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FDA proposes new “healthy” food definition

October 3, 2022

On September 29, the U.S. Food and Drug Administration (FDA) released a long-anticipated proposed amendment to 21 CFR § 101.65 describing how the agency intends to define and regulate the use of “healthy” claims on food labels and labeling.

The proposed amendment would use food group categories from the 2020-2025 U.S. Department of Agriculture Dietary Guidelines (Dietary Guidelines) to reflect the diversity of nutrients provided by different foods, while encouraging reduced consumption of sodium, saturated fats, and added sugar.

In response to prior FDA rulemaking and comment requests on this subject, AHPA communicated its support for an update to the “healthy” definition in line with the most recent Dietary Guidelines. In its comments, AHPA encouraged the agency to allow products such as salt-free herb and spice blends and unsweetened teas—including herbal teas—to use “healthy” claims to encourage their use as substitutes for products with high sodium content or with added sugar.

Raw, whole fruits and vegetables would immediately be allowed to use “healthy” claims, among other provisions of the proposed rule. Generally, any product containing the equivalent of a half a cup of vegetables would be considered “healthy” if it contains no added sugar and meets other limits for saturated fat and sodium. More complex requirements would apply to products consumed in large portions or containing ingredients from a mix of food groups.

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