On October 5, FDA sent a warning letter to Avon Products, Inc. ("Avon") concerning the cosmetic company's online promotion of its anti-aging skin care products. The letter, which FDA posted last week, objects to Avon's marketing claims for a variety of its anti-wrinkle products. Specifically, it warns that they "appear to be intended for uses that cause these products to be drugs under section 201(g)(1)(C) of the Federal Food, Drug, and Cosmetic Act ['FD&C Act']."
The cited statutory provision (21 U.S.C. § 321(g)(1).) defines "drug" to include "articles (other than food) intended to affect the structure or any function of the body of man or other animals." FDA asserts that Avon's marketing claims indicate that the creams and serums listed in the letter are intended to affect the structure of human skin tissue, in which case they would fall under that definition. For example, the company's website describes that the Anew Clinical Advanced Wrinkle Corrector as "formulated to boost shock-absorbing proteins to help strengthen skin's support layers," and "start rebuilding collagen in just 48 hours." While it is not out of the ordinary for anti-wrinkle products to claim to reduce the appearance of wrinkles and fine lines, FDA believes that Avon's statements go too far. According to the letter, the products are "not generally recognized among qualified experts as safe and effective for the above referenced uses" and are thus new drugs, requiring marketing approval.
Congress has prohibited the introduction of new drugs into interstate commerce without filing, and subsequent approval of, a new drug application ("NDA") as stated in 21 U.S.C. § 355(a). A new drug application ("NDA") must include, among other things, "full reports of investigations which have been made to show whether or not such drug is safe for use and whether such drug is effective in use." Id. at § 355(b)(1). Other requirements address labeling information and manufacturing controls. Id. The warning letter asks Avon to review its website and product labels and requests a response within 15 days of receipt (October 20) detailing the steps the company has taken to correct the alleged violations. At least some of the accused descriptions still seem to remain on Avon's website.
The Avon letter is just one example of recent regulatory oversight of marketing in the cosmetics industry. FDA also sent letters to Bioque Technology, on October 5, to Lancome USA (a unit of L'Oreal SA - the world's biggest cosmetics group), on September 7, and to Andes Natural and Janson-Beckett, on September 21, warning of similar marketing violations by a number of their anti-aging and other skincare products. Regulatory Focus notes that, in the past, FDA rarely pursed cosmetics manufacturers for violations of the Food, Drug, and Cosmetic Act, except where products posed a serious risk to consumers. These letters could be an indication that the Agency is changing course. Notably, FDA's September 2011 Marketed Unapproved Drugs - Compliance Policy Guide lists "drugs with potential safety risks" and "drugs that lack evidence of effectiveness" as FDA's highest enforcement priorities. Should Avon or the other companies be forced to submit NDAs for their products and/or suspend sales, the approval process could take years and cost billions: nearly $3 billion worth of anti-wrinkle products were sold last year alone.
