FDA proposes mandatory front-of-package labels for better health outcomes

The US FDA is stepping up efforts to address the obesity and diabetes crises in the US, focusing on front-of-package (FOP) nutrition labeling, sodium reduction and updated “healthy” food claims. The agency is also urging the food industry to provide healthier options.

The agency is concerned that ultra-processed foods (UPFs) contribute to poor nutrition and believes that FOP nutrition labeling can increase consumer awareness.

In a recent hearing before House and Senate Committees and Subcommittees, the agency’s commissioner for food and drugs, Robert M. Califf, M.D., and deputy commissioner for human foods, Jim Jones, testified on the FDA proposal for mandatory labels for diabetes and obesity on healthy F&B.

“This is an important time to testify before this committee on a growing and vitally urgent issue facing US citizens: chronic disease, including diet-related chronic disease. The food we eat is exacerbating the US’s tragic title for the lowest life expectancy among large, high-income countries,” reads the testimony.

According to the FDA, chronic diseases like heart disease, cancer and diabetes are responsible for the majority of disability and death in the US, driving US$4.5 trillion in healthcare costs annually. “Nearly everyone knows and cares for someone with a chronic disease — 6 in 10 US citizens have at least one, and 4 in 10 have two or more.”

Rural residents, members of racial and ethnic minorities and those with lower socioeconomic status are noted to have higher rates of diet-related chronic diseases.

The FDA believes the industry must play a role in “doing more to offer healthier foods; it is in everyone’s best interests for the US food supply to be a source of wellness.”

Nutrition investment against UPFs

According to the FDA, nutrition labeling is one way to educate consumers about the amounts of specific nutrients in foods, like saturated fat, sodium and added sugars, which, when consumed in excess, can raise the risk of diet-related illnesses.

The FDA believes the industry must play a role in doing more to offer healthier foods.While certain nutritious foods like whole grains, tofu, yogurt and infant formula may technically fall under the category of UPFs, the FDA emphasizes that most UPFs contribute to poor health due to their high levels of saturated fats, sodium and added sugars.

“The health impact of UPFs is at the forefront of many current discussions about nutrition. FDA agrees that the clear association between UPFs and poor health outcomes is cause for major concern,” reads the testimony.

However, researchers in the EU question whether adding processing levels to food labels can address consumer confusion about UPFs and their health impact. Experts also warn that processing levels are insufficient to determine a food’s healthiness, as research indicates that some UPF categories are not linked to increased health risks. 

“Later this month, FDA is convening a workshop with the National Institutes of Health, and a principal focus is to identify key priorities and critical next steps for research on UPFs to help accelerate higher-quality research. We are also aggressively taking policy steps where the evidence is clear.”

The FDA points to recent advancements and states that it is prepared to take the lead in enhancing nutrition in the US. On October 1, the FDA launched the biggest reorganization in the agency’s recent history, creating a Nutrition Center of Excellence as part of the new, unified Human Foods Program. 

“For every dollar we invest in nutrition, we see a return of US$119 in nutrition-related health benefits. Even relatively modest investments can still have broad public health impacts,” underlines the agency.

FOP proposal on horizon 

The FDA also suggests that FOP nutrition labeling complements the Nutrition Facts label to impact purchase-making decisions.

The FDA envisions FOP nutrition labels becoming as “iconic” as the Nutrition Facts label. “Publishing a proposed rule on FOP nutrition labeling is a priority for FDA,” the testimony states.

“As part of this effort, FDA built the scientific basis to inform our development of a proposed regulation to require an FOP nutrition label…We conducted two rounds of focus groups with US adult food shoppers and conducted an experimental research study with over 9,000 consumers from diverse populations to ensure that everyone, including those most at risk for diet-related diseases, was adequately represented,” the testimony reveals.

The FDA testimony states publishing a proposed rule on FOP nutrition labeling is a priority.“We look forward to being able to discuss the details of our research and our proposal with the committee and the public soon. We are confident it will reflect the research and what we have learned from consumers, academics, health advocates and the food industry, as well as many others.”

Promoting healthy food

The FDA reveals it is finalizing the definition of “healthy” nutrient content claims to match current nutrition science, which will be done in the “very near future.”

“Voluntary claims like ‘healthy’ on food labels can convey information to shoppers at a quick glance and help consumers identify foods that are the foundation of a healthy dietary pattern. FDA is also developing a ‘healthy’ symbol that would be a graphic representation of the claim and is engaging with interested parties to find ways to support use of the claim and future symbol,” the testimony reveals.

Further, the agency highlights its progress in reducing sodium in the food supply, which is seen as having the potential to be one of the top public health initiatives in a generation.

Since 2021, the FDA issued voluntary sodium reduction targets, and results have been encouraging, with 40% of targets achieved in 2022. Last August, it issued new targets to reduce average sodium intake by 20% from previous levels and is receiving public comments on the draft before finalizing them.

“Together, FOP nutrition labeling, the ‘healthy’ claim and symbol and helping to reduce sodium in foods work cohesively as part of a government-wide approach to better inform consumers, improve nutrition and reduce diet-related chronic diseases,” the testimony highlights.

The agency is also ramping up action due to rising concerns about additives, such as flavors or colors, which are also common in UPFs.

To address concerns over additives in UPFs, the FDA says it has established an office dedicated to post-market assessments, developing processes to reassess chemicals previously approved for food use.

“FDA recognizes that there is a clear nexus between our nutrition goals and chemical safety goals. And we will act when data demonstrates a chemical in food causes harm.”

Amid the FDA initiatives, the health landscape may shift further with the upcoming administration. President-elect Donald Trump’s choice for HHS Secretary, Robert F. Kennedy Jr., has proposed significant changes.

He has shared several plans for the department, aiming to “make America healthy again.” For example, he called for reforming the FDA and eliminating its nutrition department, banning food additives, removing UPFs from school lunches, making nutrition education mandatory in medical schools and systemic fixes in the food system instead of relying on anti-obesity drugs.