As previously reported on this blog, FDA issued a revised Draft Guidance titled, “Dietary Supplements: New Dietary Ingredient [NDI] Notifications and Related Issues,” in August 2016. The Agency received more than 7,000 comments on the draft guidance by the Dec. 12, 2016, due date.

• The Dietary Supplement Health and Education Act (DSHEA) requires the manufacturer or distributor of an NDI to submit a pre-market notification called a new dietary ingredient notification (NDIN) to FDA at least 75 days before marketing a dietary supplement that contains an NDI (unless the substance qualifies for a narrow exemption). The revised Draft Guidance, updated from the version first issued in 2011, is intended to assist the supplement industry with the NDIN process.

• Many of the comments from the dietary supplement industry suggest that the 2016 Draft Guidance is contrary to Congressional intent in passing DSHEA and exceeds FDA’s authority. Some of the concerns from industry associations are highlighted below.

  • The American Herbal Products Association (AHPA) stated, “FDA must refrain from declaring or implying that each dietary supplement that contains an NDI requires a separate NDI notification, and should instead encourage manufactures and distributors of new dietary ingredients to include in notifications very broad descriptions of the many dietary supplements that are expected to contain the subject NDI…” In particular, AHPA stressed that changes to manufacturing processes or products specification should not automatically create the need for an NDI Notification.

  • Noting that Congress intended a “lesser” safety standard for NDIs in dietary supplements that do not present a significant or unreasonable risk of illness or injury than the “higher” safety standard of reasonable certainty of no harm under the intended use conditions required for food additives and GRAS substances, the Natural Products Association (NPA) wrote, “FDA continues to blur the distinction between dietary supplements and conventional food ingredients in their testing recommendations.” NPA also recommended that synthetic copies of botanical constituents should not be treated differently from other ingredients when there is no public safety issue.

  • The United Natural Products Alliance (UNPA) suggested that since there were an estimated 77,840 dietary supplements sold in the U.S. and that FDA received a total of 930 NDI Notifications by the end of 2016, “the magnitude of these requirements FDA has proposed is both economically prohibitive for the industry and for a cash-strapped government agency.”

• The comments can be accessed from: https://www.regulations.gov/docket?D=FDA-2011-D-0376.