Todd Harrison and Claudia Lewis, both partners at Venable, LLP, discussed the regulatory landscape for dietary supplements, including changes at FDA, class-action trends, state bans on food additives, what to expect with Robert F. Kennedy, Jr. at the helm of the Department of Health and Human Services, and more this month at a presentation at Natural Products Expo West.

The Election Turnover

With the Trump Administration now in charge, and staffing cuts by the Department of Government Efficiency (DOGE), it’s not clear what initiatives at FDA from the previous administration will stick. It’s likely that HHS will be much more hands-on with matters under FDA jurisdiction with Kennedy at the helm, Harrison said.

“We’re not sure what the MAHA (Make America Healthy Again) initiative will be, or the structure it will take,” said Lewis. “This is an unusual season in D.C., and we’ve seen many administrations come and go. Usually, there are bellwether, telltale signs, but there’s no due north at this time.”

When it comes to how FDA’s reorganization might impact the agency on a broad level, “though they spent lots of money on consulting, not much is really going to change,” said Harrison. “They moved some offices and people around, and I think the focus will be on food safety for FDA for the time being, which the natural products industry sees as a great opportunity.”

‘Healthy’ Labeling Rule

Harrison said that, despite FDA’s good intentions, the finalized rule on labeling products as “healthy” excludes many health-promoting products. “FDA’s definition of healthy doesn’t take phytonutrients into consideration, it’s just RDI (recommended daily intake) and DRV (daily recommended value) nutrients.”

Under the new rule, ingredients like omega-3s, lutein, amino acids, or even whole foods such as honey or chlorella, all of which exhibit nutritive properties, cannot be described as healthy under the current specifications, Harrison noted. “These things completely miss the point of nutrition … I believe that this rule could be found unconstitutional. They’ve defined a term that doesn’t need to be defined, and they’re wrong.”

“The definition is extremely whole-food-centric, and the dietary supplements industry is very confused on how they can convey the benefits of their products, as the rule covers lots of alternative words like healthful, healthfulness, and synonyms, which you can no longer use if your product doesn’t meet the specifications,” said Lewis.

While FDA likely won’t enforce “healthy” claims heavily, expect plenty of action from the plaintiffs’ bar regarding direct or implied claims, said Harrison. “What would easily be construed as a structure-function claim today will become fodder for the class action bar … This new rule disqualifies omega-3s from being able to be described as a heart-healthy product.”

It’s hard to know how far down the rabbit hole legal challenges will go when it comes to implied claims of health promotion. “We’ve already seen demand letters targeting the word ‘wholesome’ as an implied nutrient content claim, and they’re probably going to find even more things to target. With these unintended consequences, it would’ve been better for FDA to stay out of it,” Harrison said.

The final rule has been stalled for the time being as a matter of common practice for rules finalized 90 days before a presidential election. It may serve as a litmus test of how receptive Kennedy will be toward the holistic health movement he’s championed, said Lewis.

Proposed Front-of-Label Rule

A proposed FDA rule that would require food products to feature information about relative sugar, sodium, and saturated fat content poses a risk of adding a layer of confusion to health decisions, Harrison noted.

He said that the rule, in some ways, harkens back to when the food industry prominently featured low-fat versions of products that contained excessive amounts of added sugar, ultimately coinciding with a surge in diabetes rates.

“How information is viewed and utilized is important. Important details get lost, for instance, when people fixate on added sugar rather than total sugar consumed, or what kind of sugar it is,” said Harrison. Similarly, “saturated fat gets featured, but even though trans fats are not so great for you, they’re not covered.”

“The average person doesn’t read labels carefully, but if they’re looking for something nutritious while shopping for their family, I’m not sure how helpful this is without educational overlay,” Lewis concurred.

“We can avoid all these additional layers of information. Consumers know what a nutrition facts box is. And even there, we’re still getting things wrong. We still generically declare fiber as a carbohydrate, which most of the world doesn’t do for good reason — not all carbs are the same. So why add another layer of confusion?” said Harrison.

Plant-Based Food Labeling Guidance

At the beginning of the year, FDA issued a guidance outlining its recommendations for the accurate labeling of plant-based foods that serve as alternatives to conventional animal products. The key takeaways: companies should clearly specify plant sources; have uniform naming across similar products; and clarify modified spellings if using terms like “Chick N’” or “Cheeze.”

While FDA may not prioritize enforcement of guidance documents, they often serve as ammunition for plaintiffs’ attorneys to claim that a product deceived consumers, Harrison said. “Plant ingredients are already contained within the ingredient lists, so I’m not sure I see the reason to go to all of these extra lengths,” Harrison said. “In case law, policy is policy — it’s not the law. But those demand letters keep coming. This is why Congress doesn’t like guidance documents … All of these guidance documents give plaintiffs’ attorneys more to work with, and since it’s never worth litigating, paying them off becomes built into the cost of doing business.”

Artificial Colors in the Crosshairs

State governments such as California, West Virginia, and others are phasing out artificial colors, dyes, and other additives. Importantly, no federal law preempts them from doing so, Harrison said.

While these additives are permitted by FDA, plaintiffs’ attorneys might contend that a product is unsafe, even if sold in a state where a certain additive isn’t banned. “So, formulate without these ingredients as soon as possible.”

“Because each state has its own list of banned additives, it’s going to be difficult to comply across the board,” said Lewis. “We used to have relationships with state regulators and lobbied more on the state level rather than looking to the feds for everything … There may be an opportunity to level set and better define the goal of what should and shouldn’t be in the food supply. Maybe it’s an optimistic thought and the cat is already out of the bag.”

FDA’s Guidance on AI

While FDA hasn’t yet published guidance documents on how food or supplement developers should use artificial intelligence (AI) when developing a new product, the agency laid out best practices for facilitating the development process.

“It’s very tangential to the natural products industry, but FDA is looking at it, and it’s only a matter of time before we have some information on the disclosures you might need to use, or other specifics surrounding it,” Harrison said.

‘GRAS Loophole’ On the Chopping Block

Discussions about the GRAS (Generally Recognized As Safe) pathway to market for dietary supplement ingredients are sure to heat up. Kennedy has directed the acting FDA commissioner to explore rulemaking which would bring an end to the self-affirmed GRAS pathway, effectively requiring all companies to get FDA approval upon the introduction of any new ingredient.

For many years, FDA has voiced its concerns about the supplement industry simply declaring that its ingredients meet GRAS specifications when in reality they should be subject to a safety review by the agency.

The industry’s propensity to blur the lines between supplements and functional foods/beverages, which are each subject to different safety standards, certainly isn’t favorable for those who prefer the status quo, Harrison said.

“The difference between a supplement and functional food has absolutely collapsed,” he said. “Functional beverages, especially, contain all of these dietary ingredients which FDA definitely wouldn’t consider GRAS, and it would consider these products to be technically unlawful. FDA has allowed the system to collapse, and now there’s no more clear distinction between supplements and foods, even though they’re subject to different safety standards.” Harrison noted. “But there are beverages and bars, both conventional foods, that are loaded with something like CBD, and FDA does nothing, so what kind of an effect does that have on the industry? The two categories of foods have collapsed into one, and that’s why we’re seeing talk about GRAS reform.”

“At some point, plaintiffs’ attorneys are going to figure this out and sue you for foods that are unlawful under FDA rules,” Harrison said. “It’s going to create a lot of difficulty.”

Amazon and other retailers establishing store-specific requirements for dietary supplements will likely catch up and pull products from their shelves that skirt food standards, said Lewis.