Labeling

Based on current front-of-package labeling, only 9% of people were able to identify the healthiest choice among six varieties of cereal bars in a study of 2,000 U.S. consumers done by research platform Attest. More consumers — a total of 13% — chose the least nutritious bar as the healthiest. 

Six in 10 consumers say they look for food and beverages to support their overall health when they shop, the study found. But 46% said they worry that the wellness-focused products in stores aren't actually healthy. Just over half of consumers said they want to see clear nutrition labeling on the front of products, and said that would be the top factor that would increase their trust in wellness-targeted offerings.  

While unbiased statements about health and wellness of food products are top concerns for consumers, there has not been much movement toward establishing them in the United States. Front-of-package nutritional labeling has not been required, and issuing a federally regulated definition of "healthy" has been pending at the FDA since 2016.

After two years of lockdowns related to the pandemic, personal choices to bolster health and wellness are becoming more important to many Americans. Nearly half of consumers in the Attest study said they want food to offer them better overall health and well-being.

But even though there are many guidelines in place for how food can be labeled, it's very easy for manufacturers to use front-of-pack product terminology that isn't untrue, but may be a bit misleading. The 1990s-era standards for labeling products as "healthy" allow products like pudding cups, sugary cereals and toaster pastries to bear the label — but not items that have naturally high fat content, like nuts or avocados.

Companies can also call out the amount of different nutrients in their products — including protein or whole grains — on the front of their packages. However, manufacturers don't have to also call out the amount of potentially less desirable ingredients, like sugars, sweeteners, sodium or saturated fats. Attest found that this kind of potentially selective attribute labeling — "whole grains," "naturally flavored" and "100 calories" — had the biggest sway in leading consumers to make incorrect health-related choices.

In the recent past, there have been several efforts to revamp food labeling to bring more clarity to consumers about the nutritional value of the products they are buying. While the Nutrition Facts panel was officially revamped in 2016 and changes were made by 2020, those shifts haven't necessarily impacted the way consumers choose food. Although the new panel reflects common serving sizes, makes total calories easier to see and notice, breaks out added sugars and adds new nutrients to the chart, it is still a back-of-pack chart. And consumers must read and decipher what the information means on their own.

Redefining label claims — including "healthy" and "natural" — have long been on FDA's docket, though not much progress has been made. In 2017, there was a public hearing on defining "healthy." The USDA has come out with new parameters for the term, but there has been no publicly known progress from the FDA. In terms of "natural," FDA put out a press release trying to explain natural and artificial flavors in 2016, which some thought could be a precursor to an official action to set a definition. Nothing further has come out of the department since then.

The Consumer Brands Association and Food Industry Association (FMI) have been leading the voluntary Facts Up Front initiative, in which manufacturers put key information from the Nutrition Facts panel on the front of their packages, in order to increase transparency for consumers. This labeling regime has not been universally adopted, but studies have shown front-of-pack labeling is effective in both driving manufacturers to make products more nutritious, and helping consumers make better choices.

A bill proposed in Congress last year would mandate several of these labeling changes, prohibiting labels from improperly implying a high fruit, vegetable or yogurt content; requiring detailed information about artificial additives; adding nutritional parameters to define "healthy"; and requiring the FDA to define "natural." However, the future of the bill is uncertain. Rep. Frank Pallone Jr. and Sen. Richard Blumenthal, the bill's primary sponsors, have been proposing similar legislation since 2013. It's never had a hearing in either the House of Representatives or the Senate.

The FDA will conduct consumer studies to find a regulated, voluntary front-of-package symbol that shows whether a product is "healthy." In its Federal Register announcement about the studies, FDA said this symbol will help consumers easily determine if a product has the nutritional content represented by the term's definition.

There will be two studies: an online survey of about 2,000 adult consumers focusing on clarity, relevance and appeal of several symbols, and an online study of about 5,000 adults testing their reactions and understanding of what a "healthy" symbol means on package mock-ups.

"Healthy" was first defined by the federal government as a regulated term in the 1990s, but there has been movement toward revamping that definition to comply with current nutritional standards and eating habits. Redefining the term has been pending at the FDA since 2016.

While this announcement does not herald the long-awaited new definition of "healthy," it shows a bit of progress toward it. The FDA notes that when this study is completed and a front-of-package "healthy" symbol is approved, that symbol would represent whatever the agency has defined as nutritional requirements for that term. However, it doesn't make much sense to put the time and effort into coming up with a new voluntary labeling scheme for an outdated definition — under which a low-fat chocolate pudding cup and frosted toaster pastry are "healthy," but almonds, avocados and salmon are not.

