FDA’s Final Rule on the Implied Nutrient Content Claim “Healthy” Maintains Focus on Foods Rather than on Nutrients

As we previously reported in 2022, FDA published a proposed rule defining  the nutrient content claim “healthy.”  The proposed revised rule constituted a radical change from the original definition of healthy, which focused on the presence of individual (beneficial) nutrients.  In contrast, the 2022 proposed redefinition focused on food groups recommended by nutrition science and the Dietary Guidelines (DGs), 2020-2025.  Nutrients come into play only where it concerns nutrients to limit (NTL), i.e., added sugars, saturated fat, and sodium.

FDA received more than 400 comments, resulting in a final rule published on December 27, 2024, covering more than 100 pages.

The final rule maintains the concept of the proposed rule.  However, FDA made several changes in the proposed food groups equivalents and NLT criteria; these changes are based on FDA’s review of the marketplace in response to comments.  FDA revised certain criteria providing more flexibility and resulting in additional foods qualifying for “healthy” consistent with nutrition science and the DGs, including:

• Criteria for foods with small reference amounts customarily consumed (RACCs) – Comments had noted that foods with small RACCS were not eligible for the healthy claim even though they were the type of foods recommended by the DGs. FDA revised the rule to provide that the ‘‘healthy’’ criteria apply to individual foods with a RACC of 50 g or less, or 3 Tbsp or less, on a per 50 g basis instead of on a per RACC basis. Consequently, several foods consumed in small amounts recommended for healthy dietary patterns now qualify for the healthy claim.
• Exemption for raw, whole fruits and vegetables – Another issue FDA reconsidered is the exemption for raw whole fruits and vegetables from the NTL criteria.  Under the proposed rule, any raw whole fruits and vegetables could be labeled healthy no matter the level of added sugars, sodium, or saturated fat.  The final rule does not limit this exemption to only raw fruits and vegetables.  Instead, the exemption from the NTL criteria now applies to an individual food, or a mixed product that is comprised of one or more of the foods recommended by the DGs (i.e., vegetables, fruits, whole grains, fat-free and low-fat dairy, lean meat, seafood, eggs, beans, peas, lentils, nuts, and seeds), that contains no added ingredients other than water.
• FGE criteria – FDA also reconsidered the criteria for various food group equivalent (FGE) criteria, e.g., the FGE for dairy was reduced from ¾ cup to 2/3 cup, and for combination foods, each food group must have no less than ¼ FGE (instead of the proposed ½ cup FGE) and the combined amount of two or more FGEs must be at least 1 total FGE, e.g., if the product contains 2 food groups and ¼ FGE of one food group, it must contain at least ¾ FGE of another food group. The increased flexibility for FGE requirements will result in more products being able to meet the FGE requirements for combination foods.
• Nutrients to limit (NTL) – FDA revised the values for NTL for certain food groups because the proposed (lower) limits would disqualify many products recommended by DGs from the healthy definition. Among other things, FDA
  • Increased the limit for sodium in mixed products from 10% DV to 15% DV per RACC;
  • Increased the limit for added sugars for the grain group from 5% DV to 10% DV (FDA did not increase the added sugars limit for dairy products as, based on market review, yogurts and other dairy products containing 5% DV or less added sugars were available and palatable);
  • Excluded the inherent saturated fat in seafood from the saturated fat limit for seafood products and lowered the saturated fat limit for seafood products to 5% DV to provide more flexibility for seafood, which has a fat profile that is predominantly beneficial unsaturated fats but has amounts of naturally occurring saturated fat that can vary across and within different types of seafood; and
  • Streamlined the NTL criteria so that there is one limit each for saturated fat, sodium, and added sugars for mixed products, main dishes, and meals.
• Plain water and plain carbonated water – FDA proposed that plain water and plain carbonated water qualify as healthy. The final rule expands this category to cover all water, tea, and coffee with less than 5 calories per RACC and per labeled serving, including any of these products containing non-caloric ingredients such as flavors, no- or low-calorie sweeteners, vitamins, and minerals.  This category does not include diet sodas, however.
• FDA did not create separate criteria for dietary supplements to qualify as healthy. As discussed in the preamble, several comments asked FDA to exempt dietary supplements from the healthy claim requirements.  FDA refused to do so, referencing the statement in the proposed rule that “good nutrition does not come from intake of individual nutrients (as dietary supplements often provide) but rather from foods with their mix of various nutrients working together in combination.”  The purpose of the healthy claim is to highlight foods that are useful in creating a healthy diet that includes foods from several different food groups.  As discussed in the preamble, FDA recognizes that, although most dietary supplements may not qualify as healthy, some may.
• Important in the context of private litigation in which the issue has come up, FDA acknowledges that the term “healthy” is a nutrient content claim only when the term is used in a nutritional context and not when it is used in a structure/function claim or health claim.

Recognizing that the final rule redefining the term “healthy” is a significant change from FDA’s previous approach (in effect for thirty years), FDA plans to issue guidance documents intended to help industry understand the rule and how to work with FGEs.  FDA also plans to host a stakeholder webinar on the final rule at a later date.  It already published several resources regarding the final rule (e.g., “Updated ‘Healthy’ Claim – Factsheet” and examples of “Products that Now Qualify for Healthy under the Final Rule”).

An important aspect of the new definition of healthy is that for many foods it will be difficult (or impossible?) to determine if the product indeed meets the definition of healthy, as it usually will not involve analysis of the foods.  Therefore, manufacturers must maintain records for foods bearing a “healthy” claim unless it is clear from the food’s mandatory labeling information. Records must be kept for at least two years after the food is introduced or delivered for introduction into interstate commerce.

FDA continues its work on the development of a symbol that manufacturers could use on food labeling to show that a product meets the definition of “healthy.” FDA believes that such a standardized graphic will further support FDA’s goal of helping consumers identify food products that can be the basis of healthy eating patterns consistent with the DGs.

The final rule is effective 60 days from December 27, 2024, i.e., February 25, 2025.  The compliance date is February 25, 2028.