The US Food and Drug Administration issued a proposed rule on September 29 setting forth new criteria for the labeling of food products with the nutrient content claim “healthy” intended to help consumers more easily navigate nutrition labels and to make healthier purchasing decisions.
Per the proposed rule, labeling is to be consistent with current nutrition science, the Food and Drug Administration’s (FDA or Agency) updated Nutrition Facts label, and the Federal Dietary Guidelines. Use of the “healthy” claim by food manufacturers is voluntary.
The new “healthy” criteria are focused on food groups identified under the Federal Dietary Guidelines as part of a healthy dietary pattern, including:
- fruits (especially whole fruit);
- grains (especially whole grains);
- dairy, including fat-free or low-fat milk, yogurt, and cheese, and/or lactose-free versions, fortified soy beverages, and soy yogurt alternatives;
- protein foods, including lean meats, poultry, and eggs; seafood; beans, peas, and lentils; and nuts, seeds, and soy products; and
- oils, including vegetable oils and oils in food, such as seafood and nuts.
FDA’s rationale is that using these food groups as the criteria for “healthy” labeling, rather than the Agency’s prior focus on a limited set of nutrients, would allow consumers to more easily identify foods with a nutrient content that is helpful in maintaining healthy dietary practices.
To qualify for “healthy” label claims, food products would need to:
- contain a certain meaningful amount of food from at least one of the food groups or “food group equivalents,” such as mixtures that contain a food group (e.g., ½ cup of fruit, 1 cup of vegetables, ¾ cup of dairy, etc.) recommended in the Federal Dietary Guidelines; and
- follow specific limits for certain nutrients, such as saturated fat, sodium, and added sugars. The threshold for the limits is based on a percentage of the daily value (DV) for the nutrient and varies depending on the food and food group. For example, a product that contains a food from one of the food groups but exceeds the sodium intake limit would not qualify for “healthy” labeling.
- The limit for sodium is 10% of the DV per serving (i.e., 230 milligrams per serving for adults and children age 4 and older);
- The limit for saturated fat is 5% of the DV per reference amounts customarily consumed (RACC); and
- The limit for added sugars is ≤ 5% of the DV per RACC.
Some food products contained in the updated criteria for “healthy” labeling, including raw whole fruits and vegetables, and water will not need to meet requirements for food group equivalents and nutrient limits. These food products are included in categories of food that will be able to automatically use the “healthy” claim because of their nutrient content and positive contribution to a healthy diet. Notably, the proposed rule removes the prior limit for total fat content in the updated criteria for “healthy” to focus instead on the types of fat in the diet due to their different effects on health outcomes.
- Changes to Labeling: The final rule will be aimed at ensuring consumers can identify nutrition information quickly and easily on product labels in order to make healthier choices in accordance with the Federal Dietary Guidelines. Manufacturers of certain food products bearing a “healthy” claim will therefore be required to update the product labeling, likely incurring significant costs in the process. Notably, product names or brand names that include the word “healthy” will also need to be reviewed to ensure compliance with the final rule.
- Changes to Product Formulation: Manufacturers of existing food products which would likely not qualify for “healthy” label claims would need to reformulate their products to meet these requirements. Such product reformulation would entail significant costs, while continuing to market a non-compliant product would likely result in a high risk of enforcement and litigation.
- New Recordkeeping Requirements: For certain food products bearing the “healthy” claim, the label will not be sufficient to verify that the food meets the requirements and manufacturers will be required to maintain records to demonstrate compliance. Specifically, manufacturers of certain food products containing multiple components (such as most grain products and all combination food products) would be required to maintain records for a period of two years, demonstrating compliance with the food group equivalent requirements, given the nature of the information necessary to determine compliance and the number of food products potentially affected. These records would verify that the food bearing the “healthy” claim meets the food group equivalent requirements. As noted above, this recordkeeping requirement would not apply to water or to raw, whole fruits and vegetables, which do not have food group equivalent requirements.
- Potential Risk of Enforcement and Litigation: FDA’s new labeling requirements are also likely to raise new risks of class action litigation and competitor challenges before the National Advertising Division (NAD) for non-compliance. Further, FDA would likely take enforcement action against any non-compliant labeling, product name, and brand name that uses the term “healthy.”
- “Healthy” Claims in Dietary Supplements: Although the proposed rule does not directly prohibit the use of the term “healthy” in dietary supplement labeling, FDA notes in the preamble that the Federal Dietary Guidelines emphasize meeting nutritional needs “primarily from food products and beverages—specifically, nutrient-dense food products and beverages” as opposed to dietary supplements. FDA further states that, although the definition of food includes dietary supplements, they may not always be included in what the nutrition science literature refers to as ‘‘foods,’’ emphasizing that good nutrition does not come from intake of individual nutrients (as dietary supplements often provide) but rather from food products with their mix of various nutrients working together in combination. The Agency’s silence on the rules governing “healthy” labeling statements for dietary supplements will likely elicit strong industry pushback on the proposed rule.
FDA intends to finalize the proposed rule on December 28, 2022, with a compliance date of February 26, 2026. Comments may be posted on the proposed rule’s docket prior to its finalization. Written comments may be submitted to:
Dockets Management Staff (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852
All comments should be identified with the docket number FDA-2016-D-2335.