FDA proposes updated criteria for "healthy" claims in labeling

Hogan Lovells
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Hogan Lovells

The Food and Drug Administration (FDA) has issued its proposed rule updating the definition of the implied nutrient content claim “healthy” for use in labeling. Under the proposal, to be considered healthy, a food would need to meet: (1) a new requirement to contain a minimum amount of food from at least one of the food groups or subgroups to encourage (i.e., fruit, vegetables, whole grain, dairy, protein foods, oils); (2) a new added sugars limit of between 0-5% daily value (DV), depending on the type of food; and (3) updated sodium (generally 10% DV) and saturated fat (generally 5% DV) limits, with variation in the limits depending on the food type, and with no limit on total fat. The proposed updates are aimed at making the healthy criteria consistent with current nutrition science and federal dietary guidance, and to limit use of the claim to circumstances in which a food may help consumers achieve a healthy dietary pattern. Comments are due December 28, 2022.

Background

The existing “healthy” criteria have been in place since 1994 and take a nutrient-based approach, imposing limits on total fat, saturated fat, cholesterol, and sodium; and requiring minimum amounts of nutrients whose consumption is encouraged, such as vitamin A, vitamin C, calcium, iron, protein, and dietary fiber. These criteria, according to FDA, are outdated in several respects, including (a) the sole focus on nutrients without considering food group contributions, (b) the lack of an added sugars limit, and (c) the focus on total fat rather than the type of fat. FDA had previously issued enforcement discretion with respect to some of the existing criteria in the healthy regulation until the rule could be updated.1 The agency also issued a request for information in September 2016 and held a public meeting in March 2017 to seek comments on potential revisions to the healthy definition.

Unlike the existing approach, which is solely focused on nutrients, the proposed rule uses a food group-based approach in addition to nutrients to limit. FDA recognizes that “nearly all foods can be incorporated into a healthy dietary pattern to a greater or lesser extent,” but explains that current dietary guidance recommends choosing “nutrient dense” foods while staying within overall calorie limits.2 FDA comments that a number of nutrient dense foods are not able to bear the current “healthy” claim (e.g., salmon, olive oil, and canola oil due to their fat levels); while other foods such as “certain ready-to-eat cereals that may be high in added sugars” meet the current criteria, despite not being consistent with dietary recommendations. FDA believes the proposal would modernize the criteria to better reflect the overall nutrient content of a food, including nutrient density, and reflect its role in a dietary pattern.

Proposed updated “healthy” criteria

Under the proposed rule, there are separate standards for individual foods, mixed products, main dishes, meal products, water, and raw whole fruits and vegetables. Generally, to qualify as healthy, food products would need to:

  • Contain a certain amount of food (a “food group equivalent”) from at least one of the food groups or subgroups (e.g., fruit, vegetable, dairy, whole grains, protein) recommended by dietary guidelines,3 where the following food group equivalents are used; and

    • ½ cup equivalent (eq) vegetable

    • ½ cup-eq fruit

    • ¾ oz-eq whole grain

    • ¾ cup-eq dairy

    • Protein foods: 1 oz-eq for seafood; eggs, beans, peas, and soy products; and nuts and seeds; 1 ½ oz-eq for game meats

  • Adhere to specific limits for certain nutrients, such as saturated fat, sodium, and added sugars, with the thresholds varying depending on the type of food.

    • Saturated fat: The baseline limit is 5% DV per reference amount customarily consumed (RACC) (≤ 1 g), consistent with the low saturated fat criteria. The baseline would be adjusted for dairy, game meats, seafood, and eggs (10% DV); and oils and oil-based spreads and dressings (20% of total fat).

    • Sodium: The baseline limit is 10% DV per RACC (≤ 230 mg), though some categories must contain less than this.

    • Added sugars: The baseline limit is 5% DV per RACC (≤ 2.5 g), though some categories must contain less than this.

FDA provides examples of the type of foods that would be covered by each food category.

  • Vegetables and fruits, a 1 c-eq is: 1 cup raw or cooked vegetable or fruit, 1 cup 100 percent vegetable or fruit juice, 2 cups leafy salad greens, or ½ cup dried fruit or vegetable.

  • Grains, a 1 oz-eq is: ½ cup cooked whole grain rice, whole grain pasta, or cereal; 1 oz dry whole grain pasta or rice; 1 medium (1 oz) slice whole grain bread, tortilla, or flatbread; 1 oz of ready-to-eat whole grain cereal.

  • Dairy, a 1 c-eq is: 1 cup fat-free or low-fat milk, yogurt or lactose-free versions, or fortified soy beverage or yogurt alternatives; 1 ½ oz natural cheese or 1 oz processed cheese.

  • Protein foods, a 1 oz-eq is: 1 oz game meat or seafood; 1 egg; ¼ cup cooked beans or tofu; 1 tbsp nut or seed butter; ½ oz nuts or seeds.

We are providing the proposed criteria as Appendix A.

FDA is proposing not to require foods to contain minimum amounts of nutrients to encourage, nor would foods need to meet limits for total fat or cholesterol. There are two categories that would automatically qualify as healthy, regardless of whether they meet the criteria above: (1) raw, whole fruits and vegetables; and (2) plain water and plain carbonated water without any flavoring or additional ingredients.

FDA also proposes to revise the language regarding when use of the term healthy is considered an implied nutrient content claim and subject to the criteria in the regulation. The new language would cover those situations when “healthy” is used to characterize the food itself and “where there is also implied or explicit information about the nutrition content of the food.” According to FDA, this clarifies that information on the label that provides a nutritional context would not necessarily be immediately adjacent to the implied nutrient content claim, but could appear anywhere on the label or labeling. As examples of statements on labels bearing the term “healthy” that would trigger the nutrient content claim requirements, FDA lists the MyPlate symbol, voluntary front of pack labeling, or a statement such as “made with whole grain ingredients”, “made with real fruits and vegetables”, or “contains a variety of nuts.”

Recordkeeping

Under the proposed rule, manufacturers making a “healthy” claim would need to make and keep written records where the food group equivalent content is not apparent from the label of the food. The records would need to verify that the food group equivalent requirements are met. Examples of appropriate records could include analyses of databases, recipes, formulations, information from recipes or formulations, or batch records. Such records would need to be provided to FDA upon request, during an inspection; and electronic records would need to comply with 21 CFR part 11.

Next steps

FDA is accepting comments on the proposed rule for 90 days. The agency will then proceed with drafting a final rule. The compliance date is proposed to be 3 years after the effective date of the final rule. We will continue monitoring FDA’s actions related to the “healthy” definition.

References

1 FDA is exercising enforcement discretion for foods that contain primarily monounsaturated and polyunsaturated fats but do not meet the “Low fat” definition, and on foods that contain at least 10% daily value per reference amount of potassium or vitamin D, provided all other criteria in the regulation are met.

2 According to FDA, “nutrient dense” means foods and beverages that provide vitamins, minerals, and other health-promoting components and have little added sugars, saturated fat, and sodium”.

3 The food group contributions are based on an assumption of four eating occasions per day; FDA seeks comment on this.

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