FDA’s proposal to mandate front-of-pack nutrition labeling that quantifies and qualifies the percent daily value of saturated fat, sodium and added sugar to help consumers more easily make informed dietary choices triggered frustrated outcry from industry trade groups and accolades from public health advocates.
Public health groups, including the American Heart Association, the Center for Science in the Public Interest and Health Eating Research lauded the proposed rule published yesterday as an empowering tool for consumers, an incentive for food companies to make healthier products and a want to reduce diet-related chronic diseases.
Industry trade groups, including the Consumer Brands Association, the Sugar Association and FMI – The Food Industry Association, however, argued that while they share FDA’s goal in reducing diet-related chronic disease they believe the suggested FOP changes will be expensive to implement, will not improve consumer understanding of overall dietary patterns and is based on outdated and “opaque” research.
The divided response could signal an acrimonious battle to come around what the final rule could include, which will unfold as a new presidential administration takes office and appoints new agency leaders who could influence the content and the course or timeline of the regulatory review process.
Front-of-pack ‘Nutrition Info’ box is minimalistic
In the front-of-pack nutrition information food labeling proposed rule, FDA argues a mandatory Nutrition Info box that details the percent daily value of saturated fat, sodium and added sugar per serving paired with “interpretive” language qualifying each amount as Low, Medium or High, would help consumers, including those with lower nutrition knowledge, “quickly and easily identify how foods can be part of a healthy diet.”
FDA considered several potential designs with different nutritional information. These included black-and-white and green-yellow-red designs similar to the existing Facts Up Front system created by industry trade groups. Two more minimalistic designs considered were reminiscent of the Nutrition Facts boxes on the back panel and called the amount of specific nutrients in a serving.
In the proposed rule, FDA decided on a black-and-white version of the box closer in style to the Nutrition Facts panel and to focus only on the three primary nutrients of concern. The proposed box would include the percent daily value of saturated fat, sodium and added sugars per serving as well as interpretive descriptions of High, Medium and Low to help consumers contextualize the numbers in relation to their overall diets.
The agency based its decision on a literature review, two focus group tests and a peer-reviewed experimental study that evaluated consumer reactions and responses to the different schemes.
The interpretive descriptions will be based on the Dietary Guidelines for Americans.
FDA’s case for front-of-pack labeling
The agency explained the FOP Nutrition Info box will complement the back-of-pack Nutrition Facts label, which it says many but not all consumers use and understand.
It explains that nearly 90% of US consumers report looking at the Nutrition Facts label, but fewer people look at the nutrients to limit (including sodium, saturated fat and added sugar) within the Nutrition Facts label. Likewise, men and consumers with lower education levels and household incomes are less likely to regularly use the Nutrition Facts label, according to FDA.
“Additional nutrition labeling that is interpretive and prominently displayed on the front of food packaging could help improve consumer awareness of nutrients to limit by providing a more accessible description of certain information contained in the Nutrition Facts label,” FDA said.
Independent research conducted by the International Food Information Council (IFIC) confirmed that interpretive language in the FOP labeling scheme “may help consumers more correctly identify the ‘least healthy’ option when comparing products,” said IFIC Senior Director of Research & Consumer Insights Kris Sollid.
The ability to more easily understand how a particular food fits into consumers’ daily diets could help them improve their overall dietary pattern which in turn could reduce the prevalence of diet-related chronic disease, FDA argues in the rule. It notes that currently one in 10 Americans have diabetes and nearly half of American adults have high blood pressure, which is associated with heart disease and strokes. Both are influenced by several factors, including unhealthy dietary patterns.
Discord about cutting calories from Nutrition Info spans stakeholders
Missing from the proposed FOP Nutrition Info box is calories – one of the few pieces of information that both industry stakeholders and public health advocates argued should be included.
Calories were included in potential schemes tested by FDA focus groups in 2022, but were dropped in later versions – a change that FMI and CBA argued against during a public meeting in the fall of 2023.
Their exclusion in the proposed rule also rankled the Sugar Association with the group’s President and CEO Courtney Gaine arguing in a statement that the Sugar Association supports transparency, “but this draft label offers only the illusion of transparency” in part because it does not include total calories.
Healthy Eating Research and CSPI also expressed disappointment that calories were missing from the proposed Nutrition Info box.
“I personally would like to see calories on the label to help people,” many of whom eat too many, said Healthy Eating Research Program Director Mary Story. She explained that she was on a committee tasked by Congress in 2009 to make FOP recommendations, which included having calories on the front of pack.
She hypothesized FDA cut calories from its design because it wanted a label that was not “too cluttered with too many words or numbers,” and because brands can still include callouts for calories on the front of pack under existing regulations.
Rancor surrounds other missing nutritional information
FDA’s decision to leave out of the proposed Nutrition Info box other key nutritional information drew sharp criticism from several trade groups, many of which helped create the voluntary Facts Up Front front-of-pack initiative – which was the basis for one of the FOP design schemes FDA rejected.
