FDA Proposes Update to "Healthy" Food Label Claim Standard

Jonathan Havens, Seth Gitner


The U.S. Food and Drug Administration (FDA or the Agency) today published in the Federal Register a proposed rule that, if finalized, would update the standards that food products must meet in order to be labeled as “healthy.” 

Per FDA, the proposed rule would “align the definition of ‘healthy’ with current nutrition science, the updated Nutrition Facts label and the current Dietary Guidelines for Americans,” with the aim of helping consumers increase their intake of underconsumed dietary components – by requiring “healthy” foods to contain a minimum quantity of at least one of the specified food groups or subgroups (i.e., fruit, vegetable, dairy, etc.) recommended by the Dietary Guidelines – while limiting nutrients that are over-consumed and may lead to negative health consequences (i.e., sodium, added sugars, and saturated fat). 

Under the proposed standard, for example, a cereal would need to contain ¾ ounces of whole grains and contain no more than 1 gram of saturated fat, 230 milligrams of sodium and 2.5 grams of added sugars to be labeled as “healthy.”

Pursuant to the updated definition, more foods that are part of a healthy diet and recommended by the Dietary Guidelines would be eligible to bear the claim, including nuts and seeds, higher fat fish (e.g., salmon), certain oils, and water. 

With FDA’s new focus on food groups and subgroups, the Agency plans to no longer include minimum amounts of nutrients to encourage (i.e., nutrients that are underconsumed and whose low intake in the general population or in individual subpopulations raise public health concern). The reason for this change? FDA is concerned that including criteria for nutrients to encourage could lead to fortification to allow foods that are low in saturated fat, sodium, and added sugars to qualify for the ‘‘healthy’’ claim, despite these foods not contributing to a meaningful amount of a food group (e.g., white bread fortified with calcium).

Under the proposed rule, the term “healthy,” along with related terms (e.g., healthful), could be used for:

  • Raw whole fruits and vegetables;
  • Foods (including individual foods, main dishes, and meal products) that contain a minimum serving of at least one food group or subgroup (i.e., vegetable, fruit, grain, dairy, protein or oils), and do not exceed the specified limit on added sugars, sodium, and saturated fat; and
  • Plain water and carbonated water without any flavoring or additional ingredients.

Beyond discussing the proposed rule, the Agency announced some of its other plans to improve nutrition and health, and empower consumers to make and have access to healthy choices. These future plans include:

  • Developing a front-of-package (FOP) labeling system to quickly and more easily communicate nutrition information to empower consumers to make healthy decisions. 
  • Facilitating making nutrition information easily available when grocery shopping online. 
  • Facilitating lowering the sodium content of food in the food supply, including by issuing revised, lower voluntary sodium reduction targets for industry.
  • Holding a public meeting regarding future steps the federal government could take to facilitate lowering added sugar consumption.
  • Releasing additional education and outreach efforts to ensure that parents and caregivers are aware of the latest recommendations for healthy eating in young children and for taking steps to reduce exposure to toxic elements in food.

FDA is accepting comments on the proposed rule until Wednesday, December 28th. If you would like assistance in drafting comments or have any questions regarding the proposed rule, please do not hesitate to contact Jonathan Havens (jonathan.havens@saul.com), Seth Gitner (seth.gitner@saul.com), or the Saul Ewing attorney with whom you are regularly in contact.

Jonathan A. Havens
Seth Gitner