The FDA Gets Tough on Skin Care Claims

I knew it was only a matter of time before the U.S. Food and Drug Administration (FDA) took a close look at the anti-aging claims being made for skin care. I've discussed those claims here before, wondering how skin care could be billed as penetrating the surface of the skin to repair skin cells or alter their functioning. Those claims are reserved for FDA-approved drugs, but many beauty companies have made them, with seeming immunity.

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

FDA Warns Dermatologists

Today's New York Times featured an article by Natasha Singer titled "F.D.A. Aims at Doctors' Drug Pitches." All credit for reporting belongs to Ms. Singer and the New York Times. The article was so interesting to me, I want to encourage you to read it on the New York Times Web site. For those who don't have time, here's a recap.

The Food and Drug Administration (FDA) has regulations that prohibit clinical trial investigators from promoting drugs before they receive FDA approval. These regulations are intended to protect the public from unscrupulous investigators who "push" products that may not be deemed safe and/or effective once study results are examined by the FDA. So far, so good.

Now the FDA has turned its attention to the "rarified world" of fashion magazines and beauty editors, including Allure, and dermatologists who specialize in beauty, cosmedicine, injectables, and cosmetic surgery. The government agency recently warned Dr. Leslie Baumann (shown here - she looks great, huh?) that her comments to the media in 2007 regarding Dysport (an injectable anti-wrinkle drug that has not been approved) violated their regulations. Cited in the New York Times article were Dr. Baumann (frequently quoted in Allure) and Dr. Fredric Brandt, both considered "celebrity dermatologists."

The article left me wondering, "What's the difference between providing information and promoting an investigational drug?" Where do doctors draw the line between the public's insatiable appetite for news about beauty advances and promotion of unapproved drugs? I'll bet there are a lot of dermatologists trying to figure out what they can and cannot say - and to whom!

What do you think? Do you feel a need to be protected from advance information?

Photo and news courtesy of the New York Times