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# FDA Grants, Denies Parts of Microbiome Petition
- URL: https://www.fdaweb.com/fda-grants-denies-parts-of-microbiome-petition/
- Published: 2022-11-30T12:00:00.000Z
- Updated: 2026-09-14T18:08:06.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5153284

FDA has granted in part and denied in part a 7/2/20 petition submitted by the Microbiome Therapeutic Innovation Group (MTIG) asking the agency to take certain actions regarding fecal microbiota for transplantation (FMT) to treat *Clostridium difficile* infection. The agency’s 11/29 [response](https://downloads.regulations.gov/FDA-2020-P-1633-0006/attachment%5F1.pdf?ref=fdaweb.com) says MTIG sought these four actions:

- finalize a 2016 draft guidance and specify that sponsors and manufacturers of commercial-scale FMT products are required to operate under an IND;
- retain the safe harbor for the use of FMT when the stool donor and stool are qualified by screening and testing performed under the direction of the licensed healthcare provider for the purpose of providing the FMT product to treat his or her own patient;
- provide additional guidance on the comprehensive approach FDA is considering for the study and use of FMT products under an IND; and
- reiterate that the FMT enforcement discretion policy is an interim policy that is subject to change or revocation following further evaluation of its effects on patient safety and efficacy.

As part of its response, FDA published the [final guidance](https://www.fdaweb.com/enforcement-guide-on-fecal-microbiota-for-transplantation/) requested in the petition. The letter says the guidance “informs members of the medical and scientific community and other interested parties that FDA intends to exercise enforcement discretion under limited circumstances, regarding the IND requirements … for the use of FMT to treat *C. difficile* infection not responding to standard therapies. In light of safety concerns with respect to centralized manufacturing of FMT products in stool banks, the guidance explains that FDA’s enforcement policy does not apply to FMT obtained from a stool bank.”

Publication of the final guidance was part of granting the petition’s first request. FDA also said that to the extent that the petition can be interpreted to request that the agency initiate or take enforcement action against stool banks, such a request is not a proper subject for a petition.

The response says FDA believes that the policy described in the final guidance strikes the appropriate balance and that additional guidance on a different or more comprehensive approach is not needed. It also denied the final request, saying it is unnecessary to state in the guidance that the policy is interim in nature since all guidances may be withdrawn or revised in the future as circumstances warrant to protect the public health.