FDA’s Front-of-Pack Labeling in LimboFDA’s Front-of-Pack Labeling in Limbo

The long wait for a proposed rule from the US Food and Drug Administration (FDA) on mandatory front-of-package (FOP) nutrition labeling continues as the United States prepares for a new presidential administration.

FOP labeling came under scrutiny at a recent Senate hearing on what FDA is doing to reduce diabetes and obesity, with a focus on the food and beverage industry.

FDA Commissioner Robert M. Califf and Deputy Commissioner for Human Foods Jim Jones testified at the hearing held by the Senate Committee on Health, Education, Labor, and Pensions (HELP) in Washington, D.C., on December 5, 2024.

HELP Committee chairman Senator Bernie Sanders highlighted the need for FOP nutrition labeling that would help consumers better understand the levels of sodium, saturated fat, and/or added sugars in packaged foods and beverages — and through that knowledge make healthier food and drink choices.

Sanders expressed frustration with FDA, citing several deadlines the agency had missed for making public a proposed rule on FOP nutrition labeling.

Referencing the diabetes and obesity epidemics, Sanders said, “From where I’m standing … FDA has not responded in any way with the urgency of the crisis. How long does it take to put a bloody label on a product?”

Related:Think Your Food Packaging Complies with FDA? Maybe Now. Maybe Not Later.

Califf, who will step down from his FDA post this month, cited legislative and political issues as contributing to the delays.

FDA’s proposed rule not yet public.

FDA did submit a proposed FOP labeling rule to the White House’s Office of Management and Budget (OMB) two weeks before the hearing. The proposed rule must be reviewed by OMB before publication in the Federal Register and public comment.

The OMB submission states: “This proposed rule, if finalized, would require the front of food labels to display certain nutrition information to help consumers, including those who are busy and those with lower nutrition knowledge, make more informed dietary choices” and eat more healthily, ultimately reducing chronic disease and advancing health equity in the United States.

In written testimony prepared for the hearing, Califf and Jones said FDA’s FOP nutrition label “could complement the Nutrition Facts label by displaying certain nutrition information right on the front of the food package, so it is immediately visible at the point of decision making.”

They added, “It also has the potential to be as iconic as the Nutrition Facts label. For these reasons, publishing a proposed rule on FOP nutrition labeling is a priority for FDA.”

The agency’s FOP labeling research activities, which were instrumental in developing the proposed rule, included consumer focus groups in 2022 and 2023 and a survey of 9,200 US adults in 2023.

The research included tests of FOP layouts, aka schemes, including some with red-yellow-green color coding to indicate high-medium-low levels of sodium, saturated fat, and/or added sugars (as shown in the below table):

“I think everyone is in a wait-and-see mode for now, especially as we can expect a new FDA commissioner in the coming months,” says David Joy, a food and drug lawyer with Keller and Heckman who previously worked at FDA. “There’s been lots of talk about front-of-pack labeling, including at a public meeting organized by FDA. But FDA has yet to issue a proposed rule.”

Joy adds, “Typically, it takes several years after a proposed rule is issued before we see a final rule. And then there would be a future compliance deadline. So this is not something that’s right around the corner. … FDA is not under a statutory mandate to issue an FOP nutrition labeling regulation. It’s possible the incoming administration will decide we don’t need FOP nutrition labeling after all. It’s early to know.”

Facts up Front label stays the course.

The food and beverage industry is unfazed by the uncertain fate of mandatory FOP nutrition labeling, with the Consumer Brands Association (formerly the Grocery Manufacturers Association) continuing to support the industry-led Facts up Front label that launched in 2011.

“The industry has worked in partnership with the FDA for over a decade to improve nutrition facts for consumers, including recent efforts to solidify updated Facts up Front guidelines,” says Sarah Gallo, senior vice president of product policy at the Consumer Brands Association.

Facts up Front is a voluntary front-of-pack labeling scheme for nutritional information drawn from the Nutrition Facts panel. The Facts up Front data include calories per serving together with grams/milligrams and percent daily value of saturated fat, added sugars, and sodium.

“To provide the most consumer-friendly labeling, the FDA should continue to rely on collaborative efforts with industry and data-driven research,” Gallo says. “This requires a holistic approach, which should involve important nutrient information, including both nutrients to encourage and nutrients to limit.”