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

Background

FDA has previewed its plans to issue the FOPNL proposed rule since the Fall 2022 White House Conference on Hunger, Nutrition, and Health. The proposed rule is positioned as a response to the growing prevalence of preventable diet-related chronic diseases in the U.S. and the Dietary Guidelines for Americans (DGA) recommendations that Americans limit the intake of saturated fat, sodium, and added sugars to achieve healthy dietary patterns. The agency also found that while many consumers use and benefit from the Nutrition Facts label, fewer people who use the Nutrition Facts label look at information on nutrients to limit. FDA points to evidence that suggests interpretive, rather than solely numeric, information displayed on the front of food packages helps consumers notice and use the nutrition information when making dietary choices. Finally, FDA positions the proposed rule within a global trend of countries in North America, South America, Asia, and Africa implementing mandatory FOPNL schemes, and several other countries in Africa, Europe, Asia, and Oceania implementing voluntary schemes.

The proposed rule uses a “High/Med/Low” scheme.

The proposed rule would require a “Nutrition Info” box located on the top third of a product’s PDP that includes the %DVs of three nutrients to limit (NTL) – sodium, saturated fat, and added sugars – accompanied by the interpretive markers “High,” “Med,” or “Low” for each nutrient. FDA cites evidence from a focus group that showed many participants found the presence of the %DV next to the interpretive description helpful because it provided context for the interpretative term, and an experimental study that found Nutrition Info schemes that included %DV declarations performed better in measures assessing ease of use and understanding. Accordingly, although the Nutrition Facts label already includes the %DVs, the proposed rule would also require the percentages to be listed in the Nutrition Info box. Finally, the proposed rule would require use of a single, easy-to-read type style, aligned with the type style requirements for Nutrition Facts labels,² and a type size of at least 8 point.  An example can be found in Appendix A.

Definitions of High/Med/Low

The proposed rule defines “Low” as food products containing 5 percent or less DV of the applicable nutrient per serving size, which is similar to FDA’s definition of “low saturated fat” and “low sodium,” though the latter definitions apply per reference amount customarily consumed (RACC) rather than per serving.³ Similarly, working off the nutrient content claim regulation for “high,”⁴ the proposed rule defines “High” as food products containing 20 percent or more DV per serving of the applicable NTLs. Notably, the existing regulation for “high” typically is used for food products bearing voluntary claims about a quantity of nutrients to encourage as opposed to mandatory disclosure of nutrients to limit. Indeed, under the statute, all nutrient content claims are voluntary. Lastly, for the first time, the proposed rule introduces a “medium” interpretive marker for nutrients. The agency defines “Med” as products containing between 6 percent to 19 percent DV of the applicable NTLs and bases this definition solely on the fact that the range is between the “Low” and “High” ranges.

The agency requests data and other information on alternative criteria for the “Low,” “Med,” and “High” descriptions. The agency also seeks comment on using the “Low” categorization for products that declare 0% DV of any of the applicable NTLs.

Compliance Date

The proposed rule would establish a compliance date of 3 years after the final rule’s effective date for businesses with $10 million or more in annual food sales and a compliance date of 4 years after the final rule’s effective date for businesses with less than $10 million in annual food sales.

The proposed rule would amend existing definitions of “low sodium” and “low saturated fat.”

The proposed rule would amend the existing nutrient content claim regulations defining low sodium⁵ so that foods other than a meal product or main dish may bear a “low sodium” claim if a serving of the food contains 115 mg or less sodium per RACC rather than 140 mg per RACC. FDA explains that this aligns with the revised DV for sodium of 2,300 mg. Additionally, the proposed rule would require the display of “Low” in the Nutrition Info box for sodium or saturated fat as a prerequisite for making voluntary nutrient content claims of “low sodium” or “low saturated fat,” respectively. The agency states that these changes would prevent potential confusion by eliminating the possibility of a food falling under the “Med” or “High” Nutrition Info box categorization for sodium or saturated fat while bearing a “low sodium” or “low saturated fat” claim.

Special considerations and exemptions.

Foods in intermediate packages

The proposed rule would allow food in packages with a total surface area available to bear labeling of 40 or fewer square inches to use an alternative, “intermediate-package” Nutrition Info box. The intermediate-package Nutrition Info box would be smaller than the proposed box and would only contain the interpretive markers “High,” “Med,” and “Low.”  An example can be found in Appendix B.

Foods with smaller serving sizes

FDA notes that other countries use different categorizations based on product type, including using different criteria based on serving size; for example, a higher threshold for “High” for some foods with larger serving sizes such as prepackaged main dishes, or a lower threshold for “High” for foods with smaller serving sizes such as peanut butter. FDA has adopted a similar approach for certain nutrient content claims such as “low.”⁶ The agency seeks comments on how to address this serving size issue.

Foods marketed for children under 4 years 

The proposed rule would apply to foods intended for adults and children ages 4 years and older, including pregnant and lactating people. However, noting that infants and children ages 1 to 3 years are “vulnerable subpopulations and have specific nutritional needs,” the proposed rule would not apply to foods marketed for children under 4 years old.

Dietary supplements

In addition to foods marketed to children under age 4, the proposed rule would also exempt “most” dietary supplements, recognizing that while dietary supplements are considered foods, they serve a different purpose than conventional foods and are often intended to supplement diets by providing individual nutrients (e.g. Vitamin C)  rather than constituting a core part of a diet. While the proposed rule doesn’t specify which dietary supplements would be exempt, the agency notes, without opining further, that there are some dietary supplements that may contain “High” levels of the applicable NTLs per serving.  FDA invites comments on exempting dietary supplements.

