On September 7, 2012, the FDA issued a Warning Letter to Lancȏme USA, a subsidiary of L’Oreal, advising that claims made on Lancȏme's website for a series of products sold under names containing “Youth Activating” and “Regenerating and Reconstructing” caused the products to be drugs under the Food, Drug, and Cosmetic Act. (the FDA sometimes considers websites to be “labeling” or, alternatively, evidence of intended use) In its letter the FDA stated that the listed claims were only “some of the claims” the FDA observed on Lancȏme's website that were problematic. The FDA gave Lancȏme the standard 15-business-day period within which to respond to the Warning Letter.
Of note here is that the Warning Letter was issued by the FDA’s Center for Food Safety and Applied Nutrition (CFSAN) and not one of the agency’s Regional Field Offices, which have been responsible for most of the Warning Letters issued to cosmetic companies whose claims had crossed over what is popularly called the "drug/cosmetic line," thereby rendering the products drugs that were unlawfully on the market. The significance of this Lancȏme Warning Letter, beyond the specific claims issues that it raises, is the fact that the letter was issued directly by CFSAN, where the Office of Cosmetics and Colors, which has primary regulatory responsibility for cosmetic products, is located. This could indicate that the Office of Cosmetics and Colors, which has been the subject of Congressional criticism because of its inactivity in recent years, will now become more active. A second Warning Letter, issued to Greek Island Labs on September 7, 2012 as well, suggests we should expect greater activity.
It will probably take time before we can be certain whether this is a single Warning Letter or whether the Office of Cosmetics and Colors is positioning itself to become more active in the claims area – taking on the role it took back in the late 1980s, when the Office was responsible for sending over thirty Warning Letters to larger companies, advising them that their marketing claims transformed their products into illegal drugs. It is important to keep in mind that, in addition to the Warning Letters in the late 1980s, the FDA at that time sent inspectors out to make rounds to all of the major cosmetic companies to “encourage them” to drop the claims. There were threatened seizures at that time and at least one customs detention. This activity was the genesis of the FDA’s current import alert for “anti-aging” products.
Because federal action has been shown to encourage consumer class action lawsuits, we recommend that organizations review their claims, continue to be vigilant, and watch to see whether the Lancȏme letter will be a singular incident or an indication of a new initiative on the part of the FDA.
The Lancȏme website claims identified in the Warning Letter include the following:
Génifique Youth Activating Concentrate, Génifique Eye Youth Activating Eye Concentrate, and Génifique Cream Serum Youth Activating Cream Serum:
- “[B]oosts the activity of genes and stimulates the production of youth proteins.”
Absolue Precious Cells Advanced Regenerating and Reconstructing Cream SPF 15 Sunscreen:
- “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.”
- “See significant deep wrinkle reduction in UV damaged skin, clinically proven.”
Rénergie Microlift Eye R.A.R.E.™ Intense Repositioning Eye Lifter:
- “Immediate lifting, lasting repositioning. Inspired by eye-lifting surgical techniques...helps recreate a younger, lifted look in the delicate eye area.”
- “[U]nique R.A.R.E. oligopeptide helps to re-bundle collagen.”