September 17, 2019

September 17, 2019

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September 16, 2019

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Labeling Requirement: FDA Publishes Nutrition Facts FAQs

FDA publishes resources to assist food industry with compliance with revised nutrition labeling requirements.

  • As food manufacturers know, in May 2016, FDA issued final rules to implement changes to the nutrition and dietary supplement labeling and serving size regulations.

  • On August 3, 2016, FDA published a Nutrition Facts label “Industry Resources” web page to assist the food industry with compliance with the requirements of the final rules.  The new resources include:

    • Frequently Asked Questions specifically focused on industry’s common questions and concerns

    • Annotated graphic illustrations of new label specifications for the most commonly used label formats

    • High-resolution examples of label formats

    • Tables from the final rules showing daily values for vitamins, minerals, and food components, as well as reference amounts customarily consumed per eating occasion (RACCs)

    • Links to the final rules and reference materials

  • Among the FAQs — and consistent with our recommendations on this point — FDA has confirmed its current thinking that compliance with the new nutrition labeling requirements will be required for “food products that are initially introduced into interstate commerce on or after July 26, 2018 (or July 26, 2019 for manufacturers with less than $10 million in annual food sales).”  This approach is consistent with that used for the regularly scheduled labeling for the Uniform Compliance Date, where FDA bases enforcement on whether the food products are initially introduced into interstate commerce on or after the scheduled compliance date.  FDA has indicated its intent to address this issue further in guidance, so stakeholders should remain attuned to potential future developments in this area.

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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...

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