The Food and Drug Administration has proposed its long-awaited front-of-pack labeling rule, featuring a black-and-white nutrition box that lists information on saturated fat, sodium and added sugars.
The labeling guidelines are a key piece of the Biden administration’s 2022 National Strategy on Hunger, Nutrition and Health. Since the initiative was unveiled, FDA has tested a number of potential schemes, with input from industry stakeholders.
FDA’s proposed scheme is similar to the Nutrition Facts box found on most food products, but the proposal only highlights saturated fat, sodium and added sugar. It also includes the serving amount, percent of daily value and if that proportion is high, low or medium.
If finalized, the proposal would require most foods display this label on the “principal display panel.” It would also revise the low sodium and low saturated fat nutrient content claim definition.
The ranges for the daily value descriptions are 5% or less for “Low,” 6% to 19% for “Med” and 20% or more for “High.” This follows a general FDA framework that has been in place for decades, and is used by health agencies, academic institutions, medical and public health groups and media outlets.
FDA said in its proposal that including the high, med, and low descriptions puts the percent daily value into context, and supplements the existing Nutrition Facts label to help consumers more quickly identify foods that meet their health needs.
“This Nutrition Info box would address our public health goal of providing consumers with interpretive nutrition information that can help them quickly and easily identify, at the point of decision-making, how foods can be part of a healthy diet—including by allowing them to compare nutrition information across foods,” according to the proposal.
Nancy Brown, CEO of the American Heart Association, said the front-of-pack labeling proposal is an important step in making nutrition information more accessible.
“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,” Brown said in a statement.
Peter Lurie, president of the Center for Science in the Public Interest, celebrated the labeling proposal as a "vast improvement on the status quo." In a statement, he pointed out that U.S. adults are overconsuming the recommended levels of sodium, added sugars and saturated fat per day.
"This long overdue proposal has potential to usher in healthier consumer purchases, incentivize companies to produce healthier products, and stem the rising tide of preventable conditions like type 2 diabetes and heart disease," Lurie wrote in a statement.
Still, Lurie noted studies that show "High In" labels rather than the traffic light scheme FDA proposed are more successful in reducing purchases of foods high in sodium, sugar and saturated fat.
Mary Story, director of Healthy Eating Research, echoed Lurie's comments and said by putting nutrient information in the FOP labeling is one of the most important ways the country can reduce diet-related chronic diseases. She also celebrated that the label is simple and mandatory for industry.
The proposed rule is not intended for foods marketed to children under 4 years old, but covers a large swath of foods marketed for the general public.
Under the proposal, businesses with $10 million or more in annual food sales would have three years after the final rule’s effective date to be in compliance. Businesses with less than $10 million in sales would have an additional year.
FDA’s primary cost estimate for relabelling under the rule is $105 million per year. However, the agency also notes that some industries may reformulate products to maintain nutritional content claims. This process could cost an estimated $227 million per year.
In total, the agency’s primary estimate for both relabeling and reformulation reaches $333 million.
The nutrition box differs slightly from voluntary industry initiatives like “Facts up Front” (FUF). These labels include information on calories, saturated fat, sodium and added sugars, but are presented in a different format. It also does not include the low, med or high descriptions the FDA proposes.
FDA considered including a calorie disclosure, but determined it would not provide consumers with new, interpretive information. However, the proposal would not change existing regulations that allow food manufacturers to voluntarily include calorie information.
The Food Industry Association (FMI) said it was disappointed FDA did not follow a scheme similar to FUF given consumers are already familiar with those icons.
The group also criticized the proposal as "overly simplistic" and said it would not help educate consumers on how to improve overall diets.
Roberta Wagner, senior vice president of regulatory and scientific affairs at the International Dairy Foods Association, echoed these concerns. In a statement, she said by solely focusing on nutrients to limit, the proposed labeling could stigmatize nutrient-dense dairy products like milk, cheese and yogurt.
“With this proposed rule, the FDA has missed an important opportunity to educate consumers about the nutrients they need to live healthy lives," Wagner said. "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."
The Sugar Association also opposed the proposal out of concern the lack of requirements for calories and industrial additives could backfire and incentivize the use of artificial sweeteners.
"Most Americans prefer to avoid low- and no-calorie sweeteners in food, and health organizations have repeatedly raised concerns about their widespread use," said Courtney Gaine, president and CEO of Sugar Association. "At some point, some agency needs to acknowledge that we don’t have a good grasp on how pervasive these sweeteners have become in our food supply, unbeknownst to most Americans.”
Additionally, FMI said it was concerned the new labeling scheme would be required in the upper third of the principal display. The group said could require a redesign of most packaging labels and could displace other important labeling.
Consumer Brands Association also pushed back against the proposal, and said it appears to be based "upon opaque methodology and disregard of industry input and collaboration."
"For over a decade, the industry’s Facts up Front initiative has provided key nutritional information on the front of packaging, facilitating quick assessment by consumers," said Sarah Gallo, senior vice president of product policy at CBA. "As the country’s largest domestic manufacturing employer, the industry looks forward to working with the incoming Trump administration to support public health, build consumer trust and promote consumer choice.”
Lurie at CSPI said in his statement that the FUF labels do not show if a product is high in a nutrient, don't affect consumer purchases and "mainly served to drag out this process for more than a decade."
Consumer groups had pushed for the proposed labels to include simple indicators like color coding to best help shoppers navigate labels. Food manufacturers, on the other hand, supported the black-and-white format FDA settled on in the proposal.
Story with Healthy Eating Research said she would still recommend FDA also require colors for the "Low, Med, High" description and suggested that including the percent daily value number could clutter up and confuse consumers.
"I think that this whole area of getting Americans to eat healthier is imperative," Story said. "Our American diet is killing people. So hopefully this would be bipartisan and have the support of both Democrats and Republicans to do what's really needed to reduce diet-related chronic diseases. We just can't wait."
The proposal was expected ahead of the election, Agri-Pulse reported in August, but the agency's extensive outreach may have delayed it.
Comments on the proposal are due by May 16.
It's not clear what action the Trump administration will take on the proposal. Robert F. Kennedy Jr., who has been nominated to be secretary of the Department of Health and Human Services, and his allies in the Make America Healthy Again movement have supported more “healthy” offerings and criticized ultraprocessed foods. FDA is part of HHS.
Some public health groups are hopeful that Kennedy will fulfill promises to stand up to industry groups and support front-of-pack labeling.
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