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  Title	Industry insiders describe potential impacts of RFK Jr., Marty Makary on FDA, dietary supplements
  ID	6416273
  External ID	7513450741
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  Published Date	Jan. 31, 2025, 10:50 a.m.
  Summary	Changes at FDA could be on the horizon if Robert F. Kennedy Jr. is confirmed as the nation's top health official. Reporter Rachel French asked industry insiders about the potential impact on FDA's reg
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  URL	https://www.supplysidesj.com/supplement-regulations/industry-insiders-describe-potential-impacts-of-rfk-jr-marty-makary-on-fda-dietary-supplements
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  Content	Changes at FDA could be on the horizon if Robert F. Kennedy Jr. is confirmed as the nation's top health official. Reporter Rachel French asked industry insiders about the potential impact on FDA's regulation of dietary supplements if RFK Jr. is confirmed to lead HHS and Marty Makary, M.D., is confirmed to lead FDA. President Donald Trump is making moves heading into his second term that could have big implications for the U.S. Food and Drug Administration (FDA), the agency responsible for regulating dietary supplements. Top of the list is his nomination of Robert F. Kennedy Jr. for the position of secretary of the U.S. Department of Health and Human Services (HHS). If confirmed by the U.S. Senate, following fiery hearings this week on Capitol Hill, Kennedy would be tasked with managing and directing such health agencies as FDA, the U.S. Centers for Disease Control and Prevention (CDC), and National Institutes of Health (NIH). “Robert F. Kennedy cares more about human beings and health and the environment than anybody,” Trump said during a rally at Madison Square Garden in New York City on Oct. 27, just days before the Nov. 4 election. He added, “I'm going to let him go wild on health. I'm going to let him go wild on the food. I'm going to let him go wild on medicine.” Trump, who took office again on Jan. 20, made the announcement of Kennedy's nomination on Nov. 14 — making good on his campaign promise to give the environmental lawyer and former 2024 presidential candidate authority in the public health sector. Several stakeholders in the dietary supplement industry, who spoke to SupplySide Supplement Journal in 2024 prior to RFK Jr.'s confirmation hearings this week, have welcomed the move with enthusiasm. Kudos for Kennedy Loren Israelsen, founder and president of the (UNPA) said Kennedy is “very quickly becoming a hero” to the natural health community, including the organic regenerative and functional medicine communities. Kennedy is an avid supporter of alternative, holistic and preventive health solutions, calling for such measures as greater regulation of food additives and ultra-processed foods high in refined sugar, processed grains and seed oils as a means to help end widespread chronic disease in the U.S. “This is unprecedented to have someone who holds his views that would be at such a high level of government,” Israelsen said. “We've had members of Congress — Senator Hatch, Senator Harkin, [and] others — that have been advocates … of equal enthusiasm, [but] never the White House and never as crystal clear about intentions to make significant changes at FDA.” Daniel Fabricant, Ph.D., CEO and president of the (NPA), described Kennedy's approach to dietary supplement regulation as “a complete 180.” “The usual approach is, ‘Well, there's going to be more regulation, and things need to be tougher' and all that sort of rhetoric kind of painting the industry as irresponsible,” he said. “Whereas now, you've got somebody who says, ‘Wait a second, the industry has been plenty responsible, and Americans are healthier because of it. Now what can we do to advance that?'” Fabricant said, if confirmed, Kennedy's appointment to HHS secretary could drive engagement with FDA and stimulate greater focus on health and wellness. “Health and wellness is not just something that needs to be policed, as I think has really been the agency's take on it for the past 30 years,” he said. “The laws work, they protect consumers very well, but … FDA's mission is to protect and promote public health, so I think the notion that dietary supplements can play a role in health and wellness will certainly be discussed.” During Kennedy's confirmation hearings this week, including before the (HELP), the issue of FDA's regulation of dietary supplement products did not emerge. RFK Jr., however, did raise concerns about food additives, conflicts of interest within government and a nation whose citizens greatly suffer from chronic diseases. Passion points for reform Kennedy has been openly critical of FDA and other health agencies. In an Oct. 25 post on X, he criticized FDA for its “aggressive suppression” of “anything … that advances human health and can't be patented by pharma,” citing examples like psychedelics, raw milk, vitamins, clean foods, exercise and nutraceuticals as his ideas. Critics of Kennedy have contended many of his positions are not rooted in conventional science. “Robert F. Kennedy Jr. is not remotely