given the option to choose to use this product or not knowing that
risk, but they did not have the option to do so.
Mr. Krishnamoorthi. Your time has expired. Thank you, Ms. Pressley.
Ms. Pressley. Thank you.
Mr. Krishnamoorthi. Mr. Cloud, five minutes.
Mr. Cloud. Thanks again for being here.
One of the things, as we look for a solution in this, and I guess
it is the puzzle for me, is the FDA approval process can tend to be
politicized. We talk about the regulation of the food industry, but we
know that there are carcinogens still in food that is available on the
market. We can look at the opioid crisis that was in large part driven
not by illegal drugs but by legal drugs.
So what happens a lot of times in the regulatory environment is
that it actually favors the bad actors in the sense that the companies
most likely to be helped in a situation like this would be a Johnson &
Johnson. I think it is two-thirds--the industry has 3.6 million
domestic jobs. Two-thirds of those are in companies with less than 50
employees. I think labeling is probably an easy solution, but when it
comes down to granting FDA expansive new regulatory authority, how do
we do that in a way that is properly scalable and effective?
Mr. Faber. Thank you. Thank you for your question.
To be clear, the legislation that has been introduced in the Senate
by Senator Feinstein and Senator Collins and that is being developed
now by Chairman Pallone and Mr. Shimkus does not anticipate creating a
premarket review program like we have for pharmaceutical drugs or
devices. The Feinstein-Collins bill and the drafts that are being
developed by others simply imagine that FDA would be given the power to
review the most controversial ingredients in personal care products and
then set a limit on those ingredients. Formulators would then be given
a limit around which to reformulate their products if indeed those
particular chemicals were in those products.
I want to emphasize that most of the 88 chemicals that companies
themselves have reported that are linked to cancer or birth defects or
reproductive harm in men and women are not in most products. They are
in some products. And in most cases, when other countries have looked
at these chemicals, they have not simply banned them but placed
restrictions around them, around which formulators have to reformulate.
So I think--I just want to be very clear that we are not imagining,
no one is proposing to my knowledge a premarket review program but
instead giving rules of the road to cosmetic and other personal care
companies that they would have to reformulate around, in particular
giving FDA the power, if necessary, to require a warning. In this case,
a warning would seem to be a sort of obvious solution. Mrs. Dingell has
introduced legislation in past Congresses to require a warning. Some
companies have now begun to put warnings related to ovarian cancer on
these talc-containing products.
And even if there is a very small amount of asbestos present--and
again, the detection methods we have now cannot ultimately prove that a
product is asbestos free--a warning would at least alert consumers to
this potential risk and allow them to make their own choices.
Mr. Cloud. That was going to be my next question in the sense of
from a scientific standpoint, what testing mechanisms are there
available? Asbestos is not always in talc. Is that right?
Mr. Faber. That is right.
Mr. Cloud. Are there testing methods available to find out if----
Mr. Faber. I am not a geologist, but I will share that there are
basically three testing methods available to determine whether or not
asbestos has co-mineralized with talc, whether the talc might contain
asbestos. One is called x-ray diffraction, the other is called
polarized light microscopy or PLM, and the last one is called
transmission electron microscopy or TEM. These detection methods get
more and more refined, from XRD to PLD to TEM.
The important point is that none of them are an absolute guarantee
that there is no asbestos present in the talc. They can magnify the
sample to a level that is incredibly precise, but none of these methods
can ever provide a guarantee that a talc-based product is completely
free of asbestos.
Mr. Cloud. Mr. Chairman, I have three documents from the Personal
Care Products Council, a trade association that represents companies
that make products such as cosmetics and baby powder. These documents
are two statements by the association's President and CEO, Lezlee
Westine, indicating their eagerness to work with the FDA and Congress.
I ask unanimous consent to include these documents in the record.
Mr. Krishnamoorthi. Without objection, so ordered.
[The information referred to is in the Appendix section.]
Mr. Cloud. Thank you.
Mr. Krishnamoorthi. And before I give Congressman Khanna his time,
I acknowledge the memo Congresswoman Pressley submitted. It is, without
objection, so ordered into the record. Thank you.
[The information referred to in is the Appendixsection.]
Mr. Krishnamoorthi. Congressman Khanna, you have five minutes.
Mr. Khanna. Thank you, Mr. Chairman.
I first want to recognize you, Mr. Salter. Thank you for being
here. My heart goes out to you for your loss, and I appreciate your
courage in showing up and trying to make a difference on this.
I want to focus my questions on Representative Pressley's memo that
she introduced. I find it, frankly, quite shocking. As I understand the
situation, by 1982 we understood the risks of some of the talcum powder
and the link to cancer-causing activity, and yet Representative
Pressley has a memo 10 years later, from 1992, that Johnson & Johnson
is intentionally trying to sell more of this product to African
Americans and the Hispanic American community.
