As customers reach for healthier food options to meet their New Year’s resolutions, having a “healthy” claim on your product can add significant value. However, if you want to claim that a product regulated by the FDA is healthy, or use the term “healthy” in any labeling, your food will have to meet the qualifications for a “healthy” claim.
The term “healthy” or related terms such as “healthful” constitute an implied nutrient content claim and the product must meet certain nutrition requirements. The majority of food products must meet the following requirements to use a “healthy” claim:
- Fat Level: A product making a “healthy” claim is required to meet the nutrient content claim of “low fat”. A “low fat” product must have 3g or less of total fat per reference amount of the food and, if the reference amount is less than or equal to 30g or 2 tablespoons, it must have 3g or less of total fat per 50g of the food. In 2016, FDA released a guidance document that states a product may still qualify for a healthy claim even if it is not “low fat” as long as it meets two requirements:
- The majority of the fat content comes from monounsaturated fat and polyunsaturated fat.
- The amounts of monounsaturated fats and polyunsaturated fats are declared in the nutrition facts panel.
- Saturated Fat Level: The product must meet the definition of “low saturated fat” so the saturated fat value must be 1g or less per reference amount of the food and not more than 15% of calories can come from saturated fat.
- Cholesterol Level: The amount of cholesterol must be equal to or less than the disclosure level of 60mg per reference amount and per labeled serving. If the reference amount is less than 30g or 2 tablespoons, the food must have 60mg or less cholesterol per 50g.
- Sodium Level: The sodium level must be at or below the disclosure level of 480mg per reference amount and per labeled serving. If the reference amount is less than 30g or 2 tablespoons, the food must also have 480mg or less of sodium per 50g.
- 10% RDI or DRV: Per reference amount, the product must have at least 10% of the daily reference value (DRV) or reference daily intake (RDI) for protein, fiber, vitamin A, vitamin C, calcium, iron, vitamin D, or potassium. Since the industry is transitioning from the old nutrition format to the updated nutrition format and vitamin D and potassium are replacing vitamin A and vitamin C as mandatory nutrients, the FDA is allowing vitamin D and potassium to be used to meet the 10% daily value (DV) requirement. If the manufacturer has not yet implemented the updated nutrition facts label, the old RDI values for the vitamins and minerals should be used. Companies that have implemented the updated nutrition facts must use the updated RDI values.
There are exceptions to some parts of the “healthy” requirements listed above for various product categories including:
- Raw fruits or vegetables
- Single-ingredient, or mixture of, frozen or canned fruits and vegetables
- Enriched cereal grains that meet the standards of identity for “Bakery Products”, “Cereal Flours and Related Products”, or “Macaroni and Noodle Products”
- Raw, single-ingredient seafood or game meat
- Meal products or main dish products as defined in 21 CFR 101.13(l) and 21 CFR 101.13(m)
These exceptions and additional information about “healthy” claims can be found in 21 CFR 101.65.