FDA Issues Final Guidance on Serving Sizes, Dual-Column Labeling

FDA Issues Final Guidance on Serving Sizes, Dual-Column Labeling

3 Jan, 2020

The U.S. Food and Drug Administration issued a final guidance to help manufacturers of packaged foods comply with the FDA’s updated Nutrition Facts labeling regulations.  The final guidance addresses serving sizes of foods, including single-serving foods and other foods that can reasonably be consumed at one eating occasion and require dual-column labeling.  It finalizes a draft guidance issued in November 2018.

The final guidance provides questions and answers on topics related to: (1) the definition of a single-serving container; (2) reference amounts customarily consumed, which are used by companies to determine serving sizes; (3) dual-column labeling, including formatting issues for products that have limited space for nutrition labeling; and (4) miscellaneous issues, such as requirements relating to the labeling of chewing gum and to multi-unit retail food packages.

Changes from the draft guidance include:

  • Providing additional background information in response to a question regarding reference amounts customarily consumed (RACCs) for non-juice beverages for infants and young children (question B.9)
  • Modifying for clarity 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 (question D.2) 
  • 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 (question D.4)

Compliance with the updated Nutrition Facts labeling regulations is required by January 1, 2020, for manufacturers with $10 million or more in annual food sales, while manufacturers with less than $10 million in annual food sales will have an additional year to comply. During the first 6 months following the January 1, 2020, compliance date, FDA plans to work cooperatively with manufacturers to meet the new Nutrition Facts label requirements and will not focus on enforcement actions regarding these requirements during that time. FDA intends to exercise enforcement discretion to give manufacturers of single-ingredient sugars such as honey and maple syrup, and certain cranberry products, until July 1, 2021, to comply.