# Isn't the FDA Claim Contradictory (Re: Health Foods)? **URL:** \ **Category:** Great Debates\ **Created:** [January 28, 2015, 7:30am UTC](https://boards.straightdope.com/t/isnt-the-fda-claim-contradictory-re-health-foods/711088 "2015-01-28T07:30:31Z")\ **Posts on this page:** 20\ **Page:** 2
**Author:** ![Peremensoe](https://avatars.discourse-cdn.com/v4/letter/p/ce7236/32.png) [@Peremensoe](https://boards.straightdope.com/u/Peremensoe)\ **Post date:** [January 29, 2015, 1:00am UTC](https://boards.straightdope.com/t/isnt-the-fda-claim-contradictory-re-health-foods/711088/21 "2015-01-29T01:00:07Z")
> [@Jackmannii](#): > > 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. Don’t they? ---
**Author:** ![Jackmannii](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/jackmannii/32/311_2.png) [@Jackmannii](https://boards.straightdope.com/u/Jackmannii)\ **Post date:** [January 29, 2015, 1:24am UTC](https://boards.straightdope.com/t/isnt-the-fda-claim-contradictory-re-health-foods/711088/22 "2015-01-29T01:24:46Z")
> [@WhyNot](#): > > 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. 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. > [@](#): > > Dandelion leaf is a diuretic. I know it’s a diuretic. [Doctors know it’s a diuretic.](http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3155102/) 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. 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). ---
**Author:** ![Grumman](https://avatars.discourse-cdn.com/v4/letter/g/43a26b/32.png) [@Grumman](https://boards.straightdope.com/u/Grumman)\ **Post date:** [January 29, 2015, 1:56am UTC](https://boards.straightdope.com/t/isnt-the-fda-claim-contradictory-re-health-foods/711088/23 "2015-01-29T01:56:27Z")
> [@Peremensoe](#): > > Don’t they? Not without limit. Fraud is not protected speech. ---
**Author:** ![Twoflower](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/twoflower/32/22_2.png) [@Twoflower](https://boards.straightdope.com/u/Twoflower)\ **Post date:** [January 29, 2015, 2:18am UTC](https://boards.straightdope.com/t/isnt-the-fda-claim-contradictory-re-health-foods/711088/24 "2015-01-29T02:18:26Z")
> [@Jim\_B](#): > > They know they are trying to cure your diseases. You know they are trying to cure disease. Um, no. They’re just trying to get your money, and have learned that making health claims is an effective means toward that end. ---
**Author:** ![Ambivalid](https://avatars.discourse-cdn.com/v4/letter/a/a5b964/32.png) [@Ambivalid](https://boards.straightdope.com/u/Ambivalid)\ **Post date:** [January 29, 2015, 2:20am UTC](https://boards.straightdope.com/t/isnt-the-fda-claim-contradictory-re-health-foods/711088/25 "2015-01-29T02:20:34Z")
> [@CurtC](#): > > 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. 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”. ---
**Author:** ![rock\_party](https://avatars.discourse-cdn.com/v4/letter/r/e19b73/32.png) [@rock\_party](https://boards.straightdope.com/u/rock_party)\ **Post date:** [January 29, 2015, 11:21pm UTC](https://boards.straightdope.com/t/isnt-the-fda-claim-contradictory-re-health-foods/711088/26 "2015-01-29T23:21:29Z")
> [@](#): > > 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. ---
**Author:** ![Sage\_Rat](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/sage_rat/32/399_2.png) [@Sage\_Rat](https://boards.straightdope.com/u/Sage_Rat)\ **Post date:** [January 30, 2015, 12:22am UTC](https://boards.straightdope.com/t/isnt-the-fda-claim-contradictory-re-health-foods/711088/27 "2015-01-30T00:22:49Z")
> [@rock\_party](#): > > 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. ---
**Author:** ![Little\_Nemo](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/little_nemo/32/3120_2.png) [@Little\_Nemo](https://boards.straightdope.com/u/Little_Nemo)\ **Post date:** [January 30, 2015, 2:00am UTC](https://boards.straightdope.com/t/isnt-the-fda-claim-contradictory-re-health-foods/711088/28 "2015-01-30T02:00:47Z")
> [@griffin1977](#): > > 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. 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. ---
