The U.S. Food and Drug Administration (FDA) released its final ruling on requirements for the “healthy” nutrient claim, more than two years after initially proposing an update.
Manufacturers must satisfy two main criteria to use the healthy claim: A food must contain a certain amount of food from the food groups or sub-groups in the Dietary Guidelines – including vegetables, fruits, fat-free and low-fat dairy and others – and the food or beverage must meet limits for added sugar, sodium and saturated fat.
The new requirements also apply to derivatives of healthy, including health, healthful, healthfully, healthfulness, healthier, healthiest, healthily and healthiness, the agency stated.
Among the three nutrients listed, FDA requires:
- Added sugar cannot exceed 2% of the daily value (DV) in vegetables, fruits, game meats, seafood, eggs, beans, peas, lentils, nuts, seeds, soy products and oil-based dressings containing at least 30% oil. Additionally, added sugar cannot exceed 5%, 10%, 15% and 20% for dairy products, grain and mixed products, main dishes and meal products, respectively.
- Sodium limits are set at no more than 230 milligrams or 10% DV for adults and children above the age of 4, approximately 50% less than the sodium limit from the initial healthy criteria, the FDA reported. Sodium limits for mixed, main dish and meal products have higher sodium limits, set at 15%, 20% and 30% DV, respectively.
- Saturated fat content is limited to 5% DV for vegetables, fruits, grains, beans, peas and lentils, and the same limit applies to seafood, nuts, seeds, and soy products minus the saturated fat inherent in those products. Dairy products, game meats, eggs and mixed products have a saturated fat limit of 10% DV, main dishes at 15% and oils and meal products at 20%.
In Sept. 2022, the FDA proposed an update to requirements for the healthy claim, which were established in 1994. Per the 1994 definition, healthy foods required limits on saturated fat, sodium, total fat and dietary cholesterol and required minimum amounts of specific nutrients, including vitamin A, vitamin C, calcium, iron, protein and fiber in products.
The healthy claim is being updated “to be consistent with current nutrition science and federal dietary guidance,” and is aligned with the Dietary Guidelines for Americans, 2020-2025 and the updated Nutrition Facts Label, the agency reported.
Compliance for the new rules is set for Feb. 25, 2028, and the FDA will provide an overview of the final rule and address questions during an upcoming webinar.
Consumer Brands Association: New criteria ‘to exclude some packaged foods’
Trade groups and associations quickly responded to the new definition, with various groups calling out the exclusion of certain foods like cereals and yogurts.
The Consumer Brands Association reaffirmed its commitment “to protecting access to nutritious, affordable, convenient and safe food as well as providing transparency for the consumer,” while calling into question several aspects of the update, Sarah Gallo, senior VP of product policy at Consumer Brands Association, told FoodNavigator-USA in a statement.
“FDA’s update to the healthy claim on food labels stands to exclude some packaged foods, despite countless years of industry innovation to provide healthier options. We remain concerned that this government regulation is not based on clear and unambiguous scientific evidence or an in-depth economic analysis that considers all the potential impacts to consumers and the market, as well as sends the wrong signals to consumers and creates confusion about what food options can contribute to a healthy diet,” Gallo elaborated.
The Sugar Association calls out use of low- and non-caloric sweeteners
Similarly, The Sugar Association called out some of the products that will be excluded with the updated definition but supports some added sugar limits, Courtney Gaine, The Sugar Association president and CEO, shared in a statement with FoodNavigator-USA.
“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,” Gaine elaborated.
The Sugar Association called out “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,” Gaine elaborated.
Sugar remains one of the most popular sweeteners compared to no- or low-caloric sweeteners, according to a recent International Food Information Council (IFIC) report. In the report, IFIC surveyed 1,000 consumers to rate their favorite sweeteners out of 10 (1 being the least likely to consume and 10 the most) with sucrose receiving an average score of 6.3, compared to monk fruit, aspartame, allulose and erythritol at 4.3, 3.9, 3.5 and 3.4, respectively.
“At some point, the government needs to acknowledge that we don’t have a good grasp on how pervasive these low- and no-calorie sweeteners have become in our food supply, unbeknown to most Americans. It is past time we bring some transparency to these additives like we have for added sugars,” Gaine said.
American Heart Association: Update ‘should give consumers more confidence’ on healthy claims
The American Heart Association (AHA) signaled optimism on the updated requirements for the healthy claim and what the move will mean for consumers, CEO Nancy Brown of the American Heart Association, shared in remarks with FoodNavigator-USA.
“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,” Brown said.
While acknowledging the importance of updating food labels, the AHA noted that the healthy claim “may only appear on a small number of food and beverage packages,” highlighting “why the FDA’s work on front-of-pack nutrition labeling is so important,” Brown explained.
Last month, the FDA proposed new mandatory front-of-pack nutrition labeling requirements to the Office of Management and Budget, following two years of hearing industry feedback and exploring different labeling methods. Front-of-pack labeling requirements are designed to help consumers improve their health by highlighting healthy and nutritious foods.
“A front-of-pack labeling system based on the best available science and consumer research would give consumers valuable information about the nutritional value of foods and beverages and help them quickly and easily identify healthier options. We urge the administration to move forward with a proposed rule for a front-of-pack nutrition labeling system,” Brown elaborated.
