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FDA warning letter defines differences between cosmetic, medical devices

The FDA posted a statement regarding recent warning letters they have sent out to a number of companies hoping to clarify the differences between cosmetics and medical devices. 

According to an FDA press release, the letters illustrate that although these devices are intended to affect the consumer’s appearance, the fact that they are intended to diagnose or treat a medical condition or affect the structure or function of the body classifies them as medical devices under the Federal Food, Drug & Cosmetic Act (FD&C Act).

This act requires medical device manufacturers to obtain marketing clearance before offering the products for sale, according to the release.

Additional information from the FDA about cosmeceuticals, additional warning letters and medical devices can be found online.

Reference: www.fda.gov.