Summary
Background In 2025, the US Food and Drug Administration (FDA) proposed a mandatory single front-of-package label (FOPL) listing low, medium, or high descriptors and the percent Daily Value (%DV) for saturated fat, sodium, and added sugars. Effects of this scheme (referred to as Nutrition-Info-%DV) on consumer understanding, perceptions, and behaviours are largely unknown; thus, this study aims to compare the FDA’s proposed label against potential alternatives. Methods This online randomised controlled trial recruited a national sample of US adults aged 18 years or older who reflected US demographics. Participants were randomly assigned (1:1:1:1:1) via the Qualtrics randomiser to view products labelled according to one of five conditions: (1) a no-label control; (2) the FDA’s proposed scheme (Nutrition- Info-%DV); (3) a Nutrition-Info scheme with no %DV and High highlighted in red (Nutrition-Info-Red); (4) a single label scheme listing all nutrients contained in a high amount (High-In); or (5) a multilabel scheme with separate labels for each nutrient contained in a high amount (Multi-High-In). Participants were masked to the study objectives. Primary outcomes included consumer understanding (ie, correct identification of products with the healthiest and least healthy nutrient profiles, correct assessment of high nutrient content) and perceived healthfulness of unhealthy products (high in one, low in two nutrients). This study was registered with ClinicalTrials.gov (NCT06903403). Findings A total of 15 582 participants were randomly assigned (3121 assigned Nutrition-Info-%DV, 3115 assigned Nutrition-Info-Red, 3117 assigned High-In, 3116 assigned Multi-High-In, and 3113 assigned no-label control), with recruitment and data collection occurring April 1-25, 2025. 1653 participants were excluded, yielding an analytical sample of 13 929 (7021 [50%] women, 6851 (49%) men, and 57 (<1%) identifying another way (eg, gender non- conforming or non-binary). All FOPLs improved consumer understanding compared with the control. Nutrition- Info-Red outperformed Nutrition-Info-%DV for participants correctly identifying the healthiest (5.4 percentage points; 95% CI 4.1-6.8; p<0.0001) and least healthy (3.3; 1.8-4.9; p<0.0001) nutrient profiles. Multi-High-In outperformed Nutrition-Info-%DV for participants correctly identifying the least healthy nutrient profiles (1.7; 0.1-3.3; p=0.038). Both Nutrition-Info-Red (2.3; 1.6-3.0; p<0.0001) and Multi-High-In (0.9; 0.2-1.5; p=0.014) outperformed Nutrition-Info-%DV in correct assessment of high nutrient content. Nutrition-Info-Red and Nutrition-Info-%DV resulted in higher perceived healthfulness of unhealthy products than Multi-High-In. Multi- High-In outperformed all schemes in reducing the selection of high-in foods (range= -7.7 to -5.0 percentage points) and quickly identifying nutrient profiles (range= -31.6 s to -4.5 s). Interpretation FOPLs that only highlight high amounts of nutrients of concern, like Multi-High-In, outperformed the FDA’s proposed scheme and should be considered for implementation to help consumers quickly identify and make healthier dietary choices. Funding Robert Wood Johnson Foundation Healthy Eating Research and Bloomberg Philanthropies’ Food Policy Program. Copyright © 2026 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC 4.0 license.
Outcomes reported
All tested FOPLs improved consumer understanding versus no label. Designs that highlight high amounts of nutrients of concern, particularly the Multi-High-In label, outperformed the FDA's proposed Nutrition-Info-%DV scheme in behavioural and speed outcomes and should be considered for implementation. Topics: front-of-package labelling / warning labels; methods / modelling / statistics; nutrient cycling / nitrogen / phosphorus / eutrophication; obesity / chronic disease / public health Evidence type: Main study / source report Source report: Lancet Public Health FOPL RCT Ref#: Lancet Public Health FOPL RCT #MAIN Original: Brittany Lemmon; Anna H. Grummon; Alejandra Marquez; Lisa M. Soederberg Miller; Lauren E. Au; Susan D. Brown; Aijia Wang; Lisa M. Powell; Jennifer Falbe. Efficacy of front-of-package nutrient labels designed for mandatory implementation in the USA: an online randomised controlled trial. The Lancet Public Health (2026).
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