• by Thom Forbes  @tforbes, September 12, 2012

A Food and Drug Administration warning letter to L'Oréal's Lancôme USA president, Serge Jureidini, about the way the company is marketing some of its anti-wrinkle products indicates that the agency may be tightening its tolerance of claims made by new-agey products that purport to “affect the structure or any function of the human body.”

“The letter represents a rare FDA rebuke of a major cosmetics maker and takes aim at the lucrative and growing market for so-called premium anti-aging products,” report Jennifer Corbett Dooren and Emily Glazer in the Wall Street Journal.

The FDA letter specifically cites claims such as:

• “boosts the activity of genes and stimulates the production of youth proteins.” (Génifique Youth Activating Concentrate, Génifique Eye Youth Activating Eye Concentrate, and Génifique Cream Serum Youth Activating Cream Serum);
• “Immediate lifting, lasting repositioning. Inspired by eye-lifting surgical techniques . . . helps recreate a younger, lifted look in the delicate eye area.” (Rénergie Microlift Eye R.A.R.E.™ Intense Repositioning Eye Lifter);
• “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.” (Absolue Precious Cells Advanced Regenerating and Reconstructing Cream SPF 15 Sunscreen)

Michael W. Roosevelt, acting director of the office of compliance at the Center for Food Safety and Applied Nutrition, signed the letter, which was dated Sept. 7 and sent via certified mail.

"We are aware of FDA's letter to Lancôme and will respond to their regulatory concerns in a timely manner," a L'Oréal spokeswoman says. "Lancôme is committed to complying fully with all laws and regulatory standards."

“The FDA’s Warning Letter to Lancôme signals a potentially significant new enforcement position that the agency may be taking towards cosmetics, and, more specifically, towards cosmeceuticals that include scientific language to describe their biologically enhanced benefits,” according to an article posted by the Washington, D.C.-law firm Arent Fox.

“While the allegedly violative products do not explicitly claim to treat diseases or health conditions, it appears that their references to biological activity involving ‘genes,’ ‘proteins,’ ‘stem cells,’ ‘peptides,’ and ‘collagen’are viewed by the FDA as being outside the realm of what the agency considers to be acceptable cosmetic claims,” the firm maintains. “This is significant because nearly identical claims for cosmetics and cosmeceuticals have become commonplace in today’s ‘new age’ cosmetics market.”

The letter specifically addresses 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.

The FDA believes that the cited products “appear to be promoted for uses that cause these products to be drugs under section 201(g)(1)(C) of the Federal Food, Drug, and Cosmetic Act.” It gave L'Oréal's Lancôme USA 15 working days to either detail in writing the specific steps it has taken to correct the alleged violations or to submit arguments why it does not believe that its products do not violate the Act.

“Failure to fix the advertising claims could lead to enforcement actions, such as seizure of the products and injunctions against their manufacturers and distributors,” reports Reuters’ Anna Yukhananov.

The FDA letter points out that a new drug may not be legally marketed in the U.S. without prior approval from the agency in the form of an approved New Drug Application (NDA). A description of the new drug approval process can be found on the FDA's website.

The Lancôme USA website makes no mention of the letter as of this morning, and reactions from other cosmetics companies and beauty bloggers has been muted so far. 

Charlestowngirl, however, writes in her “Best Things in Beauty” blog: “I knew it was only a matter of time before the [FDA] took a close look at the anti-aging claims being made for skin care.” Further down in her post, she says: “I've asked many skin-care companies how they were able to make the claims they did, and the universal response has been something like, ‘We work very closely with the FDA.’”

L'Oreal is the world's largest cosmetics maker. Apparently, that working relationship is taking a different direction.