As many executives in the cosmetics industry know by now, the US Food and Drug Administration (FDA) is continuing its crackdown against companies that are marketing cosmetics with claims of biologically-enhanced benefits.

Indeed, just last month, FDA publicly released two more warning letters to cosmetic companies. This time, FDA pursued cosmetic giant, Avon, and a smaller company called Bioque Technologies. As with the agency’s previous warning letters, FDA issued the letters citing objectionable claims 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.

Just a few weeks prior, FDA issued four similar warning letters to cosmetics companies also citing objectionable marketing claims on company websites. These were sent to Lancôme USA and Greek Island Labs on Sept. 7, 2012 and to Andes Natural Skin Care, LLC and Jansen Beckett, Inc. on Sept. 21, 2012. 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.

While several of the claims made for the various 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 consistent with those appearing on vast numbers of cosmetics on drug store and retailer shelves across the U.S.

So far, FDA has objected (in part) to the following claims:

Avon Products

• “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”

Lancôme USA

• “Boosts the activity of genes and stimulates the production of youth proteins.”
• “…has been shown to improve the condition around the stem cells and stimulate cell regeneration to reconstruct skin to a denser quality.”
• “Immediate lifting, lasting repositioning.Inspired by eye-lifting surgical techniques…helps recreate a younger, lifted look in the delicate eye area.”
• “Unique R.A.R.E. oligopeptide helps to re-bundle collagen.”

Greek Island Labs

• “…a potent antimicrobial, antibacterial, and antifungal…recommended for many types of skin disorders.”
• “… used… to ward off infections …”
• “… used… against plague and fevers.”
• “Clinically proven to reduce breakouts and blemishes by 84%”

Andes Natural Skin Care

• “Takes away acne, rosacea, scars, skin blemishes and deep under skin lesions accumulated by excess UV exposure…”
• “Prevents and Clears Acne”
• “Relieves the side effects of Accutane.”

Jansen Beckett

• “Acetyl HexaPeptide (Argireline)…was the first peptide to offer effects similar to Botox. Argireline works…to block the nerve signals and by inhibiting the overproduction of catecholamines. By blocking these neurotransmitters, Argireline reduces the contraction of muscles and reduces wrinkles and prevents wrinkle formation.”
• “Leuphasyl helps moderate the release of acetylcholine… by lowering the skin’s electrical charge in the applied area… Leuphasyl’s ability to moderate the electrical charge being sent to the applied area is crucial in lessening and relaxing muscle contraction. Impairing muscle contraction is what…mitigates wrinkles and their formation.”
• “Alpha Lipoic Acid, the most potent antioxidant on the market today, helps repair aged skin while preventing future damage.”

What’s Next?
What is foremost on everyone’s mind is: what’s next? Until this past month, FDA has taken enforcement action against cosmetic companies for drug claims but a few times during the past decade. This long period of quiet is in sharp contrast to FDA’s current enforcement initiative, which, some say, appears to be one of the most ambitious enforcement strategies ever implemented against the cosmetics industry. While many in the industry were initially wondering whether the letters were just isolated notices, it has become painfully clear that this effort is part of a well-orchestrated enforcement scheme—one that can be expected to continue. Significantly, as none of the warning letters were issued by FDA’s regional field offices, this further corroborates that the warning letters are part of a new cosmetic/cosmeceutical enforcement scheme. Obviously, such action could threaten the economic viability of industry members and their promotion of cosmetic products, particularly those that are labeled with scientific language to describe their unique, enhanced benefits.

In conclusion, FDA has recognized technological advances in other areas but, as evidenced by its recent enforcement, is steeped in antiquated views of what constitutes an acceptable cosmetic claim. Granted, FDA is limited by the statutory definition of “cosmetic” which is decades old, but it’s high time that FDA recognize the strides made in cosmetic/cosmeceutical and partner with the industry stakeholders to develop a framework that permits companies to develop sophisticated cosmetic products and lawfully market them.

More info: Georgia Ravitz, 202-715-8426, www.arentfox.com