qualified for the role and should be nowhere near the science-based agencies that safeguard our nutrition, food safety and health,” Peter Lurie, M.D., president of the Center for Science in the Public Interest (CSPI) and a former FDA official, said in a statement. “Nominating an anti-vaxxer like Kennedy to HHS is like putting a flat-earther at the head of NASA.” Many Democratic senators this week grilled Kennedy on his positions related to vaccines, abortion and other issues, contending he is not qualified to serve as the nation's top health official. “The receipts show that Mr. Kennedy has embraced conspiracy theories, quacks and charlatans, especially when it comes to the safety and efficacy of vaccines,” Sen. Ron Wyden (D-Ore.) said in his Jan. 29 before the Senate Finance Committee. In the post last year on X, Kennedy warned “FDA's war on public health is about to end,” and advised FDA officials who are “part of this corrupt system” to “preserve your records” and “pack your bags.” Kennedy has openly opposed Big Food, Big Ag and Big Pharma, contending public health agencies including FDA are “controlled by huge for-profit corporations” — namely, pharmaceutical companies. He's also challenged the safety of vaccines for children, claiming vaccines cause autism. During the Jan. 30 hearing before the Senate HELP Committee, Kennedy told lawmakers that he's open to changing his positions if presented with science that proves him wrong. In a statement responding to Kennedy's nomination, NPA called for “serious reform” at FDA. “Trump's nomination of Robert F. Kennedy Jr. spotlights the need for this reform,” NPA wrote. Israelsen said Kennedy's appointment would create “an unprecedented opportunity” for the dietary supplement industry. He advised homing in on areas where improvements or changes to policy would provide the most benefit to consumers. “Pick those things that are really important to the most people,” he said. “What would support and benefit consumers as it relates to supplements?” Fabricant and Israelsen both pointed to the exclusionary clause of the Federal Food, Drug and Cosmetic Act (FDCA), which excludes an ingredient from supplements if it was first investigated or approved as a drug. “The exclusionary provision in [the Dietary Supplement Health and Education Act of 1994 (DSHEA)] … has become a bigger problem as old and often little-used drugs have been knocking out well-known and well-used dietary ingredients,” Israelsen explained. Fabricant pointed to lawsuits filed by NPA that challenged FDA's interpretation of the exclusionary clause related to NAC (N-acetyl-cysteine) and NMN (nicotinamide mononucleotide). “This isn't a safety issue with NAC; this is a technical issue,” he said. “The agency has statutory authority to declare something as a dietary supplement. The [HHS] secretary has that authority. The fact that they continue to buck against using that … is part of the problem.” More DSHEA concerns Marc Schloss, VP of government affairs at the (CHPA), cited “great interest from Capitol Hill” on the need to update DSHEA, legislation now 30 years old. “We are confident that these conversations and interest on behalf of consumers will remain in the 119th Congress and appreciate the attention given to these issues,” he said. The ability to communicate information more comprehensively is another potential effect of a Kennedy-led HHS. Israelsen pointed to a “key message” communicated by Kennedy, as well as Trump: strong opposition to attempts by government to suppress, silence or limit free speech. Israelsen added this viewpoint is “comprehensive” and includes “fairly deep territory into commercial speech.” “There's interest in expanding our ability to communicate information … whether through structure/function claims and enhancement of that, or just the ability to say what is truthful and not misleading and substantiated,” he said. According to Michael McGuffin, president of the (AHPA), the current statutory language “rooted in the pre-digital era” prevents companies from sharing “truthful, non-misleading information” about dietary supplements and ingredients. That's created a challenge for dietary supplement companies that are investing in advanced research and are unable to effectively communicate their findings. “We see research looking at mechanisms of action, bioavailability, changes in molecular performance and function, and so on,” Israelsen said. “When DSHEA was passed 30 years ago, few companies were doing this level of advanced research on ingredients and finished products.” McGuffin said, “Modernizing the law to reflect today's information economy is essential, as it would allow the industry to better educate consumers, building long-term trust in our industry.” A new FDA commissioner Also in November, the then-president-elect nominated Marty Makary, M.D., a surgeon and public policy researcher at Johns Hopkins University, for the role of FDA commissioner. Makary sparked controversy for speaking out against Covid-19 vaccine mandates. He's also publicly criticized the government for its management of public health. “Unlike previous FDA commissioners, Dr. Makary … has been very open about his criticism of the government's