The Next Wave for Probiotics?

April 25, 2016

By Ricardo Carvajal

The would-be marketer of a probiotic suppository submitted a citizen petition (Docket No. FDA-2016-P-1133) to FDA asking the agency to “amend the definition of dietary supplement under the present statutory authority [of DSHEA] and to treat probiotic suppositories the same as oral probiotic dietary supplements.”  In support of that request, the petition argues in part that:

  • A probiotic suppository should not be regulated as a drug if no drug claims are made for it;
  • Probiotics delivered through a suppository convey essentially the same benefits as those conveyed by probiotics consumed as dietary supplements, and would be consumed for the same purpose – namely “to deliver supplemental microorganisms to the existing populations of beneficial organisms in an individual to help maintain a healthy microbe state in the gut”;
  • Suppositories offer a more efficient route of administration, and avoid the possible breakdown of microbes in the stomach and upper GI tract;
  • Certain individuals have difficulties orally ingesting supplements; and
  • A probiotic suppository provides an alternative to fecal transplant (a subject that we previously addressed here).

The petition asks FDA to amend the definition of “dietary supplement” by replacing the phrase “is intended to be taken by mouth as a pill, capsule, tablet or liquid” with the phrase “is intended for enteral administration.”  Alternatively, the petition asks FDA to “allow a supplemental probiotic which is inserted as a rectal suppository to be classified as a dietary supplement as another delivery route in addition to the oral route.”  

It’s not clear which definition of “dietary supplement” the petition refers to, as the phrase “is intended to be taken by mouth as a pill, capsule, tablet or liquid” does not appear in the FDC Act’s definition of “dietary supplement” or in associated regulations (in relevant part, the statute defines “dietary supplement” as an article “intended for ingestion” in a variety of forms).  In any event, the petition does not explain what authority FDA could rely on to eliminate the statutory criterion of ingestion, or under what authority FDA could allow a suppository to be classified as a dietary supplement.  Indeed, in accord with the existing statutory definition, FDA has consistently taken the position that articles not intended for ingestion do not qualify as dietary supplements.