RegWatch / review register

Food Labeling: Nutrient Content Claims; Definition of Term “Healthy”

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Why it reaches us This FDA final rule redefines the criteria a food must meet to bear the term "healthy" or its derivatives as a nutrient content claim (21 CFR 101.65(d)). Meridian's own label-claims record shows MF-3001 (Oat & Honey Bar) carried a "Healthy" claim that no longer met the revised food-group and nutrient criteria; the claim was voluntarily withdrawn in March 2025 at a cost of $310,000 in packaging write-off and expedited reprint (per incident_history). That withdrawal was a direct consequence of this rule. Even though no SKU currently bears the "healthy" claim in market, the rule remains binding on Meridian for the full 3-year compliance window (through the compliance date) and governs whether the claim can be reintroduced on any of the 11 SKUs, including MF-3001 and the three SKUs carrying "good source of fiber" claims that could tempt a future "healthy" relaunch.</applicability_reasoning> <parameter name="what_changed">FDA finalized new criteria for using "healthy" (and derivatives like "healthful," "healthier") as an implied nutrient content claim: products must contain a meaningful amount of food from at least one FDA-recognized food group (per Dietary Guidelines 2020-2025) and stay under specified limits for added sugars, saturated fat, and sodium, with different thresholds depending on product size/category (individual food, main dish, meal). It also creates a new recordkeeping requirement (2 years) for products bearing the claim where the food-group equivalent is not apparent from the label, with failure to keep records treated as misbranding.

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