WASHINGTON — The Food and Drug Administration's New Dietary Ingredient Draft Guidance should not give the agency pre-market approval over new dietary supplement products, the Council for Responsible Nutrition claimed Monday in a commentary 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“The draft guidance attempts to apply the notification requirement to new supplements, not just new ingredients, and it expands the working definition of ‘chemically altered’ to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 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.”
According to the CRN, the FDA includes the following provisions in its NDI Draft Guidance that effectively would impose a pre-market approval restriction:
Recharacterizing many existing dietary ingredients as new dietary ingredients by expanding the definition of “chemically altered” to classify innovations in manufacturing as being chemical alterations;
Requiring physical proof with “material evidence” that an ingredient actually was available in the market before 1994, and thus exempt from the NDI requirements;
Prohibiting bio-identical synthetic versions of botanical compounds from being classified as dietary ingredients at all;
Requiring a separate notification for each new product, as opposed to just the dietary ingredient; and
Declaring The Redbook, the official textbook for evaluating food additives, which has a “significantly higher threshold” for safety than the “reasonable expectation of safety” established under DSHEA, as “authoritative for demonstrating the safety of NDIs.”
“It is time for [the] FDA to reconsider its efforts to redistribute the safety burdens allocated by Congress in DSHEA, and to recognize that the pre-market paradigm of food additives is not what Congress intended for dietary supplements,” CRN concluded.