FDA overhauls 'healthy' label definitions

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On December 19, 2024, the Food and Drug Administration (FDA) released a rule revising the definition of the implied nutrient content claim “healthy” to align with the latest nutrition science and Federal dietary guidelines, particularly the Dietary Guidelines for Americans, 2020-2025, which support consumers in maintaining healthy eating habits.

The Nutrition Labeling and Education Act of 1990 (NLEA) permits the use of label claims that characterize the level of a nutrient in a food (nutrient content claims) if they have been authorized by FDA and are made in accordance with FDA’s authorizing regulations. Nutrient content claims describe the level of a nutrient in the product. Healthy is an implied nutrient content claim that characterizes a food as having “healthy” levels of total fat, saturated fat, cholesterol and sodium, as defined in the regulation authorizing use of the claim.

Consumers rely on food labels to make informed decisions about the products they purchase for themselves and their families. The “healthy” claim provides a helpful signal on food packaging, enabling consumers to easily identify foods that support healthy dietary patterns. These requirements ensure that food labeling, including claims made on labels, is accurate, truthful, and not misleading. This rule updates the criteria for when the term “healthy” can be used as an implied nutrient content claim, helping consumers identify foods that are particularly beneficial as the foundation of a nutritious diet aligned with dietary recommendations.

The need for revision of the rule

Modern nutrition science highlights the importance of nutrient-dense foods, such as fruits, vegetables, and whole grains, as essential components of a healthy diet. Nutrient-dense foods and beverages are those that offer essential vitamins, minerals, and other beneficial components, while containing little to no added sugars, saturated fats, or sodium. These foods, which provide a range of vital nutrients, work together within a healthy eating pattern to support overall health. Many of these nutrient-dense foods were previously unable to carry the “healthy” label under the 1994 rule (e.g., salmon, due to its fat content). Additionally, the 1994 rule allowed some foods to display the “healthy” claim despite containing nutrient levels that no longer align with current nutrition science and federal dietary guidelines, such as foods high in added sugars, which are not conducive to maintaining healthy dietary habits.

Compliance date

Manufacturers who choose to use the “healthy” claim have three years to conform (until February 25, 2028) but can use the new criteria sooner. The rule encompasses the term “healthy” or derivative terms “health,” “healthful,” “healthfully,” “healthfulness,” “healthier,” “healthiest,” “healthily,” and “healthiness” as an implied nutrient content claim. Foods that qualify for the healthy claim that are not packaged (i.e. Fruits and vegetables) can have the claim communicated to consumers through signage and other materials in the store.

Food Group Equivalents

The FDA measures the nutrient value in portion sizes which vary based on the individual food.The measurement for each type of food is called the food group equivalent (FGE). The criteria for how much food from a particular food group is required and the specific limits for the three individual nutrients (sugar, sodium and saturated fat) vary for individual food products, mixed products (which contain certain amounts of more than one food group), main dishes and meals, and are based on a Reference Amount Customarily Consumed (RACC), which is the basis for determining a serving size.

Keeping Records

The rule also requires the establishment and maintenance of certain records for foods bearing the “healthy” claim where the food group equivalent contained in the product is not apparent from the label of the food.The records must be kept for a period of at least 2 years after introduction or delivery for introduction of the food into interstate commerce.During an inspection, these records must be made available to the FDA upon request.

Food sold without any added ingredients

The following automatically qualify for the designation “healthy” (without having to meet the requirements of foods with added ingredients) because of their nutrient profile and positive contribution to an overall healthy diet. To automatically qualify, the food must be sold individually or mixed with no other added ingredients except water:

Criteria for the “healthy” nutrient content claim

• Vegetable
• Fruit
• Whole grains
• Fat-free and
  low-fat dairy
• Lean meat
• Seafood
• Eggs
• Beans
• Peas
• Lentils
• Nuts and seeds
• All water, tea and coffee with less than 5 calories per serving (reference amount customarily consumed)

To meet the updated criteria for the claim, a food product needs to contain a certain amount of food from at least one of the food groups or subgroups (such as fruit, vegetables, grains, fat-free and low-fat dairy and protein foods) recommended by the Dietary Guidelines for Americans, and meet specific limits for added sugars, saturated fat and sodium.

