WASHINGTON — The Food and Drug Administration is seeking to redefine the term “healthy” on food packaging. A proposed rule scheduled to publish in the Federal Register Sept. 29 is intended to align current nutrition science, the Nutrition Facts label and the Dietary Guidelines for Americans, according to the agency.

Specifically, the proposed rule will require food products featuring the term “healthy” on packaging to contain a meaningful amount of food from one of the food groups or subgroups such as fruits, vegetables, dairy, grains, protein and oils. Such products also will be required to adhere to specific limits for certain nutrients like saturated fat, sodium and added sugars.

The threshold for the limits is based on a percent of the Daily Value (DV) for the nutrient and varies depending on the food and food group. The limit for sodium, for example, is 10% of the DV per 230 mg serving.

The FDA also is proposing removing the limit for total fat, trans fat and dietary cholesterol in defining what is healthy.

“Nutrition is key to improving our nation’s health,” said Xavier Becerra, secretary of Health and Human Services. “Healthy food can lower our risk for chronic disease. But too many people may not know what constitutes healthy food. FDA’s move will help educate more Americans to improve health outcomes, tackle health disparities and save lives.”

The FDA originally defined “healthy” in 1994. Under the existing regulation there are 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, as well as minimum amounts of nutrients whose consumption is encouraged, such as vitamin A, vitamin C, calcium, iron, protein, and dietary fiber.

“These nutrient criteria were originally included to identify foods that are particularly helpful to consumers in maintaining healthy dietary practices and achieving dietary recommendations,” the proposal said. “Instead of including a limited set of nutrients for which consumption is encouraged in the definition as surrogates for recommended food groups and subgroups, we propose to directly incorporate food groups as criteria in the definition of the claim ‘healthy.’

“We tentatively conclude that using food groups to encourage as the criteria for ‘healthy,’ rather than a limited set of nutrients, would better identify foods with the nutrient content that may help consumers maintain healthy dietary practices, consistent with current nutrition science and federal dietary guidance.”

Currently, about 5% of all packaged foods on the market are labeled as healthy, according to the FDA. The goal of the proposal is to improve dietary patterns in the United States to reduce the burden of nutrition-related chronic diseases and advance health equity as nutrition-related chronic diseases are experienced disproportionately by certain racial and ethnic minority groups and those with lower socioeconomic status, according to the proposal.

The current Dietary Guidelines, 2020-2025 identifies vegetables, fruits, dairy, grains, protein foods, and oils as essential components of a healthy dietary pattern. Yet more than 80% of Americans have dietary patterns that are low in vegetables, fruits, and dairy, the proposal said. Additionally, more than half of the population is meeting or exceeding the total grain and total protein foods recommendations but is not meeting the recommendations for the subgroups within each of these food groups

In 2019, for example, 42% of adolescents and 39% of adults said they ate fruit less than once a day, while 41% of adolescents and 21% of adults said they ate vegetables less than once a day. At the same time, most Americans exceed the recommended intake limits for added sugars, saturated fats, and sodium, nutrients that should be limited in a healthy dietary pattern.

“Diet-related chronic diseases, such as cardiovascular disease and type 2 diabetes, are the leading causes of death and disability in the US and disproportionately impact racial and ethnic minority groups," said Robert M. Califf, MD, commissioner of the FDA. “Today’s action is an important step toward accomplishing a number of nutrition-related priorities, which include empowering consumers with information to choose healthier diets and establishing healthy eating habits early. It can also result in a healthier food supply.”