Don’t they?
I’d love to know when in the history of the agency the FDA has ever sanctioned a supplement company for selling a vitamin while saying that taking it has been known to to effectively treat a deficiency of that vitamin.
That study you linked to is a good example of why a proper clinical trial is needed in order to make a valid claim for a drug/supplement. The authors of that study themselves note its glaring limitations:
“The limitations of this study design include lack of blinding, small numbers of subjects, self-monitoring for fluid input/output, no correction for water content of food consumed, and limited baseline values of urine output.”
I’d add that their results are wildly underwhelming. As I understand it, their study subjects were weeing 8 times a day before taking dandelion extract, but were weeing 9 times a day while taking it. Apparently they contorted statistical analysis to find that a significant difference, but logically that’s a highly dubious conclusion.
I don’t have a problem with adults (who are not certifiably insane) self-medicating with useless remedies, even if they harm themselves. I do have a problem with companies profiting off selling that useless crap. You read online that someone swears zebra snot cured their type I diabetes and want to try it yourself, go for it. Visit the zoo and blow a zebra’s nose, or even buy a bottle of 100% Pure Zebra Snot from Bob’s Apothecary Wonderland. But Bob should not be allowed to claim that his stuff cures diabetes or even that it “supports endocrine function” unless he can show that it actually does.
*the “FDA goon squad” is a staple of supplement pusher lore. The odds of actually being the subject of a raid, even for egregious violations is extremely low and occurs only after you’ve racked up and failed to respond to explicit warnings (i.e. a succession of Really Stern Notes).
Not without limit. Fraud is not protected speech.
Um, no. They’re just trying to get your money, and have learned that making health claims is an effective means toward that end.
It’s the use of weasel words like “supports” that allow companies to make such claims, evidence-free. It’s a vague, essentially meaningless term in the context of medicine. Sort of like “all-natural”.
This is what needs to stop. There should be no weaseling, meaningless or vague claims allowed, only the verified results of studies. If a system needs to be designed/redesigned to preform cheap, accurate tests on products to see what they actually do and to what degree, then that’s what the FDA should figure out. I’d really like to KNOW what’s helpful and what’s hype, and really, right now, there isn’t any way to know.
If it clearly said, “This works as well as a placebo.” Then, all of the “remedies” would cease working, and people would start seeing their doctor about slight coughs and indigestion.
Some of the sellers probably don’t give a damn. They’re just in the business for the money.
But others probably do believe that their products provide benefits. And these people would probably be happy to list all the benefits they believe their products provide but are prohibited from doing so by law.
I would offer that the intersecting set of people who:
- Believe in the remedies in the first place and
- Don’t know what placebo means (or don’t understand how it applies)
is large enough that it wouldn’t really make that much of a dent.
These. For example, there is some actual peer-reviewed research indicating that St. John’s Wort, a common herbal supplement sold in the US, is effective for clinical depression, and might even be as effective as Prozac. This research, however, isn’t “enough” for the FDA to green-light SJW as an approved drug. Thus, preparations of SJW offered for sale to consumers must carry the disclaimer.
So, “supplements” likely fall into one of the following categories:
- Likely to be effective, but the FDA (which is a political organization and not a disinterested, ivory tower house of Science) wants more testing.
- Probably not effective, but probably not that harmful either. Here are your bogus sugar pill and random herb crap that doesn’t do anything but drain your wallet.
- Probably harmful. Fortunately, these are probably pretty rare because if word gets out that X supplement may be killing people, it can lose market share quite rapidly.
Could a supplement manufacturer manufacture “unapproved” versions of prescription drugs provided that they include the infamous not-a-drug FDA disclaimer if the drug they are making is no longer under patent and not a controlled substance? E.g. clearly they could not sell an “herbal methamphetamine supplement” because meth is a Class 2 Controlled Substance which is inherently illegal to possess without a prescription. But could a supplement company come out with an “herbal amoxicillin supplement” product that “promotes internal balance” but is “not intended to diagnose, treat, or prevent any disease <wink wink>”? Amoxicillin is not protected by patent and is also not a federal “Controlled Substance”.
Apparently an updated disclaimer is needed for herbal supplements sold by major retailers:
“The (New York State Attorney General’s Office) said they had run tests on popular store brands of herbal supplements at the retailers — Walmart, Walgreens, Target and GNC — which showed that roughly four out of five of the products contained none of the herbs listed on their labels. In many cases, the authorities said, the supplements contained little more than cheap fillers like rice and house plants, or substances that could be hazardous to people with food allergies.”
Suggestion: “This product has not been evaluated by the FDA to determine if it does a damn thing, or even contains what the label claims it does. But we hope you’re stupid enough to buy it anyway.”
I wasn’t impressed by that article. There’s lots of situations where you can imagine having an active ingredient from a given plant without having any dna in there. Most solvent extractions or distillation procedures are going to leave DNA behind. Any sort of chromatography will get rid of DNA. If you test vanilla extract for DNA, you’re not going to find any. They should do a traditional chemical analysis and find out what actually is in there (gas or liquid chromotography then mass spec will probably give you a pretty good idea).
I have found that the best way to be impressed by an article is to read it. Nowhere in that article was DNA testing mentioned.
The tests they did were DNA tests. Cite. That article goes into greater depth about their testing procedure. I stand by my statement. There are lots of ways to imagine a product failing this “test” that still contains what it claims it does.
They came up with products that contained little to none of the active ingredient the labels claimed they contained. Your imagination notwithstanding, in the real world, this is called “fraud”.
They came up with products that contained little to none of the DNA of the active ingredients they claimed on the label. They did no other chemical tests for what was in the compound. Is it fraud that vanilla extract doesn’t have DNA from vanilla in it, or that almond extract doesn’t have DNA from almonds? Is it fraud that essential oil of oregano doesn’t contain any oregano DNA?
To be clear, it’s perfectly possible that these supp laments aren’t made with the active ingredient. You could do some perfectly normal analytic tests, like GC-MS, and confirm what chemicals are actually in there. But that wasn’t done in this case.
Does it really matter, since they didn’t test for those substances? Of the substances they actually did test for, can you name any that wouldn’t have any DNA show up?
Not in that article, which IMHO is a major omission, but other articles I’ve seen (including the one buddy431 linked to) do say so.
The article quotes one person who claims
and another who says
I too would like something more definite. But you’re being needlessly hostile toward buddy431, who fully admits he doesn’t know what DNA testing should show in this instance and is reserving judgment, but has provided an example where he knows DNA testing would not show anything.
Ginko Biloba Extract. Depends on exactly how they extract it, but I would think it pretty likely that DNA would not make it into the product
St. John’s Wort Extract. Again, depends on exactly how they extract it.
Those are just the three that I checked from target. Many, many “herbal supplaments” are going to be made by soaking the leaves of the plant in alcohol, or a steam distillation, or something, where you’ll get all sorts of small organic molecules but not biological macromolecules like DNA.