Cosmetic Industry On Notice: FDA Issues Warning on Untested

[megabuff]

March 7, 2005

http://www.ewg.org/issues/cosmetics/FDA_Warning/index.php



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.

Environmental Working Group (EWG). 2004a. Skin Deep: A Safety
Assessment of Ingredients in Personal Care Products. Available
online at www.ewg.org/reports/skindeep.

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 www.ewg.org/petition/petition.php.

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.

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.
_________________
Maree McGoldrick
www.bodiorganic.com