Efficacy of front-of-package nutrient labels designed for mandatory implementation in the USA: an online randomised controlled trial.

Abstract

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. 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). 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 unders