Document ID: FDA-2008-N-0138-0015
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2008-03-21T04:00Z

Consumer Update — FDA admits inability to ensure the safety of
personal care products

Safety decisions left to companies and consumers

"The [Food, Drug and Cosmetic Act] contains no provision that requires
demonstration to FDA of the safety of ingredients of cosmetic
products... prior to marketing the product."

— FDA response to   HYPERLINK
"http://www.cosmeticsdatabase.com/research/fdapetition.php"  EWG
petition , September 29 2005 

October 5, 2005. On September 29, 2005, the Food and Drug Administration
issued a final written response to a cosmetic safety petition filed by
the Environmental Working Group in June 2004. In this document the
Agency revealed deep deficiencies in its power to protect the public
health under the nation's cosmetics law. Notably, FDA affirmed its
inability to enforce a requirement that a warning label be posted on
products that have not been substantiated for safety.

Many consumers believe the government ensures the safety of personal
care products before they are sold. FDA confirmed in its response that
it does not: the Agency cannot require premarket safety testing of
personal care product ingredients, and, therefore, cannot prevent the
introduction of dangerous products onto the market. "The [Food, Drug and
Cosmetic Act] contains no provision that requires demonstration to FDA
of the safety of ingredients of cosmetic products... prior to marketing
the product," wrote FDA.

In its response FDA reiterated that even if it believes a product is
harmful, it generally must prove in court that the product is misbranded
or adulterated before taking enforcement actions. The Agency noted that
it cannot even require a recall of harmful products — recalls are
voluntary company actions, and the mere act of FDA suggesting a recall
requires that the Agency have firm evidence of potential human harm.
"[T]he [Food, Drug and Cosmetic Act] does not authorize FDA to order a
recall for a defective or possibly harmful cosmetic product," writes
FDA. 

In the vaccum of authority summarized in FDA's petition response,
consumers can find some assurance in knowing that the law requires
manufacturers to adequately substantiate their products for safety
before they are sold. But even this requirement fails to provide clear
protection: FDA has not defined what safe means or how to achieve it,
and companies, who make safety findings independent of FDA, do not have
to disclose the basis for their conclusions. The only thing that
companies must do is list ingredients on their product labels.

In place of government authority to ensure safety, the cosmetics
industry polices itself through an industry panel called the Cosmetic
Ingredient Review. This industry-funded panel of scientists has reviewed
just 11 percent of all ingredients in cosmetics; our 2004 petition to
FDA was based on the safety assessments that have been completed by this
panel. We challenged the claim that products were substantiated for
safety in two cases: products containing ingredients that were
contraindicated for the product use (for example, skin creams with
ingredients for which the industry review panel concluded the ingredient
should not contact the skin); and products containing ingredients that
the industry panel concluded lacked the safety data needed to support a
finding of safety in cosmetics. In our petition we also requested that
all such products bear the required warning label: Warning — the
safety of this product has not been determined.

But in their response to our petition, FDA replied that it could not
take action against these products, arguing that the Agency could not
find them misbranded or adulterated, and could not require the warning
label because it lacked the information to determine whether or not the
ingredients were adequately substantiated for safety, or were causing
acute injury. The FDA argued that the industry panel recommendations
were not sufficient evidence to determine if ingredients are, indeed,
safe, although in practice this is the only authoritative body that
reviews the safety of cosmetics ingredients.

In its petition response FDA delivers one final blow to public health
protection: the Agency declines to develop guidance for industry on what
must be done to substantiate safety, and what standard must be met to
ensure a product is safe. The agency's self-declared impotence — and,
further, their refusal even to develop safety guidance — leaves
companies to make their own choices about what is safe enough to be
sold, and leaves consumers guessing about the possible risks.

Cosmetic safety - voluntary and discretionary. Over the past year the
personal care product industry has combated a growing stream of
scientific publications raising questions about the safety of chemicals
in cosmetics. Industry representatives have fielded questions about
research linking the fragrance ingredients called phthalates to low
testosterone and stunted reproductive system development in baby boys.
They have responded to concerns over the presence in human breast tumor
tissue of the ubiquitous, estrogen-like cosmetic preservatives called
parabens, and have rebutted a new study showing that the popular
preservative called MIT, or methylisothiazolinone, kills neurons and
impairs brain signaling in laboratory animals.

