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Losing the Cancer War

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U. S. Food and Drug Administration (FDA)

  • Fails to Warn of Cosmetic Hazards
  • Federal legislation on labeling of cosmetic risks requested

Senator Edward Kennedy (D-MA) has criticized the U. S. Food and Drug Administration during hearings on the 1997 FDA cosmetics reform bill: “Our message is that cosmetics can be dangerous to your health. The American people have a right to full and fair information about the actual and potential dangers of the products they use every day."

The U. S. Food and Drug Administration continues denying consumers their right-to-know by refusing to require label warnings on the risks of cosmetic ingredients. This failure violates the 1938 Federal Food, Drug and Cosmetic Act which mandates that "each ingredient used in a cosmetic product--shall be adequately substantiated for safety prior to marketing," and which authorizes FDA to recall and seize unsafe products. Nevertheless, the Agency merely requires a listing of the complex chemical names or their abbreviations of the 10 to 20 ingredients on product labels. However, this information is incomprehensible to consumers, let alone their physicians.

- A November 1994 citizen petition to the FDA requested the agency to require that cosmetic talc products be labeled with a warning that frequent application to the genital area significantly increases risks of ovarian cancer. FDA declined to act on this petition on grounds of the "limited availability of resources and other agency priorities."

- An October 1996 citizen petition to the FDA requested the agency to require that cosmetics containing the common detergent diethanolamine (DEA) be labeled with a cancer warning, as DEA reacts with nitrites present in many products to form a potent (nitrosamine) carcinogen. DEA itself was also subsequently shown to be carcinogenic when applied to mouse skin. FDA similarly declined to act on this petition.

- More seriously, FDA has declined to request Congressional authority to require label warnings on black and dark brown coal tar hair dyes, which are technically exempt from the 1938 Cosmetic Act. This reflects disregard of a series of studies over the last three decades incriminating prolonged use of these dyes with breast and bladder cancers, and non-Hodgkin's lymphoma and multiple myeloma.

FDA policies and those of the Cosmetic, Toiletry and Fragrance Association (CTFA), the U.S. trade association, which represents the multi-billion dollar cosmetic industry, are mutually supportive. The major priority of the CTFA is to prevent "new and unnecessary" label warnings.

Label warnings are even more critical in view of the escalating incidence of cancer, now striking nearly one in two men and more than one in three women in their lifetimes. Still sharper increases are anticipated in coming decades.

Informed by user-friendly labels, consumers could reduce their avoidable risks of cancer and other disease by shunning unsafe products and shopping for safer alternatives. While currently limited, their availability will rapidly increase with increasing demand; this is well exemplified by the organic food industry which has escalated to its current $8 billion market share over the last decade. Legislative action by Senator Kennedy would not only protect consumers, but also stimulate overdue recognition by the $20 billion mainstream petrochemical cosmetic industry that safety sells.

In striking contrast to FDA policies, the Scientific Committee on Cosmetic Products of the European Union recently called for a blanket ban on all carcinogenic, gene-damaging and reproductive toxic ingredients in cosmetics.

Finally, FDA's failure to require the cosmetic industry to disclose information on risks of their products to U.S. consumers is at least as critical as SEC's failure to require disclosure of information on corporate accountability to public investors. Clearly, the FDA is a lap dog, rather than watchdog, of the cosmetic industry.

-- Samuel S. Epstein, M.D., Professor emeritus, Environmental and Occupational Medicine, Univeristy of Illinois Chicago, School of Public Health, Chairman, the Cancer Prevention Coalition,, phone 312-996-2297

-- Mark Helm, Director, Media Relations, Friends of the Earth, Washington, D.C.,, 202-783-7400 x102

-- Bryony Schwan, National Campaigns Director, Women's Voices for the Earth,, phone 406-543-3747

-- Larry Bohlen, Friends of the Earth,, 202-783-7400 x251

-- Alise Cappel, Center for Environmental Health,, phone 510-594-9864

-- Gary Cohen, Environmental Health Fund,, phone 617-524-6018

-- Mary Lamielle, National Center for Environmental Health Strategies, Inc.,, phone 856-429-5358

-- David Monk, Oregon Toxics Alliance,, phone 541-465-8860

-- Barbara Wilkie, Environmental Health Network,, phone 510-527-3567

-- Janet Zeller, Blue Ridge Environmental Defense League,, phone 336-982-2691

FOR DETAILS ON PHTHALATES in cosmetics and their dangers, visit:

Excerpted from Cancer Prevention Coalition Press Release August 16, 2002

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