FDA Cracks Down on Stem Cell Treatments

The beauty world became downright obsessed with stem cell–based treatments about 10 years ago when the very first claims—the growth of more stem cells that will lead to younger, healthier skin that doesn’t display the signs of aging—surfaced. From there, the trend exploded, cropping up in products, beauty treatments like stem cell facials, and even surgical procedures where, purportedly, stem cells are separated out from fat (removed during a liposuction-like procedure) and injected into the face. The common thread: The claim that the stem cells (or extracts) would magically erase the signs of aging.

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Over the years, many of these beauty-related therapies have been proven to be unsafe, unpredictable and unregulated. “The key thing in the area of stem cells is that there is potential hope. But at this point, the value of the science of stem cells in an aesthetic sense lags way behind the marketing hype that comes with these treatments and procedures,” says La Jolla, CA, plastic surgeon Robert Singer, MD. “At the moment, there are no FDA-approved stem cell procedures in the U.S. unless they are part of a specific study. There are also no FDA-approved stem cell–extracting devices for use in the U.S. Anyone doing something with stem cells for a cosmetic purpose is doing it without validity and are violating the guidelines and rules of the FDA. In fact, the FDA has already sent out a number of cease and desist letters to operating facilities."

In a nutshell, those commercials and advertisements you see for stem-cell facelifts that promise to make a 60-year-old look like a 30-year-old are nothing more than facelifts done in conjunction with, usually, fat transfer. “We don’t know if there is something in the fat, the plasma or other healing factors that provide results, but to claim that there are stem cells is inappropriate,” says Dr. Singer.

But, all that just may change. Come April, the FDA will hold a public hearing about stem cells and other things like fat injections. And this comes just months after the FDA issued new guidelines for “the homologous use of human cells, tissues and cellular and tissue-based products.” Dr. Singer says, “There have been so many abuses surrounding stem cells, so offices that claim to offer these stem cell procedures would have to obtain special licenses in order to say that they are truly doing something with stem cells.” 

Until then, the guidelines, rules and regulations stay the same. And, if you’re guaranteed a treatment or procedure with stem cells, you can pretty much guarantee it may as well not have them.

  • jeff horton
    Posted on

    The FDA is known for cracking down and dismissing anything that they can't profit from in some way.

  • Phillip Chang, MD
    Posted on

    Excellent article bringing attention to the promotion and use of products and services that are completely unproven. While it is true that stem cells have the ability to provide regenerative properties, it is not true that stem cells provide regenerative outcomes in all tissues and all conditions. At this point, promoting such services are misleading to the public. Until there are blinded randomized studies that treat two sides of a an individual patient in sufficient numbers ( which, by the way should not be difficult ) these patients should be warned.

  • Robert Bowen
    Posted on

    Please refer to the work of Sydney Coleman, M.D, Peter Rubin, M.D., Kataro Yoshimura, M.D. and other prominent plastic surgeons on cell assisted reconstructive, cosmetic surgery and regenerative medicine. The April FDA meeting referred to in the article was cancelled/postponed due to overwhelming outcry from the research community. Dr. Singer is certainly correct that there are false claims and hype from unqualified practioners, but this should be dealt with state medical boards or perhaps the FTC not the FDA. These autologous cell products are neither food or drugs.

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