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FDA Warns Supplement Makers To Stop Touting Cures For Diseases and Cancer
An anonymous reader quotes a report from The New York Times: The Food and Drug Administration on Monday warned 12 sellers of dietary supplements to stop claiming their products can cure diseases ranging from Alzheimer's to cancer to diabetes. At the same time, Dr. Scott Gottlieb, the agency's commissioner, suggested that Congress strengthen the F.D.A.'s authority over an estimated $40 billion industry, which sells as many as 80,000 kinds of powders and pills with little federal scrutiny. These products range from benign substances like vitamin C or fish oil to more risky mineral, herbal and botanical concoctions that can be fatal.
"People haven't wanted to touch this framework or address this space in, really, decades, and I think it's time we do it," Dr. Gottlieb said in an interview. He is particularly concerned about supplements that purport to cure diseases for which consumers should seek medical attention. "We know there are effective therapies that can help patients with Alzheimer's," he said. "But unproven supplements that claim to treat the disease but offer no benefits can prevent patients from seeking otherwise effective care." The companies included TEK Naturals, Pure Nootropics and Sovereign Laboratories. In a letter to TEK Naturals, the F.D.A. and the Federal Trade Commission chastised the company for marketing Mind Ignite as a product "clinically shown to help diseases of the brain such as Alzheimer's and even dementia."
"People haven't wanted to touch this framework or address this space in, really, decades, and I think it's time we do it," Dr. Gottlieb said in an interview. He is particularly concerned about supplements that purport to cure diseases for which consumers should seek medical attention. "We know there are effective therapies that can help patients with Alzheimer's," he said. "But unproven supplements that claim to treat the disease but offer no benefits can prevent patients from seeking otherwise effective care." The companies included TEK Naturals, Pure Nootropics and Sovereign Laboratories. In a letter to TEK Naturals, the F.D.A. and the Federal Trade Commission chastised the company for marketing Mind Ignite as a product "clinically shown to help diseases of the brain such as Alzheimer's and even dementia."
This is the first story in many months about the U.S. government doing something sensible.
Supplement makers announce pill to cure people of the desire to take supplements; FDA confused as to how to proceed.
It must have been something you assimilated. . . .
so called "medicenes" like homepathy treatments exist precisely because they do not fall under the regulations of medicenes. So that isn't anything to do with the regulator being soft, it is the regulator currently has no power over them as they aren't classified as medical treatments and as long as they keep their claims vague enough with innuendo etc they are not subject to medical regulations.
That was from the linked NYT article and scared me! Fortunately it seems that that's in referral to the seizures from a couple of years ago. There were so many complaints from satisfied customers that the FDA relented. P.S. I'm not affiliated with any companies selling Kratom, nor do I have any financial interest in it.
Theanine is generally recognized to work as advertised, and to be reasonably safe at the recommended doses. It's in tea. Same deal with Kava Kava, it was the extraction from the wrong part of the wrong plants that affected a very few people. CBD oil is now legal, thus a supplement, and its grateful users would be livid if anyone tried to deny them its benefits. It's amazing how many herbal supplements are out there that have been taken for thousands of years for specific purposes that modern analysis now can confirm as being due to specific chemical components. Safe use has always been a consideration, and that along with the BS claims of some is where the FDA should focus.
In an enlightened society, businesses that need supervision would be licensed by a non-profit, consumer supported organization
Let me know when you find an enlightened society. I want to go to there. Until then, I'll be happy to have the FDA help my grandparents not waste money on pseudoscience garbage that purports to cure my grandpa's cancer, or my mom purchasing the latest bullshit thing Doctor Oz claims is a cure-all.
The supplement industry is ripe with need for regulation. The lack of evidence, the lack of quality control or even a requirement that you're actually getting the thing you're paying for, the preying on the uneducated -- this is a very vile industry.
You could just make it illegal to scam people, you know?
As in lying about the properties of your product, claiming things that you have no evidence are true, and advertising features or advantages your product does not actually have.
But you guys dug yourself a deep grave the day some idiots in robes decided that corporations are people and thus the first amendment applies to them and now they can spread whatever lies they want and say "free speech".
The simple rule "advertisement must be truthful" would kill all this bullshit instantly. But I guess free speech for profit-based legal entities is more important than not scamming people.
Assorted stuff I do sometimes: Lemuria.org
There are entire industries (plural!) that exist by living just outside the border, like slum towns.
An ex-GF of mine studied this stuff and once said something very clear and straightforward: All those skin cremes are scams. To be actually effective, they would have to penetrate the outer layers of the skin. But if they did that, they would be classified as medicines and sold only in pharmacies. If you can buy it in a drug store, the only thing it actually does is make your topmost skin layer a bit wet.
I took that as a general concept for other stuff of the same type. You know, vitamins, supplements, pills and cremes and everything else that claims to have some effect on your body. If you can get it outside a pharmacy, it probably does nothing you couldn't do yourself with the equivalent of a damp towel.
Assorted stuff I do sometimes: Lemuria.org
The FDA shuts down companies making medical claims for "supplements" all the time, the premise being that they are falsely advertising medical treatments. Or in the words of the original press release âoeillegally marketed as unapproved new drugsâ. The word illegally is the important bit. They get the phony diet and vitamin pushers on the same premise, the same thing prevents the sale of snake oil/patent medicine in many cases, when touted as cures for disease.
The so-called Quack Miranda Warning.
