Wednesday, September 12, 2012
Yesterday, the FDA announced that Lancôme USA, a unit of L'Oreal, has claimed that some of its skin care could "boost the activity of genes" or "stimulate cell regeneration" to reduce the signs of aging.
Any product that is intended to alter the structure or function of the human body and its cellular functioning is classified as a drug, according to a warning letter posted on the FDA's Web site yesterday. Companies are not allowed to sell "drugs" in the United States without demonstrating to the FDA that their products are safe and effective - as drugs. Lancôme has not submitted the appropriate data required to market their products as drugs, but, according to the FDA, their marketing is making claims reserved for drugs. They aren't alone. Beauty companies have skated precariously close to the edge on the requirements for years.
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." Some companies made nuanced claims in writing while their representatives have explained drug-like effects.
L'Oreal said it was committed to complying with all laws and regulatory standards. "We are aware of the FDA's letter to Lancôme and will respond to their regulatory concerns in a timely manner," a company spokeswoman said.
Some of the products mentioned in the letter, dated September 7, include Genifique Repair Youth Activating Night Cream and Absolue Eye Precious Cells Advanced Regenerating and Reconstructing Eye Cream. Lancôme describes the Genifique Repair cream, which costs $98 for a 1.7-ounce container, as "our first night care that boosts the activity of genes." The company cites an in-vitro test on genes to back up the claim.
The FDA gave Lancôme 15 days to adjust its advertising claims and said that failure to do so could lead to enforcement actions, such as seizure of the products and injunctions against their manufacturers and distributors. This action will have repercussions far beyond Lancôme. There will be any number of skin-care companies scrambling to adjust their claims. Can you imagine what changing all that skin-care marketing is going to cost?
Update 9/15: Talked to someone in skin care from New York. He was not aware of the FDA's actions, but when we talked about what it would cost (marketing, packaging, training, etc.), he said it was going to be staggering industry-wide.
Photo courtesy of Lancôme