FDA’s Updated Definition of “Healthy”
Since 1994, FDA has regulated whether food manufacturers could claim that their food products are “healthy.” On December 27, 2024, FDA published the Final Rule, which establishes revised standards for when companies may use “healthy” or similar terms to describe food products. FDA first issued the proposed rule on September 29, 2022. The Final Rule marks FDA’s first update to the standard for “healthy” claims since 1994.
The Final Rule updates the definition of the implied nutrient content claim “healthy” to be consistent with current nutrition sciences and federal dietary guidelines, particularly the Dietary Guidelines. The goal of the Final Rule is to help consumers identify which foods are particularly useful as a foundation of a nutritious diet. The Final Rule limits the amount of added sugar, saturated fat, and sodium in foods that carry the “healthy” claim, while at the same time updating the definition to include foods that are higher in healthy fats. In the preamble, FDA also stresses that foods that do not meet the updated definition of “healthy” are not unhealthy, but that other food products “can still be incorporated as part of a healthy dietary pattern.”
For a food to be defined as “healthy” or other specified variations of that word (such as healthful, healthier, healthfulness), it must fit into one of the six food groups that FDA has specified. These food groups are derived from the Dietary Guidelines, along with the addition of oils. A food group equivalent (FGE) is one that has a qualifying amount of food from each food group based on the nutritional content. The qualifying food amounts that must be in an FGE are taken from the Dietary Guidelines, 2020-2025 and will depend on the type of food group:
- Vegetables: half cup equivalent
- Fruit: half cup equivalent
- Grains: three-quarters of an ounce equivalent to whole grain
- Dairy: two-thirds cup equivalent
- Protein:
- Game meat: one and a half ounces equivalent
- Seafood: one ounce equivalent
- Egg: one ounce equivalent
- Beans, peas, or lentils: one ounce equivalent
- Nuts and seeds, or soy products: one ounce equivalent
Food products can contain multiple types of FGEs depending on the product. A mixed product must contain the amounts for one total FGE and no less than one quarter FGE from at least two food groups. A main product dish must contain two total FGEs with no less than a half FGE from at least two food groups. A meal product must contain three total FGEs with no less than a half FGE from at least three food groups.
There are also specific limits to the amount of added sugars, saturated fats, and sodium present in an FGE. These limits depend on the type of FGE and are based on a percentage of the Daily Value for these nutrients. There will be enforcement discretion for some of these limits. For example, FDA noted in the Final Rule that it would exercise enforcement discretion for the added sugar limits for cranberry and tart cherry products because these products are often nutritious and would not be palatable without added sugar because of the lack of sugar found in the fruits.
FDA stated that it does not consider high intensity (low and no calorie) sweeteners to be added sugars. The addition of these artificial sweeteners thus does not factor into determining whether a product will meet the definition of “healthy.”
For foods where it is unclear from the label what FGEs are in the product, manufacturers must establish and maintain certain records if they wish to label their food “healthy.” Manufacturers must keep records for a period of at least two years after introduction or delivery for introduction into interstate commerce. The records must be provided to FDA upon request during an inspection.
In publishing the Final Rule, FDA stated that the definition of “healthy” is consistent with the current nutrition science and the federal dietary guidelines. FDA stated that 75% of Americans have low vegetable, fruit, and dairy intake, 63% exceed the limit for added sugars, 77% exceed the limit for saturated fat, and 90% exceed the Chronic Disease Risk Reduction limits for sodium. On its website, FDA stated that the updated “healthy” claim will now allow for a “healthy” claim to be used with respect to foods such as water; avocados; nuts and seeds; higher fat fish such as salmon; olive oil; and fresh, frozen, or canned fruits and vegetables. Based on the standards in the Final Rule, food products that can no longer be labeled as “healthy” include fortified white bread, highly sweetened yogurt, and highly sweetened cereal.
FDA’s Proposed Front-of-Pack Nutrition Label Rule
Weeks after publishing the final rule regarding “healthy,” FDA published a proposed rule requiring front-of-package (FOP) nutrition labels on most foods that bear a Nutrition Facts label. The proposed FOP label will be a “compact informational box containing certain nutrient information” regarding the food’s saturated fat, sodium, and added sugar content. According to the proposed rule, FDA chose these nutrients due to their “significance in building healthy dietary patterns.” FDA has also proposed amending the nutrient content claim definition for the term low sodium (including derivatives such as “low in sodium” and “little sodium”) and low saturated fat (including derivatives such as “low in saturated fat” and “a little saturated fat”).
The proposed rule would add a requirement for certain nutrition information regarding nutrients to limit in the diet to appear in a FOP compact informational box contained on the principal display panel or bulk food labelling for most foods that bear a Nutrition Facts label. In pertinent part, the proposed FOP label would describe the relative amount of these nutrients in a serving of food, by listing the serving size and the percentage of the recommended daily value for saturated fat, sodium, and added sugars contained in the food product. In addition to having the daily value percentages for these nutrients, the FOP label will also contain a “low, medium (abbreviated to “med”), and high” evaluation for each of these nutrients. An example of an FOP label published by the FDA in the proposed rule is below:
