Document ID: FDA-2008-N-0138-0014
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2008-03-21T04:00Z

CITIZEN PETITION TO CEASE UNLAWFUL SALE OF MISBRANDED & ADULTERATED
COSMETICS (2004)

To secure the safety of the millions of consumers who use personal care
products in their daily lives, Environmental Working Group (EWG)
petitions the Food and Drug Administration (FDA) to take immediate
action to cease the unlawful distribution of misbranded, adulterated and
unlabeled cosmetics. American consumers rely upon the Food and Drug
Administration for protection from exposure to unsafe food, drug and
cosmetic products. Armed with the authority of the Food Drug and
Cosmetic Act (FD&CA), the FDA is charged with the duty of ensuring the
safety of cosmetic products available to consumers. Based on an in-depth
investigation of over 10,000 personal care product ingredients,
Environmental Working Group has identified serious probable safety
violations of the FD&CA by cosmetics manufacturers and retailers, and
submits this petition seeking the following enforcement actions by the
Commissioner of Food and Drugs:

Institute a voluntary recall or court-ordered injunction or seizure for
cosmetics containing ingredients that have not been proven safe through
scientific testing that do not bear appropriate warnings, pursuant to 21
U.S.C.A. § 362, 21 U.S.C.A. § 332, 21 U.S.C.A. § 334, 21 C.F.R. §
7.40, and 21 C.F.R. § 7.45 ; 

Clarify the requirements for adequate substantiation of safety, pursuant
to 21 U.S.C.A. § 371(a), 21 C.F.R. § 740.10(a); 

Establish a requirement that manufacturers remove from cosmetic products
any ingredient that contains any toxic impurity or that may combine with
other ingredients to form harmful impurities, pursuant to 21 U.S.C.A. §
371(a); 

Initiate a voluntary recall or court-ordered injunction or seizure for
cosmetics containing ingredients that may cause injury through ordinary
use, pursuant to 21 U.S.C.A. § 361, 21 U.S.C.A. § 332, 21 U.S.C.A. §
334, 21 C.F.R. § 7.40, and 21 C.F.R. § 7.45; 

Publicly command all Internet vendors to display a conspicuous list of
ingredients of cosmetic products sold on their websites, subject to
injunction or seizure, pursuant to 21 C.F.R. § 701.3, 21 C.F.R. §
701.2, 21 U.S.C.A. § 362, 21 U.S.C.A. § 375, and 21 U.S.C.A. § 336;
and 

Conduct an investigation of products containing chemical ingredients
prioritized according to prevalence and toxicity, pursuant to 21
U.S.C.A. § 372, and 21 U.S.C.A. § 374. 

COSMETICS SAFETY CONCERNS CONFRONT MILLIONS ON A DAILY BASIS

Americans are exposed to 126 different cosmetic chemicals daily.
Cosmetics use, which supports this $35 billion industry, poses serious
safety concerns for a broad cross-section of the population. A cosmetic
is defined in the FD&CA as an article, or component thereof, which is
"intended to be rubbed, poured, sprinkled, or sprayed on, introduced
into, or otherwise applied to the human body or any part thereof for
cleansing, beautifying, promoting attractiveness, or altering the
appearance." See 21 U.S.C.A. 321 (I). EWG conducted a survey of 2,300
people, which shows that the average adult uses 9 cosmetic products each
day, with 126 unique chemical ingredients. See Environmental Working
Group, Skin Deep (June 7, 2004), http://www.ewg.org/reports/skindeep
(hereinafter "Skin Deep")(attached as Exhibit E). More than a quarter of
all women and one of every 100 men use at least 15 cosmetic products
daily. See id. Despite this population-wide exposure to cosmetic
chemicals, the existing law governing cosmetics has cast a disturbingly
narrow safety net.

89% of the 10,500 personal care product ingredients remain untested. Of
the 7,500 products that EWG analyzed, just 28 have been fully assessed
for safety by the cosmetic industry's review panel. All other products -
99.6 percent of those examined - contain one or more ingredients that
have never undergone a public safety review. See Skin Deep. According to
FDA's Office of Cosmetics and Colors, "a cosmetic manufacturer may use
almost any raw material as a cosmetic ingredient and market the product
without an approval from FDA." FDA Diethalonomine and Cosmetic Products.
Office of Cosmetics and Colors Fact Sheet, 1999,
http://vm.cfsan.fda.gov/~dms/cos-dea.html (visited May 6, 2004).

