On March 25 and 26, FDA’s Center for Drug Evaluation and Research (CDER) held a public hearing to obtain input on the over-the-counter (OTC) drug review process. Under the OTC Drug Review, FDA was able to determine, by therapeutic category, that thousands of OTC drug products were generally recognized as safe and effective (GRAS/E). FDA
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.”…