Bloomberg News

L’Oreal Creams Vetted by FDA in Drugs-as-Cosmetics Crackdown

September 11, 2012

L’Oreal SA (OR), the world’s largest cosmetics maker, is being told by U.S. regulators to tone down claims on its Lancome anti-aging creams or submit the products to a drug review process reserved for pharmaceutical companies.

The Food and Drug Administration sent a warning letter Sept. 7 to Serge Jureidini, the U.S. president for L’Oreal’s Lancome unit. The FDA cited some of the company’s night creams, sunscreens and eye lifters for youthful claims that go beyond simple beautification and instead offer to alter the body’s function or structure, making them drugs by regulatory definition. Lancome has 15 working days to respond to the FDA.

The FDA this year has targeted a growing crop of beauty treatments that are partly pharmaceutical, such as wrinkle creams with retinol, saying they may need to be regulated as drugs. Michael Landa, the director of the agency’s Center for Food Safety and Applied Nutrition, told a House subcommittee in March that these so-called cosmeceuticals often try to straddle the line between being a cosmetic treatment and a drug.

L’Oreal claims its Genifique product “boosts the activity of genes” and its Absolue Sunscreen “has been shown to improve the condition around the stem cells and stimulate cell regeneration.” Those claims require the products to go through the drug review process, according to the FDA letter.

Rebecca Caruso, a spokeswoman for Paris-based L’Oreal, didn’t immediately return requests for comment.

Regulators suggested the company review its website and product labels to ensure the claims don’t violate drug rules.

The FDA also sent a warning letter Sept. 7 to Greek Island Labs, which makes Athena 7 Minute Life, sold as “a safe and effective alternative to Botox.” Greek Island Labs also sells a nightly renewal cream meant to help promote collagen development and products that strengthen hair growth that the agency says must also bear less drug-like claims or go through a review process.

To contact the reporter on this story: Anna Edney in Washington at aedney@bloomberg.net

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net


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