FDA To Initiate Enforcement Action Against Cosmetics Manufacturers With Illegal Claims

FDA issued Import Alert no 66-38, ‘Skin Care Products Labeled As Anti-Aging Creams’ (IA 66-38) in 1988, subjecting cosmetic manufacturers, including several large, non-US cosmetics importers Estee Lauder, L’Oreal, Avon, Almay and Fleur de Sante, to ‘intensive surveillance’ for importing cosmetics with drug claims on cosmetic product labeling.

FDA appears to be cracking down on importers whose cosmetic product labels bear illegal drug claims. As recently as April 2010, FDA added 93 cosmetics products and four firms to the IA 66-38 ‘Yellow List,’ which subjects those companies’ imported cosmetics to ‘intensive FDA surveillance’ including increased import field examinations.

Mr England said: “These additions to the alert show that FDA is getting serious. Cosmetics manufacturers and importers of all sizes will likely see increased enforcement on labeling compliance generally, and drug claims, in particular.”

Recently, FDA has been increasing its reviews of imported cosmetics. As a result, it has also been detaining more shipments of cosmetic products bearing impermissible drug claims and cosmetics with more technical labeling violations.

According to some FDA officials, the agency is preparing a notification to the industry reminding companies about the importance of complying with all labeling requirements for topical cosmetics and over the counter drugs. This probably is expected to come in the form of a group of FDA warning letters to a number of cosmetics manufacturers and distributors alleging that because of the claims on the labels, the articles they are selling are actually misbranded or unapproved new drugs. The new initiative seems reminiscent to the recent ‘Front of Package’ food labeling enforcement initiative.

FDA said that, all labeling claims of the cosmetics must be ‘cosmetic’ claims. Claims that a product can be used to counteract, retard or control the aging process or its effects are drug claims and are illegal on cosmetic labeling.

Mr England added: “The new FDA cosmetics labeling initiative will likely bring a measure of parity to FDA’s enforcement practices, since it appears FDA has mainly targeted small cosmetics importers in the past.

“It’s as if, compared to smaller importers, FDA has given multinational companies a ‘get out of jail free’ card on importing cosmetics bearing these kinds of claims.

“It’s apparent FDA believes the labeling claims are illegal, so it issued Warning Letters. And yet, these products, with these same labeling claims, continue to make it to the US market. In the meantime, FDA detains products from smaller manufacturers imported by smaller importers.”