Are personal care products safe? Although the government cannot require
cosmetics manufacturers to conduct safety tests of their products before
marketing, industry experts have reassured the public that the industry
does, nevertheless, voluntarily and rigorously ensure the safety of
products before they're sold, and that the government has broad
authority to "take immediate action to top the sale of any product that
does not meet [the law's safety] standards" (CTFA 2005).

The core provision in the cosmetics law that protects public health is
held in a single paragraph:

Each ingredient used in a cosmetic product and each finished cosmetic
product shall be adequately substantiated for safety prior to marketing.
Any such ingredient or product whose safety is not adequately
substantiated prior to marketing is misbranded unless it contains the
following conspicuous statement on the principal display panel: 

Warning — The safety of this product has not been determined.

When asked if any products are sold bearing this warning label, the
answer from industry spokespeople is an emphatic no: "Why would a
company put a product that requires a warning label on the market?"
replied one expert (Solomon 2004). "The law is absolutely clear.
Companies are not allowed to put on the market a product that's not safe
or has unsafe ingredients," says the cosmetic trade association's lead
technical advisor, adding that enforcement actions can include "throwing
[violators] in jail. . . I'm sure someone looking at that would not
allow themselves to be placed in that position" (Huget 2004).

But in their September 29, 2005 response to EWG's 2004 cosmetic safety
petition, the Agency indicates that by its own interpretation of the law
and implementing regulations, FDA has little to no authority to enforce
provisions in the law that require manufacturers to substantiate the
safety of their products before they are sold.

FDA's position leaves safety testing optional and companies largely
without fear of retribution. The safety panel established and funded by
the industry's main trade association to dampen enthusiasm for stronger
regulation has, in its 30-year history, reviewed just 11 percent of the
10,500 ingredients that FDA has documented in personal care products.

Ninety-nine percent of all products contain one or more of these
unassessed ingredients, and in our 2004 assessment we found that more
than 300 products contain one of more of the 126 ingredients the panel
has reviewed but found specifically lacked the data needed to
substantiate safety. When EWG reviewed the labels of these 356 products,
we found that none of them bore the warning required on a product with
unknown safety: Warning — the safety of this product has not been
determined. Perhaps each company independently assessed the safety of
these ingredients, or perhaps not. Either way, FDA presents arguments
showing that it largely lacks the power to enforce the law that mandates
the warning.

FDA's argument for its own impotence relies on two key prongs. First,
the Agency notes that enforcement actions rely on findings that the
product is misbranded or adulterated. Both findings are impossible to
make when it comes to cosmetics containing ingredients that haven't been
assessed for safety. Proving health harms for ingredients with unknown
safety is impossible. FDA's response to EWG on this point is ironic: the
Agency writes that "your petition did not provide sufficient data and
information for FDA to evaluate the safety of [ingredients not assessed
by industry's panel] in connection with the petition's assertion that
the safety of the product [containing these ingredients] has not been
adequately substantiated." Even knowing whether or not the products have
been substantiated for safety is impossible — safety studies are not
required to be made public, and FDA has no means to know what studies
have or have not been conducted.

FDA has one fallback enforcement option: the Agency can request a
voluntary recall of products. But, as FDA notes in their response to
EWG, even this meager action requires the Agency to determine that the
product presents a risk of illness or injury or gross consumer
deception. Since FDA has no way to know the full range of studies that
have or have not been conducted — and thus the depth of consumer
deception — or the potential health harms from ingredients with
unknown safety, the Agency cannot even make this simple request.

Where does this leave consumers? Public health is in the hands of an
impotent agency, safety testing is voluntary, safety decisions are at
the discretion of individual companies, and the burden of choosing safe
cosmetics falls squarely on the shoulders of each consumer.

FDA refuses to establish guidance for safety. Consumers' expectations
for safe personal care products are embodied in the single provision of
the Food, Drug and Cosmetic Act that requires a prominent warning label
on a product with unknown safey: Warning — The safety of this product
has not been determined.