The FDA first put out a proposal for this research last May and collected comments about the undertaking. Many comments were supportive of the idea, with suggestions on modifications to the process or timing, and some recommending that the term be redefined first. The initial proposal in the Federal Register also contains a variety of potential symbols, all of which contain the text "FDA Healthy," showing an unambiguous source of the claim.

The federal government's aim with this new front-of-pack symbol is to clearly communicate when a product has a high nutritional value, giving consumers better tools to make informed decisions on food and drink. Research has shown that current front-of-package information is confusing to consumers. A recent study done by Attest showed that only 9% of people were able to identify the healthiest choice among six varieties of cereal bars when they were shown only package fronts. In fact, more consumers — a total of 13% — chose the least nutritious bar as the healthiest. Attest found that consumers were tripped up by true — but potentially misleading — claims on package fronts that spoke to other product attributes, including "whole grains," "naturally flavored" and "100 calories."

Attest's study found that more than half of consumers want to see clear nutritional labeling on the front of packages, and having that information there would be the top factor to increase their trust in wellness-targeted food products.

There are other movements to get information on the front of packages. The Consumer Brands Association and Food Industry Association (FMI) have worked together on the voluntary Facts Up Front initiative, intended to increase transparency for consumers. Facts Up Front has not been universally adopted, but studies have shown front-of-pack labeling is effective in both driving manufacturers to make products more nutritious and helping consumers make better choices.

The new FDA Healthy symbol would not be required, but it may be an effective tool for manufacturers wanting to tout their products' nutritional quality. A claim endorsed by the FDA has a lot more weight than the word "healthy" on a package front on its own. Considering the research on front-of-pack labeling, it seems there would be no reason why a qualified brand would opt not to use this kind of symbol on its products.

It's unclear how long it will take for this research to be conducted and tabulated, but there will be time in the interim period for the FDA to release its updated "healthy" definitions. After all, it's been more than five years since comments were collected on a new definition, both through Regulations.gov and a public hearing. Given the time and expense for products to make any sort of packaging changes, though, it behooves the FDA to have both done at the same time.

As of January 2022, most food products sold in the United States that are made with ingredients with detectable genetically modified DNA need to identify that on their labels. And though GMO labeling has been a hot topic of discussion for years, a new study indicates that there may not be much new consumer reaction to the required on-package disclosures. 

The study, worked on by Cornell University faculty members Aaron Adalja and Jura Liaukonyte, examined sales data from cereal products in Vermont after the state enacted its own GMO labeling law. The short-lived state law went into effect in July 2016 and was invalidated at the end of that year by the federal labeling law. Researchers' findings showed that consumers' purchase rate of products made with GMOs didn't really change once the labeling law took effect.

That doesn't mean that GMO labeling has no impact on consumer sentiment and purchase habits, though. Adalja and Liaukonyte also looked at Google searches in seven states that considered their own labeling laws, and found a uptick in interest in GMO information and the Non-GMO Project — an independent nonprofit group that has a stringent verification program — due to increased public discussion around the issue. Purchase data in Vermont showed a slight uptick in purchases of Non-GMO Project Verified products as there were legislative discussions about GMOs. Those buying trends stayed fairly stable after the issue left the news.

"Any changes in behavior that we observed were facilitated by the rulemaking process and the existence of Non-GMO [Project] labels that were already on the market, had been on the market for the last decade," Adalja said. "A lot of consumers already made changes in their behavior before the law was ever passed."

Contrary to previous studies that indicated the mandatory labels for products made with bioengineered food would herald big swings in consumer preferences and buying, this new study shows a more muted effect. 

It also shows that the most impactful labeling to consumers is not the mandatory disclosure that a product was made with bioengineered ingredients, but the voluntary certification from the Non-GMO Project, Liaukonyte said.

"For the people who care about this attribute — GMO versus non-GMO — they have the information on the shelves already to figure out which products are GMO and which products are non-GMO," Liaukonyte said. "And for the people who do not care about it, this [mandatory] label is unlikely to change their behavior."

Awareness equals behavior changes

Both Adalja and Liaukonyte were interested in taking a look at actual shopper and web search data around GMO labeling after hearing the debate about it in a handful of states and Congress. Many of the studies about the impact of GMO labeling have been done in lab settings — showing consumers potential product packages and asking their preferences. 

