By: Rebecca Bermudez and Samantha Hong
On January 14, 2025, FDA announced a proposed rule that would require that most foods displaying the familiar Nutrition Facts panel also bear a front-of-package (“FOP”) nutrition label in the form of an FOP Nutrition Info box on the principal display panel.[1] The potential addition of an FOP nutrition label has been the subject of ongoing consideration by the agency for decades and the proposed FOP Nutrition Info box would provide standardized and condensed information to consumers regarding specific nutritional content contained within a food product. FDA states that the proposed rule “would provide consumers, including those who have lower nutrition knowledge, with interpretive nutrition information that can help them quickly and easily identify how foods can be part of a healthy diet.”[2] We provide an overview of the proposed rule below. Comments to the proposed rule are due by May 16, 2025.
What information would the proposed FOP Nutrition Info box require?
The proposed FOP Nutrition Info box would provide the % Daily Value (DV) of certain nutrients in the food that are recommended to be limited as part of a healthy diet: saturated fat, sodium, and added sugars. The Nutrition Info box would also include interpretive descriptors for each of these nutrients— “Low,” “Medium,” or “High”—to “quickly provide context to consumers” regarding their relative amounts.[3] Specifically, FDA proposes a range of 5% DV or less for “Low”; 6–19% DV for “Med”; and 20% DV or more for “High.”
An example of an FOP Nutrition Info box display provided in the proposed rule is included below for reference[4]:
FDA considered whether to require calorie information in the FOP Nutrition Info box, but “tentatively conclude[d] that it would not be appropriate to provide consumers with an interpretation of the quantitative calorie information currently required on the Nutrition Facts label” as there is no established Daily Value for calories.[5] That said, manufacturers can continue to voluntarily include a calorie statement on the front of food packaging in accordance with existing regulations.
Examples of FOP Nutrition Info box labeling that includes a calorie statement are provided below. Both examples are included in the proposed rule[6]:
As with existing regulations regarding the Nutrition Facts panel, the proposed rule also includes specific formatting, placement, and size requirements, as well as requirements regarding modified or alternate displays. The proposed rule further exempts certain foods from the FOP Nutrition Info box requirements, including those in small packages, those containing an assortment of foods and marketed as gifts, and unit containers in multi-unit packages.
FDA also notes that inclusion of the Nutrition Info box would not be considered as a nutrient content claim.[7]
What other issues does the proposed rule address?
FDA is also proposing to amend existing “low sodium” and “low saturated fat” nutrient content claim regulations “to align with current nutrition science and to avoid within-label inconsistencies” as a result of the proposed rule.[8]
If finalized, by when must you comply with the proposed rule?
FDA proposes to stagger compliance dates based on business size. Specifically, for businesses with $10 million or more in annual food sales, FDA proposes a compliance date of 3 years after the final rule’s effective date and for businesses with less than $10 million in annual food sales, 4 years.
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KKB is continuing to monitor the proposed rule and will provide further updates accordingly.
[1] U.S. Food and Drug Administration, Proposed Rule on Food Labeling: Front-of-Package Nutrition Information, 90 Fed. Reg. 5426 (Jan. 16, 2025) (“FOP Nutrition Information Proposed Rule”), available at: https://www.federalregister.gov/public-inspection/2025-00778/food-labeling-front-of-package-nutrition-information.
[2] FOP Nutrition Information Proposed Rule, 90 Fed. Reg. at 5427.
[3] U.S. Food and Drug Administration, FDA Issues Proposed Rule on Front-of-Package Nutrition Labeling, available at: https://www.fda.gov/food/hfp-constituent-updates/fda-issues-proposed-rule-front-package-nutrition-labeling?utm_medium=email&utm_source=govdelivery (last visited Jan. 15, 2025).
[4] FOP Nutrition Information Proposed Rule, 90 Fed. Reg. at 5427.
[5] FOP Nutrition Information Proposed Rule, 90 Fed. Reg. at 5441-5442.
[6] FOP Nutrition Information Proposed Rule, 90 Fed. Reg. at 5442.
[7] FOP Nutrition Information Proposed Rule, 90 Fed. Reg. at 5437. FDA provides that “[s]ome of the information that would appear in the Nutrition Info box would be a nutrient content claim if a manufacturer chose to voluntarily include it elsewhere on a food label. But we have determined that the proposed information in the Nutrition Info box, when it appears in the Nutrition Info box, is not a nutrient content claim and would not be subject to the requirements for nutrient content claims.” Id.
[8] FOP Nutrition Information Proposed Rule, 90 Fed. Reg. at 5428.