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In my November 2017 column, I wrote about the Food and Drug Administration (FDA) appearing to finally begin cracking down on the unscrupulous stem cell industry that for more than a decade had preyed on vulnerable patients by offering modern-day snake oil.[1] That column was prompted by the FDA announcing in August 2017 that it had taken enforcement actions against two stem cell businesses — one in Florida[2] and the other in California[3] — for illegally marketing unapproved stem cell...
In my November 2017 column, I wrote about the Food and Drug Administration (FDA) appearing to finally begin cracking down on the unscrupulous stem cell industry that for more than a decade had preyed on vulnerable patients by offering modern-day snake oil.[1] That column was prompted by the FDA announcing in August 2017 that it had taken enforcement actions against two stem cell businesses — one in Florida[2] and the other in California[3] — for illegally marketing unapproved stem cell products for diseases such as Parkinson’s disease, diabetes and cancer.
By the time of the FDA’s 2017 enforcement actions, the number of clinics in the U.S. that peddled unproven stem cell “treatments” — which are considered to be drugs and biological products under federal regulations — directly to consumers had exploded from a handful in 2010 to 570 in 2016.[4],[5] Thus, the Florida and California stem cell clinics targeted by the FDA in 2017 represented only the tip of the iceberg for this troubling industry.
Disturbingly, rather than pursuing and shutting down all stem cell clinics that were marketing unproven and potentially dangerous therapies, the FDA in November 2017 announced a risk-based policy of “enforcement discretion” for a period of 36 months to allow stem cell clinics time to submit the required applications to the agency for approval of their products[6],[7] — a policy that amounted to a temporary “get out of jail free” card for most illegal stem cell clinics. And in 2020, the agency extended this policy for another six months (until May 31, 2021).[8]
Predictably, the FDA’s permissive enforcement discretion policy fostered the dramatic expansion of the illegal stem cell clinic industry. According to a study published on Nov. 4, 2021, in the journal Cell Stem Cell, as of March 2021, 1,480 U.S. businesses operated 2,754 clinics that marketed unapproved stem cell treatments directly to consumers for a wide range of diseases and injuries, which represented a more than fourfold increase in the number of such clinics since 2016.[9] California, Florida and Texas each have more than 300 stem cell clinics.
The Cell Stem Cell study found that of all U.S. businesses promoting stem cell products in the U.S. without FDA approval or evidence of safety and effectiveness, 671 (45%) sell autologous (cells obtained from and injected back into the same patient) bone-marrow–derived stem cells, and 437 (30%) market autologous adipose (fat)-tissue–derived stem cells.[10] Among the diseases and conditions these businesses claim to treat are Alzheimer’s disease, cardiovascular disease, cancer, diabetes, hair loss, hearing loss, liver disease, orthopedic problems, spinal cord injury and vision problems.[11]
In order to protect patients and public health, the FDA must take swift and aggressive enforcement actions against stem cell clinics that continue to manufacture or market stem cell products without the necessary FDA approval or substantial evidence of safety and effectiveness from rigorous clinical trials.
References
[1] FDA cracks down on illegal stem cell treatments. Worst Pills, Best Pills News. November 2017. https://www.worstpills.org/newsletters/view/1160. Accessed February 7, 2022.
[2] Food and Drug Administration. FDA news release: FDA warns US Stem Cell Clinic of significant deviations. August 28, 2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm573431.htm. February 7, 2022.
[3] Food and Drug Administration. FDA news release: FDA acts to remove unproven, potentially harmful treatment used in ‘stem cell’ centers targeting vulnerable patients. August 28, 2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm573427.htm. Accessed February 7, 2022.
[4] Associated Press. Stem cell clinics run amok amid lack of regulation. The Mercury News. May 18, 2015 (updated August 12, 2016). http://www.mercurynews.com/2015/05/18/stem-cell-clinics-run-amok-amid-lack-of-regulation/. Accessed February 7, 2022.
[5] Turner L, Knoepfler P. Selling stem cells in the USA: Assessing the direct-to-consumer industry. Cell Stem Cell. 2016;19(2):154-157.
[6] Food and Drug Administration. Notification of availability: Regulatory considerations for human cells, tissues, and cellular and tissue-based products: minimal manipulation and homologous use; guidance for industry and Food and Drug Administration staff; availability. November 17, 2017. https://www.regulations.gov/document/FDA-2017-D-6146-0001. Accessed February 7, 2022.
[7] Food and Drug Administration. Regulatory considerations for human cells, tissues, and cellular and tissue-based products: Minimal manipulation and homologous use; Guidance for industry and Food and Drug Administration staff. November 2017 (corrected December 2017). https://www.regulations.gov/document/FDA-2017-D-6146-0003. Accessed February 7, 2022.
[8] Food and Drug Administration. Notice: Regulatory considerations for human cells, tissues, and cellular and tissue-based products: minimal manipulation and homologous use; guidance for industry and Food and Drug Administration staff; availability. July 21, 2020. https://www.regulations.gov/document/FDA-2017-D-6146-0006. Accessed February 7, 2022.
[9] Turner L. The American stem cell sell in 2021: U.S. businesses selling unlicensed and unproven stem cell interventions. Cell Stem Cell. 2021;28(11):1891-1895.
[10] Ibid.
[11] Ibid.