**Author:** ![Zakalwe](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/zakalwe/32/270_2.png) [@Zakalwe](https://boards.straightdope.com/u/Zakalwe)\ **Post date:** [January 30, 2015, 3:49am UTC](https://boards.straightdope.com/t/isnt-the-fda-claim-contradictory-re-health-foods/711088/29 "2015-01-30T03:49:35Z")
> [@Sage\_Rat](#): > > 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. I would offer that the intersecting set of people who: 1. Believe in the remedies in the first place and 2. 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. ---
**Author:** ![robert\_columbia](https://avatars.discourse-cdn.com/v4/letter/r/e79b87/32.png) [@robert\_columbia](https://boards.straightdope.com/u/robert_columbia)\ **Post date:** [January 30, 2015, 6:35pm UTC](https://boards.straightdope.com/t/isnt-the-fda-claim-contradictory-re-health-foods/711088/30 "2015-01-30T18:35:02Z")
> [@BigT](#): > > 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… > [@WhyNot](#): > > …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… > [@Little\_Nemo](#): > > 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. 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: 1. Likely to be effective, but the FDA (which is a political organization and not a disinterested, ivory tower house of Science) wants more testing. 2. 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. 3. 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. ---
**Author:** ![robert\_columbia](https://avatars.discourse-cdn.com/v4/letter/r/e79b87/32.png) [@robert\_columbia](https://boards.straightdope.com/u/robert_columbia)\ **Post date:** [February 2, 2015, 5:23pm UTC](https://boards.straightdope.com/t/isnt-the-fda-claim-contradictory-re-health-foods/711088/31 "2015-02-02T17:23:57Z")
> [@buddy431](#): > > 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](http://en.wikipedia.org/wiki/Unapproved_Drugs_Initiative) 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](http://en.wikipedia.org/wiki/Colchicine). 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 \”? Amoxicillin is not protected by patent and is also not a federal “Controlled Substance”. ---
**Author:** ![Jackmannii](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/jackmannii/32/311_2.png) [@Jackmannii](https://boards.straightdope.com/u/Jackmannii)\ **Post date:** [February 4, 2015, 1:38pm UTC](https://boards.straightdope.com/t/isnt-the-fda-claim-contradictory-re-health-foods/711088/32 "2015-02-04T13:38:41Z")
Apparently an updated disclaimer is needed for [herbal supplements](http://mobile.nytimes.com/blogs/well/2015/02/03/sidebar-whats-in-those-supplements/?ref=todayspaper&_r=1&referrer=) 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.” ---
**Author:** ![buddy431](https://avatars.discourse-cdn.com/v4/letter/b/6a8cbe/32.png) [@buddy431](https://boards.straightdope.com/u/buddy431)\ **Post date:** [February 4, 2015, 3:12pm UTC](https://boards.straightdope.com/t/isnt-the-fda-claim-contradictory-re-health-foods/711088/33 "2015-02-04T15:12:41Z")
> [@Jackmannii](#): > > Apparently an updated disclaimer is needed for [herbal supplements](http://mobile.nytimes.com/blogs/well/2015/02/03/sidebar-whats-in-those-supplements/?ref=todayspaper&_r=1&referrer=) 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). ---
**Author:** ![Czarcasm](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/czarcasm/32/4050_2.png) [@Czarcasm](https://boards.straightdope.com/u/Czarcasm)\ **Post date:** [February 4, 2015, 4:04pm UTC](https://boards.straightdope.com/t/isnt-the-fda-claim-contradictory-re-health-foods/711088/34 "2015-02-04T16:04:00Z")
> [@buddy431](#): > > 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. ---
**Author:** ![buddy431](https://avatars.discourse-cdn.com/v4/letter/b/6a8cbe/32.png) [@buddy431](https://boards.straightdope.com/u/buddy431)\ **Post date:** [February 4, 2015, 4:20pm UTC](https://boards.straightdope.com/t/isnt-the-fda-claim-contradictory-re-health-foods/711088/35 "2015-02-04T16:20:28Z")
> [@Czarcasm](#): > > 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](http://www.cbsnews.com/news/herbal-supplements-targeted-by-new-york-attorney-general/). 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. ---
