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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.
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'
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.
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.
It could be argued that peddling opioids is a tad worse than peddling relatively harmless supplements.
Or that prescribing cholesterol, blood pressure and blood sugar medication is less benign than prescribing exercise and selling you exercise videos.
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
Yes as even some of those FDA approved drugs for chemo are incorrectly applied / diluted or generally a scam in approval clothing.
Personally would rather take a placebo then over pay for anti-cancer agents that many times are a big cheat in cost.
Number one cheat, price fixing, number two cheat valves frequently with tubing ineffectively set so no drip gets into patient or reduced dosage via ignored procedure so vacuum forms.
It goes on, so get the FDA off their corrupt arses and have them actually be effective us more delusional than AOC on LSD during SOTU white out.
http://www.aisnota.com/slashdot/ Welcome to Logic and the Future
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 like Answer
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}
I use an acne cream.("acne treatment" from Esse) I didn't get it from a pharmacy, and it's relatively expensive. Despite using the word "herbal" it works wonders compared to other creams I've tried without giving me chemical burns. This data point does away with your claim that no skin cream bought over the counter works.
If video games influenced behavior the Pac Man generation would be eating pills and running away from their problems.
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).
Your own observation of UL suggests that any regulatory agency, public or private, can and likely will be subverted eventually.
I suspect both FDA and UL would best be dismantled and rebuilt from scratch.
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 ?
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
Pretty sure its food.
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You are right. Skin conditions at the outside (acne is about the pores getting clogged up) can of course be healed from the outside. I was speaking about "anti-aging" and "reduces wrinkles" types of cremes and should've made that more clear.
Assorted stuff I do sometimes: Lemuria.org
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.
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.
Usually true, though some ingredients might cause skin irritations or other side-effects and brand names are maybe slightly more likely to be careful in their selection.
Assorted stuff I do sometimes: Lemuria.org
But it's OK to watch people die because of "everyone knows" medical orthodoxy.
What kind of argument is that?
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
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
Same here with Statins. Been on them nearly 15 years at this point. Diet, exercise, keeping my BMI smack dab in the middle, exercising rigorously 6 days a week, and my cholesterol was off the chart. Great genes from my father's side, but Statins have kept it under control. No side effects either.
Suppose you were an idiot and suppose you were a member of Congress
You mean Thanks Reagan, because that's when the regulations about supplements were loosened.
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.
Be careful of getting too broad. Vitamin supplements are perfectly fine for dealing with conditions that are known to be caused by vitamin deficiencies. Someone claiming that a vitamin supplement will cure cancer is full of shit, while your doctor telling you to take a Vitamin C supplement in order to cure scurvy is giving you correct medical advice.
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.
In other words, leaving it up to "a non-profit, consumer supported organization free of corrupt government influence" ends up not working?
Have you considered the studies that show most of the cancer drugs on the market have no better outcomes than placebos?
Aah, change is good. -- Rafiki
Yeah, but it ain't easy. -- Simba
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
https://www.fda.gov/newsevents...
Also:
Safety and efficacy concerns: There are no homeopathic drug products marketed in the United States that are FDA-approved. This means that FDA has not evaluated them for safety or effectiveness. Thus, such products may not meet modern standards for safety, effectiveness, and quality.Mar 21, 2018
Just another day in Paradise
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.
Sorry, it's from Essy
If video games influenced behavior the Pac Man generation would be eating pills and running away from their problems.
Right, because those cancer people are totally going to live!
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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Bold claim sir, bold claim, where is your evidence? You better not go selling any and claiming eating food is good for your health!
That is basically what this comes down to. The FDA is in bed with big pharma and always has been. Their approval process keeps out competition and protects pharma from lawsuits. There are thousands of known herbal remedies that work just fine and predate modern medicine, there are also hundreds of thousands of bogus snake oil products as well.
In a sane world the FDA would regulate clear labeling and prevent claims of being medicine and nothing more. They also might regulate production in much the same manner as food. They wouldn't be staffed with pharma industry employees who take lucrative consulting and lobbying gigs as bribes after leaving their positions either.
Lots of people live with and through cancer. What are you on about?
It's OK Bender, there's no such thing as 2.
Being absorbed through the skin is not an all-or-nothing affair. Some small portion of many things regarded as "not absorbed through the skin" do, in fact, get through.
Analgesic cremes such as Ben-Gay do reduce pain, and that wouldn't happen if they got no further than the epidermis.
For another example, vitamin C in water solution can reduce the effects of a sunburn.
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Vitamin C reduces the incidence of many cancers.
FWIW, it seems that there are a number of different ways to deal with cancer, some of which depend upon timing. When a cell is healthy, the goal is to protect it from the kind of damage that causes cancer; vitamins and minerals are helpful then. When a cell is somewhat damaged, sometimes it can be reverted to a healthy state; in some cases vitamins and other supplements help. In other cases, the damage can't be repaired, and we want the body to attack the cell and break it into harmless pieces. We want the damaged cell not to reproduce; some medicines and a few supplements slow reproduction of cancerous cells, some discourage the formation of blood vessels that would bring nutrients to the cancer. If a cancer is established in one place, the goal is to prevent it from establishing itself in other places, and the things that help toward that goal may differ from what works on other aspects of cancer.
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Some governments are formed partially to create and promote fraud. As the USSR did for Lysenko.
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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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I had the same experience as you - statins caused muscle pain and even cramps. Exercise is what worked; statins did not make anything better except blood tests.
And newer studies show that lowering your cholesterol with medication doesn't have much benefit anyhow. Yes, there is a correlation between high LDL cholesterol and heart disease, but not a causation. Being out of shape causes both high LDL cholesterol and heart disease, but high LDL is an indicator and not the problem. Lowering it just doesn't cure the underlying problem, much like pain killers doesn't cure what causes the pain.
Now this is something I'd like to see! Can you provide some links?
We used to have a Bill of Rights. Now, with the rights gone, all we have left is the bill.
With proper medicine they have a chance.
Without, they don't.
We used to have a Bill of Rights. Now, with the rights gone, all we have left is the bill.
Real ones or homeopathetic ones?
We used to have a Bill of Rights. Now, with the rights gone, all we have left is the bill.