Federal Agency Refuses to Publicly Release Study's Findings

WASHINGTON--The Campaign for Safe Cosmetics has learned that the FDA recently conducted a safety study of phthalates--a group of industrial chemicals linked to birth defects that are used in many cosmetics products--but is refusing to publicly release the study's findings. In response, Friends of the Earth, a founding member of the Campaign for Safe Cosmetics, today filed a Freedom of Information Act (FOIA) request to obtain the study.

According to preliminary information uncovered by the Campaign for Safe Cosmetics about the study, two-thirds of health and beauty products analyzed by the FDA late last year contained phthalates. Two of the most toxic phthalates, DEHP and DBP, have been banned from cosmetics products sold in the European Union but remain unregulated in the United States .

"The FDA is withholding an important piece of scientific research from the public," said Lisa Archer , Campaign Coordinator for Friends of the Earth. "We deserve to know if there are harmful ingredients in our cosmetics products. As a publicly-funded agency, the FDA has a duty to tell the public what it knows about which products contain phthalates."

FDA reported the existence of the study in the Center for Food Safety and Applied Nutrition 2004 Program Priorities Accomplishments, which was released in January. According to the FDA's Web site, the agency "surveyed 48 cosmetic products and identified 5 phthalate esters in 32 of the products. Phthalate levels ranging from 16 ppm to 59,000 ppm were found; the highest levels found were in nail enamels."

The FDA survey followed a 2002 report by environmental and health groups, entitled "Not Too Pretty," in which independent lab tests found phthalates in 72 percent of beauty products. Since phthalates are not listed as ingredients on product labels, they can only be detected through laboratory analysis.

Phthalates are industrial chemicals used in various consumer products, including shampoos, deodorants and hair sprays. In animal tests, some phthalates have damaged the developing testes of offspring and caused malformation of the penis and other parts of the reproductive tract.

Several top cosmetics companies, including L'Oréal (OTC: LORLY [ADR]), Revlon (NYSE: REV) and Unilever (NYSE: UL [ADR]; London: ULVR), have said they will voluntarily remove DBP and DEHP from products sold in the United States.

The Campaign for Safe Cosmetics is asking cosmetics manufacturers to sign the Compact for Safe Cosmetics, a pledge to remove EU-banned chemicals immediately, and to replace other chemicals of concern with safer alternatives within three years. To date, 93 companies have signed the Compact. See www.safecosmetics.org for more information.

A copy of the Freedom of Information Act Request filed today by Friends of the Earth can be found at www.foe.org/camps/comm/cancer/FDAPhthalateFOIA.pdf .

To view FDA's reference to the survey of cosmetics containing phthalates, visit the Center for Food Safety and Applied Nutrition 2004 Program Priorities Accomplishments at http://www.cfsan.fda.gov/~dms/cfsan804.html#summary . The survey is mentioned as item #51 in Enclosure 1 of the "CFSAN 2004 Program Priorities Accomplishments through June 2004."

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For more information and background on the campaign, see www.SafeCosmetics.org .