In EWG's review of more than 20,000 product labels in 2004 and 2005, we
have not identified a single product that bears this warning.
Implicitly, companies are claiming without exception that they have
sufficiently substantiated the safety of all their products. But FDA
provides the industry with no substantive guidance whatsoever on what
must be done to adequately substantiate safety, or even with a
definition of "safe." Companies' blanket, implicit safety claims may be
based on rigorous testing and assessment, or on nothing at all. Either
approach is legal. And, as noted above, FDA argues that it has little or
no authority to enforce the provision, anyway. EWG has requested that
FDA at the very least provide industry with guidance on what must be
done to substantiate safety.

In EWG's 2004 petition to FDA, we requested that FDA clarify the
requirements of "adequate substantiation of safety," suggesting the
following language, and argued that anything less would be a disservice
to the millions of Americans who rely upon the FDA to ensure the safety
of cosmetic products available on the marketplace:

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.

In its response to EWG's petition, FDA declined to fill this notable
vacuum of guidance. Instead of choosing to actively develop safety
criteria for the personal care product industry, FDA instead notes that
it is "looking into the possibility of issuing guidance on [the
substantiation of safety] in the future."

Looking into possibilities for guidance in the future is far less than
American consumers need. In a product use survey we conducted in 2004
with partner organizations in the Campaign for Safe Cosmetics, we found
that the average adult uses 9 products daily, with 126 unique
ingredients that contact. With companies' free rein to interpret "safe,"
the ingredients in these products include everything from oatmeal to
known human carcinogens. FDA's refusal to develop guidance not only
leaves companies on unequal footing, but also leaves consumers guessing
about the safety of their everyday brands.

In its response to EWG's request for clarification on "safety," FDA
notes that the Agency did, in fact, "discuss" the phrase "adequately
substantiated for safety" in a 30-year-old preamble to the cosmetic
labeling rule (21 CFR 740.10; 40 FR 8912 at 8916, March 3, 1975). The
totality of the discussion directed cosmetic manufacturers to first rely
on "already available toxicological test data on individual ingredients
and on product formulations that are similar in composition to the
particular cosmetic," and, secondly, to perform "any additional
toxicological and other tests that are appropriate in the light of such
existing data and information," or, in short, to review existing studies
and conduct more as needed.

These guidelines are reasonable and supported by common sense. But they
fail to cover the two crucial areas of safety assessments: what tests
should be conducted and evaluated, and what standard of safety should be
met for products that industry claims as "adequately substantiated for
safety"? On these two counts, FDA is silent. Even Superfund sites must
satisfy guidance on health-based standards of safety — no more than 1
in 10,000 excess lifetime cancer risk in surrounding communities, for
example. Companies must subject pesticides proposed for use on food to a
battery of up to 120 tests prior to approval. But for cosmetics, testing
is voluntary, and any level of risk is legal.

Thirty years ago industry's trade association (Cosmetic Toiletry and
Fragrance Association, or CTFA) established, and continues to fund and
run, an outside safety panel called the Cosmetic Ingredient Review that
serves to systematically review the safety of cosmetic ingredients, a
function that FDA in its vacuum of authority does not perform. According
to FDA's former Director of the Office of Cosmetics, "The cosmetic
industry is sensitive to the image of an uncontrolled market where
anything goes... They counter this image with well-established
self-regulation programs. Part of the incentive for such industry policy
is to avoid increased regulatory authority." He notes that "in the
absence of the CIR program, there would be no systematic examination of
the safety of individual cosmetic ingredients" (FDA 1995). This panel is
our public health backstop for safety, but it operates in a vaccum of
guidance from FDA when it comes to the safety of personal care products.
Acceptable levels of risk are entirely at this panel's discretion.

