FDA Issues Supplemental Proposed Rule On Nutrition And Supplement Facts Labels

On July 27, 2015, the Food and Drug Administration (FDA) published a supplemental proposed rule, offering changes to the original March 2014 proposal to revise the format and content of the Nutrition and Supplement Facts Labels. The two key issues raised by the supplemental proposed rule are: (1) establishment of a Daily Reference Value (DRV) for added sugars, based on evidence presented in the 2015 Dietary Guidelines Advisory Committee (DGAC) Report; and (2) the proposed language for the footnote explaining the meaning of the percent Daily Value (DV), as well as which label formats are required to include this footnote. In support of the revised proposal, FDA also is making available for comment the results of two consumer studies conducted by the agency in 2014 and completed in June 2015.

FDA will accept comments on the narrow set of issues raised by the supplemental proposal until October 13, 2015 and will accept comments on the consumer studies until September 25, 2015. FDA will not accept additional comments on other issues raised by the original proposal. In this memorandum, we provide a top-line summary of the proposed changes.

FDA Issues Supplemental Proposed Rule on Nutrition and Supplement Facts Labels