The agency sent 20 letters to manufacturers and healthcare providers telling them that they may be providing unapproved stem cell products in violation of agency regulations.
In addition, Cord for Life, a Florida stem cell manufacturer, was warned of six regulatory violations that may put patients at risk. Specifically, the company was selling unapproved umbilical cord blood products in violation of manufacturing practice requirements.
“We remain very concerned that countless clinics across the country continue to market violative stem cell products to patients, claiming that they don’t fall under the regulatory provisions for drugs and biologics. This is simply not true,” an FDA news release states.
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