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Cosmetic Industry On
Notice:
FDA Issues Warning on Untested Products
March 7, 2005
FDA calls industry's bluff on
product safety. Acting on a petition filed June 14, 2004 by the
Environmental Working Group (EWG) [view
document], on February 3, 2005 the Food and Drug Administration
issued an unprecedented warning to the cosmetics industry [view document]
stating that the Agency is serious about enforcing the law requiring
companies to inform consumers that personal care products have not been
safety tested.
Such an enforcement action could
ultimately require companies to issue consumer warnings for the more than 99
percent of personal care products on the market that have not been publicly
assessed for safety, as documented in a 2004 EWG assessment of ingredients
in nearly 7,500 products (EWG 2004a).
The implications of this warning penetrate deep into an industry that has
for years hidden behind the findings of their internally-funded safety
panel, the Cosmetic Ingredient Review, or CIR. Despite industry's control of
the panel, the FDA regards the CIR's yearly series of ingredient safety
reviews as a core component of the public health safety net, and calls CIR
assessments an "important element in ensuring the safety of the cosmetic
supply in the United States" (Brackett 2005).
In its near 30-year history, however, the industry's panel has reviewed just
11 percent of the 10,500 cosmetic ingredients cataloged by FDA (FDA 2000).
The 89 percent of ingredients that remain unassessed are used in more than
99 percent of all products on the market (EWG 2004a).
By law, companies are required to post a warning label on products that have
not been assessed for safety stating, "Warning: The safety of this product
has not been determined." With its February 3rd letter, FDA is putting
industry on notice that it is serious about enforcing consumer laws. At the
top of the list are 356 products identified by EWG (EWG 2004b) as containing
ingredients that the industry's safety panel attempted to review, but
instead found lacked basic testing data. The panel could not substantiate
the safety of these ingredients. Ultimately under threat of enforcement are
the more than 99 percent of all products that contain one or more
ingredients that have never been assessed for either data adequacy or basic
safety by the industry's panel, the FDA, or any other publicly accountable
institution. Buyer beware. Surveys show that many consumers believe that companies are
required to test personal care products for safety before they're sold. It's
not the case. According to FDA, "...a cosmetic manufacturer may use almost
any raw material as a cosmetic ingredient and market the product without an
approval from FDA" (FDA 1995).
While some companies make products that would be safe enough to eat, other
companies choose to use known human carcinogens or developmental toxins like
coal tar and lead acetate. In a competitive marketplace progressive
companies with health as their top priority may lose market shares to
companies willing to use cheaper commodity chemicals with ill-defined or
even known risks. Some companies may assess the safety of their products
rigorously and independently, but other companies may not assess at all.
That's legal. This unequal footing comes from a safety net not just of a
loose weave but full of gaping holes, leaving consumers at potential risk.
When risky chemicals are used in cosmetics, the stakes are high. These
compounds are not trace contaminants. They are the base ingredients of the
product, just as flour is an ingredient in bread. Many of these chemicals
are found in percent levels in personal care products, nearly all easily
penetrate the skin, and some are ingested directly after they are applied to
lips or hands. And increasingly, companies are adding customized, futuristic
"penetration enhancers" to drive ingredients even deeper into the skin, like
Loreal's new nanoparticle technology — a miniscule, fluid-filled sack
designed to burrow deep into the skin to deliver its "active ingredients."
No safety testing required.
Scientists find common cosmetic ingredients in human tissues, like
industrial plasticizers called phthalates in urine, preservatives called
parabens in breast tumor tissue, and persistent fragrance components like
musk xylene in human fat. Do the levels at which they are found pose risks?
Those studies have not been done. They are not required.
Consumer health in the hands of industry. Grossly under-funded and
encumbered by a cosmetic safety law that renders the Agency nearly impotent,
FDA's cosmetic office has no standing cosmetic review safety committee,
cannot require testing of products or ingredients, cannot require companies
to report injuries or even deaths from the use of their products, and cannot
force companies to recall harmful products (FDA 1995). Instead, the Agency
sends a liaison to the industry's safety panel meetings to observe and
comment. Eighty percent of the industry panel's reviews are limited to advice to
industry on ingredient levels that will minimize risk of skin rashes and
other allergic reactions (EWG 2004a). And 89 percent of ingredients used in
cosmetics have not even received a rash and allergy review from the industry
panel, let alone a serious assessment of the ingredients' potential to cause
cancer or harm the development of a baby in the womb.
When EWG cross-linked ingredient listings in 7,500 products with seven
government or industry toxicity databases, we found that one-third of all
products contain ingredients linked to cancer, 70 percent of products may be
contaminated with harmful impurities, and more than half of all products
contain "penetration enhancers" that drive ingredients deeper into the skin
to the blood vessels below (EWG 2004a). For the vast majority of these
products and ingredients, the exact health risks from consumer exposures are
unknown. Our 2004 survey of 2,300 people conducted with the Campaign for Safe
Cosmetics shows that on average people use nine products a day with 126
unique ingredients. These exposures may add up to health problems, but
neither industry nor the FDA is doing the work to define and reduce the
risks. The products are untested; the risks are unknown.
