When does a cosmetic product become a drug? When it's marketed as having advanced features that alter the body's cellular state, explained the US Food and Drug Administration (FDA) in a warning letter sent 11 September 2012 to Lancôme USA, a subsidiary of cosmetics manufacturer L'Oreal.

The letter references a number of products marketed by Lancôme, many of which claim to promote a more youthful look and go by names like, "Génifique Cream Serum Youth Activating Cream Serum" and contain modifiers such as "Precious Cells Advanced Regenerating and Reconstructing Eye Cream."

Claims Allegedly Violate Federal Regulations

In its warning letter, FDA said the products' claims, contained on Lancôme's website, make claims indicating that they affect the function and structure of the human body, which would make them a drug as defined by the Federal Food, Drug and Cosmetic Act.

Among the claims identified by FDA as allegedly being improper include:

• "[B]oosts the activity of genes and stimulates the production of youth proteins."
• "[B]oosts the activity of genes."
• "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."
• "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."
• "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."

Potential for Product Seizure

Regulators demanded that Lancôme remove the marketing claims from its website, but the company has not yet complied with FDA's orders.

Further, some of the suspect claims appear on numerous products marketed by Lancôme. For instance, the entire product line of Génifique products uses the claim that the products, "Boosts the activity of genes."

Other claims on the website, such as one that claims to, "Support cellular communication," could also to fall into FDA's definition of drug products, though they were not listed specifically in FDA's warning letter. The agency's standard qualification-"This letter is not an all-inclusive statement of violations associated with your products or their labeling"-was also contained within the letter, and FDA said it had not attempted to find all violations present on the company's website.

The company has until 21 September 2012 to respond to the agency, after which time its products may be subject to an injunction and seizure by the agency.

An email requesting comment from L'Oreal was not returned by the time of this article's publication.