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FDA Targets ‘Cosmeceuticals’ Straddling Regulatory Lines

Wrinkle creams with retinol and a growing crop of beauty treatments that are partly pharmaceutical may need to be regulated as drugs, the top U.S. official overseeing the cosmetics industry said.

The industry calls them “cosmeceuticals,” a term that doesn’t exist in regulation, Michael Landa, director of the Food and Drug Administration’s Center for Food Safety and Applied Nutrition, said in testimony prepared for a House subcommittee hearing today. The claims companies make that the products contain active ingredients may classify them as drugs, he said.

Retinol and peptides weren’t listed as ingredients in any cosmetics before 2005, Landa said in his written remarks to the House Energy and Commerce health subcommittee. Retinol is now registered in 200 items, while peptides are listed in 1,200 product statements voluntarily submitted to the FDA, he said.

“The category of products that straddles the line between cosmetics and drugs” presents new regulatory challenges, Landa said. “The use of such ingredients is increasing and we expect this trend to continue.”

Johnson & Johnson’s Roc Retinol Correxion anti-wrinkle cream is among products that include retinol, while L’Oreal SA’s skin replenishing Age Perfect line contains peptides.

Some cosmetics are classified as a drug depending on the claims they make, Lisa Powers, a spokeswoman for the Personal Care Products Council, the main Washington lobbying group for cosmetic companies, said in an e-mail. Products that claim beautification are a cosmetic, while those that alter the body’s structure or function are classified as a drug, she said.

Products that make both claims are regulated as over-the-counter drugs, such as a hydrating lipstick that also contains a sunscreen, Powers said.

James Freeman, a spokesman for New Brunswick, New Jersey-based J&J, and Pam Alabaster, a spokeswoman for Paris-based L’Oreal, didn’t return requests for comment.

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