FDA Regulation of 'Cosmeceuticals:' More Wrinkles Coming?

– Response Magazine

Compared to other popular direct response product categories, such as dietary supplements, over-the-counter drugs (e.g., anti-acne creams) and medical devices (e.g., wrinkle and acne reducing lights), cosmetics are subject to far less Food and Drug Administration (FDA) regulation. Unlike those products, for example, cosmetics are not subject to manufacturing requirements, facility registration or adverse event reporting. This low level of regulation has led some to argue that the FDA cannot adequately protect consumer safety. That, however, may be changing.

One reason for there being less FDA oversight is that the claims permitted for cosmetic products are perhaps the most limited. Under the Food, Drug and Cosmetic Act (FD&C Act), a cosmetic is limited to claiming that it is intended for cleansing, beautifying, promoting attractiveness, or altering the appearance. Unlike drugs and devices, cosmetics cannot claim to treat or prevent a disease, and unlike dietary supplements, cosmetics cannot claim to affect the structure or function of the body. That is why the claim that a cosmetic “improves the appearance of wrinkles” is so ubiquitous.

manatt-black

ATTORNEY ADVERTISING

pursuant to New York DR 2-101(f)

© 2024 Manatt, Phelps & Phillips, LLP.

All rights reserved