To bear the “healthy” claim, a food product needs to:
- Contain a certain amount of vegetables, fruits, whole grains, dairy, or protein foods and
- Not have too much saturated fat, sodium, or added sugars depending on the food product type
New “Healthy” Definition
On December 27, 2024, the U.S. Food and Drug Administration (FDA) published the updated final rule on “healthy” claims for human food and dietary supplements. The final rule applies to the claim “healthy” as well as similar derivative terms such as “health”, “healthful”, “healthfully”, “healthfulness”, “healthier”, “healthiest”, “healthily”, and “healthiness”.
The final rule outlines by product type, the amount of Food Group Equivalents (FGEs) the product must contain as well as the maximum amount of added sugars, sodium, and saturated fat.
- Individual foods (e.g., vegetable, fruit, grain, dairy, protein foods, and oils)
- With a reference amount customarily consumed (RACC) greater than 50 grams (g) or greater than 3 tablespoons (Tbsp) shall contain one FGE and meet the specified added sugars, sodium, and saturated fat limits per RACC.
- With a RACC of 50 g or less or 3 Tbsp or less shall contain one FGE and meet the specified added sugars, sodium, and saturated fat limits per 50 g of food.
- Except oils, which shall meet the specified added sugar, sodium, and saturated fat content limits.
- Mixed products
- Shall contain one total FGE with no less than 1/4 FGE from at least two food groups (e.g., 1/4 FGE from one food group and 3/4 FGE from another food group), no more than 10% Daily Value (DV) added sugars, no more than 15% DV sodium, no more than 10% DV saturated fat, excluding saturated fat inherent in seafood, nuts, seeds, and soybeans in soy products (if applicable) per RACC.
- Main dish products
- Shall contain two total FGEs with no less than 1/2 FGE from at least two food groups, no more than 15% DV added sugars, no more than 20% DV sodium, no more than 15% DV saturated fat, excluding saturated fat inherent in seafood, nuts, seeds, and soybeans in soy products (if applicable) per labeled serving.
- Meal products
- Shall contain three total FGEs with no less than 1/2 FGE from at least three food groups, no more than 20% DV added sugars, no more than 30% DV sodium, no more than 20% DV saturated fat, excluding saturated fat inherent in seafood, nuts, seeds, and soybeans in soy products (if applicable) per labeled serving.
- Individual foods or mixed products that are comprised of one or more Vegetable, Fruit, Whole grains, Fat-free and Low-fat dairy, Lean meat, Seafood, Eggs, Beans, Peas, Lentils, Nuts, and Seeds with no other added ingredient except for water automatically qualify.
- Water, tea, or coffee with less than 5 calories per RACC and per labeled serving also automatically qualify.
The following are the food group equivalents (FGEs), and subgroups:
- Vegetables – 1/2 cup equivalent
- Fruits – 1/2 cup equivalent
- Diary – 2/3 cup equivalent
- Grains – 3/4 ounce (oz) equivalent whole grain
- Protein foods
- Game meat – 1 1/2 oz equivalent
- Seafood – 1 oz equivalent
- Egg – 1 oz equivalent
- Beans, peas, or lentils – 1 oz equivalent
- Nuts and seeds, or soy products – 1 oz equivalent
If it is not apparent from the label of the food, establishments must maintain records to support the claim for at least 2 years after the introduction or delivery for introduction of the food into interstate commerce.
Companies can start using the new “healthy” claim starting February 25, 2025. If a product currently lists the “healthy” claim and does not meet the new definition, the manufacturer has until February 25, 2028, to comply with the new rule.
Background
In 1994, the FDA finalized the original rule on “healthy” labeling. Previously, to label a product with the claim “healthy” or related claim, the product must:
- Not contain much total fat, saturated fat, sodium, and cholesterol and
- Have at least 10% of the Daily Value of one or more of the following: Vitamin A, Vitamin C, Calcium, Iron, Protein, or Fiber
However, nutrition science has evolved in the last 30 years and the FDA has updated requirements for food including new Nutrition Facts labeling, RACCs, and DVs. Many foods that the Dietary Guidelines, 2020-2025 identified as part of a healthy dietary pattern were not able to list a “healthy” claim based on the previous rule while other products that contained nutrients that would not help consumers maintain a healthy diet (e.g., those with high added sugars) were able to list a “healthy” claim.
In 2022, the FDA proposed updating the definition of “healthy” to align with current nutrition science. There were several changes made since the proposed rule based on the comments received, allowing more products to list the “healthy” claim while still meeting the dietary guidelines.
Link to Constituent Update: https://www.fda.gov/food/hfp-constituent-updates/fda-finalizes-updatedhealthy-nutrient-content-claim
Link to Final Rule: https://www.federalregister.gov/d/2024-29957
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