|Footnotes for this article are available at the end of this page.
On September 28, 2022, the U.S. Food and Drug Administration issued a Proposed Rule to revise the criteria for when foods can be labeled with the nutrient content claim “healthy.”1 Since 1994, FDA has recognized that when a manufacturer describes a product as “healthy” on its label, it is implying an amount of nutritional content worth noting.2 Such practices tend to imply that the nutrient content of the food may help consumers maintain healthy dietary practices. However, the current definition of “healthy” allows manufacturers to use the claim on some foods that contain levels of nutrients not believed conducive to maintaining healthy dietary practices. Relying on the evolution of nutrition and dietary science knowledge since the 1990s, when FDA first established a definition for the implied nutrient content claim “healthy,” the Proposed Rule would update the definition of “healthy,” when used as a nutrition content claim, to be consistent with current research.
Under the existing regulation, there are specific criteria for individual nutrients found in a food that must be met for the label of that food to bear the claim “healthy.” These include limits on total fat, saturated fat, cholesterol, and sodium, and minimum amounts of nutrients whose consumption is encouraged, such as vitamin A and dietary fiber. The proposed, updated criteria for including “healthy” as a claim on a food’s label are intended to promote healthy dietary patterns by requiring that food products contain a certain amount of food from at least one of the food groups or subgroups recommended by the Dietary Guidelines, 2020-2025, in order to be labeled “healthy.” The comment period for the Proposed Rule ends December 28, 2022.
Terms Subject to the Definition of “Healthy”
- The Proposed Rule would define “healthy” as a nutrient content claim only when it is used in a nutritional context.
- Consideration will be given to claims, images, or vignettes, present somewhere on the label or labeling that concern the nutrition content of the food.
- For example, if the word “healthy” is used above a picture of vegetables or alongside another nutrient claim such as “0g of fat,” that would place it in the nutritional context.
- In contrast, if “healthy” was used on a label to say “our manufacturing processes support a healthy planet” with an adjacent picture of the earth, that would not be in the nutritional context.
- Foods that may bear the nutrient content claim “healthy” under the proposed updated criteria are broken out into several categories: (1) raw, whole fruits and vegetables; (2) individual food products; (3) combination foods, which encompasses mixed products, main dish products, and meal products; and (4) plain water.
- In sum, the proposed criteria for updating “healthy” are intended to promote healthy dietary patterns by requiring that food products contain a certain amount of food from a recommended food group in order to bear the claim “healthy.”
- The Dietary Guidelines, 2020-2025, notes that foods and beverages are not consumed in isolation, but rather in various combinations over time—a “dietary pattern.”
- The principal message of the Dietary Guidelines, 2020-2025, is to follow a healthy dietary pattern that focuses on meeting food group needs with nutrient-dense foods and beverages and stays within calorie limits.
- The updated definition of “healthy” uses a food group-based approach in addition to nutrient requirements to limit (based on the understanding that each food group3 contributes an array of important nutrients to the diet). The proposed “healthy” criteria requires that food products contain a certain amount of food from at least one of the food groups or subgroups recommended by the Dietary Guidelines, 2020-2025, in order to be labeled “healthy.”
- The Dietary Guidelines, 2020-2025, further explains that a healthy dietary pattern includes:
- vegetables of all types — dark green; red and orange; beans, peas, and lentils; starchy; and other vegetables;
- fruits, especially whole fruit;
- grains, at least half of which are whole grain;
- dairy, including fat-free or low-fat milk, yogurt, and cheese, and/or lactose-free versions and fortified soy beverages and soy yogurt alternatives;
- protein foods, including lean meats, poultry, and eggs; seafood; beans, peas, and lentils; and nuts, seeds, and soy products; and
- oils, including vegetable oils and oils in food, such as seafood and nuts.
- Evidence relied on in the Dietary Guidelines, 2020-2025 shows that a healthy dietary pattern, as outlined above, is associated with beneficial outcomes for all-cause mortality, cardiovascular disease, overweight and obesity, type 2 diabetes, and certain types of cancer.
Nutrients to Limit
- FDA plans to keep certain nutrients to limit as criteria for bearing the claim “healthy” because current nutrition science and federal dietary guidance continue to recommend limiting certain nutrients to promote healthy overall dietary patterns.
- FDA is proposing updates to criteria to limit for saturated fat and sodium, and proposing to add criteria for added sugars. The proposed criteria to limit certain nutrients are intended to help ensure that foods bearing the “healthy” claim do not contain excess saturated fat, sodium, or added sugars, which can increase calories and/or the risk of chronic disease and therefore diminish the potential beneficial public health impact of the “healthy” claim.
- In setting the criteria for limiting certain nutrients, FDA recommends baseline values for each nutrient and have adjusted the values, as warranted.
- For the majority of foods, the Daily Values (DVs) established for adults and children 4 years of age and older will be the basis of the nutrient criteria for the claim that are discussed in the following sections. However, for the subset of foods specifically directed to children 2 to 3 years of age (g., fruit pouches), the basis of the “percent DV” nutrient criteria are the specific set of DVs established for that age range.
