The U.S. Food and Drug Administration (“FDA”) issued a Proposed Rule on September 28, 2022, to revise the criteria for labeling foods as “healthy.” The purpose of the update to the definition of “healthy” on labels is to ensure the “healthy” claim is accurate based on the current nutrition science and to empower consumers with information to make healthy decisions. The FDA proposes that requiring food products to contain a certain amount of food from recommended food groups will achieve this purpose, including an estimated reduction in diseases and disabilities caused by diet-related factors (including all-cause mortality, cardiovascular disease, overweight and obesity, type 2 diabetes, and certain types of cancer). 

The Status Quo

From 1994 until now, the FDA has recognized a certain amount of nutritional content as sufficient to label a product as “healthy.” However, this allows manufacturers to claim their food is healthy despite having other levels of nutrients that are not conducive to a healthy diet. The move to update the definition of “healthy” in a nutrition content claim circumstance is meant to align with the current research on nutrition, diets, and health risks associated with both. The existing regulation includes limits on total fat, saturated fat, cholesterol, and sodium, as well as minimum amounts of nutrients required, to use the word “healthy” on the labeling. 

The Proposed Rule

The updated criteria to claim a food is “healthy” on the labeling would require that the product contain a certain amount of food from at least one of the food groups or subgroups as recommended by the Dietary Guidelines, 2020-2025. According to the Dietary Guidelines, 2020-2025, a healthy diet includes vegetables of all kinds, fruits (especially whole), grains (half of which should be whole grain), dairy (including yogurt, cheese, lactose-free versions, or soy alternatives), proteins (lean meats, poultry, eggs, seafood, beans, nuts, seeds), and oils (vegetable and oils in food). Furthermore, the proposed definition would require that food products adhere to specific limits for certain nutrients, including saturated fats, sodium, and added sugars. 

The FDA gave the following example: for cereal to bear a “healthy” claim, it would need to contain ¾ ounces of whole grains and no more than 1 gram of saturated fat, 230 milligrams of sodium, and/or 2.5 grams of added sugars to qualify as “healthy.”

In recognition of the fact that consumers are busy and seek a “quick way to identify and select healthy products,” the FDA is also considering a symbol that manufacturers could use to show the product meets the “healthy” claim criteria. 

A key part of the proposed rule is that it affects claims of “healthy” when that word is used on labeling in a nutritional context, but not in other contexts. For example, the rule would apply when a label uses “healthy” above a picture of fruits or vegetables along with a nutrient claim, such as “0g of fat.” In contrast, if “healthy” is used on the label to say “our manufacturing processes support a healthy planet” with an adjacent picture of the earth, it would not constitute a nutritional context. Though the proposed rule is narrowed to such contexts, the FDA includes a reminder in the proposed rule that they retain the authority under the misbranding provisions of FD&C Act Section 403(a) to ensure that “healthy” is not used in a misleading way. 

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The deadline for comments from interested persons was February 16, 2023. As of that date, several industry players, including government agencies, public/private companies, and national associations, have responded to the FDA’s proposal.

Several comments from entities with varied backgrounds agreed that the FDA should amend the regulations defining “healthy” to emphasize whole foods, dietary patterns, as well as production practices (e.g. organically grown and other processing methods). However, a number of notable comments criticized the FDA for overreaching and being too rigid in its approach. For example, the National Yogurt Association requested the FDA “refrain from establishing rigid limits that would preclude a ‘healthy’ claim on foods like yogurt, which are nutrient-dense and known to be associated with numerous health benefits.” In addition, companies like General Mills and Kellogg’s complained the proposed rule violates the First Amendment, exceeds the FDA’s statutory authority and is in violation of the Administrative Procedure Act, and it is unduly restrictive, and therefore inconsistent with the goals set by the FDA and the Dietary Guidelines. 

With the comment period now over, the agency may revise the proposed regulations based on the comments received and establish a second period for additional comments. The agency may also conclude that its proposed rule/solution will accomplish the goals it set out to achieve or solve the problems identified. 

If the FDA’s proposed rule is passed, the final rule would take effect 60 days after the date it is published in the Federal Register. To give time for the industry to comply, the rule proposes a compliance date within three years after the effective date of the final rule.