Major and “under the radar” changes in FDA’s Proposed Rules on Nutrition Labeling are ahead.

The manner in which food marketers use the food label to communicate nutrition information is about to undergo sweeping changes. Two proposed rules issued by the Food and Drug Administration (FDA) will impact the format and content of the so-called Nutrition Facts Panel (NFP).  Numerous changes to the serving size rules are also planned. Companies are well-served to carefully examine the many proposed changes on a product- and brand-specific basis. This article examines several of the most significant changes—and a few “sleepers,” as well.

Big Changes

1. Revised NFP Format

FDA has proposed a revised format for the NFP, encompassing the following major changes:  (1) the prominence of calories and serving size information would be increased; (2) the percent daily value (%DV) declarations would be moved to the left side; (3) the footnote table showing the amounts of nutrients in a 2,000- or 2,500-calorie diet would be deleted, and the footnote regarding daily caloric intake would be revised, pending the outcome of further FDA studies on consumer understanding of alternative footnotes.

The proposed changes raise several issues related to consumers’ ability to understand the information in the revised format. For example, would giving increased prominence to the %DV declaration improve consumer understanding of this information, particularly given that the agency notes that many consumers do not currently understand the significance of the %DVs? What type of information should the footnote on the %DVs and daily caloric intake convey (or is a footnote unnecessary)?  Another key issue is whether FDA’s alternative visual format (under which nutrition information is separated out into categories for “quick facts,” “avoid too much” and “get enough”) would be appropriate. 

2. Mandatory Declaration of Added Sugars

Under the proposed rule, added sugars would need to be declared in the NFP. FDA has proposed to define added sugars as those that are either added during the processing of foods or are packaged as such. While the agency recognizes the lack of reliable analytical methods to distinguish added sugars from naturally occurring sugars, FDA views an added-sugars declaration as needed to help consumers implement the recommendation in the 2010 Dietary Guidelines for Americans to reduce intake of calories from added sugars. In the absence of a reliable test method, FDA would expect companies to verify the amounts of sugars added through maintenance and review of records. Critical areas with respect to added sugars include (1) the need for a mandatory added sugars declaration; (2) the impact on consumers of such a declaration; (3) the proposed definition of added sugars; and (4) the proposed method for substantiating the added sugars declaration.

3. Definition of Single-serving Container

FDA proposes to amend the definition of a single-serving container to include all containers with less than 200% of the reference amount customarily consumed (RACC). This would remove the current flexibility for products with a RACC of 100g or 100mL or larger that contain between 150-200% of the RACC, under which manufacturers can choose whether to label such products as 1 or 2 servings.  Potential areas for consideration include whether this revised definition would help consumer more accurately interpret the nutrient amounts in these products; whether the current flexibility for certain products should be maintained; and whether FDA is correct that package sizes influence consumer consumption.

4. Dual-column Labeling

The agency proposes to require dual-column nutrition labeling, on a “per serving” and “per container” basis, for containers with 200-400% of the RACC. FDA’s rationale is that these products could reasonably be consumed in a single eating occasion. The proposed rule includes a number of exemptions, including for bulk products such as flour, oil, eggs and butter; some small packages; and certain products already using voluntary dual-column labeling. Key issues include whether the proposed criteria for mandatory dual-column labeling are appropriate and whether there are other products that should be exempt. Another critical element is FDA’s proposal to require clarifying information on the basis for a nutrient content claim or health claim (i.e., the RACC and not the entire container) appearing on a product with a dual-column label.

“Sleepers”

1. Definition of Dietary Fiber

For the first time, FDA would define the types of fiber that can count towards the declaration of “dietary fiber.” The agency proposes to include only naturally occurring fibers, as well as some added fibers determined by FDA to have a physiological effect that is beneficial to human health. In particular, those fibers that are subject to an FDA-authorized health claim would count as dietary fiber. Companies could also submit a petition to FDA to recognize additional sources of added fiber. In evaluating the proposed rule, companies will want to consider the impact of the proposed definition on products containing added fiber, such as inulin.

2. Changes in % DVs, Resulting in Changes to Eligibility for Nutrient Content Claims

FDA is proposing a series of changes to the Daily Reference Values (DRVs) and Reference Daily Intakes (RDIs) based on current dietary recommendations. For example, the DRV for sodium would decrease from 2,400 to 2,300mg; the DRV for dietary fiber would increase from 25 to 28g; and the DRV for calcium would increase from 1,000 to 1,300mg. These changes could result in products no longer being eligible for nutrient content claims, such as “good source of calcium.” Companies will want to evaluate the scientific justification for the proposed changes, as well as the practical impact of such changes.

3. Changes and Updates to Reference Amounts

Based in part on updated consumption data, FDA is proposing to modify the regulations for RACC categories, which are used to determine the labeled serving size for products. Examples of proposed changes to existing categories include a larger RACC for certain beverages, smaller RACC for yogurt and larger RACC for bulk ice cream. FDA recognizes that some products may no longer be eligible for nutrient content or health claims based on the proposed changes to reference amounts, or would now be required to bear a disclosure statement (e.g., “see nutrition information for saturated fat content”) as a result of the proposed RACC changes. Companies may wish to consider whether specific proposed changes are warranted or whether proposed new categories are appropriate.

Comments on the proposed rules are due June 2, 2014, although the agency has received several requests for an extension of the comment period.