“Consumer transparency is a core value of the makers of America’s trusted brands, as demonstrated by industry investment in voluntary labeling disclosure programs already in the marketplace, such as Facts up Front and SmartLabel,” said Sarah Gallo, senior vice president or product policy at Consumer Brands Association.
But, she suggested, FDA’s proposed rule for front of package nutrition labeling does not appear to share the same level of dedication to transparency.
“The FDA’s proposed rule for front of package nutrition labeling appears to be based upon opaque methodology and disregard of industry input and collaboration. The proposed rule does not include the latest research, demonstrating that data-driven labels that reinforce important nutrient information, including calories, nutrients to encourage, and nutrients to limit are most effective in helping consumers make the healthiest choice,” she said.
She added: “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.”
FMI - The Food Industry Association, which helped co-create the Facts Up Front program, agreed “it is the best suited scheme with clear facts to help consumers make informed choices based on their personal needs” and one with many consumers are already familiar given it appears on more than 200,000 products currently, said FMI Chief Public Policy Officer Jennifer Hatcher.
“We are disappointed that it was not selected as part of FDA’s proposed rule,” she added.
Hatcher also argued focusing only on three nutrients is “overly simplistic and will not help educate consumers on how to improve their overall dietary pattern.”
Could focusing on added sugars lead to unintended consequences?
FDA’s decision to included added sugars in the proposed Nutrition Info box goes against warnings from the Rudd Center for Food Policy & Health and others that doing so could have “unintended consequences,” including an increased reliance on non-nutritive sweeteners so a product could claim to be low or medium in added sugars.
“By singling out added sugars, FDA is once again knowingly incentivizing proliferation of artificial sweeteners that hide behind chemical names Americans do not recognize - including in food for children,” Gaine said in a statement.
She added that while the Sugar Association supports limiting added sugars to less than 10% of total calories, “this should not be achieved by misleading consumers or manipulating the food supply with more additives. Most Americans prefer to avoid low- and no-calorie sweeteners in food, and health organizations have repeatedly raised concerns about their widespread use. At some point, some agency needs to acknowledge that we do not have a good grasp on how pervasive these sweeteners have become in our food supply, unbeknownst to most Americans.”
Her sentiments echo concerns raised by the Rudd Center for Food Policy & Health at a public meeting hosted by The Reagan-Udall Foundation for FDA in November 2023.
Center for Science in the Public Interest’s (CSPI) Senior Policy Scientist Eva Greenthal agreed this is a “really valid concern” and something that has happened in countries with nutrient warnings for sugar, but she adds it can be mitigated several ways.
“First off, not all non-nutritive sweeteners are dangerous, and the ones that are need to be removed from our food supply entirely. Aspartame should not be allowed in our food. That needs to be dealt with simultaneously and separately,” she said.
Another option is to mandate additional front-of-pack disclosures about non-nutritive sweeteners used in products, she said. However, she acknowledged, this could require Congressional authority because non-nutritive sweeteners are ingredients rather than nutrients, and FDA authority for front of pack labeling is focused on nutrients.
An ‘important step’ despite shortcomings
FDA’s proposed Nutrition Info box also falls short of CSPI’s preferences, but Greenthal stressed the advocacy group’s overall excitement to see the proposal and its potential to help consumers select and encourage companies to make healthier products.
“We have been working towards this for a very long time,” Greenthal explained, referencing two Citizen Petitions filed by CSPI to FDA in 2006 and 2022 calling for mandatory, interpretive and nutrient-specific front-of-pack nutrition labeling.
“Front-of-pack labeling has great potential to help people make healthier choices and cut back on salt, sugar and saturated fat. We are excited to see this proposal from FDA, even though we would have preferred a slightly different format,” she said.
She explained CSPI wanted to see a “high in” or nutrient warning format for front-of-pack nutrition labeling, and that the proposed scheme was its “second choice.”
Nonetheless, she said, “it is a win for public health and really big step forward.”
The American Heart Association agreed, with CEO Nancy Brown saying in a statement that “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.”
She added, “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.”
Healthy Eating Research’s Story agrees the Nutrition Fact label includes essential and helpful information, but she also suggests its impact may be limited and to effectively reduce diet-related chronic disease consumers need additional information that is easy to find and understand.
“The status quo right now is not working. The Nutrition Facts panel is important and provides details, but it does not work well,” she explained.
“Right now the information is on the back of the pack and it is all numbers. It is really hard for people when they are in the grocery, especially if they have young children or are in a hurry, to know what foods are high in nutrients of concern,” she said.
By moving this information to the front of packages and adding interpretive language, she argues, consumers are more likely to make the healthy choice more easily and more quickly.
Comments and compliance
FDA proposes companies with $10 million or more in annual food sales comply with the proposed rule within three years of its finalization and smaller companies with less than $10 million in annual food sales comply within four years.
The agency also is accepting comments on the proposal submitted electronically on regulations.gov with the docket number FDA-2024-N-2910 through May 16.