"In the lab we're always testing kind of in isolation, right?" Liaukonyte said. " ...But what was very different in the field this time is the coexistence of all of these other signals in the marketplace that are out there. You have the GMO labeling, you have the non-GMO labeling, you have all of the other things happening."

Largely thanks to the efforts of the Non-GMO Project, which has offered its distinctive butterfly certification since 2010, there is a heightened awareness of GMO products and labeling. On the other side of that coin, very few products disclosed on their packaging that they used ingredients that are products of genetic modification or bioengineering until it became required.

When Vermont's GMO labeling law was first introduced in 2013, however, several cereal manufacturers began pursuing Non-GMO Project verification for both existing and new products. After the law passed in 2014 and just before it was set to go into effect, researchers found an uptick in new Non-GMO Project certification. The largest number of certified products came to stores in January 2016, months before the Vermont law was to take effect. According to the paper, at that time the average number of non-GMO products per grocery store grew by 29.5% and the number of stores that had at least one non-GMO product increased by 39%.

Researchers also found that the market share of both GMO and non-GMO products in Vermont stayed steady throughout 2016 at about 75% and 12%, respectively.

What did motivate consumers to change behavior was news about GMO food. In states when GMO labeling was discussed by their state legislatures — therefore elevating the issue to news stories and popular discussion — researchers found Google searches about GMO food spiked during the legislative sessions. Once those sessions were over, interest in those search terms went back down. But market share for Non-GMO Project Verified items in those states went up slightly, compared to states that had no action on the issue.

An unexpected opportunity

In the lead-up to the implementation of Vermont's GMO labeling law, there was quite a lot of pushback against the labeling scheme from manufacturers and industry groups.

But since President Barack Obama signed the federal law requiring disclosure of bioengineered ingredients on all products sold in the United States in 2016, GMO labeling has been somewhat of a non-issue in the food and beverage industry. Manufacturers have been willing to comply, and the biggest complaints within the industry have been about figuring out the nuances of what needs to be labeled.  

Most manufacturers quietly implemented the mandatory disclosures over the past year, said Jesse Zuehlke, president of food label consulting firm Prime Label Consultants. The law requires the disclosure either in simple text, by a scannable QR code, using a symbol, or through a telephone number or text message. Zuehlke said that most of the disclosures he has seen use the simple text or the QR code — both options that use a minimal amount of new space on a product label.

What has garnered more consumer attention are Non-GMO Project Verified labels. While this is a voluntary disclosure, products need to meet much more stringent standards to earn the butterfly seal. Many items with no federally required bioengineered ingredient disclosure would not be eligible for Non-GMO Project verification. But the seal has been shown to efficiently communicate GMO ingredient information to consumers.

Adalja said the attention to Non-GMO Project disclosure presents a distinct opportunity for manufacturers. Similar to the way some consumers seek out organic products and are willing to pay more for them, Adalja said the non-GMO movement has shown there is similar consumer interest in non-GMO products.

"We could see this policy initiative not as necessarily a detrimental regulation, but we could actually see it as an opportunity for firms to expand their product portfolio and try to capture some of this market," he said.

Claims including "raised without antibiotics," "hormone-free," "all natural" and "cruelty-free" are more influential over purchasing decisions than the "USDA Organic" label, according to a survey from Edelman Data shared by the Organic Trade Association.

The survey asked 2,500 consumers about their purchasing behavior and how they assess organic foods. While a majority expressed concerns about ethical issues assessed in the organic certification process, such as the use of chemicals in farming and the treatment of farm workers and animals, those numbers did not mean they are more likely to buy foods with organic labeling.

Many of the individual label claims are already covered under the USDA Organic Standard, indicating there is a lack of understanding from the general population about what “organic” labels fully mean.

While the Organic Trade Association survey indicated interest from consumers in many of the practices required by producers to be labeled organic, the results show a need for the organic certification process to be spelled out to consumers in a more easily understood way.

Consumer knowledge about organic foods is typically specific to types of products, the survey said. Organic produce and meat, which are heavily marketed as organic and often placed in their own section in the grocery store, enjoy high familiarity with shoppers at 39%. On the other hand, around 30% were very familiar with organic beverages and prepared foods. 

The confusion around organic products could be exasperated by the fact that there is a wide range of places consumers to get information. Only 11% of those surveyed said they turn to federal or state government agencies, including the FDA. The most common place, at 24%, was from family and friends. This was followed by social media and cooking publications at 17%. 

