Revised NDI Notification Draft Guidance Shrinks Divide Between FDA And Industry
This article was originally published in The Rose Sheet
More than four years after beginning to revise its widely criticized initial draft guidance on NDI notifications, FDA on Aug. 11 released a second draft. "I think it is reflective of a new effort by the agency to have a dialogue with the industry," says Steve Mister, president and CEO of the Council for Responsible Nutrition.
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Amarin's argument would swing on a finding by FDA that synthetics of omega-3s are not dietary ingredients. With such an FDA determination, a fair trade complaint to International Trade Commission about imports of omega-3 ingredients similar to the active ingredient in Amarin's Rx Vascepa theoretically would not be asking ITC to interpret FDA regulations by investigating imports of substances which FDA has not identified as noncompliant with its regulations.
FDA says it has "only received about 1,200 NDI notifications" in 25 years under DSHEA as US VMS market has grown from around $4b and 4,000 products to more than $40bn with 80,000 or more products. In interviews on potential changes agency may attempt to bring to its regulatory oversight, attorneys noted NDI notifications are among problems for both industry and FDA.