Posted: 25 Apr 2016 06:09 PM PDT 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:
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. |
martes, 26 de abril de 2016
FDA Law Blog: The Next Wave for Probiotics?
FDA Law Blog: The Next Wave for Probiotics?
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