FDA issues final guidance for new Nutrition Facts labeling regulation

December 31, 2019

FDA has issued a final guidance on serving sizes, dual column labeling to help manufacturers of packaged food comply with the updated Nutrition Facts labeling regulations. 

The U.S. Food and Drug Administration (FDA) has issued a final guidance on serving sizes, dual column labeling to help manufacturers of packaged food comply with the updated Nutrition Facts labeling regulations. For manufacturers with $10 million or more in annual food sales, compliance is required by January 1, 2020, but manufacturers with less than $10 million in sales will have an additional year to comply.

According to a press release from FDA, changes from the draft guidance include the following:

1. 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).

a. FDA recommends manufacturers use an RACC of 120 ml on beverages such as milk and water for this age group.

2. 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).

a. FDA will permit products in small packages to bear the statement “Not a significant source of other nutrients” at the bottom of the simplified Nutrition Facts label. This is in lieu of stating all the nutrients that are present in insignificant amounts.

3. 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).

The final guidance also defines the single-serving container as “product that is packaged and sold individually (i.e., that bears a Nutrition Facts panel (also known more commonly as a Nutrition Facts label)) and contains less than 200 percent of the applicable RACC for that product.” As an example, FDA explains that a 20-ounce bottle of soda is a single-serving container. The final guidance states, “The RACC for carbonated beverages is 12 oz (360 mL); a 20-oz bottle of soda contains approximately 167 percent of the RACC and meets the definition of a single-serving container. Therefore, the serving size for a 20-oz bottle of soda would be labeled as ‘1 bottle.’”

"The new Nutrition Facts label has updated serving sizes for many foods. We know that Americans are eating differently, and the amount of calories and nutrients on the label is required to reflect what people actually eat and drink – not a recommendation of what to eat or drink,” explained Claudine Kavanaugh, PhD, MPH, RD, director of the Office of Nutrition and Food Labeling in the FDA's Center for Food Safety and Applied Nutrition, in a press release. “The new label, including this dual column layout, will drive consumers' attention to the calories and Percent Daily Value of nutrients that they are actually consuming."