FDA proposes new rule for healthy labeling

UPDATE:  This alert has been edited to reflect a change in the FDA’s deadline for submitting comments.

The FDA has issued its long-anticipated proposed rule providing new criteria for when foods may be labeled with the nutrient content claim “healthy.” The proposed changes, announced on September 28, update the criteria of the preexisting rule[1] to better align with current nutrition science, the Dietary Guidelines for Americans, 2020-2025, and the updated Nutrition Facts label.

This proposed rule is part of the Administration’s overall strategy to improve nutrition and health and was issued on the same day as the White House Conference on Hunger, Nutrition, and Health and the release of the related national strategy to end hunger, improve nutrition and physical activity, reduce diet-related disease, and close disparity gaps by 2030.

FDA’s proposed updated definition of “healthy”

FDA’s proposed rule would transition away from setting minimum nutrient content thresholds and, instead, adopt a food group-based approach. As further explained below, a food product may be labeled as “healthy” if it (1) contains a prescribed amount of food (Food Group Equivalent or FGE) from at least one of the food groups or subgroups recommended by the Dietary Guidelines (like fruit, vegetables, and dairy) and (2) adheres to set limits for certain nutrients such as saturated fat, sodium, and added sugars, with the thresholds varying depending on the food type.

1. Summary of proposed requirements

The proposed rule groups foods into categories based on their nutrient content and how they are ordinarily consumed, with separate criteria based on the type of food product consumed. The FDA has proposed criteria in each of the following food categories:

Type of food	Criteria
Raw, whole fruits and vegetables, and plain water and plain carbonated water without flavoring or additional ingredients	Automatically qualifies for “healthy” claim
Individual food products	Must contain at least one FGE of one of the identified food groups AND Must not exceed the threshold limits for saturated fat, sodium, and added sugars
Mixed food products	Must contain at least one half of a FGE from at least two different food groups AND Must not exceed the threshold limits for saturated fat, sodium, and added sugar
Main dish products	Must contain at least one FGE from two or more different food groups AND Must not exceed the threshold limits for saturated fat, sodium, and added sugar
Meal products	Must contain at least one FGE from at least three different food groups AND Must not exceed the threshold limits for saturated fat, sodium, and added sugar
Oil products	Must be one of the following: 100% oil An oil-based spread whose fats come from oil or An oil-based dressing that contains at least 30% oil provided the oil meets the requirements of 100% oil AND Must not exceed the threshold limits for saturated fat, sodium, and added sugar

 

2. Food group equivalents

The proposed rule further explains the concept of food group equivalents (FGEs) needed for each food group to bear the ‘healthy’ claim.” The cup-equivalent (c-eq) and ounce-equivalent (oz-eq) amounts in the proposed rule are based on amounts discussed in the Dietary Guidelines, 2020-2025.

The following chart summarizes these FGEs and the amount of a given food product they equate to:

Food group	Food group equivalent	Amount
Vegetables	½ cup equivalent	½ cup raw or cooked vegetable, ½ cup 100 percent vegetable juice, 1 cup leafy salad greens, or ¼ cup dried vegetable
Fruits	½ cup equivalent	½ cup raw or cooked fruit, ½ cup 100 percent fruit juice, ¼ cup dried fruit
Grains	¾ ounce equivalent	⅜ cup cooked whole grain rice, whole grain pasta, or cereal; ¾ oz dry whole grain pasta or rice; ¾ medium (1 oz) slice whole grain bread, tortilla, or flatbread; ¾ oz of ready-to-eat whole grain cereal
Dairy	¾ cup equivalent	¾ cup fat-free or low-fat milk, yogurt or lactose-free versions, or fortified soy beverage or yogurt alternatives; 1 ⅜ oz natural cheese or ¾ oz processed cheese.
Protein	½ ounce equivalent of game meats	½ oz game meat or seafood; ½ egg; ⅛ cup cooked beans or tofu; ¼ tbsp nut or seed butter; ¼ oz nuts or seeds
	1 ounce equivalent of seafood, eggs, beans, peas, soy, nuts, and seeds	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

 

