CRN to FDA on NDIs: Stick to the spirit of DSHEA and reconsider pre-market approval

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CRN to FDA on NDIs: Stick to the spirit of DSHEA and reconsider pre-market approval
The Food and Drug Administration should recognize that DSHEA did not intend for pre-market approval, and reconsider its NDI draft guidance, says the CRN.

In a commentary published in Regulatory Toxicology and Pharmacology​ the Council for Responsible Nutrition (CRN) said that 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pre-market approval paradigm of food additives to dietary supplements as proposed in its New Dietary Ingredient (NDI) Draft Guidance.

“It is time for 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,”​ wrote Steve Mister, CRN’s president and CEO, and John Hathcock, PhD, senior vice president, international and regulatory affairs.

“The draft guidance attempts to apply the notification requirement to new supplements, not just new ingredients, and it expands the working definition of ‘chemically altered’ to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.

“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.”

Source: Regulatory Toxicology and Pharmacology
April 2012, Volume 62, Issue 3, Pages 456-458
“Under the law, FDA must grant different standards for new dietary ingredients and food additives”
Authors: S. Mister, J. Hathcock

Related topics: Regulation

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