Sharpless Puts Stem Cell Makers on Notice Following Judge’s Smackdown

July 3, 2019

Acting FDA Commissioner Ned Sharpless issued another warning to stem cell manufacturers following a judge’s permanent injunction against two Florida clinics, promising that the agency’s “aggressive oversight” will continue.

A U.S. district judge in the Southern District of Florida found that US Stem Cell Clinic of Weston and US Stem Cell of Sunrise adulterated and misbranded cellular products made from patients’ adipose tissue. The agency secured permanent injunctions barring the companies and their chief scientific officer Kristin Comella from making or distributing the products until they comply with the law.

“We know that there are clinics across the country that manufacture or market violative stem cell products to patients, claiming that they don’t fall under the regulatory provisions for drugs and biological products,” Sharpless said. “The FDA has consistently stated that this is not true, and the result of this case proves that.”

Sharpless warned stem cell companies that the agency intends to stay on their case — and said they aren’t coming into compliance fast enough.

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