FDA Warns Supplement Makers To Stop Touting Cures For Diseases and Cancer 199
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."
What, are you serious? (Score:2)
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They will care when they get shut down.
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Shut down how, exactly?
How can the FDA revoke approval for things it never gave approval for in the first place?
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I'm pretty sure the FDA has the authority to ban the sale of violating products in stores.
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Of course. But they can't make claims of medical utility, or that they are cures or treatments for disease, without FDA approval.
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FDA approval isn't a requirement for FDA ban. That steak in the grocery store isn't FDA approved either but you bet your ass they can block its sale.
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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.
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The thing here is that they don't actually outright *say* that their stuff will cure the disease, they only say that it *can* cure the disease, or has been recorded as being an effective treatment.
The fact that the evidence to support their claims is purely anecdotal is irrelevant, it's not really an objectively provably false claim. Any more than it's possible to prove that god doesn't exist, for example.
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Shut down how, exactly?
Are you asking about the exact process and procedure? It's probably the same as enforcement of regulations by any federal agency. Like other federal departments, Health and Human Services has Administrative Law Judges, who can issue rulings regarding federal regulations. If a company ignores a ruling from an ALJ, it's probably treated the same as any other contempt of court.
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Most federal laws concerning the FDA are part of the Food, Drug and Cosmetic Act,[21] (first passed in 1938 and extensively amended since) and are codified in Title 21, Chapter 9 of the United States Code. Other significant laws enforced by the FDA include the Public Health Service Act, parts of the Controlled Substances Act, the Federal Anti-Tampering Act, as well as many others. In many cases these responsibilities are shared with other federal agencies
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If I might point out, the companies that host their websites, ship their goods, pr publish advertising for them will care somewhat. This will make them liable for illegal behavior of their clients, especially if they are notified and fail to discard such clients.
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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.
They'll start caring plenty quick when they get sued, if not by the FDA then by their victims or, preferably, both.
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There is a flip side to the coin, they aren't given the legitimacy of big pharma or protections. If big pharma causes your penis to explode as a side effect they are immune to prosecution as long as they disclosed it during FDA trials. If your unicorn anal scrapings do the same you can sue them.
Good! Better regulation. (Score:3)
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They could put Ajit Pai in charge - just to be sure.
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If Ashit Pile ran the FDA, homeopathy would be a mandatory first-line therapy approach.
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The free market allows people to sell marvelous new products, products that make the purchasers' lives much better. The free market also allows people to sell fraudulent and dangerous products, at least until they're caught and punished (which we hope happens). The result is a net gain for humanity, progress.
The less free the market is, the slower and smaller the flow of new products will be. Some beneficial things will be prohibited entirely. Also, the people doing the prohibition have to be paid, and that
In related news ... (Score:5, Funny)
Supplement makers announce pill to cure people of the desire to take supplements; FDA confused as to how to proceed.
"F.D.A. has ordered that kratom imports be seized" (Score:3, Interesting)
But some supplements do work (Score:4, Interesting)
Re:But some supplements do work (Score:4, Interesting)
Exactly this. There are also a few supplements that contain exactly the same thing as pharmaceuticals that cost 1 or 2 orders of magnitude more. A good doctor will direct you to take the readily available OTC supplement instead.
For example [diabetesincontrol.com], extended release Niacin. $10 over the counter vs $230 for the same damned thing as prescription Niaspan.
It's no wonder that people legitimately wonder when the FDA rumbles about killing off suppliments.
In many cases, it's fair enough that the FDA insists no medical claims be made, but in other cases, if doctors are actually recommending the stuff to treat specific medical conditions, is it really fair to insist that they not say so on the bottle?
If any of the supplements don't contain what they claim or if they have harmful contaminants, by all means take action against the manufacturer. If it is something known to actually be dangerous, by all means require a warning or if it is REALLY dangerous, more extreme action. But for the latter, the determination must be reasonable. If it's not more harmful than things routinely sold OTC, leave it alone or just require the warning.
a generic is not a supplement (Score:2)
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These are a bit of a new "innovation" from the pharmaceutical companies. The supplement was on the market FIRST. The pharmaceutical company does a bit of FDA ass kissing and gets granted a shiny new exclusive on a meaningless tweak and then tries to carefully market their new expensive prescription "drug" in a way to imply that it's not actually just a repackaging of the generally recognized as safe OTC supplement. The FDA knows about the scam, but because their asses were all suitably kissed actually endor
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We already knew the dose and effectiveness. Doctors read the same paper as the pharmaceutical company). Considering that Niacin (vitimine B3) has been takes safely as an over the counter for longer than the FDA has existed, I can see no justification for trying to make it a prescription drug at 20 times the price. You've probably taken it yourself, possibly in the form of a Flintstone's chewable.
Colchicine's effectiveness and dosing has been known since George Washingtin's time. However, it really does need
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There are law firms in Washington who will literally help you craft legally meaningless statements that make medical promises by way of you misunderstanding and projecting your own desires.
