It’s a fact long understood by the beauty industry that if your product affects the structure of the human body or the way it works, it’s a drug. A cosmetic, on the other hand, is for cleansing, beautifying, promoting attractiveness or altering the appearance. A product may be both, but can only be classified as a drug if it has gone through rigorous testing by the FDA (the US Food and Drug Administration). In simpler terms, it’s the difference between a tube of lengthening mascara and a prescription of Latisse.
But try telling that to Lancôme. The FDA recently noticed that the L’Oreal-owned beauty brand makes some claims that make their products sound less like cosmetics and more like drugs. What do these amazing substances do? One claims to “[boost] the activity of genes and stimulates the production of youth proteins.” Another product, supposedly, “has been shown to improve the condition around the stem cells and stimulate cell regeneration to reconstruct skin to a denser quality.” Impressive!
Except that the FDA is far from amused. Or impressed. It has issued a warning letter (which is a very serious action) to the L’Oreal-owned brand, stating that only drugs are allowed to make such assertions and Lancôme has not submitted necessary data to market its product as a drug: “The claims on your web site indicate that these products are intended to affect the structure or any function of the human body, rendering them drugs under the Act. The marketing of these products with these claims evidencing these intended uses violates the Act.”
And: “Your products are not generally recognised among qualified experts as safe and effective for the above referenced uses and, therefore, the products are new drugs as defined in section 201(p) of the Act [21 U.S.C. § 321(p)]. Under section 505(a) of the Act (21 U.S.C. § 355(a)) a new drug may not be legally marketed in the U.S. without prior approval from FDA in the form of an approved New Drug Application (NDA).”
This is not the first time a beauty company has striven to create seductive messages while dancing up to the edge of what is legally acceptable to claim. For example, advertisements for ReVive Serum Presse (US$295) say that it “gives skin the look of instant lift and radiance….” Now, if “the look of” was left out, the company might be required to submit supporting evidence to the FDA. This is the fine distinction that Lancôme seems to have forgotten, thereby skating right over the line into murky waters that have put 8 of it’s most important skincare products in jeopardy:
- Génifique Youth Activating Concentrate
- Génifique Eye Youth Activating Eye Concentrate
- Génifique 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
- Rénergie Microlift Eye R.A.R.E. Intense Repositioning Eye Lifter
The FDA has asked the company to respond within 15 business days with a plan for toning down its language or risk having its product line yanked from the shelves. ”We are aware of FDA’s letter to Lancôme and will respond to their regulatory concerns in a timely manner,” said Rebecca Caruso, a L’Oréal spokeswoman. “Lancôme is committed to complying fully with all laws and regulatory standards.”
It shall be interesting to see how this plays out as the resolution could pretty well determine the future of the entire anti-ageing industry. On my end, I hope Lancôme can validate its claims – it would be heartening to have some hope as those sunburnt wrinkles and lines start their inevitable progress up my face. How do you think this will end? Can a bottle that costs US$89 and is sold on department store shelves really harness the complex field of stem cell research and turn back time?