FDA's consideration of standards and protocols for an authoritative list of pre-DSHEA dietary ingredients is an off-shoot of its work on guidance for submitting new dietary ingredient notifications.

Dietary ingredients available pre-DSHEA are eligible for use in dietary supplements marketed in the US without submitting to FDA evidence supporting reasonable expectation of safety for the intended use. Conversely, for ingredients that FDA deems as becoming available in the US after October 1994, marketers must notify FDA with proof of those substances' safety at least 75 days before offering products containing the ingredient.

Clearance from the agency is not required before marketing NDI-containing supplements, but FDA is authorized to enforce against marketing of products that it questions following its evaluations of NDI notifications.

The first NDI notification draft guidance in 2011 did not mention an industry-sourced list as authoritative identification, but its absence was a huge obstacle to FDA and the industry agreeing on suitable guidance for NDI notifications. The agency broached the idea in its second draft guidance in 2016, opened a docket for comments – FDA-2017-N-4625 – and conducted the meeting to start the process. It is accepting comments through Dec. 4. (Also see "‘Old’ Ingredient List On FDA Table Could Spur New Supplement Launches" - HBW Insight, 14 August, 2017.)

Finalizing the NDI guidance is a separate docket, FDA-2011-D-0376, and the comment period is closed.

Kratom: All Questions On Pre-DSHEA Ingredient Evidence In One Package

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