By Elizabeth Campbell, EAS Senior Advisor for Labeling & Claims
FDA announced on February 27, and published in the March 3 Federal Register, proposals to revise the Nutrition Facts label. This is the first time in the 20 years of the Nutrition Facts label that FDA is making major revisions. The proposed revisions incorporate updated information on advice for healthy dietary practices and food consumption patterns as well as technical updates.
FDA has articulated a detailed rationale for each change in two proposals and has posted links to several information pieces on its website.
Major proposed changes include:
- Require declaration of “added sugars” as a component of total sugars
- Add vitamin D and potassium to the mandatory nutrients and convert vitamins A and C to voluntary nutrients
- Update Daily Values (DV) for nutrients like sodium, dietary fiber and Vitamin D. Changes in DVs would affect whether certain foods qualify for nutrient content and health claims.
- Require that packaged foods, including drinks, that are typically eaten in one sitting (less than 200% RACC) be labeled as a single serving and that calorie and nutrient information be declared for the entire package
- Require “dual column” labels to indicate both “per serving” and “per package” calories and nutrient information for packages that are 200% – 400% of the RACC. Because of limited space, labels that qualify to use the tabular or linear formats would not have to declare the second column.
- Update several RACCs and establish new ones to reflect current consumption patterns. As an example, the RACC for carbonated and non-carbonated beverages, water, coffee, tea would be increased from the current 8 fluid ounces (fl oz) to 12 fl oz. Milk, milk substitutes, milk based beverages would retain the 8 fl oz RACC. Changes in RACCs could affect whether certain foods qualify for nutrient content and health claims.
- Revise the format to make calories and serving sizes more prominent and to shift the % Daily Value to the left of the label
While these changes apply to all food labels, not all the changes would affect dietary supplement labels. Dietary supplements that do not contain “food type” dietary ingredients like fat, protein, and carbs would not need to change labels. The added emphasis on calories and added sugars would mean changes for some dietary supplements, particularly flavored liquids. Some of the changes would affect protein supplements, fiber supplements, and supplements containing RDI vitamins and minerals.
FDA has established a 90 day period for interested parties to submit comments on the proposed changes. The agency will take into account information provided in comments when developing the final regulations. We encourage manufacturers to determine how the changes would affect their product labels. You may want to submit information to FDA if proposed changes would have a negative effect for your product. This article cannot include the amount of detail manufacturers need to understand the proposed changes, but EAS can help you to navigate the details to understand your status.
The proposed effective date is 60 days after the final regulation is published and FDA would allow 2 years for labels to be brought into compliance with the final requirements.
EAS has partnered with FoodMinds and Nutrition Impact, LLC to create Food Label Compass, which harnesses the expertise of all three partners to create a suite of nutrition analysis, regulatory consulting and strategic services to guide food and beverage companies in understanding the impact, complying, communicating, and capitalizing on the new FDA guidelines. Food Label Compass will conduct in-depth analyses of the food and nutrient content of clients’ brands relative to the new FDA guidelines. It will identify the potential changes to the serving size rules (Reference Amounts Customarily Consumed (RACCs)), assess the impact of potential changes on Daily Values (DVs) and on nutrition claim criteria.
Food Label Compass will develop regulatory recommendations and guidance to construct labels modified to reflect the new requirements. In addition, it will validate claim opportunities, answer questions on how to comply with the new nutrition information rules and ensure the information is presented in an approved and consumer-friendly manner.