Redefining Healthy: What the FDA’s New Rules Mean for Food Labels and Nutrition Claims

On 19th December 2024, the Food and Drug Administration (FDA) issued the final rule for the new definition of “healthy” when used in voluntary claims in food labelling.

This is an update to a 30-year-old definition and aligns it to current scientific agreement around nutrition standards. It also aligns the concept of ‘healthy’ with the ‘Nutrition Facts’ panel on food labels and the Dietary Guidelines for Americans; with the goal to “help reduce the burden of diet-related chronic diseases”.

The legislation reference in 21 Code of Federal Regulations (CFR) 101.65(d) sets new “food group equivalent” requirements linked to nutrient criteria and limits to added sugar, saturated fat and sodium, when making a health claim.

The FDA has not yet given any guidance on a logo or graphic to accompany a “healthy” claim or any imagery to call out that the limits to added sugars, saturated fats and/or sodium have been exceeded.

The date for compliance with these new criteria is 25th February 2028, but companies can begin to use the new claim criteria once the new rule is officially published. A guidance document from FDA is expected to come out as well to support implementation questions.

Products in scope include all foods sold in the United States making a specific reference to “healthy” as a claim and foods making any implied reference to this term. Implied claims are where the labelling suggests that a food may help consumers maintain healthy dietary practices using either implied or explicit information about the nutrient content of the food. Page 5 of Final Rule.

To meet the new claims criteria, the product must contain a minimum amount of food from at least one of the designated “food group equivalents” (FGE’s), which are taken from the food groups and subgroups recommended in the Dietary Guidelines for Americans. An FGE contains the following:

• Vegetable – 1/2 cup equivalent (c-eq)
• Fruit – 1/2 cup equivalent
• Grains – 3/4 ounce (oz) equivalent whole grain
• Dairy – 2/3 cup equivalent
• Protein foods:
  • Game meat – 1 1/2oz equivalent
  • Seafood – 1oz equivalent
  • Egg – 1oz equivalent
  • Beans, peas or lentils – 1oz equivalent
  • Nuts and seeds or soy products – 1oz equivalent

1oz = 28g

The amounts of each FGE, as well as limits for added sugar, saturated fat and sodium vary by food type. The food must also meet at least one of the following six criteria:

1. The food is an individual food or a mixed food product with no ingredients added except water and is comprised of one or more of the following foods: vegetables, fruits, whole grains, fat-free or low-dairy, lean meat, seafood, eggs, beans, peas, lentils, nuts or seeds.
2. The food is an individual food that contains at least one FGE and meets the nutrient limits for added sugars, sodium and saturated fat applicable to the relevant food category either per *Reference Amount Customarily Consumed (RACC) (or per 50g for items with a RACC <50g or 3Tbsp). Oils have a special exception.
3. The food is a mixed product with at least one FGE, with no less than 1/4 an FGE from at least two food groups and meets the certain nutrient limits per RACC.
4. The food is a main dish product that contains at least 2 FGE’s, with no less than 1/2 an FGE from at least two food groups and meets the certain nutrient limits per labelled serving.
5. The food is a meal product that contains at least 3 FGE’s with no less than 1/2 an FGE from at least 3 food groups and meets certain nutrient limits per labelled serving.
6. The food is a water, tea or coffee product with less than 5 calories per RACC and per labelled serving.

*RACC = the FDA reference for serving size determination

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