A self-regulating industry panel is the only existing safety screen for
cosmetics. Because the FDA lacks authority to require pre-market safety
assessments of cosmetics, the responsibility for ingredients safety
review rests largely in the hands of the cosmetic industry's
self-regulating panel, the Cosmetic Ingredient Review (CIR). No other
independent authority exists that is charged with the review of cosmetic
safety. Manufacturers may conduct their own testing, but this testing is
not required to be made public or to be reported to the FDA.

The CIR was established in 1976 as a joint effort between the Cosmetic,
Toiletry and Fragrance Association (CTFA), the FDA and the Consumer
Federation of America (CFA). FDA sits on the panel as a non-voting
member along with the other two founding organizations. See CIR website,
http://www.cir-safety.org (visited May 18, 2004). Voting members are
nominated by the three non-voting founding organizations, and are
selected from the medical and scientific community. See id. In analyzing
a particular ingredient, CIR will conduct a review of scientific
literature, provide for public comment, conduct public discussions of
the panel's findings, and issue a final report in a peer-reviewed
scientific journal. See id. The panel may direct industry to conduct
studies or release unpublished data if existing scientific literature on
the safety of ingredients is insufficient. See id. While CIR findings
are not binding on FDA, FDA has historically relied upon CIR's
conclusions in making cosmetic safety rulings. See, e.g. Alpha Hydroxy
Acid Guidance, 67 FR 71577.

In light of these safety considerations, it is of the utmost importance
that FDA exercise its authority to the fullest extent possible to
preserve the safety of American consumers.

EWG INVESTIGATION REVEALS ACTIONABLE VIOLATIONS OF FDA SAFETY LAWS

EWG has conducted an investigation of more than 10,000 personal care
product ingredients, which has revealed serious violations of FDA's
consumer safety standards. EWG's analysis compares ingredients in 7,500
personal care products against lists of known and suspected chemical
health hazards produced by government agencies such as the FDA, EPA and
CDC, industry organizations such as the Cosmetics Industry Review Panel
(CIR), and academics published in peer-reviewed journals. Through this
process, serious violations of the FD&CA have been brought to our
attention:

EWG has identified 356 cosmetic products containing ingredients that may
not have been proven safe, and fail to bear the required warning. See  
HYPERLINK
"http://www.cosmeticsdatabase.com/research/petition/exhibitA.php" 
Exhibit A . These products may be misbranded and subject to voluntary
recall, injunction or seizure. See 21 U.S.C.A. § 362, 21 U.S.C.A. §
332, 21 U.S.C.A. § 334, 21 C.F.R. § 7.40, and 21 C.F.R. § 7.45. 

EWG has discovered 20 cosmetic products containing ingredients that may
cause harm when used according to package directions. See   HYPERLINK
"http://www.cosmeticsdatabase.com/research/petition/exhibitB.php" 
Exhibit B . These products may be adulterated and subject to voluntary
recall, injunction or seizure. See 21 U.S.C.A. § 361, 21 U.S.C.A. §
375, 21 U.S.C.A. § 336, and 21 C.F.R. § 701.3(b). 

EWG has visited 41 websites offering cosmetic products for sale without
conspicuously listing the ingredients. See   HYPERLINK
"http://www.cosmeticsdatabase.com/research/petition/exhibitC.php" 
Exhibit C . These websites may be selling misbranded products in
violation of labeling requirements, and should be publicly notified of
the violation and warned of potential injunction or seizure in the event
of continued noncompliance. See 21 U.S.C.A. § 362, 21 U.S.C.A. § 375,
21 U.S.C.A. § 336, and 21 C.F.R. § 701.3, 21 C.F.R. § 701.2. 

