Tariffs, state laws regulating supplements, the Make America Healthy Again (MAHA) agenda, mass layoffs of federal workers, and federal deregulatory efforts are poised to shake up the dietary supplement industry.

At SupplySide Connect New Jersey April 8-9, legal experts and industry trade association representatives discussed the biggest risks and opportunities for the supplements market.

Standstills

A federal freeze on new rules, regulations, and guidance documents that provides the new administration time to review them will halt many substantial changes that were coming for supplements. These include the FDA’s final rule that defines which foods can be marketed as “healthy,” guidance documents on New Dietary Ingredient Notifications (NDINs), the FTC’s anticipated revisions to its Green Guides, and more, noted Rend Al-Mondhiry, partner at Amin Wasserman Gurnani.

There will be even further standstills in the months and years ahead, she said, such as the executive order “Unleashing Prosperity Through Deregulation,” which calls for all federal agencies issuing a new regulation to identify 10 potential regulations to be rescinded.

The term “regulations,” in the executive order, covers memoranda, guidance documents, and inter-agency agreements. “We have a lot of important rules and guidance documents for this industry, and portions of the revised NDI guidance that need to be finalized; what will come or go remains to be seen,” Al-Mondhiry said.

New leadership at the Federal Trade Commission (FTC) will likely shift focus to more traditional areas, such as outright fraud, protecting children from deception on social media, and online privacy. She said she “wouldn’t be surprised” if FTC’s Green Guides updates fall by the wayside.

Even the FDA-wide reorganization that went into effect October 2024 might be on the chopping block. Inside Health Policy reported based on anonymous sources that HHS may upend the reorganization with yet another plan to restructure, noted Kyle Turk, vice president of government affairs at the Natural Products Association (NPA).

Industry’s Top Goals

Turk said the most realistic short-term goal for the industry is expanding access to supplements through Health Savings Accounts (HSAs) and Flexible Spending Accounts (FSAs).

So far, the administration has taken a favorable stance on dietary supplements, as reflected by tariff exemptions on many essential nutrients and amino acids, Turk noted, and there’s a good chance that further ingredients may be exempted after public comment. “What gets lost in the shuffle in these conversations is that, even in the president’s first term, the supplements industry was considered by the administration a critical workforce infrastructure during COVID … There’s a lot that can be done moving forward.”

Robert Marriott, director of regulatory affairs at the American Herbal Products Association (AHPA), noted that relative to other product categories, there is a dire need for tariff exemptions for botanicals, as many are impossible to produce domestically.

For other ingredient categories, there’s a “can’t-miss opportunity” for the industry to be a part of discussions about reshoring manufacturing, with potential tax incentives and other forms of relief worth advocating for.

“There are a number of avenues we can take from a Congressional standpoint,” said Turk. “The Ways and Means Committee in the House specializes in manufacturing, and we’ve been working with them to explore reshoring manufacturing.”

Considering how receptive Robert F. Kennedy Jr.’s HHS appears to be to the supplement industry, there’s an opportunity to expand the types of claims natural products can make, reducing the pharmaceutical industry’s “stranglehold on free communication with consumers,” Turk noted. 

The prospect of achieving a mandatory product listing for dietary supplements under the current regime is unlikely, Turk said. “From a regulatory standpoint, I think [the administration is] all about transparency right now, but it’s also about efficiency. Think about how efficient FDA is at using the authorities already at its disposal […] Leadership in the House and Senate aren’t going to be supportive.”

‘Crisis of State Laws’

State bills seeking to preempt the FDA in regulating the food and dietary supplement industries are accelerating at an unprecedented rate, noted Marriott.

Bills seeking to ban food additives and ultra-processed foods in ways that preempt the FDA are popping up in red and blue states alike. “This is an unusual moment of cross-aisle appeal … Blue states are typically of less concern, as they’re mostly focusing on products that are being sold in schools,” he said.

One common pattern in food additive restrictions, which have been emerging more recently, is that bills don’t distinguish supplements as a separate class of products, even though the bills are meant to target conventional food products, Marriott noted.

So far, the main focus of these bills has been on color additives, which are FDA-approved and don’t go through a self-affirmed GRAS process. But there’s also often a focus on restricting what these bills define as ultra-processed foods, which could implicate anything other than a raw botanical, said Marriott.

Much rests on the outcome of the Council for Responsible Nutrition’s ongoing legal challenge against the age restriction placed on sports nutrition products in New York, said Al-Mondhiry. “Other states are waiting to see what happens with this case before they move any bills forward, and I think that if the court rules in favor of that law, other states will be empowered to pass laws that are even more expansive. We’ve had it good for so long at the state level, and haven’t been recognizing the hazard there.”

Marriott said that the industry’s relatively low involvement in state government affairs has led to the mounting pressures seen today, and there’s no better time than now to challenge them.

“These bills are going to increase costs for compliance and supply chain management … States are building regulatory apparatuses that seek to compete directly with federal regulations, and we’ll likely also see reciprocal blowback from the federal government in response to state preemption.”

Moving forward, it’s reasonable to anticipate that state governments may seek to regulate label claims, or require pre-market approvals, Marriott said. The long-term erosion of public trust in the food system, and in the supplements sector specifically, could be massive, he noted.

Outside of joining a trade association, Marriott recommended that companies reach out to their Congressional representatives, who are much more likely to be receptive about the financial impacts on their constituents. “We can make strong arguments about the science and safety issues, but legislators representing you care about your dollars and cents, and whether their bills are practical to you.”

Eliminating Self-Affirmed GRAS

While Kennedy has expressed interest in eliminating self-affirmed declarations (without notice to FDA) that an ingredient is Generally Recognized as Safe (GRAS) as a pathway to market, “there’s no reason to panic,” said Al-Mondhiry, as it’s unclear if the scope would extend into supplement ingredients, past the chemicals and additives which Kennedy has prioritized. Further, it’s still not clear if this can or would be applied retroactively, or whether it would cover supplements at all.

Marriott expressed some skepticism that such a “sea change” could be accomplished amid “fundamental tensions between cutbacks and the desire for increased regulation and scrutiny.”