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 The draft guidance governs the industry’s obligation under federal law to notify FDA before marketing a new dietary ingredient, or NDI, and provide safety-related evidence.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.