Individual foods

Vegetable

• 1/2 cup equivalent
• no more than 2% of the daily value of added sugars
• no more than 10% of the daily value of sodium
• saturated fat content no greater than 5%

Fruit

• 1/2 cup equivalent
• no more than 2% of the daily value of added sugars
• no more than 10% of the daily value of sodium
• saturated fat content no greater than 5%

Grain

• 3/4 ozequivalent whole grain
• no more than 10% of the daily value of added sugars
• no more than 10% of the daily value of sodium
• saturated fat content no greater than 5%

Dairy*

• 2/3 cup equivalent
• no more than 5% of the daily value of added sugars
• no more than 10% of the daily value of sodium
• saturated fat content no greater than 10%

*Plant-based dairy products that are labeled and marketed as dairy alternatives
will be evaluated against the criteria for the dairy food group.

Proteins

Game Meat

• 1 1/2 oz. equivalent
• no more than 2% of the daily value of added sugars
• no more than 10% of the daily value of sodium
• saturated fat content no greater than 10%

Seafood

• 1 oz.equivalent
• no more than 2% of the daily value of added sugars
• no more than 10% of the daily value of sodium
• saturated fat content no greater than 5%, EXCLUDING *

Egg

• 1 oz equivalent
• no more than 2% of the daily value of added sugars
• no more than 10% of the daily value of sodium
• saturated fat content no greater than 5%

Nuts, seeds, and soy products

• 1 oz equivalent
• no more than 2% of the daily value of added sugars
• no more than 10% of the daily value of sodium
• saturated fat content no greater than 5%, EXCLUDING**

*excluding saturated fat inherent in seafood.

**excluding saturated fat inherent in nuts, seeds, and soybeans.

Oils

Oil

• containing no added sugars or sodium
• no more than 20% of total fat is saturated fat

Oil-based spreads whose fats come solely from oil

• containing no added sugars
• no more than 10% of the daily value of sodium
• no more than 20 % of total fat is saturated fat

Oil-based dressing containing at least 30% oil*

• no more than 2% of the daily value of added sugars
• no more than 10% of the daily value of sodium
• no more than 20% of total fat is saturated fat

*The Dietary Guidelines, 2020-2025 does not categorize oils as a “food group,” but they emphasize that oils are one of the six core elements of a healthy dietary pattern, along with vegetables, fruits, grains, dairy, and protein foods, and recommend daily intake objectives for oils, similar to the food groups. Therefore, oils are included as a food group for purposes of this rule.

MIXED PRODUCTS

Some products may have the label “healthy” if they contain more than one of the product groups above.Such a product may be labeled “healthy” if it contains one total Food Group Equivalent with no less than ¼ Food Group Equivalents from at least two food groups, and

Added sugar content no greater than 10% of the daily value

Sodium content no more than 15% of the daily value

Saturated fat content no greater than 10% of the daily value (excluding saturated fat inherent in seafood, nuts, seeds and soy).

Main dish products

A “main dish” product, as defined in § 101.13(m) (21 CFR 101.13(m)), may be labeled “healthy” if it contains two total Food Group Equivalents with no less than ½Food Group Equivalents from at least two food groups, and

Added sugar content no greater than 15% of the daily value

Sodium content no more than 20% of the daily value

Saturated fat content no greater than 15% of the daily value (excluding saturated fat inherent in seafood, nuts, seeds and soy).

Meal products

A “meal product” may be labeled “healthy” if it contains three total Food Group Equivalents with no less than ½ Food Group Equivalents from at least three food groups, and

• Added sugar content no greater than 20% of the daily value
• Sodium content no more than 30% of the daily value
• Saturated fat content no greater than 20% of the daily value (excluding saturated fat inherent in seafood, nuts, seeds and soy).

The revised rule will apply to the use of “healthy” not only when directly linked to a nutrient statement (whether express or implied), but also when other labeling elements (such as claims, symbols, images, or vignettes) place the term “healthy” in a nutritional context. The FDA emphasized that it will take a flexible, case-by-case approach in determining whether the use of “healthy” constitutes a nutrient content claim.

If you have any questions about the nuances of these rules with regard to your product, contact Talati Law Firm PLLC at ashish@talati-law.com.