I actually just did a search for “kinoki” at the FDA web site and discovered that their Office of Regulatory Affairs has entered it into their import database with a refusal reason of “Unapproved” on March 20, 2008. (http://www.fda.gov/ora/oasis/3/ora_oasis_i_89.html)

For more information on what this means, take a look at this link:
http://www.fda.gov/ora/oasis/ora_oasis_ref_intro.html

It looks like my complaint actually worked!

I posted about Kinoki Foot Pads above. I recommend reporting them to the FDA each time you see one of their commercials. Keep track of the time and channel you see them so you can pass that info on to the FDA. If enough people report them, perhaps the FDA will actually take action. It’s a long shot, since the things likely have no direct risks for the user, but I think it’s better than just hitting the mute button.

I’d be immune to this sort of thing because most things with lots of herbs, etc. in them tend to have unfortunate physiological effects in me.

The woo woo thing that I’ve seen the most is “Enoki foot pads” that are supposed to remove heavy metals, and a wealth of other stuff out of your body from just being applied to your feet. (I may be spelling that wrong, but the commercial bugs me.) They are so sincere and whatever. They’re what the mute button is for….

Still, they should have a funny faux-commercial. “It’s like riding a pony! That might not sound too impressive but the pony is THREE HUNDRED FEET TALL AND COVERED IN CHAINSAWS! And you have to get on top through an elevator filled with SIXTEEN LIVE COUGARS!” Or similar.

…that are nearly as overstated…

Are we absolutely certain this isn’t a joke? Or is it more wizardry and Orc mischief?

The horrible taste makes it more effective.

The claim is that since we are talking about a straight plant extract, the formula cannot be patented because it is naturally occurring and anyone can grow, say, alfalfa, and drink a mix of it in water.

Todd W. said:
> Not sure about patenting dietary supplements, but with medicines, the patent is for the method of treating a specific disease with a particular dose form of the product, as I understand it.

No, with medicines, the patent is typically for a specific chemical formulation, and possibly also a patent for a specific process for creating that formulation. The reason medicines made from plants can be patented is because the active ingredients are separated, identified, then synthetically formulated, and then minor varients are developed that are inert to the function but chemical markers of uniqueness. But the CAM community doesn’t want chemical synthetics, they take the plant extract directly.

Thus they claim they can’t use patent protection to recoup the cost of the clinical trials. That is the claimed reason why no individual company wants to spend the dough to test their product. They spend all the money to prove alfalfa grass is safe and cures warts, then everybody else sells alfalfa grass and reaps profits while they are still recouping the cost of the studies.

>As for laws governing dietary supplements and herbals, we have President Clinton to thank for that with DSHEA.

Well, only if you blame the President for any legislation signed into law under his term.

>I haven’t looked at it in depth, yet, but I think that DSHEA may actually have been a slight improvement, since supplements look like they were regulated as food before that, or that there was at least some question about how it should be regulated.

The only improvement is the requirement that they run a generic disclaimer and don’t make specific disease claims. That improvement is very thin, given that before that there was at least the premise that anything ingested was therefore a food product and needed to meet safety requirements of the FDA.

> Frankly, if they make any health claims, I think there should be clinical trials to back ‘em up. And all dietary ingredients should be tested for safety, regardless of when they were first marketed and however much anecdotal evidence there is to claim they’re safe.

While many of us agree on that point, that is not the state of the law and it is actively opposed by the CAM advocates.

Not sure about patenting dietary supplements, but with medicines, the patent is for the method of treating a specific disease with a particular dose form of the product, as I understand it.

As for laws governing dietary supplements and herbals, we have President Clinton to thank for that with DSHEA. I haven’t looked at it in depth, yet, but I think that DSHEA may actually have been a slight improvement, since supplements look like they were regulated as food before that, or that there was at least some question about how it should be regulated. Frankly, if they make any health claims, I think there should be clinical trials to back ‘em up. And all dietary ingredients should be tested for safety, regardless of when they were first marketed and however much anecdotal evidence there is to claim they’re safe.

But isn’t some huge fraction of our curent medicine derived from plants? Couldn’t the supplement folks just foolow the same proces?

Der, I need some pseudo-pharma memory supplement, stat!

“Tooth and nail…” that gives me an uber-idea:
(“Tooth ‘N’ Naylz: The fighter’s energy drink. Ionized like a mofo, yo! Kicks the toxins’ butts and punches their mothers. Made from real tooth-essence and nail-extract. Results guaranteed! [The statements on this product have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any diseases.] Safe! Effective! KO Those Toxins.™ Operators standing by!)

Anyway, because of the intentions of vitamin makers and dietary supplements pseudo-pharma saw their chance to put any fadistic,…erm, I mean trendy natural ingredient and make any general claim they want.

The diet-pill makers went to town. I heard this one annoying one actually saying “We couldn’t say it if it wasn’t true,” and was immediately followed by the disclaimer.

Oh, pseudo-pharma, what can’t you claim?

