The US Food and Drug Administration (FDA) has taken aim at another of the cosmetic industry's giants over the use of marketing claims reserved for approved pharmaceutical products-its fourth warning to such a company in the last two months.
The agency had previously sent warning letters-advanced notices of intended regulatory action-to L'Oreal subsidiary Lancôme USA, Nevada-based Andes Natural Skin Care and New Jersey-based Janson Beckett, all of which were alleged to have been marketing their products using improper claims.
As noted in a previous Regulatory Focus report, the agency has rarely gone after cosmetics manufacturers, reserving such actions in the rare cases-such as with Brazilian Blowouts-when products posed an acute health risk to consumers.
But if a fourth warning letter to Avon Products, a New York-headquartered company with global operations, is any indication, FDA's reticence may be changing-and fast.
Its warning letter alleges the company'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)."
Under FDA's cosmetic regulations, no product can be marketed as having an effect on the structure or function of the human body without first receiving FDA approval as a new drug product, or meeting the standards set for an over-the-counter (OTC) monograph.
But numerous products marketed by Avon broke that regulation, claimed FDA. Its Anew Clinical Advanced Wrinkle Corrector products, for instance, claims to be able to rebuild collagen, stimulate elastin to "improve elasticity and resilience" and regenerate hydroproteins to reduce skin creasing.
Various other claims made about products include being able to tighten connections between skin layers, repair micro-injuries and fortify damaged skin tissue. As with all warning letters, FDA cautioned that its allegations did not necessarily constitute a full accounting of Avon's potential deficiencies, and urged the company to conduct its own review to ensure full compliance.
FDA, represented by its Center for Food Safety and Applied Nutrition (CFSAN), said the company has 15 working days to take "prompt action to correct all violations associated with your products or their labeling."
In a statement provided to Regulatory Focus, Avon spokeswoman Jennifer Vargas said the company is, "committed to complying with all applicable laws and regulations in the countries where we do business."
"We have received the letter, and intend to work with the FDA to resolve this matter."
The company's claims-and FDA's response-are similar to those of Lancôme, Andes and Janson, all of which claimed to be able to regenerate, repair and heal skin. Andes' claims went further, however, and alleged the ability to boost the immune system, form new capillaries and inhibit the growth of pathogenic bacteria, among other contested claims.
Update: A fifth warning letter, sent to Bioque Technologies, is highly similar to all four letters referenced above.