At industry's discretion are not only the range of ingredients used in
products (only nine chemicals are banned from cosmetics), but also the full
breadth of imaginable marketing claims, none of which are subject to review
or required to be true. The word "organic" could just as easily — and just
as legally — be printed on the label of a product made entirely of plants
grown to strict USDA organic standards, or on the package of a mixture of
industrial solvents and polymers derived from petrochemicals. Likewise, no
legal definition exists for "dermatologist tested," "cruelty free,"
"fragrance free," or "hypoallergenic." The claims could have substantial
scientific backing, or could mean nothing at all.
As of March 2, 2005, 68 progressive companies with health as a top priority
have signed a pledge with the Campaign for Safe Cosmetics to produce
products free of ingredients linked to cancer and birth defects (www.safecosmetics.org).
The Campaign, a coalition of environmental and public health groups working
in partnership with these companies, is taking action to help move companies
voluntarily toward safety within the current vacuum of mandatory health
protections. And now FDA is turning up the heat on the entire industry.
FDA turns up the heat. Although FDA cannot require companies to safety test
their products, and cannot require that marketing claims be true, the Agency
can require that companies print a warning on the label of products that
have not been assessed for safety. And this is what the Agency has indicated
they plan to do in their letter of February 3rd. The Agency also writes that
it will develop definitive guidelines for industry on what must be done to
substantiate the safety of a product, to absolve companies of the
responsibility to print warnings. EWG has written to FDA applauding the
Agency for the actions they have proposed in their February 3rd letter, and
requesting that FDA convene a panel of independent experts, free of
financial ties to the cosmetics industry, to develop this critical guidance
that will define, for the first time, what is safe enough to be sold as a
personal care product in the U.S.
It's time for the cosmetics industry to be honest with consumers about what
is known and what remains unknown about the safety of the products Americans
use every day. Americans deserve safe products. Short of that, consumers
deserve, and the law requires, at least a warning label, to help people make
informed decisions about the products they buy and use each day.
References
-
Brackett, Robert E. 2005. Letter to Mr. Edward Kavanaugh, President,
Cosmetic, Toiletry and Fragrance Association from Dr. Robert E. Brackett,
Director, FDA's Center for Food Safety and Applied Nutrition. February 3,
2005.
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Environmental Working Group (EWG). 2004a. Skin Deep: A Safety Assessment of
Ingredients in Personal Care Products. Available online at
www.ewg.org/reports/skindeep.
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Environmental Working Group (EWG). 2004b. Citizen Petition to Cease Unlawful
Sale of Misbranded & Adulterated Cosmetics. Petition from EWG to the Food
and Drug Administration. June 14, 2004. Available online at
http://www.ewg.org/reports/skindeep/petition/petition.php.
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Food and Drug Administration (FDA). 1995. FDA Center for Food Safety and
Applied Nutrition, Office of Cosmetics and Colors. Fact Sheet. FDA Authority
Over Cosmetics. February 3, 1995. Accessed March 2, 2005 at
http://www.cfsan.fda.gov/~dms/cos-206.html.
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Food and Drug Administration (FDA). 2000. Center for Food Safety Applied
Nutrition. Cosmetics Compliance Program. Domestic Cosmetics Program. Issued
July 31, 2000. Accessed online March 1, 2005 at
http://www.cfsan.fda.gov/~comm/cp29001.html.
Text of the response sent by EWG to FDA:
March 7, 2005
Robert E. Brackett, Ph.D.
Director, Center for Food Safety and Applied Nutrition
Food and Drug Administration
5100 Paint Branch Parkway
College Park, MD 20740-3835
Dear Dr. Brackett:
We recently received a copy of your February 3rd letter to Mr. Kavanaugh of
the Cosmetic, Toiletry and Fragrance Association (CTFA) noting that your
2005 Program Priorities include responding to and acting on issues raised in
a petition the
Environmental Working Group (EWG) filed with your Agency on
June 14, 2004. As you know, our petition documented 356 products being sold
in apparent violation of the Federal Food, Drug, and Cosmetic Act: these
products contain ingredients that have not been substantiated for safety,
and they fail to bear the warning label required by law, "Warning — The
safety of this product has not been determined."
We are writing to express our full support of the actions you outlined in
your letter, and of your Agency's efforts to ensure that cosmetics sold in
this country are safe and comply with the law. To that end we request that
the Agency convene a panel of independent experts comprised of individuals
free of financial ties to the cosmetic industry, to aid in developing
guidance for industry on the requirements for substantiating the safety of
ingredients, a task you note in your February 3rd letter that you are
undertaking. Such a panel of experts will help ensure that this guidance, if
followed, would protect human health to the fullest extent possible.
We believe that the safety issues raised in our petition are of utmost
importance to public health:
Our 2004 survey of 2,300 people shows that on average, American consumers
use nine personal care products every day, with 126 unique ingredients, some
of which are linked to cancer and other serious health concerns.
