FDA Proposes ‘Nutrition Info’ Label for Front of Food Packages

The FDA issued a proposed rule Tuesday that would require food manufacturers to put “Nutrition Info” labels on the front of their packages stating whether the food inside contains a high, medium, or low level of sodium, saturated fat, and added sugars.

“Chronic diseases — including heart disease, cancer, and diabetes — are the leading cause of disability and death in the U.S., with 60% of Americans having at least one chronic disease,” Rebecca Buckner, PhD, associate deputy director for human food policy at the FDA’s Human Food Program, said on a call with reporters. “A large body of research indicates that a major contributor to this problem is excess consumption of saturated fat, sodium, and added sugar, and yet the vast majority of Americans exceed current recommended limits for all these nutrients.”

“There is also a proliferation of foods in the food supply that are commonly considered ultraprocessed, which often contain high levels of saturated fat, sodium, and added sugar,” she continued. “The proposed ‘Nutrition Info’ box is focused on providing accessible information to help consumers quickly and easily identify how [various] foods can be part of a healthy diet.”

For labeling purposes, a food would be defined as having a “high” level of saturated fat, sodium, or added sugars if the amount was equal to or greater than 20% of that nutrient’s recommended daily value (RDV). A “medium” level would be between 5% and 20% of the RDV, and a “low” level would be 5% or less of the RDV.

The rule would become effective in 3 years for food manufacturers with $10 million or more in food sales, and in 4 years for manufacturers with less than $10 million in sales, explained Robin McKinnon, PhD, acting director of the Nutrition Center of Excellence at the Human Food Program. The rule incorporates results from a 2023 FDA study of nearly 10,000 adults, which looked at their responses to different types of front-of-package labels, she said, adding that the study sample “mirrored the U.S. population on age, sex, education, race, and ethnicity to ensure those most at risk for diet-related diseases were adequately represented.”

What about listing calorie information on the front of the package? “We did hear interest in including calories” from manufacturers, McKinnon told MedPage Today during a question-and-answer session. “We did not include calories in the proposal as a mandatory requirement … However, in the proposal, we have provided examples of how a manufacturer could include that information” alongside the “Nutrition Info” box.

One issue with the proposed rule is what will become of it under a Trump administration. Generally speaking, when a new president takes the oath of office, the chief of staff at the FDA — as well as those at other agencies — instructs department employees to halt work on regulations for 60 days, so the administration can decide which rules they want to pursue. This proposed rule does appear to align with the stated interest of Robert F. Kennedy Jr. — Trump’s pick to head HHS — for reducing Americans’ consumption of ultraprocessed foods.

The Center for Science in the Public Interest (CSPI), a consumer advocacy group, applauded the FDA’s move. “The incoming administration has the opportunity to finalize this important rulemaking and follow through on commitments to stand up to Big Food,” CSPI President Peter Lurie, MD, MPH, said in a statement. “We hope to see FDA continue to push forward with evidence-based public health protections, including mandatory front-of-package nutrition labeling.”

CSPI did have one quibble with the proposed label, the type of which is sometimes called “traffic light” labeling and is often accompanied by the colors red, yellow, and green for high, medium, and low nutrient levels, respectively. “The scientific literature generally favors nutrient warnings (i.e., ‘High In’ labels) over ‘traffic light’ labels for reducing selection or purchasing of foods high in sodium, sugar, and saturated fat,” he said. “Either, however, is a vast improvement on the status quo.”

The proposed rule will be open for comment through May 16.

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