WASHINGTON — A front-of-package nutrition label for most packaged foods would include information on saturated fat, sodium and added sugars in a rule proposed Jan. 14 by the US Food and Drug Administration (FDA).

The label, also referred to as the “Nutrition Info box,” would show whether the food has low, medium or high levels of the three nutrients. The FDA proposed a range of 5% of the Daily Value (DV) or less for low, 6% to 19% of the DV for medium (appearing as “Med” in the Nutrition Info box) and 20% of the DV or more for high.

The FDA proposed the Nutrition Info box be placed somewhere in the top third of the principal display panel on the front of the package. The proposed rule does not include foods marketed toward children under 4 years old. The Nutrition Info box would complement the FDA’s Nutrition Facts Label that gives information on nutrients.

The FDA also is proposing to amend the nutrient content claim definition for low sodium. A low sodium claim currently may be used on a food product, other than a meal product or main dish, if it contains 140 mg or less of sodium per reference amount customarily consumed (RACC). The proposed rule would lower that amount to 115 mg or less.

Chronic diseases like heart disease, cancer and diabetes are leading causes of disability and death in the United States, according to the FDA. “A large body of research” indicates that excess consumption of saturated fat, sodium and added sugars are major contributors to the health care problems, including $4.5 trillion in annual health care costs in the United States, according to the agency.

“The science on saturated fat, sodium and added sugars is clear," said FDA commissioner Robert M. Califf, M.D. "Nearly everyone knows or cares for someone with a chronic disease that is due, in part, to the food we eat. It is time we make it easier for consumers to glance, grab and go. Adding front-of-package nutrition labeling to most packaged foods would do that. We are fully committed to pulling all the levers available to the FDA to make nutrition information readily accessible as part of our efforts to promote public health."

The FDA, in creating the proposed Nutrition Info box, conducted research that included a scientific literature review, consumer focus groups and a peer-reviewed experimental study. The proposed rule, if finalized, would require food manufacturers to add a Nutrition Info box to most packaged food products three years after the final rule's effective date for businesses with $10 million or more in annual food sales and four years after the final rule's effective date for businesses with less than $10 million in annual food sales.

The FDA will accept comments until 120 days after the proposed rule is published in the Federal Register, which is scheduled for Jan. 16. Comments may be submitted electronically online at the Federal Register’s website. Written/paper comments may be sent to Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All submissions received must include the Docket No. FDA-2024-N-2910 for “Food Labeling: Front-of-Package Nutrition Information.”

The FDA estimated costs from relabeling because of the proposed rule would range from $66 million to $154 million annually at a 2% discount rate over 10 years. Although reformulation is not required under the proposed rule, the FDA estimated reformulation costs would range from $125 million to $377 million annually at a 2% discount rate over 10 years.

“By proposing front-of-pack labeling in the United States, the FDA is taking an important step to make nutrition information clearer and more accessible, and to empower consumers to make informed choices for their health and the health of their families,” said Nancy Brown, chief executive officer of the American Heart Association. “For decades, the Nutrition Facts Label has been an essential tool to educate people across the country about the nutritional content of their food and drinks, but high rates of diet-related illnesses continue to show that additional actions are needed to address the confusion and barriers consumers face in evaluating and identifying better options.”

In response to the proposed rule, International Dairy Foods Association senior vice president of regulatory and scientific affairs Roberta Wagner said the FDA missed an opportunity to educate consumers about nutrients associated with leading health lives.

“It is critical that any front-of-package labeling scheme be balanced and provide consumers with the broad scope of nutritional information that fully reflects the calcium, protein, vitamin D, potassium and other essential nutrients dairy provides,” Wagner said. “By focusing solely on nutrients to limit, FDA’s proposed front-of-pack nutrition labeling rule would unfairly stigmatize a wide variety of nutrient-dense dairy products — such as milk, cheese and yogurt — despite extensive nutrition science showing their benefits for bone health, immune function, hydration, and reduced risks of type 2 diabetes and cardiovascular disease. We urge the FDA to reevaluate its labeling approach to support comprehensive and transparent communication about the health benefits of dairy.”