FDA warning to stem cell cosmetics maker raises more questions about agency itself

The FDA has taken another action against a manufacturer of stem cell cosmetics in the form of anti-aging creams with a warning letter sent on April 20, 2016 to Crescent Health Center, Inc.

The FDA noted a number of issues in the warning letter that it termed “serious violations”, but the biggest issue was that the agency defined the anti-aging creams as unapproved drugs. The stem cell cosmetics in question are called “Ageless Derma Stem Cell and Peptide Anti-Wrinkle Cream” and “Ageless Derma Anti-Aging Intensive Skin Brightener Cream”. The letter was addressed to Dr. Farid A. Mostamand, CEO.

Ageless Derma Stem Cell and Peptide Anti-Wrinkle Cream
Screenshot from Amazon

In the past the FDA similarly warned L’Oreal/Lancome over its stem cell cosmetics products and another cream maker in 2014. However, as I noted recently you can get all kinds of similar “stem cell” cosmetic products with sky-high prices still these days at Nordstrom or elsewhere such as on E-bay or Amazon.

Update. I had originally written, “I found the Ageless Derma Stem Cell and Peptide Anti-Wrinkle Cream listed (image above), as offered by “Dr. Mostamand”, but now as of the same evening I wrote this post, this product seems to have disappeared from Amazon. In fact there are no products listed anymore for “Dr. Mostamand” on Amazon that I can see.

The FDA noted a number of medical claims on the company’s websites including  the following domains: www.skinbeautymall.com, www.agelessderma.com, and www.drskinspa.com.

This is a positive step by the FDA, but frankly there are countless other similar stem cell anti-aging creams products and companies out there so the agency needs to take more systematic action if it is going to pursue this. Warning one or two stem cell cream makers every few years is a real drop in the cosmetic bucket. What’s the rationale and fairness for warning one but not all the others?

Further, what about the very large and growing number of stem cell clinics injecting unapproved human “stem cell” drug products into patients’ bodies, and making unsupported medical claims about those far riskier procedures compared to the creams?

Why isn’t the FDA doing more on that front?

It should be noted that the different FDA Centers and offices each oversee products and can take actions. In the case of Crescent Health Center, it was the Los Angeles FDA office that sent the letter. Given that there are tons of stem cell clinics in the LA greater metro area including Beverly Hills, what action is that LA FDA office going to take (if anything) about those? If nothing, why not?

More broadly across America the FDA’s Center for Biologics Evaluation and Research (CBER) is most responsible for oversight of stem cells. While they did recently warn a string of three stem cell clinics, over the years CBER actions have been inconsistent and rare. They have dropped the ball on oversight of stem cell clinics, which is a real shame and has put thousands of patients at risk as well as risking harm to the whole stem cell field. Are they lacking the budget to handle a mushrooming stem cell clinic industry? Waiting to finalize their 4 recent stem cell-related draft guidances maybe ten years from now? Afraid of being sued by stem cell clinics?

Beats me.

8 thoughts on “FDA warning to stem cell cosmetics maker raises more questions about agency itself”

  1. “Perhaps”, “might”, “I wonder”, “I guess” …I’d rather leave it to those who have 100 years of history in the business, than go to a clinic whose therapeutic strategy is to hope and guess.

  2. It is difficult to imagine any way to waste more time on less than to take seriously all the nonsense spoken in the name of promoting this or that cosmetic cream.

    14000 people in the USA were killed by prescription opioids in 2014
    Now those would have been FDA-approved drugs, I guess? Perhaps the FDA is preoccupied cleaning up the other messes it has made.

    As for clinics using “unapproved stem cells”, these come in so many varieties that I find it impossible to generalize. Perhaps some of them work. Perhaps some of them are no better than a placebo. But even a stem cell placebo might save someone from getting on opioids. I wonder if more lives have been saved in that way than have been lost in the clinics that you worry about?

  3. @admin, it depends on how differentiated the biological product is. If we are talking about a non-processed substance (beyond separation), I can see little harm as do many of my peers who are in the scientific and medical community. In their opinion the only harm is time and $, so that is another issue. Putting creams with foreign objects on the skin can be harmful, for sure.

  4. @admin – There is a widening gap between academic and commercial enterprises in regards to the clinical trial process, said Arnold Caplan, PhD, from Case Western University, who coined the term mesenchymal stem cell in 1991 and is considered a founder of the field. “The whole value system of running a clinical trial and being judged against standard of care, which is a pharmacological concept, is completely illogical.”

  5. I really don’t think autologous stem cell treatments are harmful when performed by clinics operating with good standards that all medical professionals would come to consensus on. I am more upset by cosmetics that sound like they have stem cells in them, what the heck.

    1. @James, Thanks for the comment. But wouldn’t you say that injecting a biologic product into the blood stream or directly into the tissue of a patient is inherently of much higher risk than rubbing a cream on the skin? The latter isn’t risk free and could well be a waste of $$$, but to me at least it is not as risky as transplanting inside the body.

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