On September 28, 2022, the Food and Drug Association announced a proposed rule to redefine the implied nutrient content claim term “healthy” to more closely reflect current nutrition science and Federal dietary guidelines.
The proposed rule can be found here.
FDA’s current/original definition has not changed since it was established in 1994. Under the current definition, a food may bear a “healthy” claim (or implied “healthy” claim) if it contains at least 10% of the FDA-recognized Daily Value (DV) for the nutrients calcium, iron, vitamins A and C, protein, and fiber, and contains no more than the specified limits for total and saturated fats, cholesterol, and sodium.
In contrast, FDA’s proposed definition of “healthy” focuses on the food groups associated with healthy dietary patterns, the type of fat rather than the total quantity, and the levels of sodium and added sugars. The proposed definition is aligned with the latest nutrition science, including the federal government’s “Dietary Guidelines for Americans, 2020-2025” and the updated “Nutrition Facts” label.
Use of the “healthy” claim in labeling and advertising is voluntary. However, in order to meet the proposed definition, a food product would need to contain a certain amount of food from at least one of the food groups or sub-groups (including fruits, vegetables, grains, protein foods, and dairy) recommended by the Dietary Guidelines, while specific limits for saturated fat, sodium, and added sugars would be based on a percentage (e.g., 5% or 10%) of their DVs. For a given food product, the amount of food required from a food group and the limits for saturated fats, sodium, and added sugars would depend on the specific product, and whether it is an individual product, a mixed product containing more than one food group, a main dish, or a complete meal, with the serving size determined by FDA’s Reference Amounts Customarily Consumed.
Under the proposed definition, raw whole fruits and vegetables would automatically qualify for a “healthy” claim, but products such as white bread and highly sweetened yogurt or breakfast cereal would no longer qualify. Water (plain or carbonated), fatty fish (e.g., salmon), nuts and seeds, avocados, and certain oils (e.g., olive and canola), which are all part of a healthy diet, would newly qualify for the claim.
FDA reports that currently, 75% of people have diets low in vegetables, fruits, and dairy, 77% exceed the limit for saturated fat, 90% exceed the limit for sodium, and 63% exceed the limit for added sugars, which individually or in combination increase the risk for such common chronic diseases as cardiovascular disease and Type 2 diabetes.
The motivation underlying the proposed definition change is twofold: (1) to better inform members of the public and make it easier for them to select a more healthy diet; and (2) to encourage manufacturers to reformulate their existing products and to develop new products to meet the revised definition. To aid in these processes, FDA is contemplating the design of a standardized “healthy” symbol that manufacturers could use voluntarily to label food and that food shoppers in a hurry could readily recognize.
Simultaneously with the issuance of its Proposed Rule, FDA participated in the September 28, 2022, White House Conference on Hunger, Nutrition, and Health, one aim of which is to improve nutrition and health by enabling all consumers to make and have access to healthy dietary choices.
Comments on FDA’s Proposed Rule must be submitted by December 28, 2022.
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