FDA Publishes Proposal to Redefine the Implied Nutrient Contain Claim “Healthy” Changing Focus to Foods Rather than Nutrients Adding Limits on Added Sugar Content

On September 28, 2022, FDA announced the availability of the proposed rule for the implied nutrient content claim “healthy.”  The healthy claim has been the topic of much discussion and challenged in consumer class actions.  The term healthy, as an implied nutrient claim, was first defined by FDA in 1994.  It is focused on the nutrients in the food product rather than on it overall nutritional “quality.”

In 2015, FDA issued a Warning Letter to Kind LLC because, among other things, the company labeled products as healthy whereas these products provided more saturated fat per serving than permitted by the regulatory definition.  In response to this Warning Letter, Kind LLC with support of nutrition experts) submitted a Citizen Petition asking that FDA update its healthy definition to better reflect the nutritional quality of a product.  The existing regulation for healthy, includes specific criteria for individual nutrients that must be met in the food for it to bear the claim, including limits on total fat, saturated fat, cholesterol, and sodium, and minimum amounts of nutrients for which consumption is encouraged, such as vitamin A, vitamin C, calcium, iron, protein, and dietary fiber.  Under this rule, several foods emphasized in current nutrition science and Federal dietary guidance as key elements of a healthy dietary pattern are not able to bear the “healthy” claim; for example, salmon due to fat levels.

In 2016, FDA reversed its position on the healthy claim for Kind’s products and issued a final guidance informing industry that FDA would exercise enforcement discretion for certain products that did not meet the requirements of the current definition because of their fat (or saturated fat) content but have a fat profile makeup of predominantly mono and polyunsaturated fats.  (The guidance also advised food manufacturers of FDA’s intent to exercise enforcement discretion for foods that are a good source of potassium, and vitamin D, as these two nutrients had been designated nutrients of public health concern in the 2016 final nutrition labeling regulation).  FDA also announced it would be re-evaluating the regulatory criteria for use of the “healthy” claim.

Since then, FDA has undertaken several actions to get input on a revised definition of healthy culminating in the proposed rule.  The proposed rule is intended to align with current nutrition science, the Dietary Guidelines for Americans 2020-2025 and the 2016 nutrition labeling regulation (which also was intended to align with the Dietary Guidelines for Americans).

Some notable aspects of the proposed rule:

• Likely the biggest change is that the proposed definition no longer focuses on presence of specific beneficial nutrients, e.g., minerals or vitamins, to qualify for a healthy claim, but instead focuses on the presence of a defined meaningful amount of food from at least one of the food groups or subgroups recommended by the Dietary Guidelines 2020-2025, such as dairy, fruit, or vegetable.  As a result, there  generally will be no incentive to fortify foods with certain beneficial nutrients.
• Vegetable, fruit, and grain products and other food group definitions are based on food group 1 cup (1 c) or 1 oz equivalents (eqs) as discussed in the Dietary Guidelines 2020-2025. The preamble to the proposal provides further clarification:
  • For 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.
  • For 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.
  • For 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.
  • For 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.

This information is not included in the proposed codified language for the regulation.

• The criteria for nutrients to avoid vary for different food categories. In fact, for fresh fruit or vegetables, FDA does not define nutrients that must be avoided; all raw, whole fruits and vegetables may bear the healthy claim.
  • Individual food products: Must include at least one food group equivalent per RACC from one food group and meet specified limits on the amount of added sugars, saturated fat, and sodium.
  • Mixed products: Must include at least ½ food group equivalent each from at least two different food groups and must meet specified limits on the amount of added sugars, saturated fat, and sodium.
  • Main dish: Must include at least one food group equivalent each from at least two different food groups, and must meet specified limits on the amount of added sugars, saturated fat, and sodium
  • Meal: Must include at least one food group equivalent each from at least three different food groups and must meet limits on the amount of added sugars, saturated fat, and sodium.
  • Water: Plain water and plain, carbonated water may bear the healthy claim.

• The proposed definition lowers the limits on the sodium content from 480 mg to 230 mg per RACC  (which is 10% of the DV) for certain food products. For example, most cheeses will no longer be  eligible for the healthy claim because they contain too much sodium.
• The proposed definition no longer includes a limit on the total fat because, as discussed in the preamble, there is a shift in emphasizing total fat content of a food.  The proposed rule does, however, limit the amount of saturated fat per RACC to 5% of the Daily Value (DV) for vegetable, fruit, and grain product foods, for protein foods that are bean, peas, or soy products, and for protein products that are nuts and seeds (except if the saturated fat is derived from the nuts and seeds), and to 10% of the DV for dairy products and the protein foods game meat, seafood, egg and for oils.  The proposed rule does not include a separate limit on cholesterol content.
• Because it may not be possible to determine if processed foods meet the healthy claim criteria by analysis of the products, companies wishing to use a healthy claim may need to prepare documents to support the claim.  Consequently, the proposed rule includes recordkeeping requirements for foods bearing the claim where compliance cannot be verified through analysis or information on the product label.

Plant-based alternatives to milk yogurt will be evaluated as dairy products; products whose overall nutritional content is similar to dairy (e.g., provide similar amounts of protein, calcium, potassium, magnesium, vitamin D, and vitamin A) and are used as alternatives to milk or yogurt will be evaluated against the dairy criteria for the purposes of the ‘‘healthy’’ nutrient content claim.

FDA is conducting research on a symbol to represent the claim “healthy.” The symbol on the front of a package would function as a quick signal to allow consumers to identify foods that will help build healthy dietary patterns.

FDA proposes a compliance data of 3 years after the effective date. These three years are intended to provide industry with sufficient time to revise labeling (if needed) and, according to FDA, balance the time that industry needs to revise labeling and or reformulate certain products against the need for consumers to have the updated rule (and information) in a timely manner.

FDA seeks comments on many of the aspects of its proposal (the term seek comments occurs 22 times).  Comments must be submitted by December 28, 2022.