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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."
I dont understand why the supplement business cant be shutdown for blatently false advertising.
to the real doctors
this is a profession that can't even agree on what we're supposed to EAT three times a day but let's trust them anyways
What does a black drawf identify as first?
If they are actually wanting to make such claims about their products, I highly doubt that they'd care what the FDA has to say.
File under 'M' for 'Manic ranting'
just one line needed.
127.0.0.1 h t t p : / / a p k . i t - m a t e . c o . u k
This is the first story in many months about the U.S. government doing something sensible.
Almost every single MLM that have supplements and dietary crap market slight innuendos about how nobody has proved they can't save you from any illness...
You see, the trick is always be vague and let customer's imagination run to the painted wall.
FDA, pffft. Give me a break. That agency, like so many others, was captured long ago by the very industry it nominally regulates. When the stores have been full of quack medication for literally decades, and no one is ever held accountable, it's overwhelmingly clear that the government does not care about the lives of citizens. The bureaucrats are all too happy to take soft money from lobbyists, and not at all interested in doing their jobs. I.e., protecting the people from harm resulting from false claims. I can't think of any other reason why "medicines" such as homeopathy are permitted to exist. It's the American way... bilk the suckers, take them for everything they've got. Pay off those who are supposed to be the watchdogs.
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. . . .
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.
As long as you remember that every regulatory agency of government exists for one purpose: to serve that industry and assure their profits; you will understand their actions. Many ordinary citizens think that these agencies are there to protect citizens. Isn't that quaint!
We at Slashdot understand that every executive of these agencies is from the industry that they 'regulate', and they will return there in time. Their function is to see that companies in that industry are not disturbed by regulations and that they are given every opportunity to profit. In return, these executives receive excellent compensation and a lifetime of financial security.
This is the FDA, Food and Drugs, but the same holds true for the others in agriculture, industrial safety, insurance, transportation, agriculture, finance, etc. Even the agency that licenses your local nail salon has no interest in your safety- it is there to protect the industry from unlicensed operators who would 'steal' their profits.
So this agency, which exists to protect the profits of Food and Drug makers, now wants supervision over a $40 billion industry of herbal and vitamin providers. They sense an urgent need to protect consumers from this industry. (bullshit)
They see an opportunity to expand the agency and bring more well-paid executives into the gravy train that is their scam. Fuck the consumers, they want control over another industry.
In an enlightened society, businesses that need supervision would be licensed by a non-profit, consumer supported organization free of corrupt government influence. Underwriters Laboratories used to be such an organization but lately their endorsement doesn't seem to mean much. Consumers Union might be trustworthy. I'd love to be informed of other truly consumer oriented organizations.
...omphaloskepsis often...
They could go after the "Center for Self Leadership", the fraudulent "psychotherapy" group that claims "training doesn't matter!!!!" bot charges $1300/weekend for courses with no grades, no certification, and no training whatsoever for their instructors. They're as dangerous for the mentally ill as psychic surgeons treating cancer. But hey, they *identify* as therapists, so that makes it all OK.
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
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.
I'm going to scream bloody murder if this turns into some sort of referendum from the entire pharma-industrial complex to destroy ALL dietary supplements all the way down to garden-variety vitamin and mineral supplements. The pharmaceutical industry has wanted to make all the above 'prescription only' for decades and decades now, and everyone would suffer if that happened. Do you really want to have to get a prescription for a simple one-a-day multivitamin?
Should the FDA, often referred to the Federal Death Administration for their keeping life saving drugs off the market, be downgraded from a regulatory agency to an advisory agency? Let the FDA require information be included with drugs, ingestibles, and injectibles. But do not allow the FDA to hold these off the market. Let consumers make up their own minds. Or is that too libertarian for us?
{o.o}
In a world where politicians tell people to distrust scientists, encourage them to embrace fiction that conforms not to the real world but to how people would like it to be, it is easy to understand why these products sell so well.
If you teach people critical thinking is bad, don't expect them to think for themselves. In a world of 'just believe me, what scientists say is a hoax to win grant money", people will believe in any snakeoil that gives them hope, false or otherwise.
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."
Welcome to the 21st Century.
In most civilised countries, it's always been illegal to suggest you cure something when you have absolutely no proof of that, and even if you have proof, medical claims have to be backed up by studies, not your spurious claim made on the basis on one participant.
The best our supplement adverts have ever been able to say is things like "Helps support natural bone growth" (i.e. it doesn't make your bones snap in two, so it must be good). Same for any kind of faith healing nonsense.
