Yves here. Despite being the sort that spends more on dietary supplements than food, I am not at all keen about the weak regulation of dietary supplements being made even more threadbare under RFK, Jr. I lived in Australia where all dietary supplements (at least then) were made to pharmaceutical grade standards. Australian-standards-compliant echinacea was the only echinacea I ever found effective in warding off colds and flus. And more generally, with the US regime, you have no idea if you are getting the quantities of the various ingredients listed on the label.
And I personally have been harmed a direct result of the laxness of US standards. In the late 1990s, a new weight loss supplement got favorable reviews. I tried it. It worked because the active ingredient was tiratricol, a thyroid analogue that was a prescription medication in some European countries, but not approved as a drug in the US. At my next physical, my GP remarked, “Your blood work says you are taking thyroid” (this was before the era of good web searching so I hadn’t checked out the ingredients). Since taking it, I have had weird thyroid readings (normal TSH with low T3 and sometimes T4) and fatigue. And taking thyroid supplements has not alleviated the fatigue.
The other way consumers can be harmed is financially, via snake oil products. Here in Southeast Asia, at an expats’ club meeting, I had the misfortune to sit through a presentation touting a Japanese set of products where if you took all of them, the cost would be $600 a month. The main one was $150 a month. They cured cancer! Reversed kidney disease! Reversed diabetes! Reduced saggy jowls! Even got thinning grey hair to grow back thicker and its old color. All “proven”” by patient photos and in one case, some lab data. Despite supposedly having a lot of doctors in Malaysia in their (sales) network, there was no sign of any effort at systematic data collection/documentation. Another red flag was the claim to have a bunch of patents. Checking out the patent numbers showed nearly all had expired, and the one or two valid ones were for not particularly impressive ingredients (“Fruitflow”) that other companies licensed too.
So expect a lot more of this sort of thing in the US if RFK, Jr. gets his way.
By Arthur Allen. Originally published at KFF Health News
Last fall, before being named the senior U.S. health official, Robert F. Kennedy Jr. said the Trump administration would liberate Americans from the FDA’s “aggressive suppression” of vitamins, dietary supplements, and other substances — ending the federal agency’s “war on public health,” as he put it.
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.
Even that law’s enforcement could be undercut with a stroke of the pen that would keep FDA inspectors out of the field, Zeller said.
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.
Kennedy’s desire to rid water supplies of fluoride because of its alleged impact on children’s IQ is welcome news, he said, and not only because it could highlight the value of his products. Jones stresses, as do many health freedom advocates, that clean air and water and unadulterated food do more to prevent and cure disease than vaccines and drugs. For example, he and other advocates claim, wrongly, that the United States eliminated the crippling disease polio through better sanitation, not vaccination.
The Alliance for Natural Health hopes that in lieu of strict FDA standards, Kennedy will enable companies to make expanded marketing claims based on evidence from non-FDA sources, Verkerk said, such as the National Institutes of Health’s nutritional information site, which describes the pros and cons of different supplements.
Kennedy has also called for relaxing the strictures on psychedelic drugs, which interest some veterans as potential remedies for such conditions as post-traumatic stress disorder. VETS, a San Diego-based organization, has paid for 1,000 veterans to get treatment with the powerful hallucinogen ibogaine at clinics in Mexico and other countries, said the group’s co-founder Amber Capone.
She got involved after her husband, a retired Navy SEAL, pulled out of a suicidal spiral after spending a week at an ibogaine clinic near Tijuana, Mexico, in 2017. She wants NIH, the Defense Department, and the Department of Veterans Affairs to fund research on the illegal substance — which can cause cardiac complications and is listed as a Schedule I drug, on par with heroin and LSD — so it can be made legally available when appropriate.
Coincidentally, the push for less onerous standards on supplements and psychedelics would come while Kennedy is demanding “gold-standard science” to review preservatives and other food additives that he has said could play a role in the country’s high rate of chronic diseases.
“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.”
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The stupidity – it burns. If Kennedy really wanted to Make America Healthy Again, there is a lot that he could do. Get fast foods out of schools and ban the corporate crap that is being pushed into schools so that some corporation can make bank – at the expense of young people’s lives – and especially ban fried & re-heated foods. Introduce physical exercise programs like California use to have decades ago. Before they dropped it, military doctors knew that any Californian recruit would be physically healthy sight unseen. Instead he is going to push supplements whose manufacturers will seek to have the government subsidize them. What will be in them? Who knows? Best would be to either forget them or else to import them from a country that still uses standards. I can see that under Kennedy that there will be a tide of dodgy products hitting the market with his OK but people are going to have to be wary. As modern governments show – we are on our own.
