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  1. Economic Impact Analyses of FDA Regulations

Nutrient Content Claims; Definition of Term “Healthy” (Final Rule)

The “healthy” claim is a voluntary label claim that food manufacturers can use on FDA-regulated food products that meet the criteria defined in 21 CFR 101.65(d). In the current marketplace, about five percent of foods are labeled as “healthy.” Updating the definition of the implied nutrient content claim “healthy” to more closely align with the nutrition science underpinning current Federal dietary guidance will better inform consumers who are selecting those products to choose a more healthful diet. This may result in lower incidence of diet-related chronic diseases, including cardiovascular disease and type 2 diabetes. Quantifiable benefits of the rule are the estimated reduction over time in all-cause mortality stemming from consumers that currently use the “healthy” implied nutrient content claim in selecting and consuming more healthful foods. Discounted at three percent over 20 years, the mean present value of benefits is estimated at $686 million, or $46 million annualized. This is calculated through the inverse association between a Healthy Eating Index score and all-cause mortality.  Quantifiable costs to manufacturers associated with updating the “healthy” claim are reformulating, labeling, and recordkeeping.  Discounted at three percent over 20 years, the mean present value of costs is estimated at $403 million, or $27 million annualized.  Potential costs of rebranding certain foods are discussed qualitatively.  Net benefits are estimated at $283 million, or $19 million annualized.

Regulatory Impact Analysis

Nutrient Content Claims; Definition of Term “Healthy” (Final Rule) (PDF 876KB)

Federal Register: 89 FR 106064
Publication Date: 12/20/2024 
Docket: FDA-2016-D-2335 

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