EWG has developed a list of 9 toxic cosmetic ingredients, which are
widely used and pose a serious threat of injury. See   HYPERLINK
"http://www.cosmeticsdatabase.com/research/petition/exhibitD.php" 
Exhibit D . Products containing these ingredients may be misbranded or
adulterated, and are subject to FDA inspection, safety review, and
enforcement action where warranted. See 21 U.S.C.A. § 372, and 21
U.S.C.A. § 374, 21 U.S.C.A. § 361, and 21 U.S.C.A. § 362. 

FACTUAL AND LEGAL SUPPORT FOR ACTION REQUESTED

1. EWG Calls Upon the Commissioner of Food and Drugs to Institute
Recall, Injunction or Seizure Proceedings for Cosmetics That Have Not
Been Proven Safe.

EWG has identified 356 cosmetic products which may not have not been
adequately substantiated for safety and do not bear the required
warning. For all of the products listed in   HYPERLINK
"http://www.cosmeticsdatabase.com/research/petition/exhibitA.php" 
Exhibit A , the CIR has formally concluded that at least one component
ingredient has insufficient testing data to support the ingredients'
safe use in cosmetics. See   HYPERLINK
"http://www.cosmeticsdatabase.com/research/petition/exhibitA.php" 
Exhibit A . According to the FD&CA, a product is misbranded if its
labeling is false or misleading or if:

any word, statement, or other information required by or under authority
of this Act to appear on the label or labeling is not prominently placed
thereon with such conspicuousness (as compared with other words,
statements, designs, or devices, in the labeling) and in such terms as
to render it likely to be read and understood by the ordinary individual
under customary conditions of purchase and use.

21 U.S.C.A. § 362(a), (c). The implementing regulations require the
placement of a warning label on cosmetic products for which adequate
substantiation of safety has not been obtained. See 21 C.F.R. 740.10(a).
The regulation provides as follows:

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.

Id. None of the 356 cosmetic products that EWG identified bear the
warning required by the FDA regulations. As such, these products may be
misbranded, and should be removed from the marketplace until they are
either proven safe, repackaged according to FD&CA standards or
reformulated.

The Commissioner of Food and Drugs has the authority to institute
recall, injunction or seizure proceedings to prosecute violations of the
prohibition against misbranding. See 21 U.S.C.A. § 332, 21 U.S.C.A. §
334, 21 C.F.R. § 7.40, 21 C.F.R. § 7.45. In the case of a recall, the
Commissioner may request a cosmetic firm to initiate a recall if a
product presents a risk of illness, injury or gross consumer deception,
and a recall is necessary to protect the public health and welfare. See
21 C.F.R. § 7.45. Cosmetics with ingredients that are inadequately
substantiated for safety clearly meet this standard. As to risk of
illness or injury, the fact that the CIR found that there is not
sufficient data to show that the chemicals are safe for cosmetic use
shows that there is potential for illness or injury to the consumer. In
terms of consumer deception, FDA's labeling requirement creates a
reasonable basis for a consumer to believe that the absence of a label
indicates that no ingredients with unproven safety are present in a
given cosmetic product. Thus, where the industry's own review panel has
determined that the cosmetics are not sufficiently tested to meet this
standard, the consumer has been misled by the absence of the label. An
injunction may be sought to restrain any violation of the Act. See 21
U.S.C.A. § 332. An injunction is appropriate because the 356 products
that EWG has identified fail to include the required warning. A seizure
may be sought when a misbranded cosmetic has entered into interstate
commerce. See 21 U.S.C.A. § 334. Seizure would be proper because all of
the products identified by EWG are available for sale either on the
Internet or in stores throughout the United States.

The only way to prevent the risk of injury, illness or consumer
deception is to prohibit the continued distribution of misbranded
products until the cosmetic firms either prove the safety of the
ingredients, include the required warning label, or reformulate the
product to remove all ingredients which have not been proven safe for
use in cosmetics. EWG therefore requests that the Commissioner institute
recall, injunction or seizure proceedings for the cosmetics detailed in 
 HYPERLINK
"http://www.cosmeticsdatabase.com/research/petition/exhibitA.php" 
Exhibit A .

2. EWG Calls Upon the Commissioner of Food and Drugs to Clarify the
Requirements for Adequate Substantiation of Safety for the Purposes of
the Labeling Provision in 21 C.F.R. § 740.10(a).

