August 4, 2020

Volume X, Number 217

August 03, 2020

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FDA Issues Final Guidance Document on Nutrition Facts Label and Serving Size Rules

In May 2016, FDA issued final rules changing the Nutrition Facts label for packaged foods and updating regulations on serving sizes to – among other things – provide realistic Reference Amounts Customarily Consumed (RACCs).  Detailed summaries of both rules may be found here.  For manufacturers with $10 million or more in annual food sales, the compliance date is January 1, 2020.  For manufacturers with less than $10 million in annual food sales, the compliance date is January 1, 2021.  Products that are labeled (i.e., when the label is placed on the product) on or after the applicable compliance date must bear a nutrition label that meets the new nutrition labeling requirements.

On December 31, 2019, FDA announced a final guidance, titled ‘‘Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion, Reference Amounts Customarily Consumed, Serving Size-Related Issues, Dual-Column Labeling, and Miscellaneous Topics,’’ which replaces FDA’s November 2018 draft guidance.  Changes include:

  • Providing additional background information on RACCs for non-juice beverages for infants and young children;

  • Clarifying a question and response concerning whether the Nutrition Facts label for products sold in small packages (e.g., certain sugar-free chewing gums) must list all nutrients that are contained in insignificant amounts; and

  • Modifying the response to a question regarding the placement of the Nutrition Facts and Supplement Facts labels to clarify that the Nutrition Facts or Supplement Facts label should not be placed on the bottom of packages (such as the bottom of boxes, cans, and bottles), unless they are visible during normal retail display and consumer handling.

The final guidance reiterates that FDA will exercise enforcement discretion with respect to certain bottled water products, coffee beans, tea leaves, plain unsweetened coffee and tea, condiment-type dehydrated vegetables, flavor extracts, and food colors that do not meet the new requirements until a future rule specific to labeling requirements for those products is enacted.

© 2020 Keller and Heckman LLPNational Law Review, Volume X, Number 6


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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...