Eleutherococcus senticosus (aka Siberian Ginseng) – http://www.drugdigest.org/DD/DVH/HerbsWho/0,3923,552084%7CEleutherococcus%2Bsenticosus,00.html
Crataegus oxyacantha (aka Hawthorn) – http://www.drugdigest.org/DD/DVH/HerbsWho/0,3923,4023|Crataegus+oxyacantha,00.html
Rhodiola Rosea (aka Rhodiola, Roseroot, Golden Root) – http://www.drugdigest.org/DD/DVH/HerbsWho/0,3923,9320|Rhodiola+rosea,00.html
Schizandra Chinensis – http://www.mskcc.org/mskcc/html/69365.cfm
Inonotus Obliquus (aka Chaga) – http://www.ncbi.nlm.nih.gov/pubmed/18203281
Glycyrrhiza Uralensis (aka Licorice) – http://www.ncbi.nlm.nih.gov/pubmed/18295200?dopt=Abstract
Rhaponticum Carthamoides – http://www.eje.cz/scripts/viewabstract.php?abstract=574&browsevol=92(1)

Sorry for the long web addresses. I don’t know how to format them into hyperlinked words.

For the most part, it seems like they are relatively harmless, though the first two I listed appear to have cardiovascular effects which could be dangerous in too high a dose or for too long a use. But, not knowing the bioavailability of these things from clinical trials, I can’t really say whether the amounts in the drink are likely to have any effect, let alone what their safety may be.

On a side note, does anyone know if all of the ingredients actually grow in the Tunguska Basin?

Kinoki Foot Pads. I reported those to the FDA, since they do not include anywhere in the commercial or on their web site the disclaimer that the claims have not been reviewed by the FDA, combined with the fact that they make distinct medical claims about treating, mitigating or curing disease. Next time you see that, make a note of the time and channel and report it to the FDA’s Center for Devices and Radiologic Health.

I recall early expeditions into the Tunguska area encountered swampy, insect infested waters. Yum?

The drink is worthless if it doesn’t clean the colon, remove toxins and impurities from the liver, increase virility, sharpen vision, and give me the minty fresh breath I crave. I’m picky with my choice of energy drinks.

It’s ironic how they talk about what’s scientific and unscientific, then launch into unsupported claims designed to baffle you with bull…. errrr you know. Business as usual.

It’s a little unclear, but I lean toward sourced from Tunguska. They claim the botanicals grown in that area have special properties, grow faster and larger and more potent, and that the cause is carried over into their product.

Jon Niehof said:
> Irishman: According to my girlfriend’s father (who works for a major pharmaceutical company), it’s not even possible to get supplements approved in the US. This may be a legal obstacle (they aren’t regulated as drugs so you can’t get the paperwork, perhaps?), but there’s definitely a practical one: you can’t patent it, so who’s going to pay for the clinical trials and such?

Yes, you can’t get them approved because of the legal loophole that they are not subject to FDA oversight, so you don’t need to get them approved, so the FDA doesn’t want to spend time on them. As for paying for clinical trials and stuff, wouldn’t that be a great place for a non-profit organization wishing to advocate for AltMed/CAM? Maybe all those AltMed/CAM practitioners who are tired of getting derided as quacks could, I don’t know, form a joint effort to get some scientific validation of their practices. Of course there is also the National Center for Complementary and Alternative Medicine (branch of the National Institute of Health).

Hey, from the handy link provided by space cadet:

Under the Dietary Supplement Health and Education Act of 1994 (DSHEA)… a health product can be marketed as a supplement and make “structure/function” claims for the product without any FDA oversight, as long as they place a disclaimer on their label and advertising stating that the claims have not been reviewed by the FDA and that they do not make “disease” claims for the product.

What this means is that any company can put together an essentially random combination of vitamins and herbs and make any structure/function claim they choose (boosts the immune system, gives energy, improves sleep, aids mental focus -whatever) as long as they don’t mention a specific disease by name. There is no FDA oversight to make sure their claims have been validated scientifically.

Companies are still responsible for the claims that they make, but accountability is entirely post-marketing. The Federal Trade Commission (FTC) can take action for false advertising – just as it can with toasters, vacuum cleaners, or any product. And, of course, the civil courts can always be used to seek compensation for any deception or wrong-doing by the company. But there is no pre-marketing oversight – no hurdle to get over before getting to market with specific claims.

Tom Marking said:
>>“I think they are alluding to nuclear contamination, such as might come from a nuclear bomb. If so, they are confused, probably because the measure of the blast is in megatons”

> The idea that the Tunguska event of 1908 was caused by a nuclear explosion of an alien spacecraft has been firmly entrenched in woo-woo land for quite some time. Oberg has an interesting article about it:

True, there is that lore, but I don’t think that’s relevant to the quote I was addressing. They were specifically saying that the scientific explanation is a giant meteor or comet, but that doesn’t explain the lack of a crater “or contamination”. What contamination could they mean? The only thing I can come up with is nuclear, and thus my rant comment.