Include Probiotic Suppositories Under DSHEA: ProbioTech

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 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.”