I hope GD is the proper place for this. Because this isn’t just an opinion or a poll. It is a legitimate question, because I am confused:confused:.
Everyone is familiar with the FDA warning all health food products have bear:
The only thing is, what on earth does it mean? First, you read all kinds of claims that the product insists their health aid can do for you. They know they are trying to cure your diseases. You know they are trying to cure disease. That is the very reason why you buy it!
Okay, maybe the statements haven’t been evaluated by the FDA is true. But the rest of the disclaimer is pure BS (pardon my French). So what on earth does it really mean? Or put another way, what is it supposed to tell you, the consumer?
It’s called the “Quack Miranda Warning”. Sort of a wink-wink-nudge-nudge way of getting around any liability for people who take the product and then don’t get better. After all, you weren’t selling “medicine”, so how can they sue you when your “medicine” gets someone killed? And yeah, if you see this on medicine you’re taking, chances are phenomenally good that it isn’t medicine, and that it’s going to have all the effectiveness of a wet fart on your condition. Quoth RationalWiki:
Rational Wiki leaves out that you may buy the item for reasons other than reading the packaging. There is some stuff that shows preliminary promise in research, and there are specific things that we not only know help but that doctors will prescribe.
For example, my doctor prescribes that I get Vitamin D and B12 to maintain my levels after having done acute administration in the past. as he knows that, without them, my levels get low. It’s a real medical phenomenon. But you’d better bet they have that warning on them.
My understanding is that no product can claim to be a medical treatment unless it has been submitted to FDA testing and its effectiveness has been established.
So if an untested product implied it could treat some medical problem, the manufacturers would be arrested. So they protect themselves by including an explicit statement that they are not a medical treatment. This explicit statement supposedly trumps any implication you might read elsewhere and protects them from charges that they are claiming health benefits.
And once they’ve protected themselves from arrest by explicitly stating their product is worthless, they can safely go back to implying how valuable it is in order to sell it.
The wording is that way because those products fall into a huge loophole between foods and drugs, called “supplements”. If you read what the “supplements” say carefully they don’t CLAIM (legally speaking) to do any of those things. But the language is very very carefully designed to give the impression they do, without crossing the line into something the FDA would consider a violation.
What’s interesting to me is what kind of cognitive dissonance must go in at the peddlers of these snake oils (which are very large multi-billion dollar companies at this point). They must know they are selling snake oil, but they can’t say that or base their business plan around that, or they are opening themselves up to a huge liability should it become public. Presumably also they don’t want to actually end up selling something with real active ingredients, as they would cause real side affects which would also open them up to liability.
Remember that major forces behind the Dietary Supplement Health and Education Act (DSHEA), which included Senators Tom Harkin and Orrin Hatch (both in bed with supplement companies), set this system up to allow supplement marketers a loophole with which to make drug claims for products that never were adequately tested as drugs.
*"What does the FDA require of “supplements”?
Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed. FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market. Generally, manufacturers do not need to register their products with FDA nor get FDA approval before producing or selling dietary supplements.* Manufacturers must make sure that product label information is truthful and not misleading.
To paraphrase: “sell whatever you want, just don’t let us catch you.” *
Not only do companies routinely get away with claiming their supplements treat/alleviate medical conditions, in the relatively few cases where violations are damning enough for the FDA to take action, it’s a long drawn-out process, the companies in a few instances will pay fines, but can start right back up again under different names (look how long it took to nail Kevin Trudeau).
Note that your product does not have to bear a Quack Miranda Warning if you are honest about what it does and stick to proven uses.
To me it seems purposely dishonest. I mean, some supplements do have benefits. Like vitamin C for scurvy or vitamin D for rickets. So they should be able to note that on the label, like, “This product has been shown to help with scurvy.” But by not showing study results, they’re basically saying, “this product is worthless.”
Also, when a product does clearly work, like ephedra (which was sold as a supplement for years),
it gets taken off the market.
Ephedra wasn’t banned because it worked, it was banned because people were dying. The co-founder of one of the companies that sold it was sent to prison for not telling the FDA about the 14,000 complaints of side effects that they had received.
For almost all individuals a bit of greens or fruit will prevent those vitamin deficiencies. Most healthy people gain no benefit by taking these outside of food.
The CAM Scammers have an amazing amount of political power, and money as these snake oil cures account for 11.2 percent of total out-of-pocket expenditures in the US. This is their “value.” It is a more than 28 billion dollar industry.
On a similar note, at my old job at a clinical laboratory, we used to buy kits made by Roche that were designed and marketed to detect certain mutations in certain genes. There was no other possible use for them. I always thought it was odd that on every package, it said clearly, “Not for clinical use; for research purposes only!”