FDA's current regulations do not sufficiently explain requirements for
substantiating the safety of cosmetics. See 21 C.F.R. § 740.10(a). The
FDA has "broad statutory authority to protect the public health by
'making such rules and regulations as may be necessary to carry out the
provisions of the (Federal Food, Drug and Cosmetic Act) of 1938, 21
U.S.C.A. § 301 et seq. (1976)).'" See Pharmaceutical Manufacturers
Association v. Food and Drug Administration, 634 F.2d 106, 108 (D. Del.
1980) quoting Mourning v. Family Publications Service, Inc., 411 U.S.
356, 369 (1973), see also 21 U.S.C.A. § 371(a). While the FDA
regulations require that each ingredient used in a cosmetic product and
each finished cosmetic product shall be adequately substantiated for
safety prior to marketing, no specific details are included to explain
the meaning of the phrase "adequately substantiated for safety." The Act
and its implementing regulations are completely silent on the definition
of the phrase as well as the terms "substantiated" and "safety," as they
apply to cosmetics.

The safety net cast by the government's oversight of cosmetics is
disturbingly narrow. FDA's want of authority to require pre-market
safety review makes cosmetics the least regulated industry under the
agency's protection. For instance, in regulating pesticides in food, the
FDA defines "safety" as "reasonable certainty of no harm from aggregate
exposures ... including all anticipated dietary exposures and all other
exposures for which there is reliable information," and calls for an
assessment of safety for vulnerable populations such as infants and
children. 21 U.S.C.A. § 346 (b)(2)(A)(ii) & (b)(2)(C). In the cosmetics
regulations, FDA has provided no guidance on the meaning of the term
"safety." From a health perspective, there is no logical reason why
cosmetics shouldn't meet the same standard as food.

The average adult uses nine cosmetic products each day, and many of
these products are formulated with penetration enhancers that increase
the delivery of component chemicals to the bloodstream. Furthermore, the
industry safety review panel has identified potential hazardous
impurities for about one of every ten ingredients assessed. See
Cosmetics Ingredient Review, 2003 (hereinafter "CIR 2003"). Of the four
product concerns for which FDA explicitly requests direct contact from
imported cosmetic inspectors, three are related to harmful impurities in
the products. See Center for Food Safety and Applied Nutrition Cosmetics
Compliance Program-Imported Cosmetics Program, December 8, 2000, at
Chapter 29-Cosmetics and Color Technology,   HYPERLINK
"http://vm.cfsan.fda.gov/~comm/cp29002.html" \t "_blank" 
http://vm.cfsan.fda.gov/

~comm/cp29002.html  (visited May 12, 2004) (hereinafter "CFSAN 2000").

While the cosmetics industry has created a self-regulating ingredient
review panel, the marketplace still includes thousands of cosmetic
ingredients that have never undergone a public safety review. How can a
regulatory agency continue to allow such a serious breach of safety to
persist?

FDA must clarify the meaning of its requirement that ingredients and
finished products be "adequately substantiated for safety" to ensure the
safety of cosmetics and the consumers who use them. EWG has investigated
7,500 products, not one of which bears a warning stating: "the safety of
this product has not been determined." Only 28 of these 7,500 products
have been fully reviewed for safety by CIR or FDA; all other products
contain at least one ingredient not assessed for safety. The CIR did
conduct a review of the ingredients in the 356 likely misbranded
products identified by EWG, but none of these products bore the
appropriate label either. These incongruities are cause for concern.

The efficacy of FDA's regulatory scheme must be revisited. Without a
clear standard, FDA's enforcement and cosmetic industry's compliance
efforts are undermined. Most significantly, the lack of a definitive
safety standard leaves consumers without a basis for confidence in the
safety of the overwhelming majority of cosmetic products. Under the
current standard, a cosmetic firm could conduct unreliable tests, or
even no tests at all, and still place an unsafe product on drugstore
shelves without having to include a warning label or face FDA
enforcement. The effect of this safety gap is that consumers will be
exposed to untested chemicals that can cause serious harm, such as
reproductive abnormalities or cancer. Consumers should not have to bear
the burden of the government's poorly defined safety scheme.

