Video: Dissecting 2016 NDI Draft Guidance

In this seven-minute video, leaders of the U.S. dietary supplement industry weigh in on the pros and cons of an important guidance document that was published in 2016 by FDA, while INSIDER takes a look back at the reaction from a powerful U.S. senator to the previous draft.

In August, FDA issued a 102-page document for the nearly US$40 billion dietary supplement industry. The draft guidance governs the industry’s obligation under federal law to notify FDA before marketing a new dietary ingredient, or NDI, and provide safety-related evidence.

In this seven-minute feature video, INSIDER highlights:

-- the criticism that was unleashed by Sen. Orrin Hatch (R-Utah) and the supplement industry after FDA published the 2011 draft NDI guidance;

-- the pros and cons of the 2016 draft from the perspective of industry leaders; and

-- the relationship between the 102-page document and the NDI notification requirements under the law.

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