It was explained to me that this is essentially Roche saying “we haven’t done the research necessary to prove things like sensitivity or specificity in a clinical setting to the satisfaction of licensing agencies. If you’re going to use this clinically, it’s YOUR job to do that testing before you use this. If you don’t do it, we’re not going to be held liable.” It’s essentially offloading liability on to the end user. We HAD done the required testing ahead of time, so all was kosher, but still, it was odd to see that every time I opened a kit.
My understanding is that they’re not allowed to put any claims in their advertising that the products treat any diseases, that aren’t supported by evidence. What they can get away with is saying crap like “supports immune system health.”
In my opinion, even saying that a product supports your immune system should need evidence, but the SCAM manufacturers (which in many cases is Big Pharma) have pushed their wording as far as they can get away with, and the FDA so far has not objected to that wording.
In part, it should be mentioned, because the alternative medicine industry has some powerful politicians on their side that work to keep regulatory agencies as toothless as possible. Orrin Hatch springs to mind.
I am a teeny bit more charitable than most of y’all. Teeny bit.
In short, many people don’t actually require scientific evidence in order to reach a conclusion. They’re willing to accept folk wisdom, magical thinking (red flowers cure blood diseases, that sort of thing), anecdotes (my son stopped throwing up after I gave him this bottle of water labeled “homeopathic remedy”, so it must have worked), and the like.
The FDA isn’t willing to accept these things. They want good hard scientific evidence from rigorous studies.
The question I think most of y’all are looking at is whether businesses should be able to sell products with claims unsupported by good scientific evidence. But a lot of consumers look at it the other way: should they be able to hear claims that meet their much lower personal standards of evidence?
The FDA warning is, I think, a compromise: it allows marketers to communicate with those people who use a much lower standard of evidence than the FDA uses, but at the same time, those marketers must make it plain that they’re not clearing the FDA’s higher standard.
By that logic, sellers of any product (gold and other investments, home improvements, various consumer goods etc.) should be able to make unfounded claims about the attributes and benefits of what they sell, since a substantial number of people are willing to take them on faith, without requiring evidence that they can deliver on their promises.
The idea of weakening consumer protections dealing with such matters is bad enough - but with “dietary supplements” we’re talking about people’s health and the possibility of serious harm (directly or through lack of seeking effective care), which should raise the bar considerably.
A vitamin C manufacturer probably could do some studies, submit his tablet to the FDA, and get it approved to treat scurvy. But, what’s the benefit for him? He’s not going to sell more of his because it’s FDA approved. He doesn’t hold a patent on it, so he’s not going to sell it for lots of money.
Incidentally, the FDA is actually giving companies some incentives to do actual studies on older drugs and such. It’s a good idea, but as a reward the companies get an exclusive ability to sell the drug for a few years, and so you see things like a 50-fold increase in price.
I doubt the FDA or other advocates of evidence-based medicine would have a problem with a manufacturer noting on a label that vitamin C has been shown to be effective in treating vitamin C deficiency.
Claims like “prevents flu”, “eliminates diabetics’ need for insulin” or “cures cancer” which fall into the category of poorly supported to outright ludicrous, are a different matter.
For all intents and purposes, the majority of these products are nothing other than “food”. The FDA allows you to sell them for people to injest because…well…the contents are just food. It’s food that’s been shredded down and mixed so that it looks like a pill or an ointment or whatever, but from a health standpoint, it’s not a relevant difference.
If the FDA banned these products, they’d have a million woo-heads campaigning to get them shut down and in the meanwhile, the woo-heads would start trying out weird concoctions that they brewed up at home, from poisonous materials. They would also be denying the populace what, really, is the best cure for most of their complaints: a placebo.
The quack warning seems like a reasonable compromise. The FDA guarantees that quack medicine is a food-grade placebo and makes sure that people don’t put too much stock in it.
That is not allowed. That is a structure or function claim. If the FDA catches wind of it, they will send a cease and desist, and if that doesn’t work, they’ll send goons.
It’s really very clear. A supplement may not make claims about structure or function. It may not use a medical diagnosis or the name of an organ. It may not claim to cure a disease.
“Supports urinary health” is not a structure or function claim. Allowed
“Cures a bladder infection” is a structure and function claim. Not allowed.
“Promotes water balance” is not a structure or function claim. Allowed.
“This product is a diuretic” is a function claim. Not allowed.
I used to write these labels for a living. It’s maddening. Even if your Thing is known to have a function, unless your actual product is submitted through the (very expensive) approval process, you can’t say it.
Dandelion leaf is a diuretic. I know it’s a diuretic. Doctors know it’s a diuretic. The whole fucking world knows it’s a diuretic. But because I don’t have the money to run clinical trials to the satisfaction of the FDA, I can’t call it a diuretic on the label.
