FDA WARNING_LETTER - MG Infusions - March 18, 2025

The FDA issued a Warning Letter to Mr. Garcia regarding the sale of Fecal Microbiota for Transplantation (FMT) products through mginfusions.com. The FDA determined these products, sold as capsules and enema infusions for treating various diseases like ulcerative colitis and irritable bowel syndrome, are unapproved new drugs and unlicensed biological products.

The products are classified as drugs under section 201(g)(1)(B) of the FD&C Act and new drugs under section 201(p) because they are not generally recognized as safe and effective. They are also biological products under section 351(i) of the PHS Act. Lawful marketing requires a valid Biologics License Application (BLA) or an approved application under 21 U.S.C. § 355, neither of which is in effect for these products. There is also no Investigational New Drug (IND) application.

The FDA's November 2022 enforcement discretion policy for FMT applies only to *Clostridioides difficile* infection not responsive to standard therapies, under specific conditions including licensed healthcare provider direction for donor and stool qualification. Mr. Garcia's products are offered for other conditions and shipped directly to patients for self-administration, lacking the required healthcare provider oversight. Additionally, the products raise significant safety concerns due to inadequate donor screening, thus not falling under the enforcement discretion policy.

The introduction of these products into