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Supplement NDI Draft Guidance Discussions Snagged On Basic Criteria

This article was originally published in The Tan Sheet

Executive Summary

FDA’s dietary supplement division is concerned that firms are not submitting NDI notifications in cases where they should be, while industry stakeholders assert the agency needs to clarify the criteria for determining which products should be the subject of notifications and what information is needed.

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In Brief

EWG slams FDA sunscreen oversight; NARB stays the course in Healthy Directions case; AHPA presses FDA on NDI ID guidance; CRN comments on “chemically altered” NDIs; and Desert Rose products lack full labels.

FDA Revision Of NDI Draft Guidance Starts With Grandfathered List

Trade groups say FDA committed to revisiting issues in the NDI draft guidance including how firms prove ingredients’ grandfathered status, notifications required for ingredients or finished products and data necessary to demonstrate NDI safety. The agency’s decision followed a meeting between industry allies Sens. Hatch and Harkin and FDA Commissioner Hamburg.

Abbott's ‘Bedrock Of Good Health’ Nutritionals Business Faces Mounting Infant Formula Litigation

Nutritional product business had 5.1% Q1 sales growth and is like Abbott’s other segments, “super well-aligned to the global demographics and trends in health care,” says CEO Ford. But as it defends complaints of damages from powder formulas made at facility found with unsafe levels of bacterial contaminants, Abbott’s also targeted in litigation alleging failure to warn about risk of infants born prematurely developing necrotizing enterocolitis if fed cow’s milk-based formula.

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