A program of Breast Cancer Prevention Partners

Cosmetic Industry on Notice: FDA Issues Warning on Untested Products

Acting on a petition filed June 14, 2004 by the Environmental Working Group (EWG), on February 3, 2005 the Food and Drug Administration issued an unprecedented warning to the cosmetics industry 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 2004).

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 2004).

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.

More info at http://www.ewg.org/node/17356

EWG is a not-for-profit group that uses the power of information to protect human health and the environment by researching pollution in food, water, air and people.

Founding members of the Campaign for Safe Cosmetics include the Breast Cancer Fund, Friends of the Earth, Women’s Voices for the Earth, Environmental Working Group, National Environmental Trust, National Black Environmental Justice Network, Health Care Without Harm and Commonweal.

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