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Cosmetic Industry On Notice: FDA Issues Warning on Untested Products

March 7, 2005

_http://www.ewg.org/issues/cosmetics/FDA_Warning/index.php_

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

(?subject=Have a look

at this website & body=Hi, The cosmetic industry is on notice from the FDA to

put warning labels on all their products - full report at

www.health-report.co.uk/FDA_warning_untested_ingredients.htm)

FDA calls industry's bluff on product safety. Acting on a petition filed

June 14, 2004 by the Environmental Working Group (EWG) [_view document_

(http://www.ewg.org/reports/skindeep/petition/index.php) ], on February 3, 2005

the Food and Drug Administration issued an unprecedented warning to the

cosmetics industry [_view document_

(http://www.ewg.org/issues/cosmetics/FDA_Warning/FDA2CTFA_letter.pdf) ] 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,, 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.

* _View FDA's warning letter to cosmetics industry_

(http://www.ewg.org/issues/cosmetics/FDA_Warning/FDA2CTFA_letter.pdf) (PDF

document)

 

Text of the response sent by EWG to FDA:

March 7, 2005

Robert E. Brackett, Ph.D., 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)

[1] Cosmetics Ingredient Review (CIR) (2003). 2003 CIR Compendium,

containing abstracts, discussions, and conclusions of CIR cosmetic ingredient

safety assessments. Washington DC.

[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.

[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.

[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. "

[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

__

 

Health-Report Comment

At long last we are seeing some concrete action being taken to limit the

exposure unwitting consumers are subjected to by the cosmetic/skin care and

chemical industries toxic compounds they describe as being 'beneficial " to

us!

The powerful cosmetic and beauty industry will not take any action to

limit the use of these toxic chemicals lying down, so it may be many years yet

before we will see some common sense being displayed on this issue. Rest

assured the almighty dollar and corporate profit comes first in the eyes of

directors and greedy shareholders. Their attitude is to hell with it, let's

just keep on pumping this stuff out and milking the cash cow while it lasts!

The fact vested interests are contaminating the bodies of millions of

consumers throughout the world with their toxic chemical concoctions is

immaterial to them

The bottom line is profit and the bigger the better! That's what drives

industry. BIG PROFIT! Certainly the health concerns of consumers are the

least of their worries. Just so long as they have their own paid " experts " to

tell us chemicals are safe, the gullible consumer will continue to slather

toxic synthetic chemical compounds, 30% of which are deemed to contain known

carcinogens, onto their skin, blithely unaware they are accelerating their

journey towards cancer. It's amazing how a lithe young model with

absolutely perfect skin, projecting an image of youth and beauty and through

that

image, can convince millions they too can look like her if they rub chemicals

into their skin.

How soon before the cancer rate hits 1 in 2? Less than ten years? It's

already knocking on 1 in 3 now in most " developed " countries.

I guess ignorance is bliss until cancer strikes - perhaps by then, it is

too late for most.

Geoff Goldie

_www.health-report.co.uk_ (http://www.health-report.co.uk/)

 

__

For ACO Certified Organic skin care, cosmetics and personal care products

made to food grade standards.

_www.hallgold.com/ep.htm_ (http://www.hallgold.com/ep.htm)

Geoff Goldie

1713 Topaz Rd

Malanda

4885

Australia

 

 

 

 

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