FDA Issues Proposed Rule on Front-of-Package Nutrition Labeling

The U.S. Food and Drug Administration (FDA) is proposing to require a front-of-package (FOP) nutrition label on most packaged foods to provide accessible, at-a-glance information to help consumers quickly and easily identify how foods can be part of a healthy diet. 

The proposed FOP nutrition label, referred to as the Nutrition Info box, would detail and interpret the relative amounts of three nutrients — saturated fat, sodium and added sugars — in a serving of food and would appear on the package’s front so that it is immediately visible when a consumer is deciding whether to buy, use or eat the food. Current federal dietary recommendations advise U.S. consumers to limit these three nutrients to achieve a nutrient-dense diet within calorie limits.  

While calories would not be included in the Nutrition Info box, a manufacturer could voluntarily include a calorie statement on the front of the food package, per existing FDA regulations. See additional Nutrition Info box examples, including those listing calories near the box.

Diet-related chronic diseases in the United States are the leading causes of death and disability. Many of these chronic diseases are experienced at higher rates by certain racial and ethnic minority groups and those with lower socioeconomic status, compared to the overall average. Healthy eating patterns, which are, among other things, lower in saturated fat, sodium and added sugars, are associated with improved health, such as reduced risk of cardiovascular disease, type 2 diabetes and certain types of cancers. Providing informative and accessible food labeling empowers consumers to make informed choices.

The proposed Nutrition Info box would complement the Nutrition Facts label that is already required on most packaged food. While many consumers use and benefit from the Nutrition Facts label, regular use of the label is lower among some segments of the population. The Nutrition Info box would quickly provide context for consumers on the front of food packages by detailing and interpreting (through “Low,” “Med” or “High” descriptions) the relative amount of saturated fat, sodium and added sugars in a serving of food. Other countries have successfully implemented FOP nutrition labeling, and FDA’s research and other data show that its proposed Nutrition Info box could be useful for U.S. consumers, the agency said.

The FDA conducted a literature review, two sets of focus group testing and a peer-reviewed experimental study to explore consumer reactions and responses to various FOP nutrition labels. The first set of focus group testing provided FDA with qualitative feedback and insight into the varying ways that consumers react to and comprehend FOP nutrition information and helped the agency understand which schemes might be most helpful for U.S. consumers to quickly and easily identify how foods can be part of a healthy diet.

The second set of focus group testing showed that participants viewed the FOP nutrition information on beverages and non-beverage products similarly. The experimental study showed that the black and white “Nutrition Info” scheme with the quantitative and interpretive percent Daily Value performed best in helping consumers identify healthier food options in a number of instances. These results align with the scientific literature, which indicates that interpretive FOP nutrition information is helpful for consumers and simpler schemes are easier for consumers to understand.

The proposed rule would establish a compliance date of three years after the final rule’s effective date for businesses with $10 million or more in annual food sales and a compliance date of four years after the final rule’s effective date for businesses with less than $10 million in annual food sales. 

Comments on the proposed rule can be submitted electronically on http://www.regulations.gov by May 16.

Written comments can be submitted to: 
Dockets Management Staff (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All written comments should be identified with the docket number FDA-2024-N-2910 and with the title “Food Labeling: Front-of-Package Nutrition Information.”