FDA Proposes Updated Definition of "Healthy" Claim for Food

The U.S. Food and Drug Administration ("FDA") responds to the Dietary Guidelines for Americans, 2020-2025 directive to "make every bite count" by proposing significant revisions to the implied nutrient content claim.

On September 28, 2022, the FDA proposed updated criteria for when foods can bear what FDA refers to as the implied nutrient content claim "healthy" on their labeling.

According to the FDA, a "healthy" label signals to consumers that the food can be helpful in maintaining healthy dietary practices because of its nutrient content. The FDA first defined and regulated the use of "healthy" claims in 1994. Since that time, nutrition science and federal dietary guidance have evolved, and the foods Americans commonly consume have changed, while the definition of "healthy" has not. For example, some foods, including nuts and seeds, higher fat fish (such as salmon), certain oils, and water, cannot be labeled "healthy" under the existing regulations despite being part of accepted healthy dietary patterns. Conversely, some foods currently appropriately labeled as "healthy" may not be consistent with modern dietary guidelines. 

Consequently, the proposed rule seeks to update the definition of "healthy" to conform with current nutrition science and the Dietary Guidelines for Americans, 2020-2025, which are developed jointly by federal agencies to provide recommendations on healthy eating. 

The proposed framework uses a food group-based approach and limits the amount of certain nutrients contained in foods labeled "healthy," based on the understanding that each food group contributes an array of important nutrients to the diet. Specifically, under the proposed definition, food products would need to meet the following key elements in order to bear the "healthy" claim: 

  • Contain a certain meaningful amount of food from at least one of the food groups or subgroups (e.g., fruit, vegetable, dairy, etc.) recommended by the Dietary Guidelines
  • Adhere to specific limits for certain nutrients, such as saturated fat, sodium, and added sugars. 

The proposed regulation would also add certain recordkeeping requirements. 

While the FDA stated it received widespread support for updating "healthy" in accordance with current nutrition science, stakeholders should scrutinize the proposed criteria alongside current and contemplated foods to assess likely impact. 

Comments on the proposed rule must be submitted by December 28, 2022. 

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