FDA Regulation of ‘Cosmeceuticals:’ More Wrinkles Coming?
Response MagazineMay 8, 2012
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.
Read the article here.
© 2013 Manatt, Phelps & Phillips, LLP. All rights reserved.