With Dr. Martin Makary, MD, MPH, nominated to lead the U.S. Food and Drug Administration (FDA), and Robert F. Kennedy, Jr. nominated to lead the Department of Health and Human Services (HHS), observers within the dietary supplements industry are mostly optimistic about how the incoming Trump Administration may shake things up.

Makary is an oncology specialist and chief of islet transplant surgery at the Johns Hopkins School of Medicine. He also holds an appointment at the Johns Hopkins Carey Business School. He directs Johns Hopkins’ evidence-based medicine and public policy research group and has published more than 300 scientific articles there. He is a member of the National Academy of Medicine, and previously served in a leadership role at the World Health Organization’s patient safety program.

During the COVID-19 pandemic, Makary was an early advocate for vaccines and masking; later on, he questioned certain aspects of the mandates for lockdowns, vaccines, and masking. He criticized FDA for not allocating more funds toward researching the disease early on, and has characterized the agency as being mired in bureaucracy and unable to adapt to public health crises.

He has also written several books critiquing various transparency and accountability issues within the healthcare industry.

“Dr. Makary’s extensive work as a surgeon and public policy researcher demonstrates his professional commitment and leadership in the medical field,” Johns Hopkins Medicine said in a statement. “We congratulate him on his nomination and the opportunity to work with the exceptional team at the U.S. Food and Drug Administration as the agency’s next commissioner.”

While Kennedy hasn’t said much publicly about dietary supplements, he’s expressed interest in advancing non-pharmaceutical healthcare products.

On X, he stated he’ll end FDA’s “aggressive suppression of psychedelics, chelating compounds, ivermectin, hydroxychloroquine, vitamins, clean foods, sunshine, exercise, nutraceuticals, and anything else that advances human health and can’t be patented by Pharma.”

Fresh Perspectives

Scott Melville, president and CEO of the Consumer Healthcare Products Association, lauded Kennedy’s nomination as a victory for consumer choice. “Consumers rely upon an evidence-based regulatory framework to ensure the products they choose are safe and beneficial as labeled. And public health decisions must always be grounded in strong science. CHPA and its member companies share Mr. Kennedy’s stated intent to improve the public health and provide greater choice for consumers in their self-care options, and we look forward to learning more about his positions and priorities as he proceeds through the confirmation process.”

Similarly, Melville lauded Makary for his “academic and medical credentials,” “contributions to scholarly and professional publications,” and “commitment to evidence-based medicine.”

Duffy MacKay, senior vice president of dietary supplements at CHPA, said that while it’s too early to make predictions, it seems like “nutrition and holistic wellness will be a key public health priority,” and supplements will get some long-overdue attention and acknowledgement.

“We are pleased to see attention given to the many benefits of supplementation in addressing nutrition gaps,” said MacKay. “CHPA encourages the incoming administration to recognize and prioritize the essential role consumer healthcare products, including dietary supplements, play in supporting our nation’s public health.”

MacKay said Makary’s “previous critiques of the U.S. healthcare system and the way dietary supplements are regulated could advocate for increased transparency in the marketplace, which may translate to FDA’s continued support for Mandatory Product Listing and other modernizations to the current framework overseeing supplements.”

Additionally, the emphasis on transparency and evidence could translate to better claims substantiation requirements for supplements as a product class, MacKay said.

Michael McGuffin, president of the American Herbal Products Association (AHPA), said to expect broad, sweeping changes. “The incoming administration is arriving with a mission to reshape public health in America as we know it,” he said.

Steve Mister, president and CEO of CRN, told Nutraceuticals World that both Kennedy and Makary have “a much broader view of healthcare than we have seen in the past … We’ve been talking about this country moving from being a ‘sick care’ to a health care system, and that means we have to look at health from a much more integrative standpoint … dietary supplements have a big role to play in all of that.”

Loren Israelsen, president and founder of the United Natural Products Alliance (UNPA), said that the industry should view Kennedy’s and Makary’s nominations as a prime opportunity to improve engagement with FDA.

“I can’t remember a presidential election where MAHA [Make America Healthy Again] or anything even remotely approaching that has been a major point of a campaign, let alone part of a winning campaign,” Israelsen said.

Kennedy “has a remarkably strong following and many underestimate the level of support and agreement he has among the general public, especially younger moms,” Israelsen added. “He’s speaking to issues of high interest and concern and he’d be the first secretary of HHS that takes a direct interest in what we do day-to-day, and I see that as very welcome.”

