November 2, 2018
“As part of our ongoing efforts to modernize the Nutrition Facts label, the FDA is providing additional clarity for food manufacturers to help them meet the new requirements established in a set of final rules issued in 2016. Today, we are providing two new guidances that answer important questions we have received to date on the recently established serving-size labeling requirements for single-serving packages and on compliance questions, including ways manufacturers can calculate the amount of added sugars in certain products,” said FDA Commissioner Scott Gottlieb, M.D. “While today’s actions focus on helping manufacturers meet their obligations set forth by the law, we also know just how important it is for consumers to understand the nutritional content of the foods they eat – after all, the goal of implementing these changes is ultimately to provide consumers with relevant information when selecting foods to eat. We are also pleased to announce that we will soon launch a new educational campaign to help all Americans better understand the new nutrition information that they’ll be seeing in the marketplace.”
Today, the U.S. Food and Drug Administration published two guidances to provide clarity on a variety of issues related to Nutrition Facts label final rule and serving size final rule published in 2016. The guidances address various labeling issues relating to serving sizes and other compliance issues, including calculating the added sugars for certain products such as juice concentrates. They also facilitate compliance with the two rules for which compliance is required by January 1, 2020, for manufacturers with $10 million or more in annual food sales, and by January 1, 2021, for smaller manufacturers.
The first guidance, which is draft, 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: Guidance for Industry, relates to various serving-size labeling requirements. Among other issues, the guidance (1) clarifies the conditions under which manufacturers can provide an additional column of nutrition information for single-serving containers that contain more than one unit, like two individually wrapped ice cream bars, (2) provides further details on when dual-column labeling may be used for single-serving containers that contain more than 150 percent of the amount customarily consumed, and (3) explains that FDA intends to exercise enforcement discretion in certain circumstances for certain products containing 200 to 300 percent of the amount customarily consumed when the products could reasonably be consumed by one person in a single eating occasion.
The second guidance, which is final, Nutrition and Supplement Facts Labels: Questions and Answers Related to the Compliance Date, Added Sugars, and Declaration of Quantitative Amounts of Vitamins and Minerals: Guidance for Industry, includes recommendations to manufacturers to help them calculate “added sugars” in their products. One area where manufacturers have indicated they need guidance is in the labeling of juice concentrates. The guidance clarifies that the declaration of added sugars should not include fruit or vegetable juice concentrated from 100% fruit juice sold to consumers or used as the fruit component in jellies, jams or preserves in accordance with the standards of identity for those products. The guidance also provides clarity on other topics including the new requirement to declare quantitative amounts of vitamins and minerals on the Nutrition Facts label. We are taking these steps to help manufacturers update their Nutrition Facts label, which will ultimately benefit consumers by helping them maintain healthy dietary practices.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.