It is imperative that FDA exercise its authority to ensure that such an
unjust burden is not placed on consumers, and clarify its cosmetic
safety standard to offer the greatest possible consumer protection. EWG
proposes that FDA define "adequately substantiated for safety" as
follows:

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.

Anything less will be a disservice to the millions of Americans who rely
upon the FDA to ensure the safety of cosmetic products available on the
marketplace.

3. EWG Calls Upon the Commissioner of Food and Drugs to Establish a
Requirement that Manufacturers Remove from Cosmetic Products any
Ingredient that Contains any Toxic Impurity or that May Combine with
Other Ingredients to Form Harmful Impurities.

At least 146 cosmetic ingredients have potentially hazardous impurities
linked to cancer and other serious health impacts, but the FDA has not
articulated any firm safety standards limiting such impurities in
cosmetic products. See CIR 2003, CFSAN 2000, see also Office of
Cosmetics and Colors, Prohibited Ingredients and Related Safety Issues,
March 30 2000,   HYPERLINK "http://www.cfsan.fda.gov/~dms/cos-210.html"
\t "_blank"  http://www.cfsan.fda.gov/~dms/cos-210.html  (visited May
12, 2004) (hereinafter "CFSAN 2000a"), see also Faust and Casserly,
Petrolatum and Regulatory Requirements, NPRA International Lubricants &
Waxes Meeting, November 13-14, 2003, Houston, TX,   HYPERLINK
"http://www.penreco.com/newsevents/tradearticles/%20NPRA2003_Pet_Regulat
ions.pdf" \t "_blank"  www.penreco.com/newsevents/tradearticles/
NPRA2003_Pet_Regulations.pdf  (visited May 17, 2004) (hereinafter "Faust
and Casserly"), and see The Scientific Committee on Cosmetic and
Non-Food-Products, Opinion concerning a clarification on the
formaldehyde and para-formaldehyde entry in Directive 76/768/EEC on
cosmetic products, SCCNFP/587/02 (December 17, 2002) (hereinafter
"SCCNFP"), and see EU directive on classification and labeling of
dangerous substances, Directive 67/548/EEC, Annex 1, Chemical compendium
at   HYPERLINK
"http://europa.eu.int/comm/enterprise/chemicals/legislation/markrestr/cm
rlist.pdf" \t "_blank"  http://europa.eu.int/comm/enterprise/chemicals

/legislation/markrestr/cmrlist.pdf  (hereinafter "EU 2002"). The
Commissioner has the authority to issue safety standards under the
FD&CA. See Pharmaceutical Manufacturers Association v. Food and Drug
Administration, 634 F.2d 106, 108 (D. Del. 1980) quoting Mourning v.
Family Publications Service, Inc., 411 U.S. 356, 369 (1973), see also 21
U.S.C.A. � 371(a). Government and industry sources reveal 24
industrial chemicals or groups of chemicals identified as potential
impurities in a wide range of products, with health concerns spanning
cancer, neurotoxicity, and reproductive problems. See CIR 2003, CFSAN
2000 & 2000a, Faust and Casserly, SCCNFP, and EU 2002. The FDA issued a
recommendation to manufacturers to voluntarily remove a carcinogenic
impurity, nitrosamines, from products in 1996. See Food and Drug
Administration, Are nitrosamines in cosmetics a health hazard?, Office
of Cosmetics and Colors, November 1996,   HYPERLINK
"http://vm.cfsan.fda.gov/~dms/qa-cos25.html" \t "_blank" 
http://vm.cfsan.fda.gov/~dms/qa-cos25.html  (visited May 6, 2004). EWG
proposes that FDA adopt a similar standard for all hazardous impurities:

Remove from cosmetic products any ingredient that contains any toxic
impurity or that may combine with other ingredients to form harmful
impurities.

FDA's regulation of these hazardous impurities will limit consumers'
risk of cancer and other avoidable harm from cosmetic products.

4. EWG Calls Upon the Commissioner of Food and Drugs to Initiate Recall,
Injunction or Seizure Proceedings for Cosmetics Containing Ingredients
that May Cause Injury During Ordinary Use.

