Backgrounder: FDA Draft Guidance on New Dietary Ingredients for the Dietary Supplement Industry
CRN filed thoughtful and extensive comments that elaborated how FDA's 2011 draft guidance misinterpreted the legislative history of DSHEA, and ignored the precedent of years of FDA implementation of the NDI requirements. After reviewing over 7,000 comments from stakeholders, FDA responded with a revised draft guidance in August 2016 in which the agency affirmed many of its previous positions while providing further clarification in areas that were subjects of consternation.