One way to Make America Healthy Again is to just let the weak ones die.
but where’s the money in that?
This is a man that apparently has at least one US falcrony license despite not knowing how to feed them.
Thank you t. Regarding this “has at least one US falcrony (falconry) license despite not knowing how to feed them.” …… can you supply any links to back up this claim or is it something you just “read” or “heard about”.
Search for “RFK Jr falconry license” in your search engine. Most resulting articles will state, that he has one of the 4K falconry licenses in the US. He stated that he had been practicing falconry since age nine…
Kennedy articles tend to not have quotes from Kennedy.
No where in this article did it say his policy goal is to free up supplement makers to go wild. The article uses a supplement lobby group and their stated goals as an interchangeable with his.
His stated goals (and his executive orders) are to get undue influence from industry out of health in general, why wouldn’t that wouldn’t include the world of supplements?
I think that if some of these things come to be, it ideally would come in the form of govt funding for study of supplements. The idea being , If there is a natural alternative proven for a specific ailment, people should know about it and have safe access to it.
Also, school food should be an easy target for reform.
Sorry, the onus is on your to prove that Kennedy has been misrepresented. He has not been. This is what he wrote:
https://www.bhfs.com/insights/alerts-articles/2024/a-look-at-rfk-jr-s-take-on-fda
For RFK, Jr. to depict barely regulated dietary supplements as heavily regulated is a gross misrepresentation. The only serious barrier is on advertising and labeling, that they can’t make medical claims if they have not made a clinical trial to prove it. Oh, and peptides are a fad these days. The scam product from Japan via Malaysia I mentioned in my intro hung its hat on having peptides made from salmon ovaries. I kid you not.
And his approach will kill people. Thailand now has tight regulation of stem cells because patients died under the unregulated regime.
Hi Yves! hope you are doing good, but just google the above quote you gave and look at the first page results sources (NYT is twice above then fold) and tell me again who’s the boss.
I don’t think deregulation just to make money is the bed RFK, jr lies in. I think he wants to actually help regulate the food and drugs of the US to improve peoples health. If people die, like in Thailand, I’m sure it gets regulated here too. That process happens with drugs and procedures that come from the traditional medical establishment as well.
Sorry, I just don’t buy it. It was a poor article. Everything points to the $medical industry as the only POV. He just is not their guy and the whole world knows it from the campaign against him. Great job. Now how do we work with him from here?
The article is from the Kaiser Family foundation. 30 percent of their budget comes from industry, the rest from papa Kaisers big medical money endowment. Their stated independence is suspect – especially with lack of counters in this particular article.
Why is that because he isn’t on their side, he is only framed as from the dark side? Why represent him only with a trade lobby group that has their $ in mind? Is everything an either/or? A make bank and run fight that one side or the other wins.
I think (and hope) that first research gets funded for alt medicines and food. The quiet part in the article was that lack of funding and regulation hurdles prevent small natural medicine from being researched in a FDA approved way (which is by design to keep the small players out of the game! – just like all industries)
If after more funded study, these ideas are bunk – they don’t get the label or FDA approval! Lets give the only glint of light in this administration a chance to actually beat the regulatory capture/corporate self dealing a chance!
First, your argument is ad hominem, which is a violation of our written site Policies.. You need to debunk the points it made, which you did not, and not attack the authors.
Second, you regard RFK Jr. as a good faith actor. I do not. RFK. Jr’s repeated insistence that vaccines cause autism, when that has long been disproven, raises fundamental questions about his competence regards medical evidence. I read his book on Fauci and could not get past the first chapter. I read all his footnotes. In about 25% of the cases, the text and footnote totally misrepresented what the cited study said. In an additional 25%+ the footnote cited studies that were on point but had been debunked.
He also professes to be an environmentalist but has joined an Administration dedicated to tearing down American’s not all that strong environmental regulations, particularly regarding greenhouse gases and fracking. Microplastics, air pollution, particularly PM2.5, and many many chemicals are implicated in bad health outcomes in the US. Why are alt health types obsessed with detoxing?
Third, you ignore the damage lax regulation can do, such as my own case of now having permanent fatigue as the result of taking a dietary supplement (I went from needing 7 hours of sleep a day to 10). That occurred under the CURRENT US regime.
