July 15, 2025
Dear Human Foods Program of the U.S. Food and Drug Administration:
The National Center for Health Research (NCHR) appreciates the opportunity to submit these comments regarding the U.S. Food and Drug Administration’s (FDA’s) Proposed Rule “Food Labeling: Front-of-Package Nutrition Information,” 90 Fed Reg 5426 (January 16, 2025) for most foods that must bear a Nutrition Facts label.
NCHR is a non-profit think tank dedicated to bridging the gap between scientific evidence and public policies that affect the health and safety of adults and children. We primarily focus on the safety and effectiveness of medical and consumer products, and consider the front-of-package nutrition label (FOPNL) as an important strategy to help individuals and families optimize their health and prevent the onset of diet-related chronic disease and health conditions.
We applaud the effort and dedication of the FDA’s Human Foods Program (HFP) to develop and test a FOPNL to provide consumers with nutrition information that can help them quickly and easily identify how foods can be part of a healthy diet, particularly consumers with lower use of the Nutrition Facts label (i.e., men, those with lower education levels, and those with lower incomes).
Diet-related chronic diseases and health conditions are pervasive in the United States (US) and have a negative impact on the quality of life for American consumers and the US economy. There is real-world evidence that consuming an unhealthy diet over time is a risk factor for cardiovascular disease and diabetes, and also increases medical costs.12 The FDA’s FOPNL is a targeted strategy that will enable consumers to make personal dietary choices to meet their health goals and to reduce their risk for chronic disease and health conditions.
NCHR generally agrees with the letter of support submitted by the Center for Science in the Public Interest. In addition, NCHR strongly supports these provisions of the FDA HFP’s proposed rule:
- To require a FOPNL for most foods that must bear a Nutrition Facts label. 2. To include nutrients to limit.
- To be interpretive, helping individuals understand the implications of the label information.
Here are our additional recommendations for the proposed rule for FOPNL:
- Require FOPNL on foods marketed and intended for children ages 1 to 3 years within the proposed rule.
- Test an FOPNL that communicates the percent daily calories from saturated fat and added sugars in a food or beverage product.
- Test FOPNLs with and without the presence of a “Healthy” nutrient content claim. 4. Comment on adapting the Healthy Eating Index to assess the quality of individual food and beverage products.
- Test and consider, within the existing proposal, adding the color red to the FOPNL when a nutrient is categorically “High”.
- Include rather than exempt the proposed Nutrition Info box from foreign language declarations.
- Consider incorporating ultra-processed foods into the FOPNL schema. Our specific recommendations for these 7 issues are below.
Scope/Applicability (Proposed § 101.6(a)(1))
- We strongly urge the FDA HFP to require FOPNL on foods marketed and intended for children ages 1 to 3 years within the proposed rule.
Children ages 1 to 3 years are a vulnerable subpopulation and have specific nutritional needs and the eating habits formed in early years substantially influence their eating habits and health in the years to follow. Parents and caregivers would greatly benefit from a FOPNL to “help them quickly and easily identify how foods can be part of a healthy diet.”
This is important because research indicates an unfortunate disconnect between parents and caregivers’ intentions and their feeding practices. Results from a 2021 survey of parents (n=1,000) found that roughly 88% were confident in their nutrition knowledge to make informed decisions for children and reported that they try to avoid or limit sugar in their child’s diet. However, parents indicated that their kids regularly drank juice (n=750, 75%) and ate a sweet every day (n=900, 90%).3 The 2020-2025 DGAs also indicate that more than 85% of boys and girls ages 2 to 4 exceed the limits of saturated fat, nearly 60% exceed limits for added sugars, and 95% – 97% exceed sodium limits.4 While there are a multitude of factors that influence choice, a FOPNL on foods marketed to kids aged 1 to 3 years would support decision-making among caregivers.
Fortunately, the FDA has codified DRVs for children ages 1 through 3 years (81 FR 33742 at 33927–31, codified at § 101.9(c)(9)).5
We understand the 2020-2025 Dietary Guidelines for Americans (DGA) established daily nutrition goals for two subpopulations of kids aged 12 to 23 months and 2 to 3 years for saturated fat, sodium, and added sugars and that the FDA wants food labels to align. However, the DRVs established in 2016 by the FDA for saturated fat, sodium, and added sugars for kids 1 to 3 years remain on the Nutrition Facts label (21 CFR 101.9(c)(9)). If the FOPNL aligned with the DGA, the nutrition information would be inconsistent with the NFL. Further, the 2025-2030 DGAs may again update the daily nutrition goals though at the time of our comment, have not been released.