Labeling of ingredients - optional. Although the safety of products is
discretionary, ingredient labeling is not. The law requires that
ingredients appear on a label "likely to be read and understood by the
ordinary individual under customary conditions of purchase and use."
Even if the vast majority of ingredients in cosmetics have not been
assessed for safety by FDA, the industry safety panel, or any other
publicly accountable institution, consumers can still fall back on
reading ingredient labels to make safe choices for their families. The
Food, Drug and Cosmetics Act requires that "each package of a
cosmetic... bear a declaration of the name of each ingredient in
descending order of predominance," and that "[t]he declaration of
ingredients ... appear with such prominence and conspicuousness as to
render it likely to be read and understood by ordinary individuals under
normal conditions of purchase." (21 CFR 701.3)

Unfortunately, though, labels are not always so easy to read. The names
can be inscrutable for those without a strong chemistry background, and
the cosmetics industry makes it even more difficult when it fails to
follow FDA's ingredient name convention guidelines. In EWG's assessments
of product labels, we found more than 13,900 unique ingredient names on
the labels of 14,200 products, but upon rigorous analysis of
misspellings and synonyms, these ingredients collapsed into just over
9,800 unique chemicals; approximately half of all ingredients were
mislabeled. Just one example — we found 22 unique spellings of the
botanical ingredient "witch hazel." The industry's spelling challenges
complicate a consumer's ability to interpret labels.

FDA's new interpretation of the labeling law, embedded in their response
to EWG's petition, further weakens consumer's ability to make use of
ingredient labels. EWG identified 41 online retailers of cosmetics that
fail to post ingredient labels likely to be read under normal conditions
of purchase (in this case, an online purchase), as required by law. We
requested that FDA require that ingredients be posted as required by
law. FDA has declined to do this, stating that "[t]here is no
requirement that a manufacturer put an ingredient list on a website."
There is specific language requiring ingredients to be posted on
bottles, boxes, brochures, and catalogs, but not online. Thus, consumers
can't know what is in products until after their purchase.

Drugs and cosmetics and the FDA. The now notorious health risks
uncovered for the millions of people who relied on VIOXX and Celebrex to
relieve arthritis pain spurred deep and widespread doubt about FDA's
ability — or willingness — to screen drugs for safety before they
are sold. In the wake of these debacles, FDA found itself both headed by
a new Commissioner and facing a public skeptical of the Agency's ability
to ensure that drugs are safe.

But while some government leaders might have used such a revelatory low
point to inspire broad and sweeping reform, FDA's recent response to
EWG's safety petition is one more lift of concrete over the feet of an
Agency accused repeatedly of prioritizing corporate profit over public
health.

Every day the average consumer uses nine personal care products with 126
unique ingredients - shampoo, lotion, sunscreen, lip balm, deodorant,
and other products that nearly all of us rub, spray or pour onto hair,
skin or lips daily throughout our lives. Companies that manufacture
these products do not face the same burden as drug manufacturers for
premarket testing — and even with premarket testing, people can face
risks.

Cosmetics and drugs find broad common ground. Many cosmetic ingredients
are designed to penetrate the skin, just like drugs delivered through
skin patches. Many use ingredients that are also active ingredients in
over-the-counter drugs — cosmetics that contain ingredients linked to
cancer or reproductive harm, like progesterone, hydroquinone and
selenium sulfide, are just three examples. Many ingredients in cosmetics
are biologically active, just like drugs, and many cosmetics cross over
into the gray area FDA calls "cosmeceuticals" — products that are half
drug, half cosmetic.

Are cosmetics safe? As one national media outlet reports: "[The]
director of the FDA's office of cosmetics and colors, said the agency's
lack of authority to require pre-market safety testing makes it
difficult to enforce the law." (Huget, 2004). Product safety is any
company's choice and any consumer's guess.

References

CTFA (Cosmetic Toiletry and Fragrance Association). 2005. How cosmetics
are regulated. Accessed online October 5 2005 at
http://www.ctfa.org/Content/NavigationMenu/Consumer_Information/ 

Cosmetic_Regulation/Cosmetic_Regulation.htm.

Huget, Jennifer. 2004. Purely cosmetic? A new report gives risk ratings
to thousands of personal care products. It reveals how little is known
about them 151; but not whether there's really much to fear. The
Washington Post. June 22, 2004.

Solomon, Goody. 2004. Wash those fears right out. The Washington Times.
August 14, 2004.

  

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