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MG Infusions was warned for illegally marketing and distributing fecal microbiota for transplantation (FMT) products in capsule and enema forms as drugs without FDA approval. The company's website made disease treatment and prevention claims for conditions including Clostridium difficile infection, ulcerative colitis, and irritable bowel syndrome, establishing the products as unapproved new drugs and biological products subject to FDA regulation. MG Infusions had not obtained the required Investigational New Drug (IND) application or Biologics License Application (BLA) necessary to legally market these biological products in the United States.