[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

                              ----------                              
                                                                   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.]
    
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]