Stem cell cosmetics is an exploding area ranging from facial creams (e.g. from L’Oreal and its Lancome) to face lifts to boob jobs to baldness treatments (see two key posts here and here for background and great stories).
The stem cell cosmetics field has not been held back by issues such as the fact that there is no science behind their expensive creams and treatments or that they do not have FDA approval.
Today the FDA gave the stem cell cosmetics field a wake up call in a big way.
The FDA issued warning letters (a very serious action by the FDA–see other examples here) to Lancôme and Greek Island Labs.
Lancome, owned by L’Oreal, was smacked down for a number of problems by the FDA related to several products claiming anti-aging efficacy. Just one example of a product mentioned by the FDA as problematic is shown in the image above, now for sale at Nordstrom for “only” $84.
Both companies received nearly identical verbiage in their letter indicating they had new drugs on their hands that they were pitching without FDA approval:
Your products are not generally recognized 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).
The stem cell cosmetics companies should not by any means believe they can bluff their way out of this. The FDA means business as indicated by the cautionary passage in the warning letter (emphasis mine):
We request that you take prompt action to correct all violations associated with your products, including the violations identified in this letter. Failure to do so may result in enforcement action without further notice. The Act authorizes injunctions against manufacturers and distributors of illegal products and seizure of such products.
Wow.
I applaud the FDA for these actions, but something does not add up here.
As much as the stem cell creams that concern the FDA also concern me, they seem relatively benign compared to actually injecting stem cells into patients. Thus, I am wondering why the heck the FDA seems to treat so many stem cell clinics without the appropriately firm approach seen here with the cosmetics companies?
Why so few warning letters?
Why the kid gloves on the clinics injecting grown stem cells into patients’ actual bodies, which is dramatically more dangerous than any cream applied to the skin?
I don’t get it.
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I too have a few questions, seems odd the FDA is playing super hard ball with the cosmetic industry…and yet…I ask
1. Who are the qualified experts, wouldn’t proving something doesn’t work take some time to test, or is it L’Oreal just meets “drug” status and that’s the rub here?
2. I would venture to say @ $85 a pop, that’s only 235 ageless beauty’s at the cash register……I would say the cumulative rip off here is in the $10-100 million range, and has mass media appeal?
I also don’t get it , pretty much most wrinkle creams are hope in a jar at best. Presumably by the time ‘cells’ are buffered with preservatives and processed they are just another form of inactive protein. Yet action seems slow and uncertain against non compliant clinics where there are real concerns for safety due to poor lab conditions and lack of scientific and medical expertise not to mention lack of evidence without substantial bias. Financially it is easier to recover from an 85.00 mistake than a 20,000.00 plus procedure
Perhaps it’s a matter of reach? As utterly baffling as I find the idea of spending $85 on a false promise, for a lot of woman, that’s an inexpensive price for hope. (And I admit that I may feel differently if I didn’t look quite a bit younger than I am.) I suspect that Lancome, for example, reaches far, far more women with their face serum than any of the stem cell injection companies do (yet), just due to cost/access.
You may be right, Kelly, but the risk from a cream seems so minimal compared to injecting say 1 billion amplified stem cells into a patient’s body. Also how does $85 compare to $20K for a stem cell treatment?
Something’s out of whack here in terms of the FDA’s relative level of response. I don’t get it.
Okay, I did some poking around. The OTC beauty industry as a whole is approaching USD 60 billion a year, and L’Oreal (who owns Lancome) just posted their first half 2012 sales, which is Euro 11.2 billion/USD 15 billion.
That’s a significant chunk of the market. How much of that is taken up by the single product, Genifique, is harder to determine. However, more interesting is the fact that the FDA made it clear that the issue went beyond named products and to anything that had similar advertising.
It seems to me that it may actually be a much larger amount of money than these stem cell clinics are generating – and again, a matter of reach.
That said, I agree that it’s much more problematic to be injecting things into people than smearing a very expensive cream on your face. It seems like the FDA has a very odd scale for measuring when to intervene, based on number of people affected rather than severity of the potential effect. I suppose it’s coolly utilitarian when you are having to base decisions from a limited budget on where you can have the most impact (reaching many more by going after L’oreal), but I wonder if going after the most impact by reducing harm wouldn’t be a better focus.