Under the law, FDA must grant different standards for new dietary ingredients and food additives
DOI: 10.1016/j.yrtph.2012.01.006
Title: Under the law, FDA must grant different standards for new dietary ingredients and food additives
Journal Title: Regulatory Toxicology and Pharmacology
Volume: 62
Issue: 3
Publication Date: April 2012
Start Page: 456
End Page: 458
Published online: online 28 January 2012
ISSN: 0273-2300
Author: Steven Mister, John Hathcock
Affiliations:
  • Council for Responsible Nutrition, Washington, DC, United States
  • Abstract: ong>FDA’s draft Guidance on notifications for new dietary ingredients attempts to narrow the scope of “old” dietary ingredients that do not require notification to FDA and repeats some mistakes from the past by going beyond what is required or permitted by the Food, Drug & Cosmetic Act, as amended by the Dietary Supplements Health and Education Act of 1994. The draft Guidance attempts to apply the notification requirement to new supplements, not just new ingredients, and it expands the working definition of “chemically altered” to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.
    Received: 1 November 2011
    Keywords: New dietary ingredients; Notification; DSHEA; FDCA; Premarket approval
    Email: jhathcock@crnusa.org

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