Human Microbes

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Your products are not the subject of an approved BLA or an approved application under 21 U.S.C. § 355. In addition, there is no IND in effect for their use. Therefore, your products are both unapproved new drugs and unlicensed biological products.

Passage 2

Based on a review of your website, you offer FMT for treatment of diseases and conditions other than C. difficile infection. As noted in FDA’s November 2022 guidance, data related to the use and study of FMT to treat diseases or conditions other than C. difficile infection not responding to standard therapies are more limited, and study of FMT for other uses is not included in the aforementioned enforcement policy.

Passage 3

Although your website recommends that patients “discuss their plans with their doctor,” it offers your products directly to patients, including for self-administration. For example, your website indicates that donors can ship your products directly to patients and provides instructions on methods of self-administration. Therefore, there is no assurance that a licensed health care provider treating each of these patients is directing the screening and testing of the stool donor and stool for the patient, as described in the November 2022 guidance.

Passage 4

Your products also raise potential significant safety concerns due to inadequate donor screening. We also note the reported safety concerns described in the “donor results spreadsheet” on your website (e.g., “increased intestinal pain, nausea, sweating, and loss of appetite among other things”).