Organic food producers and advocates recognize the confusion and know greater transparency is needed. At the Organic Trade Association’s 2022 annual policy conference, Edelman Global Advisory Senior Advisor Darci Vetter said positive impressions from consumers around organic practices “didn’t necessarily translate to their purchasing behavior,” Food Navigator reported. Vetter added there should be a more accessible, go-to source for consumers to access information about organic certification. Based on the survey data, reaching consumers where they are likely to retain information on organic, like social media and recipe websites, could prove effective.

The Organic Trade Association similarly stressed in the report a need for USDA’s organic label to become consumers’ go-to source. It stated that as claims are pushed by food companies, the USDA must make it known it is the standard for what constitutes organic.

To educate consumers, the USDA could work with CPGs on providing more clarity through labeling and marketing campaigns. Or, they could create stricter guidelines for labeling products that adopt claims found in organic foods but are not actually certified organic.

For CPG makers, however, being clear about claims on packaging could be beneficial, even if those claims already fall under the USDA’s definition of "organic." SPINS data from fall 2021 showed more transparent label claims increase sales. Products citing animal welfare claims on their labeling sparked a 27% sales increase over the previous two years, the data found.

When used as a food ingredient, tagatose — a naturally occurring but rare sugar — will need to be disclosed on product labels as Added Sugars, the FDA ruled in May.

Sweetener maker Bonumose, which produces the sugar through a streamlined method using plant-based starches and enzymes, had petitioned the FDA to exempt the sweetener from the Added Sugars designation in 2018. The company argued the FDA should use its discretion to give tagatose a different designation because research has found that it does not increase risk for chronic disease and instead has been shown to have positive health effects, which conflicts with the rationale behind the Added Sugars labeling.

In its seven-page response, the FDA agrees with the health research submitted by Bonumose, but says tagatose has too many calories to be exempted from the label designation. Tagatose has 1.5 calories per gram, while allulose — another rare sugar that the FDA has exempted from the Added Sugars designation — has 0.4 calories or less per gram.

"We are not prepared to amend our regulations regarding the declaration of D-tagatose on Nutrition Facts labels at this time," the ruling states.

The ruling could make it difficult for Bonumose to sell its new tagatose ingredient to U.S. manufacturers. The Virginia sweetener company had scaled up its tagatose production and was prepared to produce and market it this year. In general, today's manufacturers are looking for sweeteners that are natural, close to the taste of sugar, low in calories, and that don't add to a product's sugar load as indicated on the Nutrition Facts label. Tagatose already met the first three criteria. It's naturally found in small amounts in fruits, cacao and dairy. It's 90% as sweet as sugar and has similar structural properties. and it has about a third of the calories of sugar.

If it needs to be included on labels as an "Added Sugar," however, it may dissuade manufacturers from including it. Under the revamped Nutrition Facts panel, products must report the grams of additional sugars each serving of a product contains, as well as the percentage of the recommended daily intake of sugar a person will get from eating it. Considering tagatose is so similar to sugar in terms of sweetness value and structure, this number may not be much different.

A decision that 'ignored the other health benefits'

Bonumose CEO Ed Rogers said he believes the decision was arbitrary and does not make sense.

"It just is an illogical decision and an inconsistent decision. And we think one that will ultimately be changed," he said.

Rogers provided reasons that tagatose shouldn't be labeled as an added sugar, and why it stands on its own as a beneficial food ingredient. Similar reasons — and scientific studies to back them up — were in Bonumose's 2018 petition to the FDA.

Unlike most common sugars, tagatose doesn't spike blood glucose levels. In fact, Rogers said, it can reduce blood sugar levels when consumed with other foods. It doesn't cause tooth decay, and has been found to break up dental plaque. It also has prebiotic effects, feeding healthy gut bacteria with dietary fiber. And, Rogers said, those fibers are the entire reason tagatose has the caloric load that it does. Tagatose has been shown in studies to be as effective at managing hyperglycemia as diabetes drugs, as a toxin inhibitor for people with a gut pathogen, and can be used in a treatment for sickle cell anemia. It also can be used as a sweetener in toothpaste.

In its decision, the FDA didn't contest any of this research and affirmed the health benefits of tagatose. In an email, an FDA spokesperson confirmed that the calories in tagatose was behind its decision.

"The Dietary Guidelines for Americans recommend that Americans limit calories from added sugars to less than 10 percent of total calories. In determining which sugars should be included in the declaration of Added Sugars on the label, a key consideration is whether the ingredient provides empty calories to the diet," the email states.

