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# FDA Denies Probiotic Suppository Petition
- URL: https://www.fdaweb.com/fda-denies-probiotic-suppository-petition/
- Published: 2017-03-21T12:00:00.000Z
- Updated: 2026-09-14T22:12:48.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138254

FDA has denied a 4/7/16 ProbioTech petition asking the agency to amend the definition of “dietary supplement” under the Dietary Supplement Health and Education Act of 1994 so that probiotic suppositories could be treated the same as oral probiotic dietary supplements. The company said that if the definition is not changed, FDA should allow a supplemental probiotic that is inserted as a rectal suppository to be classified as a dietary supplement as another delivery route in addition to the oral route.

The agency’s denial [letter](https://www.regulations.gov/contentStreamer?documentId=FDA-2016-P-1133-0004&attachmentNumber=1&contentType=pdf&ref=fdaweb.com) says the definition in the Federal Food, Drug, and Cosmetic Act (FFDCA) indicates that ingestion is the only permissible route of administration for dietary supplements. It notes that a request to amend the act is not an action that can be the subject of a citizen petition and the agency does not have the authority to amend a statutory definition. It also denied the alternative request to consider a suppository as another delivery route because FDA cannot take administrative action that conflicts with the FFDCA.