As for FDA, Israelsen said there may be “a new opportunity to engage on issues both DSHEA [Dietary Supplement Health and Education Act] related and more broadly on health, nutrition, chemicals in the food supply, and policy changes,” Israelsen said. “Not all of my colleagues share this view but I have a sense of optimism that if both nominees are confirmed, there will be opportunities we have never seen before and may never see again.”

Likewise, Jay Bhattacharya, MD, PhD, NIH director nominee, will challenge the status quo, and “so clearly believes there is a role for nutrients and supplements in the broader health and medical arena,” said Israelsen.

Dr. Janette Nesheiwat, an ER medicine doctor nominated for Surgeon General, and Dr. Mehmet Oz, nominated to lead Medicare and Medicaid, will also likely speak positively about dietary supplements from their respective bully pulpits, observers noted.

‘Lightning Rods’ for Scrutiny

Mister noted that while administration nominees are pro-supplements, they will also serve as “lightning rods,” drawing in stronger scrutiny and negative press, due to perceived conflicts of interest or other controversial viewpoints.

While Kennedy has recently insisted in unequivocal terms that he’s “not anti-vaccine” and “won’t take vaccines away,” he is the founder and former chair of the nonprofit Children’s Health Defense, which has campaigned legally and through demonstrations against public vaccine programs. Aaron Siri, an attorney helping Kennedy select federal health officials for the incoming administration, has petitioned the government to revoke its approval of several vaccines including the polio vaccine.   

Several mainstream publications, including the Wall Street Journal, NBC, and others have criticized connections between nominees and supplement brands. One of the most controversial instances was FBI director nominee Kash Patel’s apparent endorsement on social media of Warrior Essentials, a supplement brand that reportedly marketed its products as a “detox” to rid the body of the COVID-19 vaccine.

The election made clear that Kennedy’s messaging on food policy was extremely resonant, signifying the public’s shift to new forms of media like podcasts and social platforms for information, said Israelsen. Across old and new media, “there’s a big divide between voices that characterize the industry as under-regulated and those who don’t but want to see more openness and informed regulators.”

Supplement industry critics are also sounding alarm bells that the industry will see far-reaching deregulation. S. Bryn Austin, director of the Strategic Training Initiative for the Prevention of Eating Disorders (STRIPED) and Amanda Raffoul, a STRIPED-affiliated faculty member, reported the supplements industry is “gleeful about the prospects of a free pass from the feds,” and will “no doubt take Kennedy’s stance as a free pass to relentlessly promote its deceptive and predatory products.”

Mister said that, contrary to suggestions that “the guardrails are coming off at the federal level, that’s not the case at all. FDA is still going to be there, and they’re still very much entrenched in our issues. We still expect that we’re going to have inspections and be held to account for our products.”

Topline Goals for the Industry

Makary has often asserted that FDA is mired in bureaucracy, and unable to respond swiftly to pressing issues.

When asked about where he’d like to see decisive action, Mister said he’d like clarity on the drug preclusion provision of DSHEA. This provision precludes any ingredient from being marketed as a dietary supplement if ever authorized for research as an investigative new drug.

“FDA promised that they’re going to answer our citizen petition by July … if you have people in charge who are thinking about a much more holistic approach, they’re much more likely to balance the pharmaceutical industry’s interest and the supplement industry’s interest in a way that we think the law was intended,” Mister said.

“The previous administration sat on the CBD issue for over 5 years, and didn’t do anything except conclude that they can’t regulate it,” concurred Israelsen.

Israelsen also said the rules in DSHEA surrounding structure-function claims are due for reassessment. Structure-function claim rules were written in an analog world, which didn’t foresee consumers becoming inundated with online information at all times, Israelsen noted. Now, “there’s too much information, and people need to feel confident in the sources they choose to follow and learn from. The industry has an important role to play — we can communicate more and bear more responsibility, especially with claims related to a finished product.”

Israelsen said improving Good Manufacturing Practice (GMP) inspections should also be a top priority. “There simply aren’t enough inspections, and there’s no adequate training or harmonization of knowledge and skills of investigators. I know Jim Jones (FDA Deputy Commissioner for Human Foods) is well aware of that and has a robust plan to address that. Assuming Makary is confirmed, I hope Jones stays on and the work he’s done continues.”

