|
|
|
|
Dave W.
Info Junkie
USA
26022 Posts |
 Posted - 11/07/2003 : 13:40:54
|
The Dietary Supplement Health and Education Act of 1994 (the DSHEA) is a Federal law which is generally seen by anti-quackery activists to be a bad set of legislation which stripped the Food and Drug Administration (FDA) of much of its regulatory authority from them in regard to dietary supplements, and especially the claims made for supplements on product labels or in advertising.
For a detailed criticism of the DSHEA see, for example, Quackwatch.
It was not until 2000 that the FDA issued its final rule regarding what is and isn't allowed on product labels without FDA review. And the Small Entity Compliance Guide wasn't completed until 2002.
Reading over the compliance guide, I found it to be very reasonable. There is a real-life balancing act that the law and the compliance guide attempt to meet: manufacturers will be unfairly burdened if supplements - which are generally safe - are treated as drugs, and even obvious claims were required to have reams of clinical-trial data, while the consumer shouldn't be overwhelmed by whacky claims along the lines of the snake-oil salesmen of old. There's also the consideration that the ingredients of most supplements are in our food, anyway, so if we were to make vitamin-C tablets go through a drug-approval process, we'd also need to make oranges go through the same process, or be rightly accused of hypocrisy.
The compliance guide lays out what's okay and what's not. For example, on a calcium supplement, "calcium builds strong bones" would be an acceptable claim to make without pre-approval by the FDA. On the other hand "calcium cures asthma" would not be okay, with or without required the "these statements have not been evaluated by the FDA" disclaimer.
For a real example, this page is making illegal claims for the product advertised, by implying that the product is useful for the treatment of acne, liver spots, stretch marks and constipation, to name just a few of the conditions mentioned.
And according to the recent settlement between the FDA (and the Federal Trade Commission - FTC), and Seasilver, even web-page "keywords" can imply disease claims. The above example therefore is also making an illegal claim for the product by implying, in its keywords, that it can treat spider veins.
So what's the problem? Companies like Seasilver are getting "busted," but the vast majority, like the example above, go about their business making illegal claims without apparent censure by the FDA or the FTC. The reason why most companies can act without fear of governmental interference is due to the fact that both the FDA and FTC are woefully underfunded compared to the amount of regulation they are supposed to enforce.
There is also the fact that the DSHEA stripped the FDA of its ability to remove dangerous dietary supplements from the market. The FDA now has to demonstrate that a supplement is, indeed, dangerous, when - in my opinion, at least - they should be able to get a product off the shelves after just a handful of substantial adverse effects are reported. But supplement makers don't even need to report adverse events that they know of, to anyone.
With regard to the DSHEA, last month I was alerted to two bills working their ways through the Senate by this Healthfraud Discussion List message. (More about this can be found in this Contra Costa Times story of October 29th.)
While the tone of criticism against the Durbin bill (S.722) as reported in the U.S. Newswire item seems a bit hysterical, what I read in the bill (PDF file) appears to be a demand that supplement manufacturers report adverse events associated with their products. I consider such reporting to be along the same lines as "being a decent and honest human being," but the way it's written most likely would cost the industry a pretty penny. Plus, without increasing the FDA's budget, they would have no way to police these new regulations (which also include making stimulants and steroid precursors more highly regulated than they are under the DSHEA).
On the other hand, S. 1538 (PDF file) appears to do nothing more than hand millions of dollars over to the FDA in order to "fully fund" the DSHEA - including regulatory actions - based upon estimates offered by FDA officials. Whether $20 million in 2004 (or even $65 million in 2008) would be a substantial enough sum to get most of the companies like the one above to quit making illegal claims, I can't even begin to guess.
So, what do you all think? Would either of these bills make a reasonable dent in the activities we see going on? Should we instead simply throw the DSHEA on the trash heap entirely, and go back to the way things were? Do we need more explicit legislation, since there are many products which are not dietary supplements (herbal creams, for example) which are trying to play by the DSHEA's rules anyway? Something else? Other comments?
|
- Dave W. (Private Msg, EMail)
Evidently, I rock!
Why not question something for a change?
