2012 > 09

On Friday, Sept. 7, 2012, FDA sent beauty giant L'Oreal a warning letter regarding its luxury line, Lancome USA, and claims associated with its Génifique, Absolue and Rénergie products. According to FDA, the claims associated with these products classifies them as drugs, as they imply the products are "intended to affect the structure or any function of the human body, rendering them drugs under the Federal Food, Drug, and Cosmetic Act."

Some of the claims include: "Boosts the activity of genes and stimulates the production of youth proteins," and "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."

FDA said "Your products are not generally recognized among qualified experts as safe and effective for the above referenced uses and, therefore, the products are new drugs." The agency went on to say its letter is not exhaustive of all the violations associated with the company's products.

"It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations. We advise you to review your website, product labels and other labeling for your products to ensure that the claims you make for your products do not reflect intended uses that cause the distribution of the products to violate the Act.

"We request that you take prompt action to correct all violations associated with your products, including the violations identified in this letter. Failure to do so may result in enforcement action without further notice. The Act authorizes injunctions against manufacturers and distributors of illegal products and seizure of such products."

Since L'Oreal is the largest cosmetic company in the world, FDA's letter may be more than just a warning to the company; it may be a warning to the industry as a whole. Everyone knows drugs need pre-market approval and cosmetics don't; so when companies' product claims are suggesting an affect on the structure or the function of the body, they better have filed for a new drug application (NDA). In the case of Lancome, although FDA did highlight some specific claims and products, its warning letter is really a blanket scolding for its entire collection. That's a lot of clean up work. I think it's wise for cosmetic companies large and small to use this warning letter proactively by evaluating their current product claims and ensuring they're within the legal confines of cosmetic claims.

Claims about anti-aging creams increasingly blur the line between drugs and cosmetics, a problem for consumers given how differently the two product classes are regulated for safety and efficacy. 

The U.S. Food and Drug Administration, FDA, has warned Lancôme to stop making grand claims for several of its anti-aging products - claims that would require the agency to approve them before the products could be sold to consumers.
The agency's letter told the company, a division of global cosmetics maker L'Oreal, that marketing materials for its Génefique, Absolue and Rénergie lines may not promise that the products will actually remove wrinkles and restore skin density.
Products that make these types of "structure/function" claims - rather than just promising to make consumers more beautiful - are classified as drugs and require the agency's approval before they can be sold, FDA told the company. It gave Lancôme 15 days to prepare a plan to correct the violations and describe how it will ensure that they do not occur again.

If companies want to sell products that truly defy aging, they should have to prove to the FDA that their products actually live up to the hype. Unlike drugs, cosmetics do not require premarket approval by the FDA, and the agency does not assess whether they are safe or effective before. The FDA has issued multiple warning letters this year to companies making claims similar to Lancôme's.
The Lancôme claims cited by the FDA included these:

Génifique Youth Activating Concentrate, Génifique Eye Youth Activating Eye Concentrate, and Génifique Cream Serum Youth Activating Cream Serum - "boosts the activity of genes and [stimulate] the production of youth proteins."
Génifique Repair Youth Activating Night Cream - "boosts the activity of genes."
Absolue Precious Cells Advanced Regenerating and Reconstructing Cream SPF 15 Sunscreen - "See significant deep wrinkle reduction in UV damaged skin, clinically proven."
Rénergie Microlift Eye R.A.R.E.™ Intense Repositioning Eye Lifter - results in "Immediate lifting, lasting repositioning. Inspired by eye-lifting surgical techniques... helps recreate a younger, lifted look in the delicate eye area."

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