MacKay said that HHS, FDA, and Congress must work closely for “meaningful and balanced reform of the dietary supplement framework,” including DSHEA, which balances the need for safety, innovation, and market access. Improving the oversight of online marketplaces is a key area of concern for CHPA, MacKay said, and he’s hoping for “legislation holding e-commerce platforms accountable for hosting safe or unregistered products. Industry also plays a vital role in these efforts by advocating for bipartisan solutions, emphasizing shared goals like transparency and safety, and supporting measures that protect consumer trust.”

With few updates to the regulatory framework for dietary supplements that was created more than 30 years ago, it’s important to keep in mind that “meaningful change takes effort and time,” MacKay noted. HHS and FDA leadership need to “align with Congress, and engage industry, healthcare providers, and consumer stakeholders to ensure access and safety are balanced. CHPA supports measures like mandatory product listing and broader reforms, including addressing illegal activity, enhancing preclusion provisions, enabling third-party audits, and improving access to scientific information.”

How Will These Changes Impact FDA Operations?

On top of the administration change, FDA is managing a major reorganization, so it’s hard to predict what FDA’s day-to-day function will look like, said Mister.

“We don’t have any reason to think that [Makary] is going to undo [the reorganization] and put things back the way they were,” Mister said. “Will they keep Jim Jones? He’s not a political appointment […] but they could decide to go in a different direction.”

It’s also unclear how much money the agency will have at its disposal to implement sweeping changes.

“Most of FDA’s budget on the pharma side comes from user fee authorizations, and the food side is underfunded. If this administration truly wants safer foods, comprehensive inspections, and fewer recalls, it requires more people and more money. In this Congress, I don’t know if they’re going to get that,” said Israelsen.

Despite budgetary challenges, “I think establishing a dietary supplement advisory committee would be really helpful … the industry should be able to identify where the ‘potholes’ are, and what’s clunky,” said Israelsen. “Up to this point, you make a phone call and feel like nothing is going to happen. So on top of the foundational problem of no resources, there needs to be a change in attitude, and precision when enforcing against these rogue companies, adulterated products, out-of-line claims, and severe GMP failures. I’m hopeful that if it’s going to happen, it’ll happen in this administration.”

McGuffin expressed a similar hope, stating that “the potential changes to rulemaking and day-to-day operation of the agency are too numerous to list, but, at the highest level, we expect a change in tone from the agency in its interactions with Congress as well as a new openness to legislation that addresses product safety and safeguards consumer access. One such reform would be the creation of a new ‘prohibited act’ under section 301 of the Federal Food, Drug, and Cosmetic Act. AHPA believes the addition of such a new prohibited act, carefully tailored to give regulators only the power they need, would give the agency greater power to enforce against marketers of drug-spiked products that masquerade as dietary supplements. Reforms like these, built on common ground, represent a path forward for an industry divided over controversial proposals like mandatory product listing.”

Bracing for Tariffs

While industry leaders are optimistic about health agency nominations, Trump’s promise to instate 10% tariffs across the board on all Chinese imports is a source of worry. With the lion’s share of all dietary supplement ingredients sourced from China, the effects on pricing and supply stability could be profound.

At the moment, critical nutrients like vitamins and amino acids are excluded from tariffs and were during the first Trump administration. However, botanicals, mushrooms, protein isolates, omega-3 fatty acids, and minerals are presently subject to tariffs of either 7.5% or 25% on a product-by-product basis. With virtually all global companies vying for tariff exclusions for some or all of their goods, it’s difficult to predict what if any nutritional ingredients may be excluded outside of those established critical nutrients.

“Many of our ingredients and raw materials are sourced from other parts of the world, and in some cases we don’t have much choice to onshore them back to the U.S. if we wanted to,” Mister said. “We don’t know yet whether the tariffs are being used as leverage in order to get better trade policies, or if we’re actually going to see these go into effect…”

“This is really where the day-to-day effect on businesses will be felt,” Israelsen said. “I believe this administration is going to move quickly to establish its global trade and tariff policies, and it could be quite aggressive … will there be a real deterioration of the U.S.-China relationship?”

It’s more than likely that product quality will diminish unintentionally due to fractured supply chains and potential shortages, like what was experienced due to the Covid pandemic, said Israelsen. The potential for intentional economic adulteration is also strong, as it historically correlates with rises in pricing. “We have to be extremely watchful about that.”