The letter, which is addressed to Serge Jureidini, president of Lancôme USA, refers to a list of the company, highlights a total of 11 different skin care products marketed under the Génifique, Absolue and Rénergie brand names on the company’s US-dedicated website portal.
In the warning letter the FDA highlights its concern that all the products are marketed in such a way that they should be promoted as drugs under section 201 of the Federal Food, Drug and Cosmetic Act, because the products purport to affecting the structure or function of the human body, in this particular case, the skin.
“The claims on your web site indicate that these products are intended to affect the structure or any function of the human body, rendering them drugs under the Act. The marketing of these products with these claims evidencing these intended uses violates the Act,” stated the letter, penned by Michael Roosevelt, director of office compliance, at Center for Food Safety and Applied Nutrition.
This is the complete list of products highlighted in the warning letter:
- 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
- Rénergie Microlift Eye R.A.R.E. Intense Repositioning Eye Lifter
The FDA stated that it had observed product claims such as, ‘Boosts the activity of genes and stimulates the production of youth proteins’, ‘Boosts the activity of genes’ for products marketed under the Genefique name.
The Absolue range was earmarked for marketing claims that included “A powerful combination of unique ingredients – Reconstruction Complex and Pro-Xylane™, a patented scientific innovation-- has been shown to improve the condition around the stem cells and stimulate cell regeneration to reconstruct skin to a denser quality.”
Meanwhile, the promotional text for the Rénergie Microlift Eye product was cited for its ability to help ‘re-bundle collagen and a ‘lifted look in the delicate eye area’.
The warning letter goes on to state that the products are not recognized as safe and effective for these claimed references and requests that the company reviews the website and product labels to ensure that all the products throughout its portfolio comply with the FDA’s regulations specific to the effect they have to physiology or function of the body.
The company is also requested that it contacts the FDA department to outline the specific action it intends to take to ensure that the products comply with the Federal Food Drug and Cosmetic Act within 15 days.
FDA keeps a close eye on cosmetic product claims
The FDA regularly raps cosmetics companies over marketing claims associated with cosmetic and personal care products, and is particularly vigilant over anti-aging claims.
In July of this year, the FDA sent a warning letter to Set-N-Me-Free Aloe Vera that ‘Aloe Milk Moisturizing’, ‘Aloe Moisture Cream’, ‘Day-Night Emollients’, ‘Moisturizing Aloe Lotion’ and ‘Aloe Comfrey Gel’ amongst other items, were being promoted for conditions that cause the products to be drugs under the Federal Food, Drug, and Cosmetic Act.
In this complaint the organization cited concerns over the company’s ingredients claims, particularly Apricot Kernel oil in the brand’s Day-Night Emollient, which was claimed to be a natural source of cancer fighting laetryl lipids, a claim akin to the drug category.