UPDATE 1-FDA warns L'Oreal about claims for anti-aging creams

Wed Sep 12, 2012 2:17am IST

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* FDA says L'Oreal claiming creams work like drugs

* Companies that sell drugs must do clinical trials

By Anna Yukhananov

WASHINGTON, Sept 11 (Reuters) - U.S. regulators warned L'Oreal SA, the world's biggest cosmetics group, to stop advertising skincare products using language that makes them sound like drugs.

The U.S. Food and Drug Administration said Lancome USA, a L'Oreal unit, claimed some of its skin creams could "boost the activity of genes" or "stimulate cell regeneration" to reduce signs of aging.

Any product that is intended to affect the structure or function of the human body is classified as a drug, the FDA said, according to a warning letter posted on its website on Tuesday.

Companies are not allowed to sell drugs in the United States without demonstrating to the FDA that their products are safe and effective.

L'Oreal, a French company, said it was committed to complying with all laws and regulatory standards.

"We are aware of FDA's letter to Lancome and will respond to their regulatory concerns in a timely manner," a company spokeswoman said.

Some of the products mentioned in the letter, dated Sept. 7, include Genifique Repair Youth Activating Night Cream and Absolue Eye Precious Cells Advanced Regenerating and Reconstructing Eye Cream.

On its website, Lancome describes the Genifique Repair cream, which costs $98 for a 1.7-ounce container, as "our first night care that boosts the activity of genes." The company cites an in-vitro test on genes to back up the claim.

The FDA said failure to fix the advertising claims could lead to enforcement actions, such as seizure of the products and injunctions against their manufacturers and distributors.

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