Two long-awaited, proposed rules to revise the regulatory requirements for nutrition labeling of conventional foods and of dietary supplements have been sent by FDA to the Office of Information and Regulatory Affairs within OMB for final review before publication.
The first proposed rule, “Food Labeling; Revision of the Nutrition and Supplement Facts Labels,” would amend FDA’s nutrition labeling regulations for conventional foods and for dietary supplements to provide updated nutrition information on the labels. Most provisions for these products have not been amended since mandatory nutrition labeling was first required. New scientific evidence and consumer research has become available in the interim that can be used to update the content and appearance of the Nutrition Facts and Supplement Facts panels so that consumers can use the information more effectively to select foods that will assist them to maintain healthy dietary practices. Among other possible changes, the proposed rule is anticipated potentially to:
- Update the Daily Reference Values for macronutrients and the Reference Daily Intakes for micronutrients that serve as the basis for the percent Daily Values declared;
- Revise the nutrients subject to mandatory declaration;
- Define dietary fiber for the first time, and update the analytical method used to determine the amount of dietary fiber; and
- Change the format and appearance of the Nutrition Facts and Supplement Facts panels to improve the prominence of important information (e.g., Calories).
The agency contact for this proposed rule is Blakeley Fitzpatrick within FDA’s Center for Food Safety and Applied Nutrition (CFSAN).
The second proposed rule, “Food Labeling: Serving Sizes of Foods that Can Reasonably Be Consumed at One-Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain RACCs,” would amend FDA’s regulations to provide updated Reference Amounts Customarily Consumed (RACCs) for certain food categories. The updated RACCs would be based on current, nationwide consumption data. The RACCs that are updated are most likely to be increased, resulting in larger serving sizes for some foods. In addition to updating certain RACCs, FDA is also considering:
- Amending the definition of single-serving containers;
- Requiring dual-column nutrition labeling, which would declare nutrient information on both per serving and per container bases, for certain containers; and
- Setting the serving size for breath mints as one unit.
The agency contact for this proposed rule is Cherisa Henderson at CFSAN.
These proposed nutrition labeling reforms are the most significant regulatory undertakings for both Nutrition Facts and Supplement Facts in over 15 years.