failure to prioritize chronic disease,” Israelsen said in a statement. He pointed to a roundtable discussion hosted by Sen. Ron Johnson (R-Wis.) in September, at which the surgeon called the U.S. government “the greatest perpetrator of misinformation” for its promotion of the food pyramid. He went further to describe the U.S. as “the most over-medicated, sickest population in the world.” Israelsen continued, “This suggests a very different view of how FDA should focus its resources. Certainly, the reorganized Human Foods Program under Jim Jones would be given full support and a priority position within the new FDA.” In a statement, Fabricant said NPA is “hopeful that many of the reforms needed at FDA will come to fruition under [Makary's] leadership.” Scott Melville, president and CEO of CHPA, applauded Makary's academic and medical credentials, and the nominee's commitment to evidence-based medicine. “CHPA specifically hopes this nomination will help further FDA's mission to protect and promote public health with more evidence-based self-care options for consumers,” he added in a statement. Steve Mister, Esq., president and CEO of the (CRN), expressed optimism that Makary's leadership would contribute to innovation at the agency while maintaining “a commitment to safety, transparency and accountability.” He further highlighted CRN's interest in working with the new leadership to improve DSHEA. “In particular, we are eager to collaborate on ways to find regulatory efficiencies within the Dietary Supplement Health and Education Act (DSHEA), ensuring it continues to serve consumers effectively in today's marketplace,” he continued in a statement. The DOGE effect In November, Trump announced the new Department of Government Efficiency (DOGE) that will “slash excess regulations, cut wasteful expenditures and restructure federal agencies.” Two entrepreneurial heavyweights were poised to lead the program: Elon Musk, who owns X and also serves as CEO of Tesla and SpaceX, and Vivek Ramaswamy, a presidential candidate and founder of Roivant Sciences, a pharmaceutical research company. But after Trump began his second term in the White House, According to Trump's statement, the department will function outside of government while partnering with the White House and Office of Management and Budget to “drive large-scale structural reform and create an entrepreneurial approach to government never seen before.” How the new department would affect the dietary supplement industry is “a really good question,” Israelsen said. “Laws become accretive,” he explained. “It's like layers of sediment that build up over time. And for every law passed, there is seldom a law that is withdrawn or revoked.” Musk's DOGE will help to “de-layer” government and cut redundant laws, which Fabricant described as a “good thing.” DOGE also aims to cut unnecessary government expenditures — a feat that involves “mass headcount reductions” of government workers, Musk and Ramaswamy in The Wall Street Journal in November. Mister said he is “concerned” about potential cuts in resources, funding and staff at FDA. “If anything, we need an agency that is more effective than they are now,” he said. “We need them to do more enforcement. We need them to do more inspections. We need them to be smarter about how they interact with the industry. And I am concerned that if we start talking about wholesale cuts to FDA, even if it's in the name of government efficiency, I think that we could undercut our position as a respected, credible health care industry.” However, Mister acknowledged there are things relating to dietary supplements that FDA “needs to do better,” and he expressed his support for “making FDA more effective and more efficient.” Ongoing initiatives Also of interest to the supplement industry is the impact of the incoming administration on initiatives and ongoing developments at FDA that impact dietary supplements. One such development is FDA's recent overhaul, which the agency called the “single largest reorganization” in its history. As part of the revamp, FDA introduced the Unified Human Foods program. According to FDA officials, the reorganization, which took effect on Oct. 1, 2024, would strengthen the oversight of dietary supplements and the effectiveness of the Office of Dietary Supplement Programs (ODSP). “We've just gone through this reorganization of the food program, and I think we'd like to see that have a chance to actually take effect and to see how this new structure at FDA will impact dietary supplements,” Mister said. Israelsen said he does not expect FDA's plans to implement a mandatory product listing (MPL) to advance in Congress, “given that both the House and the Senate now are Republican majorities.” That's because there's “very often” a correction in one or both parties at the midterm elections, which can affect the “level of change” and “level of upheaval” that “may happen in terms of policy,” he explained. On the flipside, the political trifecta creates “that sort of efficiency” that “makes it more likely that there will be some sort of lasting effect” at FDA, Fabricant concluded. About the Author
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