On January 16, 2025, the U.S. Food and Drug Administration (FDA) published a proposed rule titled, Food Labeling: Front-of-Package Nutrition Information. The rule would require front-of-package nutrition labels on most foods that must bear a Nutrition Facts label. This action would require the display of a compact informational box containing certain nutrient information on the principal display panel. The new label would provide all consumers with standardized, interpretive nutrition information that allows for quick, easy identification of how the food item can be part of a healthy diet. On May 9, 2025, the FDA extended the comment period on the proposed rule by 60 days until July 15, 2025.
The FDA prepared an initial regulatory flexibility analysis (IRFA) as required by the Regulatory Flexibility Act (RFA), but the agency noted its intention to certify the rule in the final rule. The FDA’s small business impact analysis stated that they had no information on the number of Universal Product Codes (UPCs) owned by small businesses and suggested that they were unable to properly assess the rule’s costs per small entity as a result.
Stakeholders shared concerns that the FDA underestimated the rule’s costs and that compliance would be more expensive than projected. On July 15, 2025, the Office of Advocacy (Advocacy) submitted a comment letter to the FDA on the proposed rule, arguing that the agency’s certification was improper given the data limitations. In its comments, Advocacy provided recommendations on how the FDA could improve the rule’s RFA analysis so that small business impacts are fully considered and alternatives are analyzed. Advocacy also encouraged the FDA to use additional data resources that would paint a more complete picture of the small businesses likely impacted by the rule.
COMMENT LETTER
Comments on Front of Package Labeling Rule
(PDF, 301 KB)
CONTACT:
Linwood Rayford
EMAIL:
Letters to Agencies
TAG(S):
FDA