Fourth, you ignore that the effect of this deregulation will be to allow more aggressive marketing and the making of medical claims with no/pathetically weak evidence. I’ve read many of the purported studies. Too small sample sizes, seldom with placebo controls.
And there is plenty of bogus marketing now. For instance, glucosamine + chondroitin supplements. Chondroitin is claimed to be a co-factor to increase the efficacy of the glucosamine. But the condroitin in these supplements is NOT the ones used in studies that showed some benefit. That one would be too expensive to include. Instead an ineffective compound is put in the supplements.
So the result is you will see aggressive marketing of high-priced dietary supplements…like the bogus one I discussed in my intro…and they’ll be free to make all sorts of claims with no real proof, or worse, fabricated anecdata. And you think this is a good thing?
I have a good friend who used to successfully treat the LA rich and famous with Chinese medicine when western medicine failed to cure their chronic illness. She would have to talk with each source to determine the quality of the herbs she was getting. It was a crazy amount of work and of course it helps if you can speak Chinese. She has since retired to a farm in Canada. Unfortunately at the moment, like with food, the only way to know the quality of the product is to know the farmer or grow it yourself. Here in Oregon I can grow quite a bit, but with a foot of snow on the ground now the season is pretty short. With a good mulching plants like ginger, turmeric, licorice will survive the winter yields are not that great. Also losses can be high. For example Gophers took out my saffron patch, though I likely never would have had the patience to harvest it the lawn looked beautiful when they were in bloom.
I don’t believe using Xclear as an example is very fair as they actually did a double blind placebo controlled study to show the effectiveness and have quality controls in place.
Yes school lunches along with school food gardens are an obvious place to start. I’ve set up two gardens at schools now and both have since been abandon. One because they were worried the the honey bees that were attracted to the garden would sting a child and the other because a change in administration resulted in loss of funding.
“Unfortunately at the moment, like with food, the only way to know the quality of the product is to know the farmer or grow it yourself.”
Well, that does seems to be a problem with 90% of the 340 million Americans having breakfast tomorrow.
I agree that good regulation of supplement ingredients seems like it should be at the top of the list. And I can’t imagine that the MAHA movement would be 100% opposed, since uncertainty about the contents of a supplement is more of a problem for them than it is for people who don’t take supplements. (Die-hard libertarians will remain opposed because haters gonna hate).
However I am quite happy that insurance companies may be forced to pay for supplements. I have ME/CFS, and if you think there is no answer for Long Covid … well, my situation is at least quite similar. Supplements, however, can provide some relief. They can spell the difference between semiautonomous disabled living, and requiring a caregiver for stuff like cooking, cleaning, or going to the store.
One does wonder if, once doctors can prescribe supplements, some supplement makers will start hosting pharma-like parties for doctors in the Bahamas, though. And being able to make unfounded health claims will only make that worse. However I think the solution is to regulate drugs and supplements equally in this respect–no gifts to doctors, no TV or radio advertising. Not that this is likely, under the mostly libertarian Trump administration.
But overall I am happy that insurance may soon cover supplements, just as I am happy that insurance currently covers prescription drugs. Both can be prescribed in unhelpful, or even harmful, ways. Both, when paid for by insurance companies or the government, can be prescribed in scammy ways (ie pill mills or simply the way name brand drugs are prescribed instead of generics, partly because of advertising and partly because of concerns about the quality of generics, both of which are fixable problems). But both can be essential to patients’ wellbeing, and to the degree that the problems are the same for both drugs and supplements, I would hope that the solutions would be the same.
I am not sure what regulatory framework (if any) RFK Jr is suggesting for forcing insurance companies to cover supplements but I propose that supplements should be treated by doctors and insurance companies like off-label pharmaceuticals. As I understand it (and I am not a medical professional) off-label drugs are not proven to treat the disease they are prescribed for, but the drugs must be known to be safe at the dose at which they are prescribed, and there must be some kind of theoretical explanation for why the drug could be useful.
So I, for one, hope he figures out a way to make this “supplement prescription” thing work. I know many chronically ill people who are too poor to afford supplements on their own who stand to benefit.
recalling that AFOne picture of the new deal guys sitting table with the dregs of multiple golden arches leavings…Rfk not seated but present…was that a can of coke in his hand? What was his expression? I cannot recall as laughter became me.