FDA recently announced a draft rule that would change the regulatory definition, as applicable to FDA-regulated products, of the implied nutrient content claim “healthy.” Currently, FDA regulates the use of “healthy” under a regulation finalized in 1994 and through use of enforcement discretion as to the use of “healthy” in certain, defined circumstances. FDA’s draft rule seeks to modernize both the use of “healthy” on foods, and the agency’s regulation as to the use of the term.
Current Definition
Currently, 21 C.F.R. 101.65(d) provides the basic definition of healthy. Though the requirements differ slightly based on the type of product, foods must generally be low fat, low in saturated fat, and below a set disclosure level for cholesterol and sodium to legally use the term “healthy” and similar descriptive terms. For certain product categories, the food must also be a good source, providing at least 10% of the daily recommended amount of certain nutrients.
In addition to the regulatory definition of “healthy,” FDA has also issued guidance that permits the use of “healthy” in certain circumstances that would not be permitted under the regulations. Under these specific circumstances, FDA has stated that the agency will exercise enforcement discretion and will not take regulatory action against uses of “healthy.” When a food is not low in total fat, but the fat profile makeup of the food is predominantly mono and polyunsaturated fats, the agency will permit the use of “healthy.” In addition, the guidance document also extends the nutrients that can be considered when a “good source” is required for the claim. Now, in addition to those nutrients historically considered by the regulation, foods that provide at least 10% of the daily value of potassium or vitamin D can qualify for the use of “healthy,” when the other criteria are also fulfilled.
This guidance was intended to update the use of “healthy” to match current scientific understanding of the impact of diet on overall health, as well as the updated Dietary Guidelines. This intent to update and modernize claims such as “healthy” additionally drives FDA’s intent as to the proposed rule.
Proposed Rule
The proposed rule for use of “healthy” claims shifts the regulatory framework to better match the 2020-2025 Dietary Guidelines for Americans. In part, the proposed regulation would set requirements for “healthy” based on the food group or subgroup, so that the nutrient requirements for use of the claim are better targeted to the nutrient profile of the food group. In addition, FDA has shifted its focus to limiting added sugar, sodium, and saturated fat when a claim that a food is “healthy” is used.
FDA has identified five food groups: vegetables, fruit, grains, dairy, and protein foods. Individual foods within each group are subject to different nutrient level requirements to use “healthy.” In general, foods must be below set levels of added sugars, sodium, and saturated fat to use “healthy” under the proposed definition. In addition, foods must provide servings of either a single food group or multiple food groups. Foods that are made of multiple food groups would also be required to meet defined added sugar, sodium, and saturated fat levels.
The required nutrient levels are based on the nutrient profile of the food groups represented. For example, when one of the food groups represented is a protein and the food includes game meat, seafood, or egg, higher saturated fat levels are permitted for the food to be “healthy” than when other protein foods are incorporated. FDA has developed a chart of the proposed requirements, which outlines the added sugar, sodium, and saturated fat levels for each food group and combination foods. This chart is available from the FDA: https://www.fda.gov/food/food-labeling-nutrition/use-term-healthy-food-labeling.
Unlike the existing regulatory framework, foods need not provide a “good source” of nutrients to qualify for use of “healthy,” nor is FDA considering the total fat level of the food. Instead, FDA has shifted the requirements for “healthy” to better reflect current nutrition science and dietary guidelines.
Notably, all raw whole fruits and vegetables would automatically qualify for the use of “healthy” under the proposed rule; under the existing regulatory framework, certain fruits and vegetables are not eligible.
FDA has indicated that foods such as water, avocado, nuts and seeds, and higher fat fish would be eligible to use the claims “healthy” under the proposed definition, but do not comply with the current requirements. Similarly, products such as white bread, highly sweetened yogurt, and highly sweetened cereal can currently use the claim “healthy” but would not be able to under the proposed requirements.
What Happens Next
FDA has published the proposed rule in the Federal Register and is currently accepting public comments on the proposed change. Comments on the proposed rule can be submitted until December 28, 2022 and can be submitted through the Federal Register website. After comments are submitted, FDA will review all comments and make any modifications to the proposed rule determined to be necessary following the agency’s review of the comments. This version will then likely be published as a final rule and will become law following publication.
Liz Presnell is a food industry consultant and lawyer, and has worked in the food industry for nearly a decade. She can be reached at presnell@foodindustrycounsel.com.