Between a top-down leadership approach, an objective to eliminate the self-affirmed GRAS (Generally Recognized As Safe) pathway for ingredients, efforts to reduce the prevalence of additives and ultra-processed foods in the U.S. food supply, and more, the Make America Healthy Again (MAHA) Commission has been shaking things up since Robert F. Kennedy, Jr. became Secretary of the Department of Health and Human Services (HHS).

The Natural Products Association (NPA) hosted a panel discussion to discuss the most pressing challenges and important opportunities for the dietary supplement industry. Panelists included Daniel Fabricant, PhD, president and CEO at NPA; Sibyl Swift, CSO of Johnson Foods; and Stuart Pape, partner at Polsinelli, all of whom are former U.S. Food and Drug Administration (FDA) officials.

Structural Shakeups

Panelists noted that while there are always structural changes inherent in the transfer of presidential administrations, the second Trump administration’s efforts have been anything but ordinary.

Pape said that Kennedy’s involvement in decisions under HHS jurisdiction are unprecedented.

“All major and minor decisions are being made by political appointees, much more than before, especially at FDA … This top-down structure presents opportunities and some challenges. Having greater access to the Secretary means that certain things can be expedited, but working problems out with career people in the agency will be harder, because they’re uncertain about whether they should try to solve issues at their level, or raise them upward, which gets more people involved, and brings in more meetings and delays … Most secretaries want to be involved episodically when things have political ramifications or cut across multiple departments, but we now have the opposite.”

Fabricant noted that, in some ways, the MAHA agenda has changed where certain issues land along party lines, creating “division and unification on new sides.” For instance, Kennedy’s proposal to eliminate the self-affirmed GRAS pathway to market was previously championed by Democratic lawmakers in years past.

Observers noted that the FDA’s agency-wide reorganization, which started during the Biden-Harris administration, became even more complicated with the administration change layered into it. “Things are happening fast because political people are making decisions with less reliance on career people. As they say, speed kills, and sometimes, if you move too quickly, you forget to cross all of the i’s and dot all of the t’s,” said Pape.

Swift noted that the reorganization has been reminiscent of the agency’s pre-2014 structure, before the Office of Dietary Supplement Programs had been elevated from a “Division” in the Center for Food Safety and Applied Nutrition. However, despite initial concerns that dietary supplement issues would be “buried,” the administration still considers the product category a high priority, especially for safety concerns.

Closing the ‘GRAS Loophole’

FDA is expected to publish a notice of proposed rulemaking seeking to eliminate the self-affirmed process of declaring ingredients as GRAS (Generally Recognized As Safe) by the end of the year, Pape noted. Eliminating self-affirmation from this process would require companies introducing new ingredients to, at least, provide the agency with notice that they have declared an ingredient is GRAS.

“This whole issue is fascinating, because the administration has been trying to avoid having to use a rulemaking process,” said Pape. “They didn’t propose anything for artificial colors, they browbeat the industry into agreeing to remove them. On this issue they have no choice but to use rulemaking, which slows things down by a lot.”

A key issue will be how ingredients already on the market might be grandfathered into the new rule, and potential retroactive application.

Fabricant noted that retroactive elimination of self-GRAS would significantly complicate the issue of determining whether those already-marketed ingredients should go through the New Dietary Ingredient Notification (NDIN) process. “Toxicology is toxicology … The science is the same as it would be in an NDI, but then you run into definitional issues. The FDA says no to certain botanicals and other bioactives, like NAC, NMN, and more, and while those are related to drug preclusion, there’s a lot to unpack and some nuances that HHS may not be as familiar with as we are.”

Another problem is the fact that FDA has no list of self-affirmed GRAS ingredients to look at if they want to retroactively apply the rule, noted Swift. Self-affirming an ingredient as GRAS requires publishing safety data on an ingredient, however, and while it’s no small task, developing such a list is theoretically possible, she said.

Swift also noted that, regardless of if and how self-GRAS is eliminated, companies should be prepared to share thorough information and manufacturing specifications for ingredients they’ve already self-affirmed as GRAS to FDA. “You’re on notice; prepare to answer some questions. If you’re feeding something to people you should be able to prove that you’re sure it’s safe and that’s not a bad thing. The more information you can provide on why something was taken to market, the better,” she said.

“You’ll need to prioritize if there are a bunch of ingredients in your portfolio that don’t have safety dossiers as robust as you’d like them to be,” Pape concurred. “Consultants and lawyers who can help you prepare are in limited supply, so it’s important to get in the queue to get professional advice before it’s too late.”

MAHA in the States

More than 100 bills aligned with the MAHA strategy have been introduced across state legislatures in the U.S. during 2025 legislative sessions, and many directly impact dietary supplements.

“Not all states are in the position to address the things that are being proposed,” said Swift, noting that having expertise at the federal level is already difficult. “Trying to address consumer safety in a piecemeal way with state laws is incredibly concerning, and very expensive for businesses.”

“The spirit of it is well-informed and states do some things very well, such as food safety recall coordination. But things get wonky,” said Fabricant. “We were close to the Food Uniformity Act at one point and this further emphasizes why that’s needed.”

“We’re returning to the 19th century where people are once again needing to recognize that food is an interstate commerce,” said Pape. FDA has historically taken little action to prevent state government from usurping their authority on food policy matters, and no signs suggest that will change, he said.

Stressing the Role of Supplements in Public Health

Despite Kennedy’s apparent interest in dietary supplements, there’s been little mention of their role in promoting health in communications from the MAHA Commission, so far.

Fabricant emphasized the importance of reshaping the narrative to give nutrition a more prominent place. For instance, healthcare practitioners receive just 16 hours of nutrition coursework throughout their entire education. Similarly, supplements have largely been overlooked in the dietary guidelines, even with longstanding evidence supporting supplementation in key populations such as pregnant women, or mechanistic relationships such as the role of folate in supporting metabolic functions in the liver, for example.

Swift noted that HHS has expressed concerns about issues like stress, reactive versus proactive healthcare, and over-medicalization, all areas where the industry is well-suited to provide support.