Overview
On December 19, 2024, the US Food and Drug Administration (FDA) issued a new final rule titled “Food Labeling: Nutrient Content Claims; Definition of Term ‘Healthy.’” The rule revises regulations that govern when food products may be labeled as “healthy” and when a derivative term (e.g., “health,” “healthful,” or “healthier”) may be used to make a claim about the product’s nutritional content. Broadly, the new final rule adopts the regulatory approach spelled out in the FDA’s September 29, 2022, proposed rule.
These amendments represent the first significant changes to “healthy” labeling requirements in 30 years. In its new scheme, the FDA attempts to bring labeling requirements in line with 21st century advances in nutrition science that have resulted in new federal dietary guidelines. To do so, the FDA places newfound emphasis on food products’ umbrella food groups as opposed to individual nutrients.
In addition to changes in nutrition science, changes in US culture and dietary patterns prompted the amendments. The FDA describes the changes as part of its contribution to a government-wide initiative to address the “ever-growing crisis of preventable, diet-related chronic diseases in the U.S.” (such as cardiovascular disease, diabetes, and obesity) that “requires immediate action.” The FDA states that the crisis disproportionately affects certain racial and ethnic minority groups and the disadvantaged. The FDA anticipates that the amendments will advance health equity by helping consumers identify foods that can be the foundation of a healthy diet. The updated criteria allow affordable, accessible, and nutrient-dense foods associated with disparate cultural traditions and found within varied food groups and subgroups to bear the “healthy” claim, including frozen, canned, dried, and other shelf-stable products.
The FDA will begin to enforce these new regulations in February 2028, but manufacturers can start using a “healthy” claim in accordance with the new requirements as soon as the rule enters into effect on February 25, 2025.
In Depth
BACKGROUND
In 1990, Congress enacted the Nutrition Labeling and Education Act, which had three primary objectives:
- To enable consumers to make informed decisions about their dietary choices by providing them with relevant nutritional information.
- To standardize definitions for claims related to food products’ nutritional content.
- To encourage manufacturers to produce and market food products with greater nutritional value.
Acting in line with these objectives, the FDA adopted regulations in 1994 that created enforceable standards for manufacturers to follow when labeling their food products as “healthy” or a related derivative term (e.g., “health” or “healthful”). These regulations apply specifically to labeling that uses the term “healthy” or the like to imply that consumption of a food product comports with healthy dietary practices. These claims are distinct from those referring to a food product’s special dietary functions or effects on a consumer’s bodily structures.
The criteria established by the 1994 regulations focus on whether food products contain certain enumerated levels of nine individual nutrients, such as protein, cholesterol, and saturated fat. Although many stakeholders continue to support this approach, the FDA has concluded that it is difficult to reconcile with advances in nutrition science over the past three decades.
According to the FDA, nutrition science has evolved to take a more holistic view of diet, focusing on an individual’s consumption of synergistic, foundational food groups (foods that, because of their overall nutrition profiles, can be the “foundation” or “building blocks” of a healthy dietary pattern) – e.g., vegetables, fruits, whole grains, fat-free and low-fat dairy, lean game meat, and seafood with no added ingredients – rather than on pure nutrient intake. The FDA argues that under the 1994 regulations, foods that are now widely considered to be healthy cannot be labeled as such. For example, manufacturers have likely been unable to include “healthy” on a salmon food product’s packaging because of the fish’s high fat content. Similarly, some foods that could previously carry the “healthy” claim, such as white bread and heavily sweetened cereal and yogurt, will no longer qualify. In addition to salmon, newly qualifying foods will include nuts and seeds, olive oil, and some peanut butters and canned fruits and vegetables.
KEY CONCEPTS
In place of individual nutrients, the FDA has centered its new criteria on the five food groups recommended in the current federal dietary guidelines: vegetables, fruits, grains, fat free or low-fat dairy, and proteins (e.g., lean meat, seafood, eggs, beans, peas, lentils, nuts, and seeds). The FDA applies some nuances to these groups. Vegetable or fruit pastes, purees, and powders may qualify if they represent a mere change in the food product’s form. Likewise, the FDA intends to consider plant-based dairy alternatives as members of the dairy group when they have similar nutritional content to true dairy products.
Under the “food group equivalent” (FGE) system carried over from the 2022 proposed rule, a “healthy” nutrient content claim generally must contain a certain amount of food from at least one of the food groups or subgroups recommended by the federal dietary guidelines and also must fall below specific nutrient limits for added sugars, sodium, and saturated fat. For example, one FGE for a vegetable food is established as a half cup equivalent. The exact amount of a vegetable product that would satisfy this criterion may vary based on its preparation. To illustrate, both one cup of raw spinach and a half cup of cooked green beans equal half cup equivalents, and thus each would individually constitute one FGE.
These FGEs form the basis of the FDA’s new labeling criteria. In total, there are six scenarios where a food product may carry a “healthy” claim:
- Single Ingredient Exception: Food products with only ingredients from the five food groups and water.
- Individual Food: Consumed in quantities of greater than 50 grams, contains one or more FGE. Includes oil-based products and those less than 50 grams if they meet FGE and nutrient requirements per 50 grams.
- Mixed Food Product: Contains one or more FGE, with at least one quarter FGE from two food groups. Example: one quarter vegetable FGE and three quarters protein FGE.
- Main Dish Product: Serving contains two or more FGEs, with at least one half FGE from two food groups. FGEs can be aggregated.
- Meal Product: Serving contains three or more FGEs, with at least one half FGE from three food groups. FGEs can be aggregated.
- Low-Calorie Beverages: Coffee, tea, and water with fewer than five calories per serving. FDA may exercise discretion in labeling these as “healthy.”
Manufacturers that ultimately decide to make a “healthy” claim for a qualifying food product must also follow new bookkeeping requirements. The final rule establishes that in situations where a food’s ability to qualify under the “healthy” criteria is not obvious from its nutritional label, manufacturers must maintain written records establishing the same. The form these records take may vary based on a manufacturer’s preferences, but they must be kept for at least two years after a product’s introduction to the market.
The FDA stresses that manufacturers whose products fail to meet the above criteria still have an array of valid marketing options at their disposal. Indications of a product’s low sodium content, for example, would still be acceptable in a variety of circumstances. The FDA also intends to engage in consumer education efforts so that failure to meet the listed criteria is not equated to a product’s being “unhealthy.”
NEXT STEPS
Manufacturers can begin to use a “healthy” claim in accordance with the new requirements as soon as the rule enters into effect on February 25, 2025. The FDA intends to create and publish additional resources to aid manufacturers in determining FGE amounts before the regulation’s compliance date in February 2028. The FDA stated that these resources may include guidance documents, FAQs, direct responses to questions, or online webinars.
The agency also announced an intent to publish a proposed rule on front-of-package nutrition labeling, which may include a “healthy” symbol to designate qualifying food products.
For more information on how to comply with the FDA’s new “healthy” labeling requirements, contact the authors of this article or any other member of McDermott’s Food, Drug & Medical Device Regulatory Group.
