On March 3, 2014, FDA published two notices of proposed rulemaking detailing the agency’s proposed revisions to its nutrition labeling requirements. The proposed rules: (1) update the list of nutrients required or permitted to be declared, the Daily Reference Values and Reference Daily Intake values of several nutrients, and the format and appearance of the Nutrition Facts label; and (2) amend certain serving size requirements (which we discuss here). FDA states that it has proposed these amendments in light of current scientific evidence, the most-recent dietary recommendations, and public comments received in response to advance notices of proposed rulemaking. With regard to FDA’s proposed changes to the nutrition labeling requirements, major changes relate to:

  • Nutrition Facts Label: FDA proposes to amend the format of the Nutrition Facts label to increase the prominence of the “Calories” and “Serving Size” declarations, change “Amount per Serving” to “Amount per [serving size],” move the “% DV” to the left of the name of the nutrient, and replace “Total Carbohydrate” with “Total Carbs.” These amendments are intended to help ensure that the labels comply with the Nutrition Labeling and Education Act requirement that consumers are able to readily observe and comprehend the information presented and understand its relative significance in the context of their total daily diet.

FDA also introduced, and seeks comment on, an alternate concept for the label format that divides the information presented into “quick facts” about the product’s nutrient content and advises consumers of which nutrients to “avoid too much” and “get enough.”

  • Mandatory Nutrient Information: FDA is proposing to amend the list of nutrients that are required or permitted to be declared on the Nutrition Facts label. Specifically, the agency proposes to remove the mandatory “Calories from Fat” declaration because research demonstrates that the type of fat is more important than the amount. In response to several CSPI petitions, and to enable consumers to follow the 2010 Dietary Guidelines Advisory Committee report conclusion that on average Americans get 16 percent of their total calories from added sugars, and recommendation that individuals reduce their intake of calories from added sugars, FDA is proposing to require declaration of “Added Sugars.” “Added Sugars” is defined as sugars, syrups, naturally occurring sugars isolated from a whole food and then concentrated (i.e., concentrated fruit juice), and other caloric sweeteners. Because there currently is no way to distinguish between naturally occurring and added sugars in a finished food product, FDA also proposes to require that manufacturers maintain records, for two years, of the amount of sugars added to food products. The rule would also remove the provision allowing for voluntary declaration of “Other carbohydrate.”

FDA is also proposing to amend the definition of “dietary fiber” to mirror the definition of “total fiber” provided by the Institute of Medicine and which is consistent with the Codex Alimentarius definition. Under that definition, dietary fiber would include non-digestible soluble and insoluble carbohydrates (with 3 or more monomeric units) and lignin that are intrinsic and intact in plants. Thus, naturally occurring fiber would automatically meet the proposed “dietary fiber” definition, but for other fiber sources (isolates or synthetic non-digestible carbohydrates (with 3 or more monomeric units) that are added to food) to be counted as “dietary fiber,” the physiological benefit of the ingredient would need to be established by the evidence provided to the agency in the form of a citizen petition or health claim petition.

Additionally, the proposed rule would remove the mandatory vitamin C and vitamin A declarations, noting that, while vitamin C enhances iron absorption and vitamin A is required to maintain adequate liver stores, because deficiency is uncommon, they are no longer nutrients of public health significance for the general U.S. population. Their declaration would still be required when they are added to foods as a nutrient supplement, or claims are made about the vitamins on labeling. In their place, FDA proposes to require declaration of vitamin D and potassium amounts, as both are nutrients of public health significance due to vitamin D’s role in maintaining bone health and potassium’s in lowering blood pressure. The rule would also permit the voluntary declaration of choline.

  • Daily Reference Values (DRV) and Reference Daily Intake Values (RDI): FDA is proposing to update several DRV and RDI values based on current dietary recommendations. In particular, the rule would amend the DRV for dietary fiber, setting it at 28 grams, and reduce the sodium DRV from 2,400 mg to 2,300 mg. Additionally, FDA proposes to lower the RDI for vitamin B12 from 6 to 2.4 mcg/day, and to establish an RDI, instead of a DRV, for potassium of 4,700 mg/day (an increase from the current DRV of 3,500 mg/day).

Importantly, FDA also proposes to require that all vitamins and minerals (mandatory and voluntary) declared on the Nutrition Facts label include their quantitative amounts, in addition to the requirement for corresponding percent DV declarations. The proposed rule would also exclude non-digestible carbohydrates, which includes soluble and insoluble non-digestible carbohydrates that do not meet the definition of dietary fiber, from the “Total Carbs” calculation.

The FDA proposed regulation has far-reaching implications with respect to nutrition labeling requirements and nutrition-related marketing claims for both conventional food and dietary supplement products which merit careful consideration by affected companies. The FDA proposed regulations are open for public comment for 90 days – until June 2, 2014.