On September 28, 2022, the Food and Drug Administration (FDA) announced its proposal to update its 1994 definition of  “healthy” when used on food labels and labeling to align with the current nutrition science, the Dietary Guidelines for Americans, and updated Nutrition Facts label requirements. Comments on FDA’s proposed rule can be submitted until December 28, 2022.

Under the described proposed rule, “healthy” would no longer be an implied nutrient content claim used only in connection with a specific nutrient, such as ‘‘healthy, contains 3g grams of fat.’’ Instead, information elsewhere on the label, or even a website, that puts the term ‘‘healthy’’ into a nutritional context would make ‘‘healthy’’ an implied nutrient content claim about the food.  FDA’s goal is to capture how different food groups work together to form healthy dietary patterns.

Significantly, FDA’s proposal broadens the types of food that can include a “healthy” claim to include many that did not meet the prior nutrient-related criteria, such as certain nuts, seeds, higher-fat fish, and oils that contained more fat than allowed under the 1994 definition, as well as water. Under the proposed rule, to bear a “healthy” claim, the product must: 

• Contain a specified, meaningful amount of vegetables, fruits, grains, dairy, protein foods, or oils (e.g., ½ cup of fruit or ¾ cup of dairy) from at least one of the food groups suggested in the Dietary Guidelines.
• Adhere to specific criteria to limit the amount of saturated fat, sodium and added sugars. The baseline limits are calculated based on Daily Reference Value (DV) and vary depending on the food group.

Notably, the criteria are broken out into several food categories: (1) raw, whole fruits and vegetables; (2) individual food products, such as grains, dairy, and FDA-regulated protein foods (e.g., eggs, nuts, seafood, legumes); (3) combination foods, which encompass mixed products, main-dish products, and meal products; and (4) plain water, both still and carbonated. The minimum amount of food necessary for the product to bear a healthy claim varies depending on the food group or subgroup (e.g., 1 oz eggs vs. ¾ cup of whole grain), and the nutrient DV limits also vary for each food group (e.g., the permissible added sugar in fruit is 0% DV, while the permissible added sugar for dairy products or cereal is 5% DV).

While water itself is not categorized under a recommended food group in the Dietary Guidelines, FDA notes that the Dietary Guidelines recommend that the “primary beverages consumed” should be ‘‘beverages that are calorie-free — especially water — or that contribute beneficial nutrients, such as fat-free and low-fat milk and 100% fruit juice.” FDA therefore proposes to allow water to be labeled as “healthy,” including, potentially, waters containing non-caloric flavors or other non-caloric ingredients. Likewise, because the Dietary Guidelines recommend beverages that are calorie-free, and coffee and tea with little, if any, sweeteners or cream can be part of a healthy diet, FDA also seek comments on the eligibility of calorie-free beverages, coffee, and tea to bear the “healthy” designation.

FDA also continues to research the development of a symbol to indicate to consumers that a product meets the new “healthy” claim criteria to help consumers quickly recognize healthier food products. 

Implications for Food and Beverage Manufacturers

FDA’s discussion of its proposal offers a valuable preview of what a final regulation defining “healthy” may encompass. Until then, food manufacturers may want to exercise caution in making new “healthy” claims on product labels and, at the same time, may want to review their product labels and websites to understand how current “healthy” claims fit within FDA’s proposed framework.

Recordkeeping may also warrant attention. While FDA may be able to verify compliance using the Nutrition Facts Label, the ingredient list, the statement of identity and other label information to determine whether a food meets the applicable criteria, a label may not provide sufficient information for FDA to verify that foods containing multiple components (such as most grain products and all combination foods) meet the food group equivalent requirements. For those foods, manufacturers must maintain records that verify that the food meets the requirements for a “healthy” claim, such as recipes or formulations, batch records providing data on the weight of certain ingredients, or certificates of analysis from ingredient suppliers. Those records may have to be produced during inspection by FDA but can be redacted, if necessary, to ensure confidentiality of a food product formulation.

However, the compliance date for any final rule on “healthy” remains years away. FDA is currently seeking comments only on its described proposed rule. Any final rule FDA may issue after it receives comments and engages in further rulemaking will not become effective for 60 days after publication, with a compliance date three years after the effective date. FDA recognizes that industry needs time to analyze products, update records and print new labels.