January 27, 2021

The Niche

Trusted stem cell blog & resources

FDA warning letter to stem cell facial cream maker

The FDA has issued a warning letter to Cell Vitals, a company that manufactures and sells stem cell facial creams. Cell Vitals is apparently owned by Irene Hardy according to the letter and the business has an address in Irvine, CA. A screenshot from their website is shown below.

Cell Vitals

The stem cell creams sold by Cell Vitals are called “ReLuma Advanced Stem Cell Facial Moisturizer”, “ReLuma Skin Illuminating Stem Cell Anti-Aging Cleanser”, and “ReLuma Stem Cell Eye Cream”. The creams, listed on the skin care webpage of the company, range in price from $108.75-$165 on sale.

Notably, the FDA considers these creams to be biological drugs based on this statement in the warning letter ” (the creams) appear to be promoted for uses that cause these products to be drugs under section 201(g)(1)(B) and/or 201(g)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B) and § 321(g)(1)(C)].”

The FDA’s primary concerns seem to be that these creams have a variety of components that could have drug-like activity including adipose stem cell conditioned media and the creams are not known to be safe or effective. These stem cell cream drugs are also misbranded according to the letter.

This particular warning letter was taken not by the FDA Center for Biologics Evaluation and Research (CBER), but rather by the FDA Center for Food Safety and Applied Nutrition.

Two years ago the FDA issued a warning letter L’Oreal/Lancome for their stem cell creams and to another stem cell cream maker. These 2012 warning letters also came out of the FDA Center for Food Safety and Applied Nutrition.

I support these actions by the FDA on the stem cell cosmetic drugs, but I think they need to be doing more on the dubious stem cell clinic front. There has been zero apparent FDA action in 2014 on more than 100 dubious stem cell clinics in the US that inject unapproved and unlicensed stem cell concoctions internally into patients, posing a much graver risk than a facial cream.

I asked the FDA CBER about regulation of stem cell drug products such as SVF and the lack of action related to dubious clinics in an interview posted earlier this week, but they were not willing to say much. For context, the FDA issued multiple warning letters against stem cell clinics in both 2012 and 2013 when there were far fewer dubious clinics than today.

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