Criteria for Front-of-Package Nutrition Label
The FDA states on page 5442: “We invite comment on the inclusion of a mandatory or voluntary quantitative statement of calories in the Nutrition Info box. We also invite comment on any ways we could consider inclusion of an interpretation of quantitative calorie information in the Nutrition Info box, including any new data or other information on which to base such an interpretation.”
NCHR commends the FDA HFP for its comprehensive consumer research on FOPNLs in The Front-of-Pack Focus Groups (OMB No. 0910-0497) and The Quantitative Research on Front of Package Labeling on Packaged Foods (OMB No. 0910-0920). We offer additional recommendations for the FDA HFP to test with consumers, if appropriate.
- The FDA HFP should test an FOPNL that communicates the percent daily calories from saturated fat and added sugars in a food or beverage product.
The proposed rule states there is “evidence showing it is difficult to meet nutrient needs within calories limits when added sugars consumption is high, and consumption data showing that Americans consume too many calories from added sugars (81 FR 33742 at 33759 and 33768 through 33770).” This approach aligns with the 2020-2025 DGAs for consumers to “Limit: 10% of total energy” for added sugars and saturated fat,” and provides interpretive nutrition information not found on the Nutrition Facts label, based on a 2,000 calorie diet.
The 2020-2025 DGAs also recommend for children ages 2 to 4 years old to consume no more than 10% of total energy for added sugars and saturated fat.4 So, this nutrition information would be consistent for products intended for people aged 2 years and older.
- The FDA HFP should test FOPNLs with and without the presence of a “Healthy” nutrient content claim.
The FOPNL schema and updated “Healthy” nutrient content claim provide interpretive nutrition information to facilitate consumers to make comparisons of foods and beverages to make informed decisions for their personal dietary needs. The goal of the FOPNL is “to compare nutrition information across foods” or “to make more informed food selections and comparisons” (89 FR 106150).6
The FOPNL appears to be an adaptation of the “Healthy” nutrient content claim with the same nutrients to limit (sodium, saturated fat, added sugars) though different % DV per food group equivalents (FGEs) or “qualifying amounts of foods from each food group based on nutritional content” (21 CFR 101.65(d)(2)).
We surmise the combination will confuse consumers when comparing two of the same packaged foods, with different labels / claims; meaning, one product displays the required FOPNL and the voluntary “Healthy” claim and a second product only displays the required FOPNL. We urge the FDA HFP to test this combination with consumers if both labeling initiatives have the same intention of comparing products for their nutritional content.
- We request the FDA HFP explore the possibility of adapting the United States Department of Agriculture’s (USDA) Healthy Eating Index (HEI)7from assessing diet quality to the quality of packaged food products.
The HEI was designed to “assess how well a set of foods aligns with key recommendations and dietary patterns published in the Dietary Guidelines for Americans (Dietary Guidelines)” in persons 2 years and older. New in 2020, the USDA Food and Nutrition Services (USDA FNS) developed an HEI in 2020 for foods intended for Toddlers aged 12 to 23 months old. We encourage FDA HFP to collaborate with USDA FNS to explore the potential to adapt this dietary assessment tool for packaged food products and the FDA’s FOPNL.
- We encourage the FDA HFP to test and consider, within the existing proposal, adding the color red to the FOPNL when a nutrient is categorically “High”.
The FDA’s literature review found that, among other things, “summary systems incorporating [text and] color worked better than those using only numeric information in attracting consumer attention and informing them about the relative healthfulness of foods.” However, FDA’s Quantitative Research of FOPNL on Packaged Foods provided evidence that a multi-color FOPNL (i.e., red, yellow, green) resulted in consumer confusion.
Recent research shows that incorporating the color red for “High” nutrients is easily understood by consumers and we encourage the FDA HFP to test this FOPNL combination. Researchers from the University of California at Davis, Stanford University, the University of Illinois Chicago tested several label combinations and found that the Nutrition Info Red FOPNL outperformed FDA’s Nutrition Info %DV FOPNL.8
Foreign Language Declaration
The FDA states on page 5454: “Section 101.15: Food; prominence of required statements (proposing to exempt the proposed Nutrition Info box from foreign language declarations due to space considerations).”
- We strongly urge the FDA HFP to include rather than exempt the proposed Nutrition Info box from foreign language declarations.
The proposed rule states, “(2) If the label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the act to appear on the label must appear thereon in the foreign language, except for labeling in accordance with § 101.6: Provided, however, That individual serving-size packages of foods containing no more
than 11⁄2 avoirdupois ounces or no more than 11⁄2 fluid ounces served with meals in restaurants, institutions, and passenger carriers and not intended for sale at retail are exempt from the requirements of this paragraph (c)(2), if the only representation in the foreign language(s) is the name of the food.”
