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FDA Regulation of 'Cosmeceuticals': More Wrinkles Coming?

8 May, 2012 By: Ivan J. Wasserman

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.

Advances in technology have led to the creation of cosmetic products that can do some incredible things – things that Congress could never have envisioned when it passed the law in 1938. Cosmetics now contain ingredients that can increase collagen production, decrease melanin and truly provide other amazing anti-aging benefits. This has led to the proliferation of so-called “cosmeceuticals,” a term that has no legal definition.

In March 2012, Michael Landa, the director of the FDA center that regulates cosmetic products, testified before Congress about the challenges facing the FDA due to the rise of these types of products and the FDA’s limited regulatory oversight. He stated:

“The category of products that straddles the line between cosmetics and drugs also presents new regulatory challenges. The industry often refers to these products as “cosmeceuticals,” a term which has no legal or regulatory definition in the United States. This class of products presents new regulatory challenges in a number of ways, including how such products should be regulated and with what requirements such products should comply. Many products in this category are advertised as containing ‘active ingredients,’ which, by virtue of the ingredients themselves or the claims made for the product, may cause the product to be classified under the FD&C Act as a drug. The use of such ingredients is increasing, and we expect this trend to continue, posing additional regulatory challenges.”

Perhaps in response to this testimony, on April 18, Rep. Leonard Lance (R-NJ) introduced the Cosmetic Safety Amendments Act of 2012, which, if enacted, would significantly increase the FDA’s regulation of cosmetic products. Among other things, the bill would require registration of certain cosmetic product manufacturers, the submission of cosmetic product and ingredient statements, and the reporting of certain serious adverse events. It would also direct FDA to establish Good Manufacturing Practices (GMPs) for cosmetic products, and to review the safety of cosmetic ingredients.

Whether or not this particular bill is ultimately passed into law, it seems inevitable that the scrutiny of these products, at both the federal and state levels, is likely to increase. Direct response marketers should not only ensure their products are currently compliant, but also stay on top of developments to ensure that their compliance, like the beauty they are protecting, does not fade.

Ivan J. Wasserman is a partner in the Advertising, Marketing and Media division of Manatt, Phelps & Phillips LLP, based in the firm’s New York office. He can be reached at (202) 585-6529 or [email protected].

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