EWG has discovered 20 cosmetic products containing ingredients that may
cause harm when used according to package directions. See   HYPERLINK
"http://www.cosmeticsdatabase.com/research/petition/exhibitB.php" 
Exhibit B . The FD&CA prohibits the distribution of cosmetics that
"contain[] any ... deleterious substance which may render it injurious
to users under the conditions of use prescribed in the labeling thereof,
or under conditions of use that are customary or usual[.]" 21 U.S.C.A.
§ 361(a). For every product listed in   HYPERLINK
"http://www.cosmeticsdatabase.com/research/petition/exhibitB.php" 
Exhibit B , the CIR found that a component ingredient is not safe for
the specific use indicated on the product's package directions. Four of
these products are baby products containing ingredients that the CIR
determined should not be used on infant skin. These products, mostly
baby skin creams and diaper rash ointments, contain directions such as
"apply ointment liberally ... with each diaper change" and claims such
as "especially effective as a ... barrier for Baby's diapered area." See
  HYPERLINK
"http://www.cosmeticsdatabase.com/research/petition/exhibitB.php" 
Exhibit B . Thirteen of these products are acne or rash treatments,
which include chemicals that the CIR has found should not be used on
damaged or injured skin. See id. Two are face creams that include
chemicals that CIR found should not be used in leave-on cosmetic
products. See id. One is an "overnight blemish reducer" containing a
chemical that the CIR determined should not contact the skin. Id. The
instructions on this product say "cover blemishes ... once daily" and
"[l]eave on overnight[.]" Id. All of these products appear to be in
violation of the FD&CA, and are adulterated according to Section 361 of
the Act. See 21 U.S.C.A. 361(a).

The Commissioner of Food and Drugs has the authority to institute
recall, injunction or seizure proceedings to prosecute violations of the
prohibition against adulterated cosmetics. See 21 U.S.C.A. § 332, 21
U.S.C.A. § 334, 21 C.F.R. § 7.40, 21 C.F.R. § 7.45. Cosmetics with
ingredients that are unsafe for the uses indicated in the package
direction meet the prerequisites for a recall as well. See 21 C.F.R. §
7.40, 21 C.F.R. § 7.45. As to risk of illness or injury, the fact that
the CIR found that the chemicals are not safe for the marketed use
proves that there is potential for illness or injury to the consumer. In
terms of consumer deception, the package directions make it reasonable
for a consumer to believe that the product is safe to use as directed.
Thus, where the industry's own review panel has determined that a
component ingredient is not safe to use in that application, the
consumer has been misled into the unsafe use of a cosmetic product. In
this instance, an injunction is appropriate because the 20 products that
EWG has identified include ingredients that may be harmful when used
according to the package directions. See 21 U.S.C.A. § 332. Seizure
would also be proper because all of the products identified by EWG are
available for sale either on the Internet or in stores throughout the
United States. See 21 U.S.C.A. § 334.

The only way to prevent the risk of injury, illness or consumer
deception is to prohibit the continued distribution of these adulterated
products until the cosmetic firms either prove the safety of their
products or reformulate the products to remove all unsafe ingredients.
EWG therefore requests that the Commissioner institute injunction,
seizure or recall proceedings for the cosmetics detailed in   HYPERLINK
"http://www.cosmeticsdatabase.com/research/petition/exhibitB.php" 
Exhibit B .

5. EWG Calls Upon the Commissioner of Food and Drugs to Command Internet
Vendors to Display a Conspicuous List of Ingredients for Cosmetic
Products Sold on Their Websites.

