04.25.12
FDA must reconsider imposing the pre-market approval paradigm of food additives to dietary supplements as proposed in its New Dietary Ingredient (NDI) Draft Guidance, according to a commentary by the Council for Responsible Nutrition (CRN), Washington D.C., just published in Regulatory Toxicology and Pharmacology, the official journal of the International Society of 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 “The draft Guidance attempts to apply the notification requirement to new supplements, not just new ingredients, and it expands the working definition of ‘chemically altered’ to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 co-authors Steve Mister, president and CEO, CRN, and John Hathcock, PhD, senior vice president, International & Regulatory Affairs, CRN. “Through these misinterpretations, FDA attempts to impose a food additives-like safety standard, and gain de facto premarket approval against the overt wishes of Congress.”
Additionally, FDA wants to impose a risk-benefit standard for determining the safety of new ingredients, similar to what it used to remove ephedra from the market, which would allow FDA to evaluate the benefits of a product claimed by the manufacturer against the perceived risks—another attempt to challenge Congress’ intent for the law.