But what is not known about the health risks of ingredients also raises
concerns. The FDA has documented the use of 10,500 ingredients in personal
care products [1]. In its near 30-year history the industry's safety panel
had assessed just 1,175 ingredients — or 11 percent of the total — as of the
end of 2003 [2]. Therefore, fully 89 percent of ingredients used in
cosmetics have not been assessed for safety by the CIR, the FDA, or any
other publicly accountable institution.
These unassessed ingredients are used in more than 99 percent of all
products on the market, according to our comprehensive assessment of
ingredient prevalence in nearly 7,500 products [3]. In the course of our
research on ingredients in cosmetics we have not identified a single product
bearing the required label, warning consumers that the product's safety has
not been determined.
Consumers have a right to know, under the law, whether or not the
ingredients in a product have been assessed for safety. We support FDA's
efforts to ensure that untested cosmetics bear the warning label required by
law.
In addition to notifying the industry trade organization that you are
investigating their compliance with warning label requirements, you also
note in your February 3rd letter that you plan to issue guidance on another
issue central to our petition — the requirements for adequately
substantiating the safety of cosmetic ingredients. In our petition we note
that the Agency has not provided to the industry a definition of the term
"safe" with respect to cosmetics sold in the U.S.; in the absence of Agency
guidance, the cosmetics industry currently decides what is safe and what is
not. We support your efforts to develop this critical guidance, and repeat
below the language we proposed in our petition as an appropriate definition
for "adequately substantiated for safety" that would protect public health
and absolve a company of the requirement to place warnings on products:
Substantiation, through peer-reviewed scientific publications or publicly
available industry studies, of a reasonable certainty of no harm from
aggregate exposures to the product and its component ingredients including
impurities, taking into account chemicals that may increase penetration of
the product or its component chemicals through the skin, and including all
anticipated cosmetic exposures and all other exposures for which there is
reliable information, taking into consideration vulnerable populations such
as infants and pregnant women.
Any finding of safety for a cosmetic product must explicitly account for
risks posed by impurities until such time as impurities are removed from the
component ingredients or the product is reformulated in such a way as to
preclude the formation of impurities by the component ingredients in the
product.
As you develop guidance for industry on the requirements for safety
substantiation, we urge you to convene a panel of outside experts free of
financial ties to the cosmetics industry, to aid in the development and
review of such guidance. These experts should collectively represent a broad
array of applicable areas of expertise, including toxicology, human health
risk assessment, and children's health, for example.
The creation of an expert panel to develop this guidance falls squarely
within your Agency's discretion. The FDA has a long history of effectively
utilizing advisory panels, and has broad discretion to appoint and consult
expert panels under the Federal Advisory Committee Act (FACA) and FDA
regulations [4,5]. FACA provides that the Commissioner may establish an
advisory committee if it is in the public interest and in furtherance of the
Agency's mission [4]. FDA has developed detailed guidelines in accordance
with FACA governing the development and operation of these committees [5].
In the case of developing a clear standard for the safety of cosmetic
ingredients, which Americans are exposed to an average of nine times each
day, the public interest would be well served by the advice of a panel of
truly independent experts.
Again, we support all your efforts to ensure that cosmetics are safe for
consumers. We look forward to your response to our petition and to this
letter. Please contact us if we can provide any assistance or clarify
information we provided in our petition.
Sincerely,
Jane Houlihan
Vice President for Research
Arianne Callender
General Counsel
References (for March 7 2005 Letter from EWG to FDA)
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[1] Cosmetics Ingredient Review (CIR) (2003). 2003 CIR Compendium,
containing abstracts, discussions, and conclusions of CIR cosmetic
ingredient safety assessments. Washington DC.
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[2] Food and Drug Administration (FDA). 2000. Center for Food Safety Applied
Nutrition. Cosmetics Compliance Program. Domestic Cosmetics Program. Issued
July 31, 2000. Accessed online March 1, 2005 at
http://www.cfsan.fda.gov/~comm/cp29001.html.
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[3] Environmental Working Group (EWG). 2004a. Skin Deep: A Safety Assessment
of Ingredients in Personal Care Products. Available online at
www.ewg.org/reports/skindeep.
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[4] Federal Advisory Committee Act, (FACA). 5 U.S.C. Appx § 9(a)(2). "No
advisory committee shall be established unless such establishment is ...
determined ... to be in the public interest in connection with the
performance of duties imposed on that agency by law."
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[5] 21 C.F.R. §§ 14.1 et seq. Authorizing FDA advisory committees where "the
Commissioner concludes, as a matter of discretion, that it is in the public
interest for a standing or ad hoc policy or technical public advisory
committee (advisory committee or committee) to hold a public hearing and to
review and make recommendations on any matter before FDA and for interested
persons to present information and views at an oral public hearing before
the advisory committee."
Copy: Dr. Linda Katz, Director, Office of Cosmetics and Colors |