Dr. McTiernan, do you think Johnson & Johnson acted in deliberate
disregard of the risks? And how would you characterize that memo where
they are deliberately selling a product to African Americans and
Hispanics knowing some of these risks?
Dr. McTiernan. I have not seen the memo, but I do agree that it is
questionable if there is an attempt to get people to use these products
more if there is any amount of risk. Talcum powder products in the
genital area is not required for health. It is not like a medication
where you look at the benefit and risk of something and tell the person
this is the benefit, this is the risk. We do not have that situation
here. We have something that is not necessary for health, and so it was
being marketed for other reasons.
So it concerns me that there would not be regulation that could
oversee something like this. If there are risks to a product, we would
like to be able to tell people what the risks are, and then realizing
that for them the benefit may just be some other reason other than a
health benefit.
Mr. Khanna. Let me ask this, which any of the panelists can answer.
Do you think Johnson & Johnson would have acted differently if we were
talking about Caucasians and not African Americans or the Hispanic
community?
Mr. Salter. Could you repeat the question?
Mr. Khanna. Sir, the memo that Representative Pressley presents is
that Johnson & Johnson had a deliberate strategy to market this product
to the African American community and to the Hispanic community
knowing--one can only assume they knew because 10 years earlier there
was a study linking this product to cancer. Do you think people there
may have acted differently if the risk was to the Caucasian, to the
white community as opposed to the African American and Hispanic
community? Do you think they were more indifferent to some of the
suffering because it was minority communities?
Mr. Salter. Growing up in a less-than-perfect scenario where we did
not grow up with a lot of money, poverty levels, tough life, but we
made do with what we had, there were not a lot of resources that were
available for us to learn more about different products, we did what
other generations did. Products that were used by our forefathers, our
great-grandmothers, great-great-grandmothers, that was the way of life.
Now, I have seen memos myself where J&J, Johnson & Johnson targeted
those minorities, and personally I felt like they targeted because of
lack of education, that those groups of people were easy targets. They
used the product mostly, and they specifically targeted those people
knowing the harm they were causing with their product, and they valued
that over human life with profits.
So, yes, I think they would have treated Caucasians differently
because of the money they were making targeting minorities.
Mr. Khanna. I just want to say for the record that what you are
saying is absolutely disgusting if Johnson & Johnson did that,
targeting people who did not have an education.
Mr. Salter. Yes, sir.
Mr. Khanna. That is appalling.
Mr. Faber, do you have any comments?
Mr. Faber. I would just add that all of the companies that use talc
were well aware of the presence or the potential presence of asbestos
in talc going back to the 1970's. It was never a secret that talc could
co-mineralize with asbestos. Ultimately, the companies were successful
in persuading FDA to allow them to rely on a method of testing that
could not rule out the presence of asbestos in talc.
I think it is critical to remember that when given the chance to
require a warning, FDA declined to do so twice, even though it has
required warnings on products that arguably pose less risk to consumers
than products that would contain asbestos.
Mr. Khanna. Thank you.
Mr. Krishnamoorthi. Thank you, Mr. Khanna.
Our next questioner is Mr. Connelly. Five minutes, sir.
Mr. Connelly. Thank you, Mr. Chairman.
Welcome to our panel. Mr. Salter, I join with my colleagues in
expressing deep sympathy to you and your family for your loss. I know
that we are joined today by a number of people who care enough about
this issue to be here today, and I welcome all of you, and particularly
those of you from Virginia.
Mr. Faber, the Food and Drug Administration exists for what
purpose?
Mr. Faber. To protect the safety of consumers.
Mr. Connelly. Protect the safety of consumers. So we expect that
our FDA is looking at our food supply and our pharmaceutical supplies
to ensure their safety. Is that correct?
Mr. Faber. That is correct.
Mr. Connelly. For example, I am going back but I think I am correct
that the FDA did a great job, unlike Europe, in regulating thalidomide,
and as a result the tragedies that occurred in Europe were minimized or
did not occur here. Is that correct?
Mr. Faber. That is correct.
Mr. Connelly. So when it does its job, it can be a powerful force
for consumer protection and consumer safety. Is that correct?
Mr. Faber. That is correct, sir.
Mr. Connelly. So when it comes to cosmetics, what does the law say
the FDA can do, and/or what does it limit the FDA from doing?
Mr. Faber. The law that is in place now is simply the law that was
enacted in 1938, which prohibits a product from being adulterated; that
is, in general, prohibits a product from having a substance that would
be akin to a poison that would have caused the sort of acute reaction
that might send you to the hospital.
In general, the law has not given the FDA the authority to assess
the chronic risks that might come from everyday use, from repeat
exposure to chemicals applied to the body that might ultimately
contribute to cancer or reproductive harm.