Visit Dave's Psoriasis Info, too. |
|
|
nfidel 42
New Member
14 Posts |
Posted - 11/08/2003 : 05:21:07 [Permalink]
|
I haven't yet had time to read the bills you linked to. That said, it seems to me these supplement makers should foot the bill and have the initial research done to prove the efficacy of their products. They could pay universities for doing the hard work. Or, as with real drug companies, they could build their own research facilities and hire actual scientists. Sure, some involved in the research and testing would ensure the results beforehand. Where I live, RJReynolds tobbacco for years paid researchers and scientists to come up with the results they wanted. Still, after supposed legitimate testing is done, then the FDA could take over from there.
But of course, this what the supplement industry has been trying to avoid all along. With their strong lobby and influincial friends in congress, I wouldn't hold my breath awaiting results from Washington. Maybe I'm wrong. As I said, I've not read the bills. I will when I have the time. And thanks for the links. |
Many people would rather die than think; in fact, most do." --Bertrand Russell |
 |
|
|
Kil
Evil Skeptic
USA
13477 Posts |
Posted - 11/08/2003 : 11:03:05 [Permalink]
|
First, I recommend a visit to the FDA's own "Overview of Dietary Supplements."
http://www.cfsan.fda.gov/~dms/ds-oview.html#safe
quote:
From the above site:
Who has the responsibility for ensuring that a dietary supplement is safe ?
By law (DSHEA), the manufacturer is responsible for ensuring that its dietary supplement products are safe before they are marketed. Unlike drug products that must be proven safe and effective for their intended use before marketing, there are no provisions in the law for FDA to "approve" dietary supplements for safety or effectiveness before they reach the consumer. Also unlike drug products, manufacturers and distributors of dietary supplements are not currently required by law to record, investigate or forward to FDA any reports they receive of injuries or illnesses that may be related to the use of their products. Under DSHEA, once the product is marketed, FDA has the responsibility for showing that a dietary supplement is "unsafe," before it can take action to restrict the product's use or removal from the marketplace.
And:
quote:
Do manufacturers or distributors of dietary supplements have to tell FDA or consumers what evidence they have about their product's safety or what evidence they have to back up the claims they are making for them?
No, except for rules described above that govern "new dietary ingredients," there is no provision under any law or regulation that FDA enforces that requires a firm to disclose to FDA or consumers the information they have about the safety or purported benefits of their dietary supplement products. Likewise, there is no prohibition against them making this information available either to FDA or to their customers. It is up to each firm to set its own policy on disclosure of such information. For more information on claims that can be made for dietary supplements, see (http://www.cfsan.fda.gov/~dms/hclaims.html )
And now, please indulge me in a bit of a rant.
Most of us seem to agree that the above is a problem that must be fixed. One way of fixing it is to trash the law. Since the law came into effect to benefit the supplement industry, I lean toward trashing the law and starting over with rules that are weighted toward consumer protection and not the supplement industry. A fix here and a fix there will not get the job done. Not anytime soon, anyway. As long as the makers of food supplements are handing out awards to people like Orrin Hatch, I'm concerned.
While it's true that most of the dietary supplements are safe, the DSHEA has opened the door to a host of problem "supplements" that are of much more concern than how ascorbic acid is marketed. St. Johns Wart, a prescription drug in many countries for the relief of mild depression, can be sold here as a food supplement. So what's the big deal? The label can legitimately claim that the drug is useful for depression. (Some recent studies have shown the drug to be no more effective than a placebo.) The problem is that they do not mention on any bottle of St. Johns Wart that I have seen, how using the drug may effect other drugs you might be taking. As it happens, St. Johns Wart interferes with certain AIDS medications and birth control pills. However natural this drug may be, it is still a drug and in my opinion it should be treated as such. There should be the required warnings of possible drug interactions as with any prescription drug. Since it is marketed as a dietary supplement, there is no such requirement. Furthermore, I have seen St. Johns Wart listed as an ingredient in such products as Sobie, a soft drink! Again, this practice is protected by the DSHEA.
