The Food and Drug Administration (FDA or we) is issuing an interim final rule to amend the regulation authorizing a health claim on the relationship between dietary saturated fat and cholesterol and risk of coronary heart disease (CHD) (21 CFR 101.75) by permitting its use on raw fruits and vegetables that are currently ineligible to bear the claim. These raw fruits and vegetables do not meet the “low fat” definition (21 CFR 101.62(b)(2)) and/or the minimum nutrient content requirement (21 CFR 101.14(e)(6)) in order to be eligible to bear the CHD claim. FDA is issuing this interim final rule in response to a petition submitted by the American Heart Association. The analysis of benefits and costs included in this document is the basis for the Economic Analysis of Impacts section included in the Food Labeling: Health Claims; Dietary Saturated Fat and Cholesterol and Risk of Coronary Heart Disease interim final rule [FDA-2013-P-0047].

Regulatory Impact Analysis

Food Labeling: Health Claims; Dietary Saturated Fat and Cholesterol and Risk of Coronary Heart Disease (Interim Final Rule) (PDF - 324KB)

Federal Register: 81 FR 91716, December 19, 2016

Docket: FDA-2013-P-0047