In its decision, the FDA says that because the "empty calories" of tagatose are so much greater than what a consumer takes in when eating something with allulose, small amounts of tagatose calories could "add up throughout the day and contribute to the diet in a way that makes it difficult to meet nutrient needs within calorie limits."

"That is the reason they gave, but doing so we believe was arbitrary because it ignored the other health benefits," Rogers said.

He said he can't understand how the FDA can affirm the benefits of tagatose and make its decision solely on calorie counts, especially when the caloric load of tagatose is so much less than that of more traditional sugar sweeteners.

"It would be extremely helpful if the FDA would allow consumers to understand that tagatose is not like regular sugar," Rogers said. "Why the FDA has chosen to deny that information to consumers is a little perplexing."

In its draft decision on allulose, the FDA says a sweetener's caloric contribution is important, but the department should also consider "other evidence including their association with dental caries, their effect on blood glucose and insulin levels" in deciding whether to label sweeteners as added sugars.

Conflicts of interest?

After the decision was issued, Bonumose issued a scathing press release accusing the FDA of siding "with high fructose corn syrup producers and against consumers, by suppressing truthful information about tagatose." By press time, Bonumose had taken the release down.

The release contained many of the arguments Bonumose made in its initial petition to the FDA four years ago, as well as comparing tagatose to allulose. The FDA decided in 2019 to exempt allulose from added sugar labeling because it is metabolized differently than sucrose and contributes significantly fewer calories. Since this designation, allulose has been vastly popular, with manufacturers struggling at one point to meet demand. 

But Bonumose's press release also made some accusations against the FDA. It stated the decision on tagatose "could have been ghost-written by high fructose corn syrup (HFCS) lobbyists," and brings out the point that most allulose today "is made from fructose by HFCS companies in a complicated and costly process that relies upon HFCS production." And, the press release says, internal FDA documents received through a Freedom of Information Act request "indicate a potential FDA bias against health-focused innovation and in favor of industrial corn sweetener producers."

In an interview, Rogers did not go into detail about the potential bias at the FDA referenced in the press release.

"That's not something I want to go into now," he said. "But yes, we have documents that we received from a FOIA request that indicate a potential bias, and we will bring those out at the appropriate time."

In an email, an FDA spokesperson did not know which documents Bonumose might be referring to.

"There were many statements made in Bonumose’s press release, however our decision related to their petition was based on the evidence that was presented to us by Bonumose," the department's spokesperson said.

Rogers said that in terms of action Bonumose may take about what it calls bias at the FDA, nothing is off the table.

What's next?

Rogers said it is important to note this decision only relates to how tagatose is classified on a Nutrition Facts label. Tagatose still has generally recognized as safe status, and can be used in products.

Bonumose has been working with more than 50 manufacturers on tagatose launches, Rogers said, and the company will continue. Bonumose has a high-profile partnership with Hershey, which is funding the company's new R&D center and which has been vocal in its support for tagatose. 

Rogers said some manufacturers have already said they don't care about the FDA's ruling and they will continue with their tagatose-sweetened product plans. 

There's also the possibility of concentrating on tagatose launches in other countries. Labeling laws elsewhere look at tagatose differently, not putting it in the same classification as sucrose-related sweeteners. Rogers said he has heard interest in the sweetener from potential customers worldwide.

There also may be more onus on Bonumose and manufacturers to get the message out about the benefits of tagatose, Rogers said. While it counts as a sugar, there can be marketing campaigns and label claims that can try to communicate what it does.

Rogers said they can also try to provide more information to the FDA, though he says they should have enough from Bonumose's 2018 petition. And, the FDA said in an email, if there is new information available, a new petition about tagatose can be submitted.

"It certainly makes things confusing for other companies and for us to have to wait four years and then get to get a decision which is incomprehensible," Rogers said. "And I guess it's just going to take more time and more money. Meanwhile, consumers are being harmed."

In 2020, after the FDA exempted allulose from added sugar labeling, it sought comments on how to best address similar sweeteners — metabolized differently that traditional sugars — on package labels. Thirty-one companies and individuals, including Bonumose, added their comments to the docket. To date, nothing has been decided or proposed. The FDA did not comment on whether a regulatory action would be coming from this docket.

Rogers said maybe Bonumose — which specializes in making an array of rare natural sugars scalable for ingredient use — will also change its focus for the time being.

"Maybe it's a bit ironic: We can also make allulose," Rogers said. "We can make allulose in a more streamlined process than other companies can make allulose. But we just think tagatose is the better of the two."