Ma Huang or ephedra is all over the place. The base for meth amphetamine is ephedra. Originally, and legitimately, it was only marketed as an antihistamine. Now, thanks to the DSHEA, it's being sold in energy drinks and in weightless dietary supplements like metabolite. So what's the problem? It is possible to buy Ma Huang in a sports energy drink while at the same time purchasing ephedra to help loose unwanted pounds while taking pseudophedrin for as a nasal decongestant. These are all the same drug. Since they can be marketed under different names, how is the consumer to know she has just taken an overdose? People have died doing that.
Laetrile is now marketed as a food supplement, B17. It's natural. Cyanide anyone?
As a frequent visitor to affairs like the "Whole Earth Expo" and health food stores in general, I can tell you that the problems mentioned above are not isolated. If the health claims are not found on the bottle, they can be found on the pamphlet next to the bottle, with the required FDA disclaimer. That the language may be a bit more vague than it use to be in these pamphlets in no way hides the manufacturers intended claims. Most often, the language follows the letter of the law and not the spirit of the law. Please see my Evil Skeptic report at:
http://www.skepticfriends.org/forum/showquestion.asp?faq=2&fldAuto=26
I'm with Quackwatch on this one... |
Uncertainty may make you uncomfortable. Certainty makes you ridiculous.
Why not question something for a change?
Genetic Literacy Project |
|
|
|
Dave W.
Info Junkie
USA
26022 Posts |
Posted - 11/09/2003 : 21:38:41 [Permalink]
|
nfidel 42 wrote:quote:
That said, it seems to me these supplement makers should foot the bill and have the initial research done to prove the efficacy of their products.
And in order to make most health claims, they must, right now. The DSHEA didn't open the door to any claim that somebody could conceivably make. Again, the problem as I see it is primarily that the DSHEA made the line dividing legal claims from illegal ones a bit more fuzzy, and failed to provide enough funding to the FDA to be able to police all the new claims which cross the line, either intentionally or not.
Kil wrote:quote:
St. Johns Wart, a prescription drug in many countries for the relief of mild depression, can be sold here as a food supplement. So what's the big deal? The label can legitimately claim that the drug is useful for depression.
While it may be a "legitimate" claim, it is not a legal claim. Not under current regulations, including DSHEA. Per the Overview of Dietary Supplements,quote:
Is it legal to market a dietary supplement product as a treatment or cure for a specific disease or condition?
No, a product sold as a dietary supplement and promoted on its label or in labeling* as a treatment, prevention or cure for a specific disease or condition would be considered an unapproved--and thus illegal--drug. To maintain the product's status as a dietary supplement, the label and labeling must be consistent with the provisions in the Dietary Supplement Health and Education Act (DSHEA) of 1994.
*Labeling refers to the label as well as accompanying material that is used by a manufacturer to promote and market a specific product.
The claim "St. John's Wort (SJW) is useful for depression" clearly violates the law. Except in certain pre-approved circumstances (where there is a "significant scientific agreement" by U.S. Governmental scientific bodies, for example) can such claims be made for supplements. SJW has no such pre-approved claims that I could find (there are only a couple dozen such claims, anyway).quote:
Laetrile is now marketed as a food supplement, B17. It's natural. Cyanide anyone?
Sales of laetrile with cancer claims has been banned for many years by the FDA, and the DSHEA did nothing to lift that ban. In fact, Jason Vale was convicted just this year for criminal contempt in relation to doing so.
Further, the FDA, as of three years ago, was still treating laetrile as a "new drug," in which case it cannot be sold as a dietary supplement even without health claims. The FDA cannot ban people from making dietary supplements if they don't make illegal claims, but they do get court orders forbidding people from manufacturing laetrile, so it's a different beast altogether, and doesn't fall under the DSHEA rules at all.
But, I don't want to take anything away from your rant. I just feel it's important to distinguish between the dangers posed by some supplements, and labeling issues which make up most of the DSHEA.
Clearly, there's lots of dangerous stuff out there. Aside from what you mention, a couple other interesting examples pop into mind:- Celery contains natural "psoralens," which are compounds that make your skin more sensitive to UVA light. Eating too much celery, especially before visiting a tanning salon, could have nasty short-term and long-term consequences (sunburn and skin cancer, respectively).
- Grapefruit juice reduces the efficacy of cyclosporine, an anti-rejection drug which suppresses the immune system. Too much grapefruit, and a person could reject their brand-new liver.
