On October 5, 2012, the FDA issued warning letters to two beauty and personal products companies—including multinational giant Avon Products—objecting to promotional claims that the companies make in connection with their “cosmeceutical” products. In both cases, the FDA asserted that the advertising claims in question demonstrate the products are unapproved new drugs under the Federal Food, Drug, and Cosmetic Act (FDCA).

FDA Warns Avon New Cosmetic Products are New Drugs

The FDA letter to Avon warns that several of its products, “appear to be intended for uses that cause these products to be drugs under the [FDCA].” See Avon Warning Letter. The FDA letter specifically asserts that the marketing of Avon’s Anew Clinical Advanced Wrinkle Corrector, Anew Reversalist Night Renewal Cream, Anew Reversalist Renewal Serum, Anew Clinical Thermafirm Face Lifting Cream, and Solutions Liquid Bra Toning Gel violate the FDCA’s regulations, by making claims that suggest that these products are intended to affect the structure or function of the human body. Claims of this type render the products “drugs under the Act.” As examples, the FDA cited claims that these products “ rebuild collagen,” “stimulate elastin to improve elasticity and resilience,” and “regenerate hydroproteins to reduce skin creasing.” Avon’s website also states that the products “tighten connections between skin layers, repair micro-injuries and fortify damaged skin tissue.” The FDA noted that Avon’s “products are not generally recognized among qualified experts as safe and effective for” the cited uses and, because of this, they “are new drugs” under the Act.

FDA Cites Bioque’s Marketing Claims as Violating the FDCA

A second FDA letter to Bioque Technologies, located in Blacksburg, Virginia, focuses on claims that Bioque made about its Serum XL, Serum Rejuvenate, C-Plus Moisturizing Cream, Rejuvenating Day Cream, Rejuvenating Night Cream, Pronto, Formula 9 Firming Gel, Vitamin K1 8% Intensive Serum, Gentle Purifying Skin Cleanser, and Liposome Cellulite Therapy. See Bioque Warning Letter. The FDA warned the company that claims that its products “repair[] the structural damage that actually causes” wrinkles, “activate[] production of collagen and elastane critical to rebuilding and maintaining healthy skin structure,” and “provide BOTOX-like results without the needles,” “indicate that these products are drugs because they are articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or articles intended to affect the structure or any function of the body of man, rendering them drugs under the Act.”

Cosmetic or Drug Depends on Intended Use

The FDA has stated that whether a product is a cosmetic or a drug under the law is determined by a product’s intended use. See FDA Guidance, “Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?).” Under the FDCA, cosmetics are “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the appearance.” FDCA, §321 (i). Drugs on the other hand are “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals.” FDCA, §321(g)(1). Cosmetic products and ingredients, with the exception of color additives, do not require FDA approval before they go on the market. Drugs, however, must generally either receive premarket approval by the FDA through the New Drug Application (NDA) process or conform to a “monograph” for a particular drug category, as established by FDA’s Over-the-Counter (OTC) Drug Review. The “intended use” of a product can be established in a number of ways. Product claims—whether found on labeling or in traditional advertising—are a primary source of evidence the FDA considers in making this determination. Claims like those appearing on the Avon and Bioque websites may cause a product to be considered a drug, even if the product is marketed by a cosmetics company, to cosmetics audience, using an otherwise typical cosmetic marketing approach. Both Avon and Bioque were given 15 days to respond to the letter, identifying the specific steps the companies have taken to correct the stated violations.

FDA Cracking Down on “Cosmeceuticals”

The FDA warning letters to Avon and Bioque are the latest in a series of letters that the FDA has issued in the past few months to companies marketing so-called “cosmeceuticals.” Prior warning letters were sent to Lancôme USA (FDA Letter), Andes Natural Skin Care (FDA Letter), and Janson Beckett (FDA Letter). All of these letters alleged that cosmetic products were marketed using improper drug claims. Until recently, warning letters to cosmetic companies complaining about their advertising claims have been relatively rare and seem generally to have focused on safety concerns to consumers. For example, the maker of the popular Brazilian Blowout hair-smoothing treatment agreed to begin warning consumers and hairstylists that its products contain potentially hazardous formaldehyde after receiving attention from the FDA last year. See FDA Warning Letter to Brazilian Blowout. Source: The U.S. Food & Drug Administration

This article was prepared by Kathy Grant (kgrant@fulbright.com / 210 270 7182) of Fulbright’s False Advertising Practice.