FDA’s Final Rule: A New Era for ‘Healthy’ Food Labeling

On December 19, 2024, the Food and Drug Administration (FDA or the Agency) issued a notice to the Federal Register regarding a new final rule that FDA will be publishing on December 27, 2024 (Rule). The Rule will update the definition of the implied nutrient content claim “healthy,” consistent with current nutrition sciences and federal dietary guidelines, particularly the Dietary Guidelines for Americans. The Rule will revise when food manufacturers can use the term “healthy” (or variations of that term) as an implied nutrient claim in food labeling. The aim of the Rule is to help consumers identify which foods are particularly useful as a foundation of a nutritious diet.

For a food to be defined as “healthy,” or other specified variations of that word, it must fit into one of the six food groups that FDA has specified. These food groups are derived from the Dietary Guidelines for Americans, along with the addition of oils. A food group equivalent (FGE) is one that has a qualifying amount of food from each food group based on the nutritional content. The qualifying food amount that must be in an FGE will depend on the type of food group:

• Vegetables: half cup equivalent
• Fruit: half cup equivalent
• Grains: three-quarters of an ounce equivalent to whole grain
• Dairy: two-thirds cup equivalent
• Protein:
  • Game meat: one and a half ounces equivalent
  • Seafood: one ounce equivalent
  • Egg: one ounce equivalent
  • Beans, peas, or lentils: one ounce equivalent
  • Nuts and seeds, or soy products: one ounce equivalent

Food products can contain multiple types of FGEs depending on the product. A mixed product must contain the amounts for one total FGE and no less than one quarter FGE from at least two food groups. A main product dish must contain two total FGEs with no less than a half FGE from at least two food groups. A meal product must contain three total FGEs with no less than a half FGE from at least three food groups.

There are also specific limits to the amount of added sugars, saturated fats, and sodium present in an FGE. These limits depend on the type of FGE and are based on a percentage of the Daily Value for these nutrients.

The Rule will be effective 60 days after the final date of publication (December 27, 2024) and the compliance date for the Rule will be February 25, 2028. FDA also stated that for foods where it is unclear from the label what FGEs are in the product, manufacturers must establish and maintain certain records if they wish to label their food “healthy”. The records must be kept for a period of at least two years after introduction or delivery for introduction into interstate commerce; during an inspection, upon an FDA request, the records must be provided to the Agency.

© Arnold & Porter Kaye Scholer LLP 2024 All Rights Reserved. This Blog post is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.