October 24, 2020

The Niche

Knoepfler lab stem cell blog

L’Oreal Lancome gets hammered by FDA, why kid gloves for clinics?

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).

L'Oreal Stem Cells
L’Oreal Stem Cell product.

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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