Wednesday, September 12, 2012

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

19 comments:

Modesty Brown said...

Excellent post. I've lost count at how many times I have rolled my eyes at claims that just can't possible be true. As you quite rightly mention, in many cases, if the claims were true, they would be drugs and require proper trials.

I think most often they get away with it because the ingredient CAN do the things they claim (in vitro) but it ISN'T going to get the opportunity in practice as it's not in a vehicle which it allows it to penetrate the epidermis! I will be watching out for the response from Lancome with interest.

Charleston Girl said...

Hi Modesty!

That was a wake-up call from the FDA. I knew it was coming, and I'm surprised it took so long.

I hate to say it, but many of my favorite brands claim their products penetrate the epidermis. If they do, then the FDA is giving them a chance to prove it, unfortunately with a very expensive process to prove efficacy as a drug.

tweeymma said...

I'd be interested in knowing if that have singled out that $500 orchid-based serum made by Guerlain. Worse than penetrating the epidermis, they claim it works from the inside out. I was outraged while being pressured to buy this.

Charleston Girl said...

Hi Tweeymma,

I think it's only a matter of time before the FDA gets around to everything on the counter. I got a chuckle out of the Guerlain claims. They train the SAs to spout that stuff. Most SAs have little training in science and dermatology, so they believe it. I've had them get annoyed when I said there was "no way." :)

Eileen said...

Woo-hoo! It's about time. There are some wonderful products on the market that do, indeed, help to refine, moisturize, lighten, smooth, etc., but the pseudo-scientific claims that are often made are totally rediculous. Add to that the photoshopped images that accompany such balderdash and you've got a drastic misrepresentation of what the product is capable of achieving. All that being said, Lancôme does make some fine products that work well for legions of women. They don't need to resort to misleading/false copy in their promotions.

Lancôme is just one of a large number of brands that are guilty of doing this. Perhaps they were targeted first because they have also been highly criticized for their extreme photoshopping that adds to the misleading nature of their advertising. I'd really love to see the FDA send letters to all the companies that are playing this game. An honest approach in advertising will not deter women from purchasing a product that improves the look of their complexion.

Hi Modesty,

You make an excellent point with your comment about things working in vitro that don't work when applied topically to the skin. And, I'm sure you are right that that in vitro disclaimer that is usually in tiny print at the bottom of the ad is how a brand gets away with a lot of the claims that are made. Such a game!

Lulle said...

I'm very curious to see how this crisis will develop...

And I also wonder what took them so long! Excessive claims about the biological effect of skincare on the cellular level has been around for a while.

Charleston Girl said...

That's an interesting thought, Eileen. Maybe they were targeted for the Photoshopping. I suspect that since L'Oreal is the #1 beauty brand in the world, it was a shot over the bow at the top.

Charleston Girl said...

LOL, Lulle. The only ones who will see it as a crisis are the skin-care companies. :)

lovethescents said...

Oh good. Finally. Thank you, C-girl for your article. I didn't realize the FDA did it, and I'm hoping other federal agencies will follow. The deception is irritating, and definitely immoral.

Crista said...

Yay - about time! I bet Paula Begoun is happy about this! ;)

britishbeautyblogger said...

This has been too long in coming really for any brand. Even journalists get baffled with the super-science that goes along with information we are given - it is no possible to understand a lot of what we are told without a specific science background. I am always sceptical of claims and in fact largely ignore them.. I need to see it in action, despite claims, before I can even begin to believe. Products are given tags such as 'penetrates deep into the epidermis'..the average consumer has no clue how deep it needs to go to make a difference, and deeper must be better, right? More magical and more efficacious even though the ingredients that are in the product aren't in a form that can do anything much, deeply or otherwise. It's as much about consumers are happy to believe as it is about what brands are happy to claim. xx

Charleston Girl said...

Hi Lovethescents,

I heard it on the radio while commuting and looked up the FDA Web site the moment I got home! Big news.

Charleston Girl said...

Hi Crista,

I don't follow Paula, but I suspect she will be pleased.

I stopped reading her when she started rating all competitors to her own products as inferior. It would be better if she were truly independent.

Charleston Girl said...

Hi BritishBeautyBlogger!

Ditto! Well said!

Dovey said...

Hi Charlestongirl, Thanks for posting this. Like many of the above commenters I tune out a lot of the fancy claims. Despite knowing that they're unfounded, I think I am influenced on a subconscious level to think these products may be better than products without ridiculous claims (though it should really be the other way around).

Charleston Girl said...

Dovey, it's so complicated. I have often wondered if some products really do penetrate the epidermis, but the makers won't overly advertise that for fear of the FDA. I know one company that is very careful about what they say in print, but will explain the science privately. I am going to call them as soon as I have time to get comment.

Courtney said...

It's about time, huh? With so many anti-aging products on the market, the FDA should hold them to higher standards especially since a large majority of them essentially promise to turn back the hands of time

Charleston Girl said...

Hi Courtney!

Don't you wonder how and why it took so long?

I think certain products can help slow the signs of aging, and if your skin needs help, they can turn back the clock. Those of us who use great skin-care products don't, as a rule, look our age.

I'll share one funny observation. There is a woman (maybe in her 60s) whose skin is Gawd-awful who comes to a pricey brand's master classes in my area. Apparently, she has bought everything. She takes pride in "tanning," and she is dark for someone who should have light to medium skin. She looks terrible. Her skin looks like leather, and she is deeply wrinkled. NO product can undo what she is doing to her skin.

Paula said...

Thank you for this post..... but I used Lancome to prepare for my wedding because I was told that it does have a glow effect.... and I used it for 2 months before the wedding..... it DOES work. But its good the FDA warned them not to exaggerate their claims ! Thanks again.