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L'Oréal Receives A Warning Letter From the FDA for Drug Claims

Posted: September 25, 2012

The US Food and Drug Administration (FDA) has issued a warning letter to L'Oréal for gene, stem cell and skin regeneration claims associated with Lancôme products. According to the FDA, the claims used for the 10 identified products can be interpreted as altering the structure and function of the skin and, therefore, classify the products as drugs.

Génifique's Youth Activating Concentrate, Eye Youth Activating Eye Concentrate, Cream Serum Youth Activating Cream Serum and Repair Youth Activating Night Cream are associated with claims to boost the activity of genes. Absolue Precious Cells Advanced Regenerating, Reconstructing Cream SPF 15 Sunscreen, Eye Precious Cells Advanced Regenerating and Reconstructing Eye Cream and Night Precious Cells Advanced Regenerating and Reconstructing Night Cream are associated with claims to improve the condition around stem cells and stimulate cell regeneration to reconstruct denser skin. Finally, Microlift Eye R.A.R.E. Intense Repositioning Eye Lifter claims to immediately lift skin and rebundle collagen.

The FDA advised the company to review claims associated with these products to ensure that they comply with the Food, Drug, and Cosmetic Act. L'Oréal has 15 days to respond to the letter with its plan of action, without which injunctions and seizures can take place.