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FDA Issues Technical Amendments to Final Nutrition and Supplement Facts Rule

  • FDA will publish in the December 21, 2018 Federal Register a final rule that makes technical amendments to its 2016 final rule on Nutrition and Supplement Facts labeling.  The amendments, which are not substantive in nature, affect both 21 C.F.R. 101.9 (“Nutrition labeling of food”) and 21 C.F.R. 101.36 (“Nutrition labeling of dietary supplements”).

  • While there are many technical amendments addressed in the rule, some highlights include:

    • Correcting cross references to other paragraphs in the regulations, spelling errors, and formatting errors;

    • Providing new sample labels that fully comply with the new regulations (e.g., one sample label omitted information on the number of servings per container and serving size) and sample labels that had appeared blurry;

    • Reordering the vitamin and minerals listed in the table at Section 101.9(c)(8)(iv) so that the mandatory nutrients (i.e., vitamin D, calcium, iron, and potassium) appear first in the list; and

    • Removing language from Section 101.36(e) stating that calorie information in Supplement Facts boxes needs to be bolded text and in larger type.

  • Because the amendments are technical in nature, there is no comment period, and the final rule becomes effective immediately on December 21, 2018.
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Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...