**Author:** ![Czarcasm](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/czarcasm/32/4050_2.png) [@Czarcasm](https://boards.straightdope.com/u/Czarcasm)\ **Post date:** [February 4, 2015, 4:27pm UTC](https://boards.straightdope.com/t/isnt-the-fda-claim-contradictory-re-health-foods/711088/36 "2015-02-04T16:27:16Z")
> [@buddy431](#): > > The tests they did were DNA tests. [Cite](http://www.cbsnews.com/news/herbal-supplements-targeted-by-new-york-attorney-general/). 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”. ---
**Author:** ![buddy431](https://avatars.discourse-cdn.com/v4/letter/b/6a8cbe/32.png) [@buddy431](https://boards.straightdope.com/u/buddy431)\ **Post date:** [February 4, 2015, 4:52pm UTC](https://boards.straightdope.com/t/isnt-the-fda-claim-contradictory-re-health-foods/711088/37 "2015-02-04T16:52:24Z")
> [@Czarcasm](#): > > 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. ---
**Author:** ![Czarcasm](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/czarcasm/32/4050_2.png) [@Czarcasm](https://boards.straightdope.com/u/Czarcasm)\ **Post date:** [February 4, 2015, 4:58pm UTC](https://boards.straightdope.com/t/isnt-the-fda-claim-contradictory-re-health-foods/711088/38 "2015-02-04T16:58:24Z")
> [@buddy431](#): > > 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? 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? ---
**Author:** ![Thudlow\_Boink](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/thudlow_boink/32/320_2.png) [@Thudlow\_Boink](https://boards.straightdope.com/u/Thudlow_Boink)\ **Post date:** [February 4, 2015, 5:13pm UTC](https://boards.straightdope.com/t/isnt-the-fda-claim-contradictory-re-health-foods/711088/39 "2015-02-04T17:13:28Z")
> [@Czarcasm](#): > > Nowhere in that article was DNA testing mentioned. 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 investigation looked at six herbal supplements sold at stores across the state. Testing was performed by an expert in DNA barcoding technology … The DNA tests were performed on three to four samples of each of the supplements purchased. The article quotes one person who claims > [@](#): > > “processing during manufacturing of botanical supplements can remove or damage DNA; therefore while a DNA testing method can be useful in some cases, this method well may be the wrong test for these kinds of products.” and another who says > [@](#): > > identification of an herb through DNA testing must be confirmed with established analytical tools that herbal experts use, such as chromatography or microscopy. 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. ---
**Author:** ![buddy431](https://avatars.discourse-cdn.com/v4/letter/b/6a8cbe/32.png) [@buddy431](https://boards.straightdope.com/u/buddy431)\ **Post date:** [February 4, 2015, 5:17pm UTC](https://boards.straightdope.com/t/isnt-the-fda-claim-contradictory-re-health-foods/711088/40 "2015-02-04T17:17:54Z")
> [@Czarcasm](#): > > 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? [Ginko Biloba Extract](http://www.google.com/imgres?imgurl=http://scene7.targetimg1.com/is/image/Target/14509713%253Fwid%253D480%2526hei%253D480&imgrefurl=http://www.target.com/p/up-up-ginkgo-biloba-120-mg-caplets-90-count/-/A-14509713&h=480&w=480&tbnid=SuAOpZtyM1TtYM:&zoom=1&docid=cAf-69E3Krd0bM&ei=KVPSVJPyDsqvggTFv4DoAw&tbm=isch&ved=0CB4QMygCMAI). 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](http://scene7.targetimg1.com/is/image/Target/14510520?wid=480&hei=480). Again, depends on exactly how they extract it. [Valerian Root Extract](http://scene7.targetimg1.com/is/image/Target/14515038?wid=480&hei=480) 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. [Previous page](https://boards.straightdope.com/t/isnt-the-fda-claim-contradictory-re-health-foods/711088.md?page=1) [Next page](https://boards.straightdope.com/t/isnt-the-fda-claim-contradictory-re-health-foods/711088.md?page=3)