EWG has identified 41 websites currently selling cosmetics without
displaying the ingredients, in violation of FDA ingredient listing
requirements. See   HYPERLINK
"http://www.cosmeticsdatabase.com/research/petition/exhibitC.php" 
Exhibit C . Cosmetics produced or distributed for retail sale to
consumers for their personal care must include an ingredient
declaration. See 21 CFR § 701.3. The ingredient declaration must be
conspicuous so that it is likely to be read at the time of purchase. See
21 C.F.R. § 701.2. All label statements required by regulation must be
placed on the label or labeling with such prominence and conspicuousness
that they are readily noticed and understood by consumers under
customary conditions of purchase. See 21 C.F.R. § 701.2. For all of the
websites listed in   HYPERLINK
"http://www.cosmeticsdatabase.com/research/petition/exhibitC.php" 
Exhibit C , cosmetics are offered for sale, but a listing of ingredients
is not available on the website. Thus, these websites are selling
cosmetics without providing a declaration of ingredients conspicuously
displayed as required by FDA regulations. Under normal conditions of
Internet purchase, without an on-screen display of ingredients, a
consumer would have to purchase the product without having seen the
required list of ingredients. This violates FDA labeling regulations,
and constitutes misbranding. A product is misbranded if it fails to
include required information in such a way that is likely to be
understood under customary conditions of purchase. See 21 U.S.C.A. §
362. Thus, these websites are violating FDA regulations and appear to be
selling misbranded cosmetics.

EWG requests that the Commissioner publicly instruct all cosmetic
websites to display the required declaration of ingredients, subject to
injunction or seizure. The FDA has the power to seek injunction or
seizure, as well as the power to issue a public notice or warning to
address matters that involve gross consumer deception or FD&CA
violations. See 21 U.S.C.A. §§ 336, 362, and 375, 21 C.F.R. §§
701.2-701.3. The failure to provide a list of ingredients denies
consumers the right to know what is in the products they are purchasing.
This constitutes a violation of FDA standards as well as consumer
deception. The FDA should exercise its authority to ensure that
consumers have equal access to cosmetic labels both in stores and on the
Internet. The regulations apply equally to all products, and Internet
cosmetic vendors should be required to comply accordingly. EWG requests
that FDA publicly command Internet vendors to display the required
ingredient declaration on all cosmetic products, subject to further
prosecution by the Commissioner in the case of continued noncompliance.

6. EWG Calls Upon the Commissioner of Food and Drugs to Conduct an
Investigation of Products Containing Toxic Chemical Ingredients,
Prioritized According to Prevalence and Toxicity.

EWG has identified 9 common cosmetic ingredients, which are known to
pose health hazards [See   HYPERLINK
"http://www.cosmeticsdatabase.com/research/petition/exhibitD.php" 
Exhibit D ]. Seven of these ingredients have not been studied by FDA or
CIR. FDA has the authority to conduct investigations of cosmetic
chemicals, and has done so in the past for prevalent ingredients, such
as Alpha Hydroxy Acids. See 21 U.S.C. § 372, see also Alpha Hydroxy
Acid Guidance, 67 FR 71577. EWG has identified ingredients which pose
serious health risks, including cancer, reproductive toxicity, skin
toxicity, and endocrine disruption. These toxic ingredients can be found
in at least 1,950 cosmetic products. See   HYPERLINK
"http://www.cosmeticsdatabase.com/research/petition/exhibitD.php" 
Exhibit D . These products may be misbranded or adulterated according to
FDA regulations. See 21 U.S.C.A. §§ 361-362.

In order to determine whether or not to take further action to remove
these products from the market, EWG requests that FDA utilize its
authority and investigate these 9 priority chemicals to determine their
safety for use in cosmetics.



ENVIRONMENTAL IMPACT

No environmental impact statement is included because none is required
for request.

CERTIFICATION

The undersigned certifies that, to the best knowledge and belief of the
undersigned, this petition includes all information and views on which
the petition relies, and that it includes representative data and
information known to the petitioner, which are unfavorable to the
petition.

Respectfully Submitted,

Jane Houlihan

Vice President for Research

Environmental Working Group

Voice (202) 667-6982

Arianne Callender

General Counsel

Environmental Working Group

Voice (202) 667-6982

Olivia James

Cosmetics Consumer and Advocate

P-5 Quincy Circle Dayton, NJ 08810

Voice (609) 520-7033

  

HEADQUARTERS 1436 U St. N.W., Suite 100 | Washington, DC 20009 | (202)
667-6982 | 

CALIFORNIA OFFICE 1904 Franklin St. Suite 703 | Oakland, CA 94612 |
(510) 444-0973 |