Basically, there was a push in the early 90's to put this stuff under some long overdue regulations, so the snake oil industry organized a huge campaign to defend their business model. They ran ads about how evil government was coming to take your precious, essential, life giving, natural supplements away for their Big Pharma cronies, or something to that effect, and their customers wrote a lot of letters to politicians demanding the supplement manufactures be given leeway.
It worked, con artists successfully convinced the public (enough of it anyway) to act against their own best interests, and that's how you can sell homeopathy as a sleep aid, curry powder as a weight loss pill, the latest superfruit fad as the wonder everything pill, and other items of questionable benefit as something with the deceptive appearance of medical value. You just have to say the magic words "These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease" on your product.
The FDA has somewhat strict labeling guidelines for supplement makers, in that they're not supposed to say that the supplement cures a specific disease or condition. "Label" extends to websites and advertisements as well.
That said, the FDA doesn't actively scan the world for structure/function claim violations. Even then, it's unclear what authority the FDA has when it comes to actually prosecuting structure/function claim violations.
You would think that those would fall under the FTC, not the FDA, since structure/function claims really are more false advertising.
FYI, the downside to structure/function claims is that there's apparently no process or criteria for showing that your structure/function claim is actually valid. The FDA will back down if you register your claim, though, which is more confusing.
Are we reversing the normal burden of proof? Because I have a pill for you that will make you live 20 years longer, and there are absolutely no controlled studies saying it does not work!
Anything advertised as medication should be regulated, it's got nothing to do with the origin, be it straight from nature or from a complex industrial process.
I suggest to make a nice smelling tea from the pretty Lily of the Valley, I guarantee it will solve all your physical problems!
"The likes of Facebook and WhatsApp are free to those whose privacy is of zero value."
Yeah, if you dilute the curry down til its nothing water and only eat that then you should start to see the weight drop off in no time.
Wanna buy a shirt?
https://www.redbubble.com/people/stealthfinger/shop?asc=u
He singlehandedly made America stupid? That's a feat, all the religions combined couldn't accomplish that, and not for a lack of trying.
We used to have a Bill of Rights. Now, with the rights gone, all we have left is the bill.
It's harmless until someone tries to cure cancer with sugar pills.
It's sad to watch people die that don't need to because they fell for some bullshit peddlers.
We used to have a Bill of Rights. Now, with the rights gone, all we have left is the bill.
Nearly all prescription medicine is poison in some way.
That's like claiming water is poison. People overdose on it every year (https://en.wikipedia.org/wiki/Water_intoxication). But the majority of warnings are primarily to keep the ambulance chasers away.
Sorry to hear about your issue w/statins. I had pretty much the opposite situation, discovering in my 30s that I had ~230 total, and for many years hearing from doctors that I should exercise (I was in the gym five days a week), and watch my diet (I was ~40lbs lighter back then). Years later, still with the same issue, I found out that all my aunts and uncles were on statins. So for the last ~20 years or so, I've been doing just fine on them. I've only heard of people with the muscle pain you mention...none of my family members have that issue.
Just another day in Paradise
In the UK if you claim to cure a disease then you are a medicine and have to regulated
If you claim to cure cancer then this is a special case ... your product is illegal and you will be shut down and fined
Puteulanus fenestra mortis
You mean Thanks Reagan, because that's when the regulations about supplements were loosened.
The FDA has no involvement with the pricing of drugs, if you want that, you'll need to go to India or Canada.
Sorry! We'll miss you!
Having worked in the regulated industry, I can say for a fact that you are completely clueless. You'd be right if "no involvement" meant "completely controls", but it doesn't. If you can't get a drug/treatment/device through the regulation hurdles, you can't sell it. If you can't sell it, the competitor that paid off the inspector can charge what they want. The FDA is the gatekeeper.
Aah, change is good. -- Rafiki
Yeah, but it ain't easy. -- Simba
There is nothing wrong with the existing policy. The problem is it isn't enforced. There is also a perception problem because of the myth that all things natural are safer and better than man made. Then there is reverse of that myth, that only the man made things work. Neither is true.
Ask any Olympic power lifter, there are definitely supplements that work and work so well they have to engage in efforts to restart their natural hormone cycles afterward just like steroids, hundreds of them, there are also thousands of fakes that do nothing and that is just one class of supplement.
The idea all herbal supplements are snake oil is as bogus as the claim that they are miracle cures. Try asking your doctor about drinking a cup of willow bark tea each morning with your high blood pressure and back aches. He'll tell you it works, suggest a baby Asprin instead, it could go either way since they are the same thing.
Try asking your doctor about drinking a cup of willow bark tea each morning with your high blood pressure and back aches. He'll tell you it works, suggest a baby Asprin instead, it could go either way since they are the same thing.
Actually they're only similar as the Willow contains Salicin which is metabolized into salicylic acid whereas Aspirin contains acetylsalicylic acid. The salicyclic acid is much harder on the stomach then the acetylsalicylic acid though they do have basically the same medical qualities.
From https://en.wikipedia.org/wiki/...
https://en.wikipedia.org/wiki/Inverted_totalitarianism
A side note on quality control.
There are hundreds of supplement companies. Some do thorough quality control. Some do less well. Some supplement companies to nothing but sell pills made from powders bought in bulk from outside the U.S. (even China), relying on their vendor to do the Q.C.. It's not easy to tell which companies are selling good, uncontaminated, full strength fresh product.
Try to learn which brands are reputable; be wary of extremely strong claims. Read labels carefully. Most products from non-flamboyant companies are decent quality.
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