WASHINGTON — The US Food and Drug Administration (FDA) on Dec. 19 issued its final rule on updating what qualifies for the “healthy” nutrient content claim that manufacturers may use voluntarily on food packages.

The rule marked the first major change to the claim since the FDA introduced it in 1994. Changes included limits on added sugars, which were not mentioned in the 1994 rule, and limits on saturated fat based on food groups.

“The current definition is very outdated,” said Claudine Kavanaugh, PhD, director of the FDA’s Office of Nutrition and Food Labeling, in an FDA media briefing. “It’s based just on nutrients, and it doesn’t require an added sugars limit.”

She added the updated rule should allow more foods, such as salmon and eggs, to qualify for the healthy labeling. More foods containing whole grains also may qualify, she said.

To qualify for a healthy claim, food products need to contain a certain amount of food from at least one of the food groups or subgroups, including fruit, vegetables, grains, fat-free and low-fat dairy and protein foods, recommended by the 2020-2025 Dietary Guidelines for Americans. The food product also needs to meet specific limits for added sugars, saturated fat and sodium.

If they have no added ingredients except for water, products automatically qualifying for the claim include vegetables, fruit, whole grains, fat-free and low-fat dairy, lean game meat, seafood, eggs, beans, peas, lentils, nuts and seeds. Other items such as water, avocados, nuts and seeds, higher fat fish such as salmon and olive oil also qualify.

International Dairy Foods Association (IDFA) senior vice president of regulatory and scientific affairs Roberta Wagner said FDA “missed an important opportunity” to help shoppers choose healthier food options.

“Instead, the rule is so narrow that few foods, including many nutrient dense dairy products, will be able to bear the claim,” Wagner said. “FDA notes 79% of Americans are not eating enough dairy or getting dairy’s 13 essential nutrients, and yet this new rule puts nutritious dairy further out of reach for Americans of all backgrounds and income levels. We recommend FDA rethink their approach to ensure a wide variety of nutrient dense foods accessible to Americans from all backgrounds can bear the claim. We urge FDA reopen this rule for comment with the intent of creating practical policy that benefits all people and families.”

The limits on added sugars vary by food group. Most oils, excluding oil-based dressing at 2% or less, must have zero of the Daily Value to qualify. A 2% Daily Value or less is allowed for vegetable products, fruit products, game meat, seafood, eggs, beans, peas, lentils, nuts, seeds and soy products.

Dairy products are allowed 5% or less of the Daily Value of added sugars. Courtney Gaine, PhD, president and chief executive officer of The Sugar Association, took issue with the added sugars update.

“The Sugar Association supports the Dietary Guidelines recommendation to limit added sugars to 10% of total calories, but the new ‘healthy’ definition goes well beyond that recommendation and arbitrarily excludes many foods containing added sugars that are key providers of essential nutrients, such as fruit yogurt,” she said. “With this rule, FDA is once again incentivizing further use of industrial additives like low- and no-calorie sweeteners in food, which have proliferated over the last several decades, going well beyond their well-known and easily identifiable role in beverages and now showing up as unidentifiable chemical names buried on ingredient lists for foods, including in food for children.”

Grain products, if they have a minimum of ¾-oz whole grain equivalent, are allowed 10% or less of the Daily Value of added sugars. The FDA found that increasing the added sugars limit to 10% or less from 5% or less would increase the palatability and the availability of nutrient-dense whole grain products, which are under-consumed in the United States.

The saturated fat limited range is 5% or less of the Daily Value for grains products, vegetable products, fruit products, seafood, beans, peas, lentils, nuts, seeds and soy products. The rule excludes the inherent saturated fat in seafood from the saturated fat limit for seafood products. The limit is 10% or less for dairy products, game meat and eggs. The amount of saturated fat must be 20% or less of the total fat content for 100% oil, oil-based spreads and oil-based dressing. The rule excludes the inherent saturated fat in seafood from the saturated fat limit for seafood products.

Sodium limits for most food products are 10% or less of the Daily Value.

“The American Heart Association is pleased the FDA has updated the requirements foods and beverages must meet to be labeled ‘healthy,’” said Nancy Brown, CEO of the American Heart Association. “Nearly three decades since the original designation was created, it was past time to update the requirements based on the latest nutrition science. The updated definition should give consumers more confidence when they see the ‘healthy’ claim while grocery shopping, and we hope it will motivate food manufacturers to develop new, healthier products that qualify to use the ’healthy’ claim.”

Manufacturers may choose how to use the healthy claim on packaging, said Jim Jones, the FDA’s deputy commissioner for Human Foods, in the media briefing.

“It’s a voluntary program,” he said. “We would expect that a company using the term will use it in a way that they think will be effective for them. We have not put any requirements on how big or little the labeling can be that they use.”

The FDA plans to hold a webinar to provide an overview of the final rule and address questions. A symbol that manufacturers could use on food labeling to show that a product meets the definition of healthy also will be developed.

The 1994 definition had limits for total fat, saturated fat, cholesterol and sodium. Food products also had to provide at least 10% of the Daily Value for one or more of the following nutrients: vitamin A, vitamin C, calcium, iron, protein and fiber. The FDA on Sept. 29, 2022, issued a proposed rule to update the nutrient content claim “healthy” and received about 400 comments on it.