Harkin, Hatch Take Swing At FDA Pitch To Evaluate NDIs As Food Additives
This article was originally published in The Tan Sheet
The staunch industry allies explain their concerns about the potential for regulating new dietary ingredients as food additives in a letter to FDA Commissioner Hamburg. They point out DSHEA includes “an essential exclusion of dietary ingredients from the statutory definition of food additives.”
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DSHEA, legislation Congress passed in 1994 establishing framework for FDA’s oversight of supplement manufacturing and marketing, doesn’t bear Hatch’s name. But in US consumer health products industry, his name is probably more frequently linked with DSHEA than with pivotal drug legislation he co-authored.
FDA proposes wrapping dietary supplements and cosmetics into its guidance laying out toxicological principles for assessing food and color additive safety.
Trade groups say FDA committed to revisiting issues in the NDI draft guidance including how firms prove ingredients’ grandfathered status, notifications required for ingredients or finished products and data necessary to demonstrate NDI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.