Summary Review: FDA Revised Definition of Healthy

Summary Review: FDA Revised Definition of Healthy

October 12, 2022
Annette Maggi

By RDBA Executive Director Annette Maggi, MS, RDN, LD, FAND

It’s no coincidence that the Food and Drug Administration (FDA) released a proposed rule on a new definition of healthy on the same day as the White House Summit on Hunger, Nutrition, and Health. But what is startling is the significant departure the FDA took in their proposed revisions of healthy.

While the current definition is based on limits of certain nutrients like saturated fat, cholesterol, and sodium as well as requirements for nutrients to encourage, such as key vitamins and minerals, the proposed definition is based on food group requirements. The rationale for this approach is that good nutrition comes from foods with a mix of nutrients that work in combination; the approach also aligns with recommendations in the Dietary Guidelines for Americans 2020-2025 (DGA).

The core principle of the revised healthy definition is that a food or product must include a significant portion of a food group recommended in the DGAs. These food groups are vegetables, fruits, grains, dairy, grains, protein foods, and oils. The assumption is made that the average consumers has four eating occasions per day, which leads to a healthy product needing to contain roughly one-fourth equivalent of a food group (more detail provided further in article). Given that meat and poultry are regulated by USDA, there is no discussion of these foods in the entirety of the regulation proposal.

The second key element of the proposed regulation is the continuation of nutrients to limit; however, the requirement of a minimum amount of nutrients to encourage has been eliminated. The three nutrients and their limits are as follows:

  • Saturated fat is limited to a maximum of 5 percent of the Daily Value (DV) for fruits, vegetables, grains, and two subcategories of protein — nuts and seeds and beans, peas, and soy products. Some exceptions are made including 10% DV for dairy, game meats, seafood and eggs. For oils, oil-based spreads and dressings, saturated fat can be equal or less than 20 percent of total fat.
  • Sodium is limited to a maximum of 10 percent of the DV, a significant drop from the 480 mg allowed for individual foods in the current healthy definition.
  • Added sugar is limited to a maximum of 5 percent of the DV. With a DV of 50 grams, this is the equivalent of 2.5 grams added sugar per RACC.

In the proposed rule, FDA also defines food groups that may carry the healthy claim, which are:

  • Raw, whole fruits and vegetables can all bear the claim and do not have to meet the “nutrients to limit” criteria. It’s important to note that canned, frozen, dried, or puréed forms must meet the criteria as an individual food as described next.
  • Individual foods are primarily one food (think oatmeal, yogurt, dried fruit); they can make a healthy claim if they have one food group equivalent of one food group per RACC and meet the nutrient to limit requirements.
  • Combination foods includes three subcategories:
    • Mixed products are similar in size to an individual foods but don’t have one full equivalent of a food group (think granola with grains and dried fruit). To make the healthy claim, they must have at least one-half equivalent from two food groups and meet the nutrients to limit.
    • Main dishes, by FDA definition, weight six ounces or more per labeled serving size and have 40 grams from at least two food groups. They must have one full equivalent from two food groups and meet the nutrients to limit criteria to make a healthy claim.
    • Meals, by FDA definition, are at least 10 ounces per labeled serving size and contain three 40-gram portions from at least two food groups. They meet healthy by having a full equivalent from three food groups and meeting the nutrients to limit.
  • Plain water, in either the still or carbonated version, can make the healthy claim.
  • The oil category is broken down into three subcategories:
    • Oils which are 100% oil can bear the claim as long as they contain no more than 20% of fat from saturated fat; they are not allowed to contain added sugars or sodium.
    • In Oil-based spreads, all fat must come from oil, and they must meet the saturated fat criteria. They may contain five percent DV or less sodium and cannot include added sugar.
    • Oil-based dressings must be comprised of 30 percent or more oil, meet the saturated fat and sodium criteria; they are allowed up to two percent of the DV for added sugar.

An important nuance to the regulation is the treatment of nutrients to limit in the combination food category. For mixed products, the limits are based on an average of the two food groups, for main dish, limits vary by food group, and for meal, the limits are a sum of the three food group requirements. Oils cannot be used as a food group in any of these categories and beans, peas, and lentils can be counted as either a protein food or a vegetable.

The full proposed rule is available here and FDA is accepting comments on the proposal until December 28, 2022.