FDA Issues Two Guidance Documents on Nutrition Facts Label and Serving Size Final Rules
Thursday, January 5, 2017
  • As our readers are well aware, in May 2016, FDA issued final rules to implement changes to the nutrition and dietary supplement labeling and serving size regulations.  Detailed summaries of both rules may be found here. On August 3, 2016, FDA published a Nutrition Facts label “Industry Resources” web page (available here), which includes some questions and answers, to assist the food industry with compliance with the requirements of the final rules.

  • Today, FDA announced in the Federal Register (here and here) the publication of two draft guidance documents related to the final rules on Nutrition Facts labeling and Serving Sizes to help industry comply with those rules.  See 82 Fed. Reg. 1344 (Jan. 5, 2017) and 82 Fed. Reg. 1347 (Jan. 5, 2017).

  • The first draft guidance provides the Agency’s thinking on the following topics:

    • labeling of added sugars;

    • rounding as it relates to the declaration of quantitative amounts of vitamins and minerals, and

    • label format (thickness of lines and space between lines).

  • Importantly, this draft guidance document also clarifies that products that are labeled on or after July 26, 2018 (and July 26, 2019 for manufacturers with less than 10 million in annual food sales) must bear a nutrition label that meets FDA’s new nutrition labeling requirements). Products that are labeled before July 26, 2018 (and July 26, 2019 for manufacturers with less than 10 million in annual food sales), however, do not need to be in compliance with the new labeling requirements, and therefore, may bear the old nutrition label. FDA’s position differs from their original position, which stated that the new nutrition labeling must appear on foods that were initially introduced into interstate commerce on or after July 26, 2018.

  • The second draft guidance provides examples of food products that belong to product categories included in the tables of Reference Amounts Customarily Consumed (RACCs) per Eating Occasion that are established in FDA’s serving size regulations.  The Agency intends for these examples to assist industry in identifying the appropriate food categories for their products and, in turn, determine the serving size on a product’s Nutrition Facts label.

  • FDA is currently accepting comments on the two draft guidance documents; comments submitted to FDA by March 6, 2017 will be considered in the development of the final versions of each document.

 

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