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Supplement companies do not have the financial reserves to do the testing for unpatentable products, nor can they get a loan for a product that will never pay back the cost of the testing.
Universities frequently test odd things, and the small scale tests they run often give supplement companies a clue for possible new products. The scale of such tests are orders of magnitude below what the FDA requires. The supplement companies probably can't afford the bribes, either.
depend on WHAT is advertised (Score:2)
Natural Medicine has either been proven (Score:2)
simple... (Score:5, Interesting)
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.
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You could just make it illegal to scam people, you know?
Wow, talk about an effective ad blocker....
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You could just make it illegal to scam people, you know?
Is that not already illegal in your country? I thought it was. The problem you've got is that where does a scam stop and stupidity begin. It's not quite that black and white. Whilst obvious scams should be stopped, at some point you've got to give up and admit that ultimately we can't protect a truly dedicated idiot from themselves. Here in the UK we have education campaigns and monthly articles
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You could just make it illegal to scam people, you know?
I advertise that I have the BEST car. Or the BEST lasagna. How many ways can a scammer wiggle out of that when we all know what they're selling is complete garbage?
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Learn some history. The "corporations are (like) people (before the law)" came from a corporation trying to evade paying for goods it had received, arguing that corporations don't have to pay because they don't have the financial responsibility that people have. The court said "Yes they do. Pay up." The initial corporations-are-like-people decision was to the disadvantage of the corporation and rightly so.
Free speech is for everyone, and limiting it by the sort of people involved is very dangerous.
"Profit-b
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I applaud you for thinking for yourself.
I pity you for the results of that process, but if you keep at it then one day you'll figure it out and this "thinking" thing may start to work out for you.
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It's ironic "big pharma rip you off" is quoted as a meme by people who run to supplement makers who...rip you off.
At least "big pharma" is largely proven out by outcomes studies to show statistical benefit.
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There are a LOT of "pharmaceutical" products that have even less efficacy than some supplements !
I doubt that because they have to prove that they are at least more efficient than placebo to get clearance.
But I'm sure you have dozens of studies that prove your point. Maybe list me just three? Don't have time to read more than that.
not disclosing the harsher side effects or low efficacy compared to placebos is no better than quackery.
That is true, which is why all medicine is tested against placebos. And why they have this boring papers inside that list all the side-effects, preconditions and other details that nobody ever reads (except some... ehem... nerds).
There is evidence from many studies that many advertisements:
Oh, absolutely. At least 80% of advertisement
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"There are a LOT of "pharmaceutical" products that have even less efficacy than some supplements !"
"I doubt that because they have to prove that they are at least more efficient than placebo to get clearance."
No, they do not. That's only true for new drugs. Trials of derivatives of old drugs don't have to prove efficacy at all, they only have to show that the new form will not kill statistically more people than the old drug. Then the companies seed the media with reports of the side effects of the old drug
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No, they do not. That's only true for new drugs
I didn't know that. Thanks for the information.
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There is nothing simple about that. What is the standard of "truth" here?
Which evidence do you have that your claim is true?
What evidence exists that your claim is false?
Most cases will be obvious from there. The non-obvious cases can be sorted out in court, like everything else that's in dispute. We figured that principle out in Ancient Rome, so what's the problem?
Structure/function claims (Score:3, Interesting)
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.
Snakeoil? Yes. Everything else? HELL, NO! (Score:2, Insightful)
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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.
Yes, you should require a prescription for "garden-variety vitamins".
Not because it's dangerous, but because it's useless. It would save a lot of people a lot of money.
Most people have zero deficit in vitamins. A certain, very specific amount of vitamins is needed for the body to function. Excess is either leaving through urine (harmless like vitamin C), or gets accumulated in fat (which can get dangerous if you take too much of it). No serious study (i.e. placebo controlled) has ever shown that taking more
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Sigh. (Score:2)
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 nonsens
Maybe be more credible for-fuck-sake? (Score:2)
Not a good track record at this point, pot-bitching-at-kettle.
There are a number of suppliments (Score:2)
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 ev
Re:captured by industry (Score:5, Insightful)
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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 to
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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.
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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
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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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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.
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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.
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https://www.fda.gov/newsevents... [fda.gov]
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
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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.
Re:yes, let's leave the touting for fake cures (Score:4, Interesting)
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.
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Have you considered the studies that show most of the cancer drugs on the market have no better outcomes than placebos?
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Right, because those cancer people are totally going to live!
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What kind of argument is that?
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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 th
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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
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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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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 regula
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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 uneduca
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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-
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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.
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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?
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Some governments are formed partially to create and promote fraud. As the USSR did for Lysenko.
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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 effecti
Re:false advertising... (Score:5, Informative)
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.
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The so-called Quack Miranda Warning. [wikipedia.org]
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.
And Americans wonder why we don't want to buy your meat... it could have anything in it, asbestos sold as a cure for the common cold.
At least over here in the UK, you have to keep your claims suitably nebulous that a reasonable person would not construe them as having an actual effect on medical conditions. They have to advertise "feelings" and nondescript benefits to get you to buy their pills which are specifically designed to not do anything as that way they avoid doing FDA testing. Trying to claim th
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And Americans wonder why we don't want to buy your meat... it could have anything in it, asbestos sold as a cure for the common cold.
I thought that was because the UK had the high standards of rendering down cattle with BSE(mad cow disease), and then feeding them back to the herd - despite decades of proof that it can be transmitted to humans. And of course that you sold cattle with BSE to breeder ranches outside of the UK without disclosing that the cattle had tested positive for it.
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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 th
Re:false advertising... (Score:5, Informative)
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/... [wikipedia.org]
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The FDA has a long history of threatening, stealing from, and jailing makers of supplements for making true statements. This history has been documented by the Life Extension Foundation, among others.
Durk Pearson and Sandy Shaw, using the lawyer Jonathon Emord, successfully sued the FDA on first amendment grounds. The result is the boilerplate which is commonplace now.
New legislation is not likely to be able to overturn these Supreme Court decisions because the decisions were based on the Constitution, whi
Re: false advertising... (Score:3)
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And if I'm foolish enough to buy it from you after being warned that your statement haven't been reviewed by the FDA, the Dr. Gottlier needs to stay out of my damned business.
I don't need the "Great Father in Washington" to run interference for everything I do in my life.
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"Are we reversing the normal burden of proof?"
No, that is what you are doing here. You need proof to restrict something, the default absent proof is that it is unrestricted and that proof needs to be of risks and harm greater than the things you aren't proposing restricting. For example, garlic has been shown to have some level of antibiotic and antiviral efficacy. Is there some risk if people take it rather than amoxicillin? Probably. But you can't really go saying they don't have that option and leave gar
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You need proof to restrict something, the default absent proof is that it is unrestricted and that proof needs to be of risks and harm greater than the things you aren't proposing restricting. For example, garlic has been shown to have some level of antibiotic and antiviral efficacy. Is there some risk if people take it rather than amoxicillin? Probably. But you can't really go saying they don't have that option and leave garlic unrestricted as a completely unregulated food additive, it would be nonsensical
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"As far as I understand the matter, the FDA would be fine if these unrestricted food additives would change their labels just a bit. Then you still have the option to eat as much garlic as you want. You just can't sell it to others and label it an effective antibiotic and expect nobody to go to court over it"
They already can't claim it is an effective antibiotic.
"Why should the vendors of the product not have to make sure that the attributes of their product are true?"
They do, just like all vendors do withi
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Speaking of astronomically high punitive damages, how about doling out some of those to major pharmaceutical companies that have hidden or denied fatal side effects of some "conventional medicine"?
There's lots of fraud in the medical field, and it's not limited to the purveyors of unconventional products.
Re:The FDA is not here to help you. (Score:4, Insightful)
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!
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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.
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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.
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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.
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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.
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Someone should, regulate how you, use commas.
Re:false advertising... (Score:5, Interesting)
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
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If you claim to cure cancer then this is a special case ... your product is illegal and you will be shut down and fined
Sounds like finding the cure to cancer (not that there is just one type of cancer) is quite the minefield over in the UK. If I found a cure to cancer, I couldn't sell my product as such because it is illegal!
Or did I misunderstand your words or intended meaning? :)
Yeah, yeah. I get it. A cure for cancer would be announced and it would be a HUGE medical discovery that couldn't be held back. It is just that the laws sound... somewhat odd.
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It is permissible to advertise such products and services in such a way that the only audience is members of parliament, doctors, nurses or pharmacists.
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It's no different here in the US.
They play fast and loose with things like "has been shown to" and they can point to a study or some such but it really just comes down to poor enforcement by the FDA. If you give them too much of a free hand they'll regulate the sale of willow bark tea to bring the cost up to what Asprin does or eliminate competition, if they don't enforce the rules already on the books then you end up with claims that willow bark tea will make you live to 300 and cure cancer.
There is no way
Re: (Score:2)
They can.
Any credible doctor will tell you some of these herbs do work but they usually have poor clinical support and in some cases the mechanism by which they work isn't known. In other cases there are over the counter or prescription drugs based on active components we've identified in these herbs, the herb doesn't magically stop working just because we make a pill and it likely remains cheaper than the pill.
There is nothing wrong with the existing policy. The problem is it isn't enforced. There is also
Re:Wow (Score:5, Insightful)
He singlehandedly made America stupid? That's a feat, all the religions combined couldn't accomplish that, and not for a lack of trying.
Re:Wow (Score:4, Informative)
Re: (Score:2)
I let you in on a little secret: Tracing back the ownership of a couple "herbal", "natural" and homeopathetic stuff, you'll rather quickly end up with names that are familiar, but usually in the context of medicine. They already own that market too, why did you think they don't?
If anything, your suggestion would allow pharma corps to simply stop the (very expensive) testing and simply outsource it to the end consumer. Just launch that new product with a "may" cure on its label. It works? Awesome, now we can