We disagree with this large loophole that would make it more difficult for many Americans to understand the information in the FOPNL, and instead urge the FDA HFP to test the proposed Nutrition Info box with non-English speakers and with limited literacy to determine how useful that information will be if not translated. This suggestion is consistent with information on the webpage, “Virtual Public Meeting and Listening Sessions on Strategies to Reduce Added Sugars Consumption in the United States” under “Summary of Themes Heard9,” it states there was:
“General support for Front-of-Package (FOP) labeling, participants recommended including both Total and Added Sugars as well as calories in a FOP system. They discussed the importance of providing clear labeling with icons, particularly for non-English speakers and individuals with limited literacy.”
We offer these recommendations based on the recent publication, Priorities for a New FDA published on June 10, 202510 and the MAHA Report released on May 16, 2025.11
- We recommend the concept of ultra-processed foods be incorporated into the FOPNL.
Ultra-processed foods (UPF) have been a hallmark issue for Health and Human Services Secretary Kennedy and FDA Commissioner Makary who emphasize UPFs are a key driver to chronic disease in the US. The MAHA Report specified “reductionist recommendations” as a concerning approach for dietary advice in the 2020-2025 DGAs.
“Advising people to ‘reduce saturated fat’ or ‘limit sodium’ instead of focusing on minimizing ultra-processed foods.”
We understand that FDA HFP may not yet have determined how best to do that, but urge their consideration of incorporating UPF in the FOPNL.
Our goal of these recommendations is to help to improve the FOPNL and deeply appreciate the dedicated work at FDA HFP to develop food labels that help consumers make decisions that fit their dietary needs and health goals.
Sincerely,
Diana Zuckerman, PhD, President, National Center for Health Research
Amanda Berhaupt, PhD, MS, RD, Health Policy Director, National Center for Health Research
1. Agency for Healthcare Research & Quality. Expenditures for Key Diet-Related Health Conditions, 2021-2022. Statistical Brief #561. May 2025. Steven C. Hill, PhD, and Zhengyi Fang,MS.https://www.meps.ahrq.gov/data_files/publications/st561/stat561.shtml.
2. The MAHA Report: Make Our Children Healthy Again. (2025). https://www.whitehouse.gov/wp-content/uploads/2025/05/MAHA-Report-The-White-House.pdf.
3. International Food Information Council. Knowledge, Understanding, and Behaviors When Feeding Children: Insights from U.S. Parents and Caregivers. March 2021. https://ific.org/wp-content/uploads/2025/04/IFIC-Parents-Caregivers-Survey.March-2021-pdf.jpg
4. United States Department of Agriculture. 2020 – 2025 Dietary Guidelines for Americans. https://www.dietaryguidelines.gov/sites/default/files/2020-12/Dietary_Guidelines_for_Americans_2020-20 25.pdf
5. 21 Code of Federal Regulations 101.9(c)(9). Nutrition Labeling of Food. https://www.ecfr.gov/current/title-21/part-101/section-101.9#p-101.9(c)(9)
6. Federal Register. Vol. 89, No. 248. Friday, December 27, 2024. Rules and Regulations. 21 CFR Part 101 [Docket No. FDA–2016–D–2335] RIN 0910–AI13 Food Labeling: Nutrient Content Claims; Definition of Term ‘‘Healthy’’. https://www.govinfo.gov/content/pkg/FR-2024-12-27/pdf/2024-29957.pdf
7. United States Department of Agriculture. Healthy Eating Index. How the HEI is Scored. https://www.fns.usda.gov/cnpp/how-hei-scored.
8. Lemmon, B; Grummon, AH; Marquez, A; Soederberg Miller, LM; Au, LE; Brown, SD; Wang, A; Powell, LM; Falbe J. An online randomized controlled trial comparing front-of-package nutrient labels on consumer understanding, perceptions, and behavior. 2025. Pre-print.
9. The US Food & Drug Administration. Virtual Public Meeting and Listening Sessions on Strategies to Reduce Added Sugars Consumption in the United States. November 6-8, 2023. https://www.fda.gov/food/workshops-meetings-webinars-food-and-dietary-supplements/virtual-public-meet ing-and-listening-sessions-strategies-reduce-added-sugars-consumption-united
10. Makary MA, Prasad V. Priorities for a New FDA. JAMA. Published online June 10, 2025. doi:10.1001/jama.2025.10116.
11. Presidential Commission to Make America Healthy Again. (2025, May 22). Make America Healthy Again Assessment. Washington, D.C. Published online May 22, 2025. https://www.whitehouse.gov/wp-content/uploads/2025/05/MAHA-Report-The-White-House.pdf.