**Revisions by Arthur Allen**
Last autumn, prior to his appointment as the senior U.S. health official, Robert F. Kennedy Jr. remarked that the Trump administration would free Americans from the FDA’s “aggressive suppression” of vitamins, dietary supplements, and other substances, declaring an end to what he termed the federal agency’s “war on public health.” In reality, the FDA lacks the authority to mandate that supplements be proven effective before their sale. When Congress, with the FDA’s encouragement, considered imposing legislation that would require manufacturers of vitamins, herbal remedies, and other products to prove their safety and efficacy prior to marketing, it faced an unprecedented wave of negative feedback—more than during any period since the Vietnam War, according to some reports. This backlash resulted in the 1994 Dietary Supplement Health and Education Act, which allowed the supplement industry to market products without testing them while also permitting unverified health claims, provided these claims do not explicitly state that a product can treat or cure diseases. Since then, revenue within the industry has surged from $4 billion to an astounding $70 billion.
With Kennedy now at the helm, the industry is poised for even greater changes: it seeks to expand health claims for its products and possibly secure government, private insurer, and flexible spending account funding for supplements, positioning them similarly to FDA-approved pharmaceutical drugs. On February 13, the day Kennedy was sworn in as Secretary of Health and Human Services, President Donald Trump unveiled a “Make America Healthy Again” initiative aimed at tackling perceived corruption in health regulatory agencies. This initiative instructed them to “ensure the availability of expanded treatment options and the flexibility for health insurance coverage to support beneficial lifestyle changes and disease prevention.”
Kennedy has promoted the idea that exercise, dietary supplements, and nutrition are the pillars of good health rather than conventional pharmaceutical products. Supplement industry advocates are eager for consumers to utilize programs like health savings accounts, Medicare, and SNAP (Supplemental Nutrition Assistance Program) to cover items such as vitamins, fish oil, protein powders, and probiotics. “Essentially they’re seeking a government subsidy,” noted Pieter Cohen, a physician at Harvard University who examines the supplement landscape.
During Kennedy’s confirmation hearing before the Senate Finance Committee on January 29, supporters from the Alliance for Natural Health celebrated at a quinoa salad lunch in the U.S. Capitol Visitor Center, declaring this to be a significant milestone for their health freedom movement. This movement, which merges libertarian capitalism with skepticism of the medical establishment, has advocated for unregulated health products since the 19th century. “The greatest opportunity of our lifetimes is here,” stated Jonathan Emord, the group’s general counsel, who has filed numerous lawsuits against the FDA to challenge restrictions on unverifiable health claims. “RFK has dedicated his entire life to opposing the undue influence of the pharmaceutical industry and ensuring that our interests succeed,” Emord added.
In promotional materials titled “The MAHA Mandate,” Emord and Robert Verkerk, the Alliance’s founder, articulated a vision where Kennedy would empower companies to make broader claims regarding their products’ purported health benefits. Emord indicated that the organization is preparing to sue the FDA to prevent it from imposing limitations on the non-pharmaceutical production of substances like biopeptides, which are linked to drugs such as Ozempic.
Despite reaching out for comment regarding its stance on dietary supplements, the Department of Health and Human Services, through spokesperson Andrew Nixon, did not provide a response. While the foundational law governing the FDA stipulates that any substance claimed to have therapeutic or curative effects qualifies as a “drug” and, therefore, is subject to stringent scientific evidence requirements, the new administration might redirect enforcement funds. Mitch Zeller, former director of the FDA’s Center for Tobacco Products, noted the implications of this change.
As a Senate aide earlier in his career, Zeller investigated a contaminated L-tryptophan supplement that resulted in the deaths of at least 30 individuals and sickened thousands in 1989. This incident led to heightened calls for supplement regulation, but the subsequent pushback resulted in the relatively lax regulation established in the 1994 law. Zeller commented that even the enforcement of that law could be easily diminished through executive action that restricts FDA inspectors from fulfilling their roles.
Nathan Jones, founder and CEO of Xlear, a company that produces products with xylitol, celebrated the potential for sweeping regulatory transformations. His company faced legal challenges from the Federal Trade Commission in 2021 for allegedly making false claims about its nasal spray’s effectiveness against COVID-19. Jones argues that the FDA’s requirements render it prohibitively expensive for xylitol to be approved as a drug based on a limited number of studies demonstrating its benefits for dental health. He lamented that fluoride in oral care products dominates the market, claiming that larger toothpaste corporations suppress alternatives.
Kennedy’s aspiration to eliminate fluoride from water supplies, based on concerns over its effects on children’s IQs, aligns with Jones’s interests, presenting an opportunity to spotlight his product’s benefits. Jones, along with many advocates for health freedom, asserts that factors such as clean air, water, and untainted food are fundamental to preventing and treating diseases—often incorrectly attributing the eradication of polio in the U.S. to enhanced sanitation rather than vaccinations.
The Alliance for Natural Health envisions that under Kennedy’s leadership, companies will be permitted to make extensive marketing claims grounded in non-FDA research, including resources like the National Institutes of Health’s nutritional guidance. Kennedy is also advocating for relaxed regulations on psychedelic substances, which certain veterans view as potential treatments for conditions like post-traumatic stress disorder (PTSD). Amber Capone, co-founder of a San Diego-based organization called VETS, shared their initiative to fund veterans’ access to ibogaine treatments in Mexico following her husband’s recovery from suicidal tendencies.
In what seems a fortuitous intersection, the move towards easing regulatory standards for supplements and psychedelics coincides with Kennedy’s demand for “gold-standard science” to evaluate preservatives and other food compounds implicated in America’s high rates of chronic diseases. “It is crucial to recognize that there’s little evidence to support such claims,” cautioned Stuart Pape, a former attorney at the FDA’s food center. “However, current indications suggest there is no intention to apply the same rigorous standards to supplements and nutraceuticals.”
Experts highlight that while many supplements may not pose significant safety risks, the lack of clarity on their effectiveness could lead to consumers wasting money or, worse, relying on untested products in lieu of proven FDA-sanctioned treatments for serious medical conditions. The landscape of supplement makers is divided; organizations like the Consumer Healthcare Products Association and the Council for Responsible Nutrition advocate for the FDA to regulate unsafe or misrepresented goods. In contrast, groups like the Alliance for Natural Health and the Natural Products Association largely lobby for reduced government oversight.
“The time has come for a radical shift—from reactive disease management to proactive health cultivation, from top-down public health mandates to individualized, patient-centric care,” proclaimed Emord and Verkerk in their “MAHA Mandate.”
KFF Health News invites current and former personnel from the Department of Health and Human Services or its affiliated agencies to come forward if they wish to discuss the ramifications of ongoing developments within the federal health system. For communication, KFF Health News can be reached through Signal at (415) 519-8778 or via their contact options.
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