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Products Incorrectly Labeled as Cosmetics Scrutinized by the FDA

The U.S. Food and Drug Administration (FDA) has published fresh warning letters to tackle the problem of companies that incorrectly market their products as cosmetics. Drugs and medical devices must obtain regulatory approval before they reach the market, but when a cosmetic product is launched there is no requirement to even notify the FDA.

Regulatory trap

Out of design or confusion, products labeled as cosmetics hit the market when they fit the regulatory definition of medical devices or drugs. The rise of laser devices and products that blur the distinction between cosmetics and drugs suggests that mislabeling is unlikely to go away with potential health implications for consumers. For those companies caught in a regulatory trap, serious financial and marketing consequences can present themselves.

Warning letters

To inform companies about the legal differences between cosmetics, drugs and medical devices and discourage regulatory violations, the FDA has published warning letters. For example, in August of this year the FDA sent a letter to Gaunitz Hair Sciences informing the company that marketing clearance should have been obtained for the THL-1 Handheld Laser. Threatening regulatory action if prompt action was not taken, the FDA explained that the product was a medical device and not a cosmetic because it is intended to be used to diagnose or treat a medical condition or affect the structure or function of the body.

Similar warning letters are published on a separate Web page addressing violations involving cosmetics marketed with drug claims.

Information campaign

Other information has also been published online to help prevent companies from incorrectly marketing their products as cosmetics. FDA spokesperson Stephanie Kwisnek said, “The FDA has made information on the legal differences between cosmetics and drugs readily available on the Web. In addition, an agreement between FDA’s Center for Drug Evaluation and Research and Center for Food Safety and Applied Nutrition has been in effect for several years. The purpose of this agreement is to gain a more efficient allocation of resources and better coordination of regulatory actions for products that purport to be cosmetics but meet the statutory definition of a drug.”, November 19, 2008



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