FDA’s Nutrition Initiatives: FDA’s Proposed Rule to Update the Definition of “Healthy”

As mentioned in September’s Regulatory Recap, last week, the Food and Drug Administration (FDA) issued a proposed rule on the “Definition of the Term ‘Healthy’” nutrient content claims. FDA updated its Nutrition Initiatives, and issued the proposed rule, to more closely align with the HHS and USDA’s 2020-2025 Dietary Guidelines for Americans, nutrition facts labels, and the Biden-Harris Administration National Strategy on Hunger, Nutrition, and Health (September 2022).

The issuance of the proposed rule coincided with the White House Conference on Hunger, Nutrition, and Health and is aligned with the Administration’s National Strategy to improve dietary patterns and health of Americans. In the proposed rule, FDA calls out the current definition as outdated and not aligned with the current research and science regarding dietary requirements.

Under the proposed rule, food labeled healthy would have to (1) contain a minimum amount of a food group equivalent (i.e., vegetable, fruit, grain, dairy, or protein); and (2) must not exceed the thresholds of saturated fat, sodium, and added sugars.

Manufacturers of foods labeled as healthy would also have to maintain and keep records relating to databases, recipes, formulations, and batch records for the food. Manufacturers would have to keep the records for two years after the food is introduced into interstate commerce. 

FDA also seeks stakeholder feedback regarding the proposed rule and calls out specific areas on which to comment:

• Should nutrients that consumers are encouraged to intake be included with the food group equivalents?
• Should the calculation for food group equivalents be updated?
• What limits should there be on the saturated fat content ratio, baseline sodium content, and/or baseline added sugars content?
• Should the nutritional context be more defined?
• Should there be additional requirements for individual foods?
• How feasible are the recordkeeping requirements?

Comments on the proposed rule are due December 28, 2022. 

Please contact us at OFW Law for assistance with the submission of comments.