FDA is continuing its crackdown against companies that are marketing cosmetics with claims of biologically-enhanced benefits. Yesterday, FDA publicly released two more Warning Letters that it issued in connection with its crackdown. This time, FDA went after Avon and a smaller company called Bioque Technologies due to allegedly objectionable claims the Agency found on each company’s website. This brings the total number of Warning Letters FDA issued to cosmetic companies (including some of the world’s largest) to six in a period of just one month. Such action clearly signals one of the most significant enforcement crackdowns against the cosmetics industry since the inception of the Federal Food, Drug, and Cosmetic Act. Claims made for these products to which FDA objects include:

Avon

• “Rebuild collagen to help plump out lines and wrinkles”
• “Stimulate elastin to help improve elasticity and resilience”
• “Regenerate hydroproteins to help visibly minimize creasing”
• “Formulated to boost shock-absorbing proteins to help strengthen skin's support layers”

Bioque Technologies

• “Intensive Penetrating Complex affects its long-term repair”
• “Damaged skin cells repair themselves and then replicate, creating healthier replacement cells”
• “Delivers a formula rich in peptides and active botanicals to fuel the rebuilding of skin structure and elasticity”
• “Higher concentration of beneficial elements promotes regeneration of skin cells during peak hours of sleep”

While several of the claims made for these products include terms like “muscle relaxing,” “scar healing,” and “acne” -- claims that are officially recognized as drug claims under several of FDA’s over-the-counter (OTC) drug monographs -- many of the other claims cited by FDA in the Warning Letters are, arguably, little more than “new age” cosmetic claims and certainly no stronger than those appearing on vast numbers of currently marketed cosmetics. Until this past month, FDA has taken enforcement action against cosmetic companies for objectionable claims few times over the past decade. Indeed, FDA’s current enforcement initiative appears to be one of the most ambitious enforcement strategies ever implemented against the cosmetics industry and signals that the effort is part of a well-orchestrated enforcement action that can be expected to continue. Obviously, such action could threaten the economic viability of industry members and their promotion of cosmeceuticals, products that are often labeled with scientific language to describe their unique, enhanced benefits.

Over the past month, FDA has also issued Warning Letters to Lancome USA, Greek Island Labs, Andes Natural Skin Care, and Jansen Beckett due to objectionable marketing claims. Each of these companies has been given 15 working days by FDA to respond to the Warning Letter. We will continue to monitor and report on FDA’s historic enforcement stance. For additional information, please contact Georgia C. Ravitz or Jim Hartten at Arent Fox LLP. You can read the Avon and Bioque Technologies Warning Letters here and here.