ANAHEIM, CALIF. — With the caveat there is a lot of uncertainty in Washington with the new administration, two lawyers from the firm Venable LLP took the stage at Natural Products Expo West and offered their insights into what food and beverage manufacturers can expect from a regulatory perspective with Donald Trump as president and Robert F. Kennedy Jr. as secretary of Health and Human Services.

Their short answer? We’ll all have to wait and see.

“We don't have our normal crystal ball,” said Claudia Lewis, a partner with Venable. “This is just an unusual season in Washington, DC. And I have been in DC for a very long time and seen lots of administrations come and go. And usually, we’re able to have some bellwether, some telltale signs of things and we don’t have that this time.”

Todd Harrison, also a partner with Venable, emphasized changes at the FDA will come from the top.

“We have RFK Jr. now who is head of HHS,” he said. “The HHS secretary has generally been hands off historically with FDA. Bobby Kennedy isn’t about to be hands off the FDA. That’s going to be a big change. You’re going to see more coming down from HHS and being directed by the HHS as much as being directed by the FDA.”

When the Trump administration took office on Jan. 20 it published an executive order putting a hold on all new regulations for 60 days. This affects several food-related regulations issued during the last days of the Biden administration.

“So, why don’t we start with probably the biggest thing on our minds — healthy labeling,” Harrison said.

This past Dec. 19, the FDA published a final rule updating its definition of the nutrient content claim “healthy” that processors may use on packaging.

“If you think about it this word healthy and how they defined it, the FDA somehow managed to be extremely narrow and extremely broad at the same time, which is quite the feat,” Harrison said. “It does go down to if you call your product healthy is it healthy? One thing that is important about this definition is that it doesn't take phytonutrients into consideration. It only takes in RDA ingredients and DRV ingredients. So, if you probably couldn’t call honey healthy even though honey has a lot of antibacterial, antiviral properties to it.”

Lewis said the current definition is “very whole food-centric” and raises a lot of questions about how dietary supplement manufacturers may use the term on products. She added that, if Kennedy is receptive, supplement manufacturers may be able to explain why the rule is limiting and recommend changes.

In mid-January, the FDA issued a proposed rule for front-of-package nutrition labeling.

“This will probably go through under Bobby Kennedy,” Harrison said. “I don’t see it getting withdrawn.”

He said the rule was “probably not a bad thing,” but criticized the focus on added sugars.

“It should just be sugar,” he said.

Lewis added: “My issue is we are constantly adding additional information without really educating folks about what it means — what nutrition really is and what a healthy diet really looks like.”

One set of regulations that may be ripe for updating is how the FDA defines generally recognized as safe (GRAS).

“The one thing I learned about this show (Natural Products Expo West) today is that the difference between a dietary supplement and a conventional food has absolutely collapsed,” Harrison said. “Especially when you see all these functional beverages that have all these dietary ingredients that the FDA probably doesn’t agree are GRAS. Those products are probably technically unlawful.

“That’s a problem because — and this is FDA’s fault because they’ve allowed the system to collapse — there is no real distinction any more between supplements and food, because everybody in their rush to capture the health craze are now adding into the food products because someone else is doing it.

“This is why I think we’ve started seeing Congress talk about reforming GRAS.”

Finally, one policy Harrison believes is “dead on arrival” is the draft guidance published by the FDA in early January about best practices for naming and labeling plant-based foods.

“This guidance document isn’t getting out,” he said. “Because Trump has issued an executive order that requires that every time a new regulation or policy is created the FDA will have to give up 10 policies or regulations.”