The U.S. Food & Drug Administration (FDA) just issued a warning to cosmetics giant, Avon Products, as part of its crackdown on the marketing of cosmetic products. Avon maintains global operations and is headquartered in Manhattan.
Marketing assertions made by a number of cosmetics firms involve claims that are only permitted for approved pharmaceutical products, explained Regulatory Focus. The agency warning is the fourth of its kind issued over the past two months. Prior warning letters, which are notices of intended regulatory action, were sent to Lancôme USA, which is a subsidiary of L’Oreal subsidiary; Andes Natural Skin Care, which is based in Nevada; and Janson Beckett, which is located in New Jersey. All of the FDA letters alleged the firms marketed their products using improper claims.
Regulatory Focus noted that the regulatory agency does not typically target cosmetics manufacturers, except in cases that present serious health risks to consumers, as was the case with Brazilian Blowouts, a hair straightening product and allegations it contains formaldehyde. It seems, said Regulatory Focus, that in view of this fourth warning letter, FDA may be changing its tactics.
The recent warning letter alleges that Avon’s products, “appear to be intended for uses that cause these products to be drugs under the Federal Food, Drug and Cosmetic Act (FD&C Act),” according to Regulatory Focus. Under the Act, a product cannot be marketed as having effects on the human body’s structures or functioning unless FDA approval was received deeming the product a new drug product, or unless the product meets the standards in place for an over-the-counter (OTC) monograph, Regulatory Focus explained.
The FDA letter claims that a number of products marketed by Avon violate the Act’s regulations, including Avon’s Anew Clinical Advanced Wrinkle Corrector Products. These products, said Regulatory Focus, tout the cosmetics’ ability to rebuild collagen, stimulate elastin to “improve elasticity and resilience,” and regenerate hydroproteins to reduce skin creasing, according to the letter. The claims also state that the products “tighten connections between skin layers, repair micro-injuries and fortify damaged skin tissue,” said Regulatory Focus.
Specifically, the FDA letter stated that “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 appear to be intended for uses that cause these products to be drugs” under the Act. The FDA went on to say that Avon’s “products are not generally recognized among qualified experts as safe and effective for” the cited uses and, because of this, “are new drugs” under the Act.
Avon was given 15 days to respond to the letter and was told that the warning was “not an all-inclusive statement of violations associated with” the identified products, nor had the FDA “attempted to list” all of Avon’s products promoted on its web site. It is Avon’s responsibility to ensure all the products it markets are in compliance with the Act, the FDA pointed out.