Lancôme USA, whose parent company is L’Oreal, has been issued a warning letter by the FDA for claims made on their website about the company’s Génifique products.
According to the FDA, the products in question appear to be promoted for uses that make them drugs “under section 201(g)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(C)].” Because the company states on their website that these products “are intended to affect the structure or any function of the human body,” they are rendered as drugs under the Act, which makes the marketing of these products with such claims a violation.
The FDA provides Lancôme USA with guidance about how to correct the violations and gives the company 15 working days of the receipt of the letter to demonstrate the specific steps that have been taken to address the violations.
According to an ABC News story on the warning, opinions among dermatologists about the accuracy of the claims is mixed. New York dermatologists Dr. Doris Day and Dr. Barney Kenet are both quoted in the article.
Dr. Kenet discusses the fact that far-reaching claims by cosmetic companies are nothing new, but that the warning in this case is unusual because these exaggerated claims are rarely acted upon. In regard to the Génifique products in question, Dr. Kenet states in the ABC News story: “If it truly modified the activity of the genes, it wouldn’t be sold over the counter, simple as that.”
According to Dr. Day, while some of the marketing campaigns for beauty products can be over the top, this does not necessarily mean that the product doesn’t work.
“Some over-the-counter creams are more effective than a prescription,” Dr. Day says in the ABC News story. “They may even be better than the claims they are allowed to make, but they want to stay under the FDA radar, so they have to be careful what they say.”
In the letter, which is addressed to Serge Jureidini, the president of Lancôme USA, the FDA names the following products: Génifique Youth Activating Concentrate, Genefique Eye Youth Activating Eye Concentrate, Genefique Cream Serum Youth Activating Cream Serum, Génifique Repair Youth Activating Night Cream, Absolue Precious Cells Advanced Regenerating and Reconstructing Cream SPF 15 Sunscreen, Absolue Eye Precious Cells Advanced Regenerating and Reconstructing Eye Cream, Absolue Night Precious Cells Advanced Regenerating and Reconstructing Night Cream, and Rénergie Microlift Eye R.A.R.E. Intense Repositioning Eye Lifter.
To read the warning letter from the FDA, please click here. To see the report from ABC News, please click here.