Mr. Connelly. So let me make sure I understand the distinction you
are making. So if I had a cosmetic product loaded with cyanide, FDA
would catch that and ban it.
Mr. Faber. Not exactly. That product would be adulterated. It would
be, per se, illegal. If FDA were aware that the product was for sale,
it could use its seizure powers to go into the marketplace and take
those products off the market. But FDA could not stop me from producing
it under its authorities under the FFDCA, nor could it order me to
recall that product under the FFDCA.
Mr. Connelly. It would have to seize it.
Mr. Faber. It would have to go to the Department of Justice in
order to get that product off the market.
Mr. Connelly. But that would be an immediate threat.
Mr. Faber. Correct.
Mr. Connelly. In this case, in terms of the adulteration of a
cosmetic with traces of asbestos, that is not an immediate threat. That
is a long-term cumulative threat to somebody's health. Is that correct?
Mr. Faber. FDA, in the statement that it released in response to
finding asbestos in products sold in Claire's stores, did say that the
presence of asbestos renders a product adulterated, and ultimately that
is why they asked--didn't demand but asked Claire's to clear the market
to recall that product, and to my knowledge that is the first time that
FDA has said in that sort of statement that the presence of asbestos
renders a product adulterated.
Mr. Connelly. When was that?
Mr. Faber. That was last week, sir.
Mr. Connelly. Last week. But we have testimony that Johnson &
Johnson and FDA were aware of the risks of this adulteration going back
to the 1970's. Is that correct?
Mr. Faber. That is correct.
Mr. Connelly. So why did it take over 40 years for FDA to take any
kind of action that starts to look decisive?
Mr. Faber. Beginning in the early 1970's, once FDA was alerted to
the presence of asbestos in talc products, FDA considered whether to
require warnings or to otherwise regulate talc-containing products
because of the risk that these products would include a carcinogen.
Ultimately, FDA was persuaded that the new testing method developed by
the industry's trade association would be sufficient to ensure that
those products would be free from asbestos. The evidence shows that is
simply not the case, that the testing method that was developed by what
used to be called the CTFA and is now called the PCPC could not
guarantee that those products would be asbestos free, and I think in
retrospect the FDA would likely agree, if they were called to testify,
that it was a mistake to rely on industry's assurances in 1976 that
this testing method would guarantee that these products are safe.
Mr. Connelly. Mr. Chairman, my time is up, but I think this is a
tragic case study that gives the lie to those who want to propound that
the Federal Government's hobnailed boot is on the neck of business, and
that if it would only let up, everything would be fine.
When we mindlessly deregulate or do not regulate to protect the
public, this is what can happen. I hope we will all remember that, and
frankly I hope this hearing will lead to some legislative direction
that empowers FDA, especially in the cosmetic field.
I thank the Chair.
Mr. Krishnamoorthi. Thank you, Mr. Connelly.
We are going to do a quick lightning round because a few members
have a second round of questions, and we will keep these to two minutes
this time. So please answer as briefly as you can.
I am going to start with Mr. Salter. You stated your mother used
Johnson & Johnson's talcum powder for 35 years; correct?
Mr. Salter. Yes, sir, since the day she was born, all her life. So
longer than 35 years for sure.
Mr. Krishnamoorthi. And your mother used it primarily for personal
hygiene purposes. Is that right?
Mr. Salter. Yes, Mr. Chairman, that is correct.
Mr. Krishnamoorthi. And she did not receive any kind of warning----
Mr. Salter. None whatsoever.
Mr. Krishnamoorthi. And you believe that would have made a
difference, at least a warning?
Mr. Salter. Without a doubt. At least my mother would have had the
choice to use the product or not use the product considering that she
knew the risks of its usage.
Mr. Krishnamoorthi. And what was her life like after diagnosis of
the cancer?
Mr. Salter. It was the most degrading process I have ever seen to
watch a loved one deteriorate, and to think that that happened because
of use of a product that is commonly sold on every single shelf in just
about every store across this country is devastating. So it was a hard
process, but she fought for her life, and she did it with a smile on
her face.
Mr. Krishnamoorthi. You know, you are representing a lot of people
who are sitting behind you who are looking to you to voice their
concerns. If you had something to say based on what you have heard
today at this hearing, what would it be?
Mr. Salter. I would say that awareness is key. So many people are
blind to the fact that this product is harmful, and I am thankful that
we are bringing light to the subject.
Mr. Krishnamoorthi. Thank you, Mr. Salter.
Mr. Salter. Thank you, Mr. Chairman.
Mr. Krishnamoorthi. I yield back.
Mrs. Miller is going to have two minutes.
Mrs. Miller. Thank you, Mr. Chairman.