You also can't advertise psychic services without a disclaimer that it's for "entertainment purposes only". Yep, even a seance, or a fortune-telling, or a psychic night in a pub.
How do I know? It's a hobby of mine to report the little slips-of-paper-through-the-door style of advertising when they "forget" to include such things or make such spurious claims. I've had quite a few fined for it. It's the best form of policing - society gets its censors, the idiots learn not to run such adverts, and I get to fill a quiet afternoon giggling to myself.
There's an Indian restaurant near me whose front window is splattered with quotes from various places suggesting how curry "could help" with things like cancer. Unfortunately, they skirt just the right side of the law, I think, so I'm always waiting for them to trip up, but one day when it's quiet and I'm in need of entertainment, I'll write a snotty email.
But anything claiming medical cures in any way, shape or form is illegal - there's even a specific law for claiming to cure cancer, and case-law specifically against claiming vaccines cause autism (the UK was the country that had the rubbish "doctor" who first posited that, and he did so *so* ineptly, and so without any evidence whatsoever, that they struck him off and took him to court).
Not a good track record at this point, pot-bitching-at-kettle.
In a world of the blind, the one-eyed man is king--and the two-eyed man is a heretic.
Their own interest ? That assumes that the FDA looks out for their interest, which is observably not the case.
Or haven't you noticed the insane skyrocketing of drug prices in this century ?
Do you know what they call alternate medicine that works?
Medicine.
Wanna buy a shirt?
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Fuck the supplements industry, go after the food industry that shits out garbage toxic prepared meals.
Those things are, legit, the worst thing the human race has ever invented. Worse than VX, worse than nukes, worse than weaponized anthrax, novichok, etc.
They have negatively impacted the health of more people than any other thing we've made. BILLIONS. Billions of them. Not even air pollution is on levels as bad as the run-on effects and sheer number affected.
For a start, either force them to start using refined cooking oils or force them out of business.
All these companies use cheapo shit vegetable oils that degrade to toxic levels during the cooking process.
In fact, go one step further, ban unrefined oils entirely. I'm not one for banning things, but that's one that should be banned. It causes nothing BUT harm.
Smoking 40 a day isn't even that toxic!
The human body can put up with a lot of nasty shit as long as you have a good diet and activity level, but mostly diet in the end.
If you take out the good diet, even with exercise your health goes to shit in 15-25 years, period. No amount of good genetics or marathons will save you from total collapse of regular healthy body function.
In fact, unhealthy exercisers typically end up having sudden heart attacks or strokes at gyms or later on in the day. They are as (un)healthy as obscenely obese people due to the strain they put on their body. Do not go to a fucking gym if you are unfit! Get a proper diet damn it! Gyms aren't a "fix all". An hour a day won't undo your 2 bags of chips and 20 McDonalds.
There's a reason most people in Americanized nations health has went to shit.
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.
Orin Hatch, the Republican senior US Senator from Utah (where many of these companies are based) has retired. His fellow Mormon Harry Reid, the Democrat US senator from Nevada who ran the Senate under Obama also retired. No conspiracy here, nor any anti-Mormon thing either, but it's simply the case that for various historical reasons the companies that sell many of these non-prescription non-medication "supplements" ended up based in Mormon regions and therefore Utah and these two Mormon senators cooperated in protecting those businesses which employ many Mormons.
Again, I'm not being anti-Mormon here, but just pointing out that whan a business that is concentrated in any particular community has powerful allies in congress it can end up being protected from proper enforcement, but such protection is vulnerable when the associated politicians retire or lose reelection (which is why such politicians end up with massive campaing "war chests" provided by their important consituencies). These companies are not all Utah based, Mormon owned or populated by Mormon employees etc, but when the Mormon-associated ones got protection, they all did.
I won't bother with nature or JAMA, frankly so far it looks like the usual schtick : none or negative evidence, and people stating "it works for me".
C. Sagan : A demon haunted world:
http://www.amazon.com/gp/product/0345409469/
visit randi.org
So far as I read it correctly the product with the same content are normally *generic* version of a trademarked one. What the summary is about are real crap supplement which have a lot of misleading claim. Not generic. Not the same thing. Supplement/homeopathy are a plague and should be heavily regulated as in "make clear and explicit they do nothing" rather than the skewed language they are using now.
C. Sagan : A demon haunted world:
http://www.amazon.com/gp/product/0345409469/
visit randi.org
I'm generating colloidal silver, as the generator was only the cost of two 32 oz bottles, and will make me around 1,500 gallons before I need to replace the silver wires.
