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FDA Issues Warning to MG Infusions Over Unapproved FMT Products
The FDA has issued a Warning Letter to MG Infusions for illegally distributing fecal microbiota transplant (FMT) products—such as capsules and enema infusions—without required approvals. MG Infusions claimed its products could treat or prevent illnesses like Clostridium difficile, ulcerative colitis, and IBS, classifying them as drugs and biological products under the FD&C Act and PHS Act.
However, the company does not have FDA approval through a New Drug Application (NDA) or Biologics License Application (BLA), making their sale unlawful.
The FDA emphasized that unapproved FMT products pose risks and must meet regulatory standards for safety, efficacy, and quality. The agency urged MG Infusions to take immediate corrective action, warning of potential seizures or injunctions if violations continue.
19-04-2025