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Unlicensed, Unproven Stem Cell Treatments Flourishing as FDA Increases Oversight, Findings Show

Dec 27, 2021

In paywalled coverage, Bloomberg Law reports, “Stem cell clinics selling unlicensed, unproven treatments have increased four-fold in the last five years,” according to new findings published in Cell Stem Cell “that indicate the threat of federal enforcement isn’t discouraging these companies.” The research comes “about five months after the Food and Drug Administration lifted a three-and-half year grace period to allow these clinics to come into compliance with the agency’s regulations on human cells” and tissues.

The Verge says, “The rise in the number of businesses offering the treatments even in the face of FDA action shows that the odds of someone facing consequences are, on the whole, fairly low.” The article adds a FDA spokesperson “said…the agency doesn’t comment on individual studies, ‘but evaluates them as part of the body of evidence to further our understanding about a particular issue and assist in our mission to protect public health.’”

From the news release of the American Association for Justice.

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