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  6. Nutrient Content Claims; Definition of Term “Healthy” (Proposed Rule) Regulatory Impact Analysis
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Nutrient Content Claims; Definition of Term “Healthy” (Proposed Rule) Regulatory Impact Analysis

FDA is proposing to redefine the implied nutrient content claim “healthy” to make it more consistent with current nutrition science and federal dietary guidance. The “healthy” claim is a voluntary label 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.” Because nutritional science has evolved over time, updating the definition of the implied nutrient content claim “healthy” to more closely align with the current nutrition science underpinning current federal dietary guidance will better inform consumers who are selecting those products to choose a more healthful diet, which may result in lower incidence of diet-related chronic diseases, including cardiovascular disease and type 2 diabetes. Quantifiable benefits of the proposed rule are the estimated reduction over time in all-cause morbidity stemming from consumers that currently use the “healthy” implied nutrient content claim selecting and consuming more healthful foods. This is calculated through the negative 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 $276 million, or $19 million annualized.  Potential costs of rebranding certain foods are discussed qualitatively.  Discounted at three percent over 20 years, the mean present value of benefits is estimated at $455 million, or $31 million annualized. Net benefits are estimated at $180 million, or $12 million annualized. 

Regulatory Impact Analysis

Nutrient Content Claims; Definition of Term “Healthy” Preliminary Regulatory Impact Analysis PDF- 677KB)

Federal Register: 87 FR 59168, September 29, 2022

Docket: FDA-2016-D-2335  

 
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