BOSTON — Redefining the term “healthy” and bolstering food traceability are among the Food and Drug Administration’s top priorities. More clarity around plant-based meat and dairy labels also could be in store for 2023, alongside a shift in strategy for regulating CBD-infused products.
In an interview with Food Business News, experts from the global law firm DLA Piper discussed current regulatory trends and shared their predictions for the year ahead.
The term “healthy” is getting a new definition from the FDA. A proposed rule published in the Federal Register this fall would require products labeled as “healthy” to contain a meaningful amount of ingredients from nutrient-dense food groups, including fruits, vegetables, grains, dairy and protein. The comment period for the proposed rule ends in February.
Established in 1994, the FDA’s current definition of “healthy” focuses on specific nutrients. It includes limits on total fat, trans fat and cholesterol as well as minimum requirements for beneficial nutrients like calcium, iron and protein.
“Instead of just focusing on nutrients that are good or bad for you, which are being assessed in a vacuum, the definition is being updated to look at food group equivalents and the way consumers actually eat,” said Stefanie Fogel, co-chair of DLA Piper’s FDA regulatory group.
The new definition is part of a broader goal to improve healthy eating habits by 2030. The proposed rule was published in September while the White House was hosting its conference on hunger, health and nutrition — the first event of its kind in more than 50 years.
“You have to view this in conjunction with the larger White House interest in nutrition and the larger national strategy to address diet-related diseases,” said Sharon Mayl, a member of DLA Piper’s FDA group and a former senior policy adviser for the agency. “We’re going to continue to see a trend toward providing consumers with information in a way that is as easily digestible as possible.”
A New traceability rule for high-risk foods will go into effect in January. The regulation is part of the Food Safety Modernization Act (FSMA) and is linked with the FDA’s New Era of Smarter Food Safety Initiative. Companies will have three years to come into compliance with the requirements, which include additional recordkeeping actions for harvesters, processors and distributors of products on the FDA’s Food Traceability List.
“What’s important about this rule is that it establishes a common traceability language,” Ms. Mayl said. “It sets the stage for the agency’s vision of end-to-end traceability across the food supply by creating a means for interoperability among different food systems.”
Requiring different businesses to keep new records and implementing the policy nationwide is a significant undertaking. Groups including the National Grocers Association and the Food Industry Association have called it an overstep of the FDA’s authority under the FSMA.
Industry stakeholders can expect more outreach and technical assistance on the rule in 2023, Ms. Mayl predicted.
“The rule is complicated,” she said. “There are still a lot of unanswered questions, including companies not knowing if the rule applies to them and questions around how records can best be kept. We’ll have to pay attention to see how the FDA will oversee enforcement. Will they be looking at records during routine inspections? Will they develop remote regulatory assessment of traceability programs?”
Companies that handle products on the Food Traceability List should start considering how they’ll comply with the rule now, she added.
“They’ll need to start having conversations with other companies up and down their supply chain, as well as with technology providers, to determine the best way to integrate the necessary data into their business operations,” she said.
The new rule will accelerate the adoption of technology solutions throughout the supply chain, a key component of the FDA’s New Era of Smarter Food Safety Initiative.
“A lot of companies struggled with disruptions to the supply chain during COVID, so they’ve already been looking at things like blockchain and other technologies to keep track of food, maintain a certain standard of quality and improve efficiencies for inventory,” Ms. Fogel said. “The issue of traceability and the integration of technology is going to be front and center for almost all global companies we work with. There will be a lot of smaller technology players who come into this arena, too.”
Cultivated meat achieved a major milestone in November when Upside Foods received the industry’s first “No Questions” letter from the FDA. Approval from the US Department of Agriculture is needed before the company begins selling its cell-based chicken product to consumers.
Other cultivated meat makers are working with the agencies to bring their products to market, too.
“The question for me is whether the FDA is going to have the resources to keep up with all of this,” Ms. Mayl said.
She pointed to a recent report from the Reagan-Udall Foundation that highlighted a range of challenges facing the FDA, including budget restrictions and problems with hiring and retaining scientific talent.
“That’s going to continue to be a problem for firms that want to consult with the agency,” she said. “The other issue that’s going to arise is determining how best to label these products. What’s material for consumers to know? What authority do the agencies have to require disclosure?”
Regulators also are working to provide more clarity on the labeling of plant-based products. Conventional meat and dairy companies, trade groups and a handful of state legislatures have challenged the use of terms like “burger” or “milk” to describe animal-free alternatives.
Clarity and consistency could soon arrive through FDA guidance. The agency in early 2022 began working on draft guidance documents to address the issue.
The documents were scheduled to come out in December, but the experts at DLA Piper said it is unlikely the industry will see them before the end of the year.
“We continue to see this battle out in the courts, and I don’t see it coming to any conclusion until the FDA has the resources and the guidance comes out,” Ms. Fogel said. “That will help dictate how this gets handled in front of judges.”
A recent shift in the FDA’s approach to regulating products containing CBD and other cannabinoids could be a sign of what’s in store for 2023. The agency in November issued a series of warning letters to five companies that sell CBD-infused food and beverages.
The warning letters are notable for several reasons. The FDA typically targets products claiming to cure or mitigate health concerns, focusing on dietary supplements and citing unapproved drug claims as the primary regulatory issue. One of the warning letters issued in November was based only on the assertion that CBD is not an approved food additive.
“I think the industry was feeling like, ‘Well, if I don’t make an egregious health claim about this product, then I’m relatively safe,’” Ms. Mayl said. “What we saw in this latest batch of warning letters is that the FDA is focusing on products that don’t have any health claims around them.”
The letters indicate the FDA is particularly concerned about products that may appeal to children, including cookies, lollipops and gummies, as well as products containing Delta-8, a psychoactive cannabinoid.
“The FDA is continuing to seek more data to determine if there’s a clear regulatory pathway outside of the drug context, but in the meantime, we’re going to see more enforcement actions, particularly in the conventional food space,” Ms. Mayl said.
The FDA has struggled to keep up with the proliferation of cannabinoid-infused products. As a result, it may be turning to retailers and distributors to take more responsibility. Another round of notable warning letters came in October, when the agency held two online retailers accountable for dietary supplements with unlisted ingredients.
“The FDA usually targets manufacturers and not retailers or distributors, so this was a significant step,” Ms. Mayl said. “It’s consistent with other things the FDA is doing, and it makes sense in light of the agency’s limited resources in comparison with the vast amount of products it has to regulate.”