I'm wearing bags over my socks (the ziploc gallon storage size) which I pour the silver into, then seal as much as I can and wrap velcro around my ankles. It is making the warts I've had for over a year go away.
Also, a couple weeks ago I bought some fulvic and humic acid and have been slowly increasing the dose since then, and it is starting to have an effect on the psoriasis on my scalp, which I've also had for over a year. The itching is almost gone, and there are far fewer flakes!
[Pharma] tells you not to research alternate cures. These two work, when money thrown at doctors over the past year has only resulted in pain (freezing and carving didn't help the warts) and smelling bad ("T-gel" reduces the flaking but doesn't eliminate the itching).
then FDA, step in and regulate it, if not, shut up.
You mean Thanks Reagan, because that's when the regulations about supplements were loosened.
Oops! Telling the truth about a huge government bureaucracy under regulatory capture by the biggest and most profitable global corporate industry in history....
TROLL!
"Somebody has to do something. It's just incredibly pathetic it has to be us."
--- Jerry Garcia
Idiot.
Great! Insightful argument. Terrific for persuasion!
Anything advertised as medication should be regulated
I guess you missed the part where they are marketed as supplements, not medicine. Let's not talk about the most profitable pharmaceutical product in history: statin drugs. These are nothing but derivatives of red yeast rice, which the FDA banned when the drug companies wanted to patent their derivatives. And they don't even treat a disease, just a marker of potential disease. Wow.
it's got nothing to do with the origin, be it straight from nature or from a complex industrial process.
Right and wrong. Right, it has nothing to do with the origin, it's about the patents. And wrong, because the origin determines whether you can get a patent and gouge the public for it, after multi-million dollar studies and paying off the FDA to the tune of a million dollars or so.
I suggest to make a nice smelling tea from the pretty Lily of the Valley, I guarantee it will solve all your physical problems!
Even better than the "idiot" opener, a "go kill yourself" closing! You win the argument for sure.
"Somebody has to do something. It's just incredibly pathetic it has to be us."
--- Jerry Garcia
Supplements are bullshit and all supplement advertising is based on bullshit logic.
Here's the fallacy they use:
Your body needs A to do B. Therefore, more A equals more B.
The premise is this: Your Body needs A to do B. Or, if your body does not get A, B will not happen. so, "Not A" means "Not B"
~A -> ~B
Their claim is this:
1) ~A --> ~B
2) A
3) Therefore B
This is a form of Denying the Antecedent.
Bullshit logic for bullshit products that don't do anything but exploit ignorance and fear for profit, knowing they are lying about literally everything they imply. They are "fortunately" only allowed to imply, and cannot make claims, but of course this works out for them, because only making implications means that the claimant can be impeached on making a false inference from a mere implication.
the FDA would go after some food purity regulations like labels giving the amount of wheat, amount of water in a loaf of bread....
The FDA really now just uses the 'D' part and not the 'F' part.
That are nothing more then an easy out for healthy eating. Various vitamins can be consumed just by eating properly. Then studies are out there that these vitamins are needed in a certain quantity. I will stick by trying to eat properly, especially when it comes to vegetables.
Example, I live in Cleveland. We defiantly do not get enough sun. So, supplements of Vitamin D(pill) are suggested.
Myself, I have read a number of studies(including goverment) promoting the use of Garlic. Raw garlic, from everything I have read is much better for you then the supplement. But, not everyone likes Garlic and a supplement(pill) is a substitute.
I am not a fan of Fish, but it is very healthy for you. I have no problem eating Sushi or Salmon steaks, but this does not occur regularly as a part of my normal diet. Fish oil supplement.
Where I think the goverment should regulate is, the ingredients and manufacture of these supplements.
Anonymous comments are as pathetic as the anonymous "sources" that contaminate gutless journalism from the New York Time
Why is it bad for supplement makers to lie when we're used to Fake News all OVER the place ?
Just because you disagree with the guy doesn't make him a troll. It is a valid opinion and everyone is entitled to have and express them.
Meta-moderators take notice. There is no -1 I don't like this opinion and there is a reason.
If they advertise it as medicine it already does fall under regulation. The FDA is complaining about a problem created by their own lack of enforcement of existing regulations.
Whether the truth or not, it is valid opinion held in one form or another by most of the country. It is not a troll.
not to work, or proven to work. Do you know what they call Natural Medicine that has been proven to work? Medicine
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"Meh, you will be closed in the next week anyway."