Cosmetic Industry On Notice: FDA Issues Warning on Untested Products

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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

 

 

 

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.

 

* View FDA's warning letter to cosmetics industry (PDF document)

 

 

 

 

 

 

Caroline Collard

 

World's first fully certified organic skin, body, oral and health care products

www.happyandhealthy.org.uk

 

 

 

 

 

 

 

 

 

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