I have had several thoughts listening today. I always pack baby
powder with me everywhere I go, but I use it in my shoes for sweaty
feet, just a habit I have had for years. I put it in tennis shoes,
whatever. But it kind of reminds me that there is now a warning on
cigarettes that the use of tobacco is harmful to your health, so I can
understand that there are warnings that are available.
I had one more question really for Mr. Faber, but I stopped because
my time was out, but it basically was along the same lines as before. I
understand that the FDA has a voluntary cosmetic registration program
which allows for reporting from companies to help increase safety for
consumers. What suggestions would you have for increasing the
participation in that program?
Mr. Faber. Well, I am glad to share that the vast majority of
cosmetics companies, large and small, believe that registration should
be required, in part so that FDA can alert them if an ingredient has
been contaminated and it might have been used in one of their products.
I am also happy to share that, as Senator Feinstein and Senator
Collins develop their bill, and I presume Mr. Pallone and Mr. Shimkus
will as well, they have developed an abbreviated registration process
for small companies who do not have the same resources as Proctor &
Gamble or Estee Lauder or L'Oreal or other big companies.
So I think there is a way to allow FDA to know where companies are
and what is in their products, and also to know if products are hurting
people, as is sometimes the case, without placing significant burdens
especially on the small innovators in the cosmetics industry.
Mrs. Miller. Okay, thank you. I have run out again. Thank you.
Mr. Krishnamoorthi. Thank you, Mrs. Miller.
Ms. Pressley?
Ms. Pressley. Thank you, Mr. Chairman.
Your products still contain talc; is that correct? There is still
talc in your products?
Mr. Faber. We found 2,000 products that are for sale today that
contain talc, including more than 1,000 that are loose or pressed
powders which are used around the face and mouth and are likely to be
inhaled.
Ms. Pressley. Including your baby products; correct?
Mr. Faber. There are still baby products that contain talc. There
are also baby products that are made from corn starch. Many of the
companies that sold baby powders and still sell baby powders made from
talc also sell baby powders made from corn starch.
Ms. Pressley. Excuse me. So in spite of the research and the
science and the tragic loss of life, you still would lead us to believe
that your products are safe for consumption?
Mr. Faber. I think what is important to remember is that these are
discretionary products. I think that is what is ultimately the real
tragedy of asbestos in talc, is that we are not talking about things
that people need to survive--food, water--or even things people need to
use to come to a meeting like this, shampoos and soaps and deodorants.
These are the definition of discretionary products, and that is why a
warning and further regulations would be----
Ms. Pressley. I recognize you are not Johnson & Johnson, but I am
just furious because what is the source of rebuke and retribution for
these families? We cannot return their loved ones to them. So what can
we do to make sure this tragedy does not happen again? I understand you
are science in what you are offering, but I just do not know how the
consumers can have any true trust and faith here that they are safe in
the consumption of these products.
It is a person's prerogative, but if there is predatory marketing
happening, there is a seduction happening here.
Mr. Faber. If I were in your shoes and in Commissioner Gottlieb's
shoes, I would not wait another day to require a warning on all these
products. FDA has twice refused to do so after receiving citizen
petitions. They could tomorrow require a warning on any product that is
containing talc so that consumers would know. That would be the first
step and the easiest step we could take to protect consumers.
The next step would be to really better understand whether it is
even possible to produce these products without containing asbestos,
and help companies. And if not, then there are plenty of alternatives
available, including alternatives made with corn starch.
Ms. Pressley. Thank you, and that is what I was looking for, to be
prescriptive about where we go from here to prevent this tragic loss of
life from happening to any other families.
Mr. Faber. I appreciate your questions.
Ms. Pressley. All right. Thank you.
Mr. Krishnamoorthi. Thank you, Ms. Pressley.
No more questions. We are going to move to closing statements.
To conclude today's hearing, I want to thank our witnesses once
again for discussing this critically important issue with our
subcommittee. In Mr. Salter's case, thank you for discussing your
family's personal tragedy.
My heart and my best wishes go out to all the families out here
represented by all of you for the loss of your loved ones. And I want
to thank all of you for traveling from all over the country to be here
today with us.
I said it earlier but it bears repeating: the average adult in this
country uses personal products nine times daily. Consumers use these
products trusting that they are safe and will not cause harm to
themselves or their loved ones.
Today's hearing was just our first step in protecting consumers
from potentially hazardous or carcinogenic products. Following this
hearing I will work diligently with my staff in order to determine the
best next steps, including any need for a continuing investigation into
the matters discussed this morning.
Thank you to everyone again for their time today.
Mr. Cloud. I would just echo those thoughts. Thank you for being
here. Thank you for your testimony. Thank you for the participation in
this committee. And, Chairman, thank you for your leadership on this
topic. I look forward to moving this forward. Thank you very much for
being here.
Mr. Krishnamoorthi. Thank you.
We are adjourned.
[Whereupon, at 11:25 a.m., the subcommittee was adjourned.]
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