- Saturated fat:
- The current “healthy” nutrient content claim regulation includes limits on saturated fat for all food categories.4
- The Daily Reference Value (“DRV”) for saturated fat is 20 grams (for children 1 to 3 years old, the DRV is 10 grams), which is approximately 10% of calories based on a 2,000-calorie reference intake level.
- For saturated fat, FDA is proposing a baseline limit of 5% of the DV per Reference Amount Customarily Consumed (“RACC”) (≤1 g for adults and children 4 years of age and older).
- FDA is proposing the following adjustments to the baseline limit for saturated fat, as described further in the discussion of individual foods, for certain categories of foods that are core elements of healthful dietary patterns associated with reducing chronic disease risk (e.g., low-fat dairy products):
- 10% of the DV for dairy products;
- 10% of the DV for game meats, seafood, and eggs; and
- 20% of total fat for oils and oil-based spreads and dressings.
- FDA has noted that the agency is seeking comments on the use of a limit for saturated fat based on the ratio of saturated fat to total fat, including any data supporting this approach.
- The current “healthy” nutrient content regulation includes limits on sodium content for all food categories (480 mg, or about 20% of current DV).
- Sodium intake is directly related to blood pressure, and elevated blood pressure contributes to the risk of CVD and stroke, which are leading causes of morbidity and mortality in the United States.
- The DRV for sodium is 2,300 mg (for children 1 to 3 years old, the DRV is 1,500 mg).
- FDA is proposing a baseline sodium limit of ≤10% of the DV (currently, 230 mg for adults and children 4 years of age and older) per RACC for individual foods.
- %Added sugars:
- Current consumption data indicate that most Americans are consuming more than 10% of calories from added sugars.
- Evidence shows that consumption of excess calories from added sugars can lead to a less nutrient-dense diet.
- The DRV for added sugars is 50 g (for children 1 to 3 years old, the DRV is 13 g). For individual foods, FDA is proposing a baseline value for added sugars of ≤5% of the DV per RACC (≤2 1/2 g for adults and children 4 years of age and older).
- Note that high-intensity (low- and no-calorie) sweeteners are not considered added sugars by FDA.
- The Dietary Guidelines, 2020-2025, does not make any recommendations regarding the following nutrients, therefore they are not included: total fat, trans fat, and dietary cholesterol.
Revisions to 21 C.F.R § 101.65
- As revised, § 101.65(d)(1) would no longer require that an implied nutrient content claim be used “in connection with an explicit or implicit claim or statement about a nutrient.”
- Instead, FDA proposes that in § 101.65(d)(1) “healthy” constitutes a nutrient content claim where the term “healthy” is used to characterize the food itself and “where there is also implied or explicit information about the nutrition content of the food.”
- For example, if “healthy” appears on the front of a cereal product that is described elsewhere on the label or labeling as high in dietary fiber (e.g., on the back of the package or on a website), the “healthy” claim would constitute a nutrient content claim under § 101.65(d).
- Also, the proposed rule revises § 101.65(d)(1) to no longer require that the accompanying material be a “claim or statement about a ”
- It would instead require that it be “information about the nutrition content of the food.” The intent remains to ensure that the regulation only applies where a “healthy” claim is used in a nutritional context.
- A food group equivalent is the amount of a food from a particular food group that must be contained in a food product for it to bear the “healthy” claim. Proposed § 101.65(d)(2) would define a “food group equivalent” as equal to the following:
- A food group equivalent of a vegetable would be equal to one 1/2 cup equivalent of (c-eq) vegetables.
- A food group equivalent of a fruit would be equal to one 1/2 c-eq fruit.
- A food group equivalent of grain would be 3/4 oz-eq whole grain.
- A food group equivalent of dairy would be equal to 3/4 c-eq dairy.
- A food group equivalent of protein:
- Game meats, such as deer, rabbit, quail, and wild geese, would be 1 1/2 oz-eq; and
- Seafood; eggs; beans, peas, and soy products; and nuts and seeds, would be 1 oz-eq.
- Note: FDA is not proposing a food group equivalent for oils.
- FDA recognizes how food labeling affects consumer beliefs about the healthiness of a food or beverage, thus swaying a consumer to make a purchase on that basis.
- The update to the implied nutrient content claim “healthy” to be consistent with today’s nutritional science will ultimately aid the American population in making informed decisions when forming their dietary choices.
- Companies should consider how the proposed changes to the Rule would impact their current labels and labeling and plan accordingly.
- Companies interested in participating in the conversation about the proposed revisions should take the opportunity to provide comments to the agency prior to the closing of the notice and comment period on December 28, 2022.
 See 87 FR 59168, available electronically at https://www.federalregister.gov/documents/2022/09/29/2022-20975/food-labeling-nutrient-content-claims-definition-of-term-healthy (last accessed Nov. 11, 2022).
 In the Federal Register of May 10, 1994, FDA published a final rule entitled “Food Labeling: Nutrient Content Claims, Definition of Term: Healthy” amending § 101.65(d) to define the term “healthy” as an implied nutrient content claim under section 403(r) of the FD&C Act (59 FR 24232).
 In this rule, the phrase “food group” refers to the groups of foods recommended in the Dietary Guidelines, 2020-2025, which include vegetables, fruits, dairy, grains, protein foods, as well as oils.
 See 21 C.F.R. § 101.65(d)(2)(i)(A)-(F)).