In fact, the FDA can’t even require that supplements be effective before they are sold. When Congress, at the agency’s urging, last considered legislation to require makers of vitamins, herbal remedies, and other pills and potions to show proof of their safety and worth before marketing the products, it got more negative mail, phone calls, and telegrams than at any time since the Vietnam War, by some accounts. The backlash resulted in a 1994 law that enabled the dietary supplement industry to put its products on the market without testing and to tout unproven benefits, as long as the touting doesn’t include claims to treat or cure a disease. Annual industry revenues have grown from $4 billion to $70 billion since.
With Kennedy now in the driver’s seat, the industry will likely expect more: It aims to make bolder health claims for its products and even get the government, private insurers, and flexible spending accounts to pay for supplements, essentially putting them on an equal footing with FDA-approved pharmaceuticals.
On Feb. 13, the day Kennedy was sworn in as secretary of Health and Human Services, President Donald Trump issued a “Make America Healthy Again” agenda targeting alleged corruption in health regulatory agencies and instructing them to “ensure the availability of expanded treatment options and the flexibility for health insurance coverage to provide benefits that support beneficial lifestyle changes and disease prevention.”
Kennedy has said exercise, dietary supplements, and nutrition, rather than pharmaceutical products, are key to good health. Supplement makers want consumers to be able to use programs like health savings accounts, Medicare, and even benefits from the Supplemental Nutrition Assistance Program, or SNAP, to pay for such items as vitamins, fish oil, protein powders, and probiotics.
“Essentially they’re seeking a government subsidy,” said Pieter Cohen, a Harvard University physician who studies supplements.
As the Senate Finance Committee questioned Kennedy during his Jan. 29 confirmation hearing, supporters in the Alliance for Natural Health lunched on quinoa salad in the U.S. Capitol Visitor Center and crowed that the moment had finally arrived for their health freedom movement, which has combined libertarian capitalism and mistrust of the medical establishment to champion unregulated compounds since the 19th century.
“The greatest opportunity of our lifetimes is before us,” said Jonathan Emord, the group’s general counsel, who has brought many successful lawsuits against the FDA’s restrictions on unproven health claims. “RFK has dedicated his whole life to opposing the undue influence” of the pharmaceutical industry and “assuring that our interests triumph,” Emord said.
In speeches and in a pamphlet called “The MAHA Mandate,” Emord and alliance founder Robert Verkerk said Kennedy would free companies to make greater claims for their products’ alleged benefits. Emord said his group was preparing to sue the FDA to prevent it from restricting non-pharmaceutical production of substances like biopeptides — complex molecules related to drugs like Ozempic.
HHS spokesperson Andrew Nixon did not respond to a request for comment on the agency’s plans vis-à-vis dietary supplements.
While the basic law governing the FDA establishes that a substance alleged to have treatment or curative effects is by definition a “drug,” and therefore comes under the agency’s requirements for high standards of scientific evidence, the new administration could reallocate money away from enforcement, said Mitch Zeller, former head of the FDA’s Center for Tobacco Products.
As a Senate aide early in his career, Zeller investigated a tainted L-tryptophan supplement that killed at least 30 people and sickened thousands in the U.S. in 1989. The scandal led the FDA to seek heavier regulation of supplements, but a powerful backlash resulted in the relatively weak supplements law of 1994.
Share this article
Sweeping changes couldn’t come too soon for Nathan Jones, founder and CEO of Xlear, a company that makes products containing xylitol, an artificial sweetener. The Federal Trade Commission sued Xlear in 2021 for making what it called false claims that its nasal spray could prevent and treat covid.
Jones points to a handful of studies evaluating whether xylitol prevents cavities and infections, saying the FDA would require overly expensive studies to get xylitol approved as a drug. Meanwhile, he said, dentists have been bought out by “Big Toothpaste.”
One can hardly find any products “without fluoride for oral health,” he said. “Crest and Colgate don’t want it to happen,” he said.
Credit: Montra[/caption]
“Put aside the fact that there’s precious little evidence to support” that idea, said Stuart Pape, a former FDA food center attorney. “There’s been no indication they want the same rigor for supplements and nutraceuticals.”
Although most of these products don’t have major safety concerns, “we have no idea which products work, so in the best case people are throwing away a ton of money,” Zeller said. “The worst-case scenario is they are relying on unproven products to treat underlying conditions, and time is going by when they could have been using more effective FDA-authorized products for diseases.”
Supplement makers aren’t entirely unified. Groups such as the Consumer Healthcare Products Association and the Council for Responsible Nutrition have advocated for the FDA to crack down on products that are unsafe or falsely represented. The Alliance for Natural Health and the Natural Products Association, meanwhile, largely want the government to get out of the way.
“The time has come to embrace a radical shift — from reactive disease management to proactive health cultivation, from top-down public health diktats to personalized, individual-centric care,” Emord and Verkerk state in their “MAHA Mandate.”
[KFF would] like to speak with current and former personnel from the Department of Health and Human Services or its component agencies who believe the public should understand the impact of what’s happening within the federal health bureaucracy. Please message KFF Health News on Signal at (415) 519-8778 or get in touch here.
Arthur Allen is Senior Correspondent at KFF Health News. Follow Arthur on X @ArthurAllen202
