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Reps Threaten Legislation To Align NDI Guidance With DSHEA

This article was originally published in The Tan Sheet

Executive Summary

The letter from the office of caucus co-chair Rep. Burton says the House members contacted FDA following the agency’s “dismissal” of a Senate request to withdraw or revise the NDI draft guidance. Rep. Ron Paul, a candidate for the GOP nomination for president, also signed the letter.

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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.”

Harkin, Hatch Take Swing At FDA Pitch To Evaluate NDIs As Food Additives

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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Trade groups say FDA committed to revisiting issues in the NDI draft guidance including how firms prove ingredients’ grandfathered status, notifications required for ingredients or finished products and data necessary to demonstrate NDI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.

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