Purpose of the Regulatory Action
We are amending our regulations for the nutrition labeling of conventional foods and dietary supplements to help consumers maintain healthy dietary practices. Section 403(q) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 343(q)) specifies certain nutrients to be declared in nutrition labeling, and authorizes the Secretary of Health and Human Services to require other nutrients to be declared if the Secretary determines that a nutrient will provide information regarding the nutritional value of such food that will assist consumers in maintaining healthy dietary practices. The Secretary also has discretion under section 403(q) of the FD&C Act to remove, by regulation and under certain circumstances, nutrient information that is otherwise explicitly required in food labeling under this section. The final rule revises our regulations to provide updated nutrition information on the label and to improve how the nutrition information is presented to consumers.
Summary of the Major Provisions of the Regulatory Action in Question The final rule revises the Nutrition Facts label by:
• Removing the declaration of ‘‘Calories from fat’’ because current science supports a view that the type of fat is more relevant than overall total fat intake in increased risk of chronic diseases;
• Requiring the declaration of the gram amount of ‘‘added sugars’’ in a serving of a product, establishing a Daily Reference Value (DRV), and requiring the percent Daily Value (DV) declaration for added sugars;
• Changing ‘‘Sugars’’ to ‘‘Total Sugars’’ and requiring that ‘‘Includes ‘X’ g Added Sugars’’ be indented and declared directly below ‘‘Total Sugars’’ on the label;
• Updating the list of vitamins and minerals of public health significance. For example, the final rule requires the declaration of vitamin D and potassium and permits, rather than requires, the declaration of vitamins A and C;
• Updating certain reference values used in the declaration of percent DVs of nutrients on the Nutrition Facts and Supplement Facts labels;
• Revising the format of the Nutrition Facts and Supplement Facts labels to increase the prominence of the term ‘‘Calories;’’
• Removing the requirement for the footnote table listing the reference values for certain nutrients for 2,000 and 2,500 calorie diets;
• Requiring the maintenance of records to support the declarations of certain nutrients under specified circumstances.
Effective date: The final rule becomes effective on July 26, 2016.
Compliance date: The compliance date of this final rule is July 26, 2018 for manufacturers with $10 million or more in annual food sales and July 26, 2019 for manufacturers with less than $10 million in annual food sales. See section III, Effective and Compliance Dates, for more detail. The incorporation by reference of certain publications listed in the rule is approved by the Director of the Federal Register as of July 26, 2016