The Food and Drug Administration released on Tuesday its long-awaited proposal to require food manufacturers to put some nutrition facts on the front of packages, in a bid to nudge Americans and food companies towards healthier diets in line with similar pushes in other countries.

FDA’s new “nutrition info box” focuses on telling people whether levels of saturated fat, sodium and added sugar are “high” or “medium” or “low” as well as the percentage for each serving.

The proposal will be open for public comment for 120 days. It will be up to the incoming Trump administration to decide if and how to finalize the rule. 

After that, the FDA says that large food companies earning more than $10 million annually will have three years to comply with the rule. Smaller food brands will have an additional year.

Up to $154 million will be spent by the food industry over the next decade to relabel their products with the new box, the FDA estimates. 

The agency also estimates many food brands may also spend millions more dollars to try to rework their products, changing their recipes to avoid being called out as having too much of an unhealthy nutrient.

“We assume there may be manufacturers who would want to reformulate to maybe move from the high category into the medium category, or the medium category into the low category,” Rebecca Buckner, the associate deputy director for human food policy at the FDA, told reporters on Tuesday.

Robert F. Kennedy Jr., President-elect Trump’s pick to head the federal department that oversees the FDA, has been sharply critical of federal nutrition officials for not doing enough to help Americans eat healthier diets and crack down on the food industry. 

Kennedy has not specifically addressed the proposal. A spokesperson for Kennedy did not respond to a request for comment. 

Why only saturated fat, sodium and added sugars?

The FDA said it will require the box to only call out saturated fat, sodium and added sugars. Food manufacturers would not be able to put other nutrients inside the FDA’s information box. 

They cited research showing that “simpler schemes are easier for consumers to understand” for narrowing the box down to just these three worrying unhealthy nutrients. 

Designs they tested with focus groups that included nutrients Americans need more of, like fiber and calcium, confused participants. 

The FDA said it is still weighing whether calories should be incorporated into the label and acknowledged that some food brands are already voluntarily listing the information on the front.

What determines “high,” “medium” and “low” levels?

FDA officials said Tuesday that levels of saturated fat, sodium or added sugars will be deemed as “high” if they are above 20% in the daily value, a measurement of how much Americans eat each day in the “reference” diet. Medium was set at between 6% and 19% of the daily value. And low is 5% and below.

Agency officials have used these benchmarks for “high” and “low” for decades, dating back to the formulation of the nutrition facts label back in the 1990s. 

At the time, officials decided against including the “interpretive descriptions” in the nutrition facts label. But the agency said recent data shows many Americans do not understand the percentages.

“It’s really based on longstanding usage,” McKinnon said.

What will it look like?

The FDA says food makers will be required to put the labels “somewhere in the top third” of the front of the box.

The box also uses the same Helvetica font used in the nutrition facts on the back of the package and must comply with a range of more detailed rules to avoid it from being too small or obscured by other designs on the package.

Some other design decisions were also abandoned during the focus group testing process, the FDA said. 

For example, previous mockups using the colors red, yellow and green to call out different levels did not make a statistically significant difference in helping people interpret the box.

Editor’s note: A previous version of this article misstated the number of days the public comment period is open. It is 120 days.

From the four food groups to the Food Pyramid, the U.S. government has long offered guidance to Americans hoping to eat a healthier diet. But there’s growing scientific consensus that when it comes to eating healthy, all of us respond to foods differently. And to prove it, the National Institutes of Health has embarked on the most ambitious nutrition study ever, hoping to finally provide Americans a personalized answer to the question: “What should I eat?” Correspondent Lee Cowan reports.

It’s been said the best meals come from the heart, not from a recipe book. But at this USDA kitchen, there’s no pinch of this, dash of that, no dollops or smidgens of anything. Here, nutritionists in white coats painstakingly measure every single ingredient, down to the tenth of a gram.

Sheryn Stover is expected to eat every crumb of her pizza; any tiny morsels she does miss go back to the kitchen, where they’re scrutinized like evidence of some dietary crime.

Stover (or participant #8180, as she’s known) is one of some 10,000 volunteers enrolled in a $170 million nutrition study run by the National Institutes of Health. “At 78, not many people get to do studies that are going to affect a great amount of people, and I thought this was a great opportunity to do that,” she said.

It’s called the Nutrition for Precision Health Study. “When I tell people about the study, the reaction usually is, ‘Oh, that’s so cool, can I do it?'” said coordinator Holly Nicastro.

She explained just what “precise” precisely means: “Precision nutrition means tailoring nutrition or dietary guidance to the individual.”

The government has long offered guidelines to help us eat better. In the 1940s we had the “Basic 7.” In the ’50s, the “Basic 4.” We’ve had the “Food Wheel,” the “Food Pyramid,” and currently, “My Plate.”

They’re all well-intentioned, except they’re all based on averages – what works best for most people, most of the time. But according to Nicastro, there is no one best way to eat. “We know from virtually every nutrition study ever conducted, we have inner individual variability,” she said. “That means we have some people that are going to respond, and some people that aren’t. There’s no one-size-fits-all.”

The study’s participants, like Stover, are all being drawn from another NIH study program called All Of Us, a massive undertaking to create a database of at least a million people who are volunteering everything from their electronic health records to their DNA.  It was from that All of Us research that Stover discovered she has the gene that makes some foods taste bitter, which could explain why she ate more of one kind of food than another.

Professor Sai Das, who oversees the study at Tufts University, says the goal of precision nutrition is to drill down even deeper into those individual differences. “We’re moving away from just saying everybody go do this, to being able to say, ‘Okay, if you have X, Y and Z characteristics, then you’re more likely to respond to a diet, and somebody else that has A, B and C characteristics will be responding to the diet differently,'” Das said.

It’s a big commitment for Stover, who is one of 150 people being paid to live at a handful of test sites around the country for six weeks – two weeks at a time. It’s so precise she can’t even go for a walk without a dietary chaperone. “Well, you could stop and buy candy … God forbid, you can’t do that!” she laughed.

While she’s here, everything from her resting metabolic rate, her body fat percentage, her bone mineral content, even the microbes in her gut (digested by a machine that essentially is a smart toilet paper reading device) are being analyzed for how hers may differ from someone else’s. 

Nicastro said, “We really think that what’s going on in your poop is going to tell us a lot of information about your health and how you respond to food.”  

Stover says she doesn’t mind, except for the odd sounds the machine makes. While she is a live-in participant, thousands of others are participating from their homes, where electronic wearables track all kinds of health data, including special glasses that record everything they eat, activated when someone starts chewing. Artificial intelligence can then be used to determine not only which foods the person is eating, but how many calories are consumed.

This study is expected to be wrapped up by 2027, and because of it, we may indeed know not only to eat more fruits and vegetables, but what combination of foods is really best for us.  The question that even Holly Nicastro can’t answer is, will we listen? “You can lead a horse to water; you can’t make them drink,” she said. “We can tailor the interventions all day. But one hypothesis I have is that if the guidance is tailored to the individual, it’s going to make that individual more likely to follow it, because this is for me, this was designed for me.”

      
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Story produced by Mark Hudspeth. Editor: Ed Givnish. 

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