FDA WARNING_LETTER - Human Microbes - March 12, 2024

The FDA issued Warning Letter #CBER-24-672740 to Mr. Harrop on February 9, 2024, following a February 2024 review of www.humanmicrobes.org. The website offers fecal microbiota for transplantation (FMT) products (capsules, enemas, infusions) for sale in the United States, Canada, and other regions, intended for treating or preventing various diseases. A YouTube video titled “We want your poop” also promotes these products.

The FDA determined these products are unapproved new drugs under section 201(p) of the FD&C Act [21 U.S.C. § 321(p)] and unlicensed biological products under section 351(i) of the PHS Act [42 U.S.C. § 262(i)]. They lack an approved Biologics License Application (BLA) or an approved application under 21 U.S.C. § 355, and no Investigational New Drug (IND) application is in effect. This constitutes a violation of 21 U.S.C. § 331(d) for introducing unapproved products into interstate commerce.

The FDA noted that the products do not fall under the November 2022 enforcement discretion policy for FMT to treat *Clostridioides difficile* (C.