FDA Warning Letter to MG Infusions for Unauthorized FMT Product Distribution

The FDA reviewed MG Infusions’ website and found the company distributing fecal microbiota transplant (FMT) products—capsules and enemas—in the US, marketed to treat diseases like C. difficile infection and ulcerative colitis. These claims classify the products as drugs under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and as biological products under the Public Health Service Act (PHS Act).

MG Infusions lacks FDA approval for a New Drug Application (NDA) or Biologics License Application (BLA), making their distribution illegal. The FDA warned that manufacturing and selling FMT products without proper approval violates federal law and poses risks to public health. The company was urged to correct these violations immediately, or face regulatory actions including product seizure or injunctions.

28-05-2025