April 11th, 2012 | Published in Food Business
Interesting battle raging in Washington as the FDA and Council for Responsible Nutrition duke it out over whether the New Dietary Ingredient Draft Guidance should give pre-market approval over new dietary supplement products, as reported in Regulatory Toxicology and Pharmacology.
“The draft guidance attempts to apply the notification requirement to new supplements, not just new ingredients, and it expands the working definition of ‘chemically altered’ to include many changes that were not foreseen in the Congressional Record in 1994,” wrote the commentary’s co-authors Steve Mister, president and CEO of CRN, and John Hathcock, SVP international and regulatory affairs for CRN. “Through these misinterpretations, [the] FDA attempts to impose a food additives-like safety standard and gain de facto pre-market approval against the overt wishes of Congress.”
Re-characterizing many existing dietary ingredients as being chemical alterations could hurt the supplement industry.