3. Limited nutrients

The proposed rule would continue to impose limits for nutrients with a propensity to increase calories or the risk of chronic disease, including saturated fat and sodium. The proposed rule adds limitations for added sugars and removes the prior rule’s limitations on total fat and cholesterol. The limit thresholds for baseline values are to be based on a percent of the daily value (DV) for the nutrient based on the food and food group. The baseline limit of saturated fat, sodium, and added sugars are as follows:

Nutrient type	Baseline limit
Saturated fat	5% DV per reference amount customarily consumed (RACC) (≤ 1 g)
Sodium	10% DV per RACC (≤ 230 mg)
Added sugars	5% DV per RACC (≤ 2.5 g)

 

The proposed rule would adjust the baseline limit of saturated fat, sodium, and added sugars for certain categories of food including foods that are “core elements of healthful dietary patterns associated with reducing chronic disease risk.” For example, FDA proposes adjusting the baseline limit of saturated fat for dairy products (proposed 10% of the daily value limit), game meats, seafood and eggs (proposed 10% of the daily value limit), and total fat for oils and oil-based spreads and dressings (total of 20 percent of the daily value limit).

The proposed rule does not set explicit limits on total fat, trans fat, and dietary cholesterol. FDA explains that it is “unnecessary” to include separate limits for these nutrients because the existing limitations on saturated fat would disqualify most foods containing a declarable level of naturally occurring trans fat and dietary cholesterol from meeting the “heathy” criteria.

Scope of the proposed rule

FDA’s proposed rule also expands the circumstances when use of the term “healthy” is considered an implied nutrient content claim subject to the regulation’s criteria. The proposed rule would no longer require that an implied nutrient content claim be used in conjunction with an explicit or implicit claim or statement about a nutrient to be an implied claim Instead, under FDA’s proposal, “healthy” constitutes a nutrient content claim where the term is used to characterize the food itself and where the term “healthy” is put into a nutritional context using any information on the label or labeling,  not just a nutrient content claim adjacent to the “healthy” claim. 

FDA’s proposal also explains that the new criteria for “healthy” claims would apply not only to the term “healthy” but also to “related terms” such as “health,” “healthful,” “healthfully,” “healthfulness,” “healthier,” “healthiest,” “healthily,” and “healthiness” when used in a nutritional context.

As with the old rule, FDA’s proposed updated rule would continue to limit the use of “healthy” nutrient content claims to foods directed to adults and children two years of age and older.

Recordkeeping requirement

In addition to issuing a new definition of “healthy” for purposes of nutrient content claims, FDA’s proposed rule would impose certain recordkeeping requirements on manufacturers of foods bearing a “healthy” nutrient content claim where compliance cannot be verified through the product label. These records would have to verify that a given product making a “healthy claim meets the FGE requirements.

FDA’s proposed rule states that some foods which will require additional recordkeeping (because compliance cannot be verified through the product label) include mixed products, main dish products, and meal products.

Manufacturers have discretion to determine the type of records they maintain and would not be required to produce any specific form or document. Records used to verify that a given food product meets the requirements for “healthy” could include, for example, batch records providing data on the weight of certain ingredient contributions to the total batch. These records would need to be provided to FDA upon request.

Takeaways and future planned actions

Interested stakeholders will have until February 16, 2023 to submit comments on the proposed rule to the agency through the Federal Register. The agency will consider these comments when issuing any final rule.  The proposed compliance date is three years after the final rule becomes effective.

In addition to the proposed rule, FDA stated in its September 28, 2022 News Release that it is considering several other actions aimed at creating a healthier food supply including:

1. Development of a symbol that manufacturers could use to show that their products meet the healthy claim criteria
   
   
2. Development of a front of package labeling system that would facilitate efficient communication of nutrient information to consumers
   
   
3. Ensuring nutrition information is easily available to consumers when grocery shopping online
   
   
4. Promoting the reduction of sodium content in foods, including by issuing revised, lower voluntary sodium reduction targets for industry
   
   
5. Holding a public meeting regarding steps the federal government might take in furtherance of lowering added sugar consumption and
   
   
6. Taking steps to educate parents and caregivers to ensure they are aware of the latest recommendations for healthy eating and are taking steps to reduce exposure to toxic food elements.

Learn more about the implications of this proposed rule by contacting any of the authors.