Other foods that are exempted from the proposed rule

FDA exempts the following foods from complying with the proposed rule:

• Foods exempted from bearing a Nutrition Facts label under 21 C.F.R. § 101.9(j), for example:
  • raw fruits and vegetables;
  • foods that contain insignificant amounts of mandatory nutrients;⁷
  • foods in small packages that have a total surface area available to bear labeling of less than 12 square inches;⁸ and
  • unit containers in a multiunit retail food package that comply with the relevant exemption.⁹
• Outer packaging of gift packaging.

Foods that qualify for a simplified Nutrition Facts label¹⁰ are not exempt from the proposed rule.

Alternative schemes not selected.

FDA discusses a number of alternative FOP labeling schemes that were not selected.

A quantitative calorie statement. 

While the proposed rule would not prohibit a voluntary quantitative calorie statement on the PDP, FDA argues that a quantitative calorie statement would not provide consumers with new, interpretive information. Further, FDA notes that there is no %DV for calories, making it difficult to create an interpretive calorie statement. 

FDA seeks comment on the inclusion of a mandatory or voluntary quantitative statement of calories in the Nutrition Info box. Examples can be found in Appendix C.

A “High in ‘X’ nutrient” statement reserved for foods that contain 20% DV or more of one of the applicable NTLs.

FDA explains its consumer research shows that while this scheme emphasized to consumers higher levels of NTLs, the “High in” statement performed the worst among other schemes when participants were asked to identify a product’s healthfulness.

A Guideline Daily Amount (GDA) statement.

The GDA statement tested by FDA with consumers consisted of a set of icons placed horizontally that displayed calories, quantitative amount of nutrients (sometimes including both NTLs and nutrients to get enough of), the %DV, and an interpretive description (i.e. “Low,” “Med,” and “High”). The scheme resembled the voluntary Facts Up Front scheme developed by industry though without calories and with the addition of the interpretive statements. FDA also tested a version of the GDA scheme that only provided quantitative descriptions and did not include any interpretive descriptions. 

While participants liked the look of the GDA scheme, FDA rejected this approach because participants were “significantly less likely” to correctly identify the level of applicable NTLs.

A scheme that includes “nutrients to get enough of” (i.e. calcium and fiber).

FDA notes feedback from consumer research indicating participants were confused by the inclusion of both NTLs and nutrients to get enough of in the same FOPNL scheme. 

A Nutrition Info box that used colors to help communicate interpretive statements.

FDA tested a version of the Nutrition Info box that included the colors green, yellow, and red to help communicate to consumers that a product was low, medium, or high, respectively, in the applicable NTLs. FDA found that while there is some existing evidence that suggests color coding with text can lead to improved understanding of nutrition information, the agency’s own study found that colors did not increase consumers’ understanding of interpretive information in a statistically significant way. Additionally, FDA expressed concerns about using color coding for consumers with red-green color blindness.

Further, FDA notes consumer research participants were confused by the colors when schemes contained both NTLs and nutrients to get enough of. For example, participants had trouble interpreting when red indicated a high amount of an NTL and a low amount of a nutrient to get enough of. 

Legal Authority

FDA discusses its legal authority for the proposed rule under the Federal Food, Drug, and Cosmetic Act (FFDCA).  The agency cites section 403(q) of the FFDCA, which lists certain nutrition information that must be included in food labeling and authorizes FDA to specify, by regulation, additional requirements that must be conveyed in a manner that allows the public to understand nutrition information in the context of a total daily diet.¹¹ FDA also cites section 403(f) of the FFDCA, which specifies that a food is misbranded if any information required under the FFDCA is not prominent and conspicuous on a food product’s label. Additionally, the agency points to its general food labeling authority under sections 403(a)(1) and 201(n) of the FFDCA. FDA asserts that the proposed rule is consistent with its authority to issue regulations to effectuate the efficient enforcement of the Act in section 701(a) of the FFDCA, and finds that the relative amounts of sodium, saturated fat, and added sugar in food products is material information that consumers must have as they select foods as part of their daily diet. To that end, the agency asserts that without the proposed rule’s mandatory FONPL scheme working in tandem with existing Nutrition Labels, consumers face challenges to understanding the relative contribution that individual foods make to their total daily intake of the applicable NTLs.

Further, FDA takes the position that information required in the Nutrition Information box is not a voluntary nutrient content claim (which is significant because such claims are voluntary rather than mandatory under the statute). The agency states that section 403(r)(1) of the FFDCA, which covers such claims, provides that statements appearing as part of the nutrition information required or permitted under section 403(q) are not nutrient content claims. FDA concludes that the proposed Nutrition Info box falls under its 403(q) authority. 

If finalized, FDA notes that the rule would fall under NLEA’s express preemption provision, and would therefore preempt differing or additional state laws. Finally, the agency notes that severability applies to the proposed rule, and that if certain elements of the Nutrition Info box are invalidated, such as the placement requirement, the other elements would continue to function.

Next Steps

Comments are due May 16, 2025. As a first-of-its kind proposal, we strongly encourage food companies and trade associations to submit comments. Please do not hesitate to contact us if you have any questions or if we can be of assistance in drafting comments.

Appendix A

Proposed Nutrition Info box

Appendix B

Proposed intermediate-package  Nutrition Info box

Appendix C

Examples of Nutrition Info box with calories statement

Authored by Veronica Colas and Chigozie Akah.