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# Include Probiotic Suppositories Under DSHEA: ProbioTech
- URL: https://www.fdaweb.com/include-probiotic-suppositories-under-dshea-probiotech/
- Published: 2016-04-21T12:00:00.000Z
- Updated: 2026-09-14T20:56:20.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135447

> ProbioTech is asking FDA to change the definition of a dietary supplement under the Dietary Supplement Health and Education Act and to treat probiotic suppositories the same as oral probiotic dietary supplements. A 4/7 [petition](https://www.regulations.gov/?ref=fdaweb.com#!documentDetail;D=FDA-2016-P-1133-0001) says that probiotics that are not in the form of a pill, capsule, tablet, or liquid and do not fit into the definition of a drug, device, or biologic should be considered a dietary supplement if they function essentially the same and do not come in the form of a pill, capsule, tablet, or liquid. “ProbioTech seeks to market a probiotic delivered by a rectal suppository, which should not be deemed a new drug as there is no claim to diagnose, cure, mitigate, treat, or prevent a disease,” the petition says. “The product should not be put through the onerous submission and approval process for a new drug substance.”