While these examples might at first appear extreme (on the 'mild' side), there are no warning labels on celery or grapefruit which would alert a consumer to these hazards.
What there is, though, at least in the case of grapefruit and cyclosporine, are plenty of warnings in the cyclosporine packaging against grapefruit juice. Rather than force the grapefruit themselves to carry cautions for the small percentage of the population which needs to be warned, the warnings are plastered all over the drugs, instead.
In other words, while I generally agree with your rant, Kil, I'm not sure that repealing the DSHEA would fix those problems. Sure, the legal basis for calling herbs "dietary supplements" would vanish, but as far as I know, oregano and dill were on sale for many years prior to the DSHEA, and I don't know of any reason why SJW (for example) couldn't be sold dried and crushed, as well, and still require no warning labels.
But, I must admit to a lack of knowledge about the food laws, and what constitutes a legal food item. I don't have time to find out now, but is there any reason that SJW would be prohibited from sale on the spice aisle? If not, and if further study shows it to be absolutely worthless as a depression therapy (in which case it would not be a drug), then where is the legislation which says it should be labeled with warnings for certain patients, the way grapefruit juice is not? Shouldn't the AIDS drugs require warnings against taking SJW with them, as cyclosporine does against grapefruit juice?
Please, consider the above to be mostly "Devil's advocacy."
|
- Dave W. (Private Msg, EMail)
Evidently, I rock!
Why not question something for a change?
Visit Dave's Psoriasis Info, too. |
|
|
|
Kil
Evil Skeptic
USA
13477 Posts |
Posted - 11/10/2003 : 23:37:13 [Permalink]
|
quote:
DaveW:
In other words, while I generally agree with your rant, Kil , I'm not sure that repealing the DSHEA would fix those problems. Sure, the legal basis for calling herbs "dietary supplements" would vanish, but as far as I know, oregano and dill were on sale for many years prior to the DSHEA, and I don't know of any reason why SJW (for example) couldn't be sold dried and crushed, as well, and still require no warning labels.
A couple of things. Come to think of it, I have never seen a bottle of St. Johns Wart with anything on the label but the ingredients. What it's used for is pretty much common knowledge. As for Laetrile, I see what you mean. I must admit, I made an assumption about B17. I just did a search for it and you know what? I could buy it today if I wanted to. http://www.1cure4cancer.com/ Still, this has nothing to do with DSHEA. Maybe I should have used one of the hormones that are sold as dietary supplements, or Emu oil as an example. Oh well...
I strongly doubt that most the crap that's on the shelves at Sav On or any supermarket would be so easy to sell, raw. It wouldn't be as convenient to use and there is the problem of dosage. Many of these "natural" products need to be heavily processed to be of any commercial value, and would not fit neatly in the produce or spice aisles. Just where would the hormones go? Next to the garlic powder? Of course, I suppose a person could shlep off to a herbalist, though the hormones may still be hard to find. And, it's so out of the way...
No one will ever be able to stop some schmuck from drinking so much carrot juice, for beta-carotene, that he turns orange. The thing is, that guy had to have some real dedication to his foolishness. He had to work at it. How hard is it to pop a pill?
Hopefully, AIDs Meds do have warnings about SJW. If they don't, they should. Of course, I am not really comfortable with the idea that my son can buy soda with SJW in it. Or Gin Sing, or any other dietary supplement. A kid doesn't have to go to a dealer anymore to get speed. I mean "energy."
See, this stuff has become so, well, everyday. And it was not always that way. Before DSHEA you actually had to work at and be a true believer in the benefits of taking crap that "Prevention Magazine" told you was good for you. You really did have to go to a health food store to get it. And, a lot of stuff that is legal now couldn't be found then.
This may be a useful link.
http://www.quackwatch.org/01QuackeryRelatedTopics/DSH/suppsherbs.html
Dave, I know I responded to a few parts of your post without quoting you. Sorry, I'm tired and that makes me lazy.... |
Uncertainty may make you uncomfortable. Certainty makes you ridiculous.
Why not question something for a change?
Genetic Literacy Project |
|
|
|
Dave W.
Info Junkie
USA
26022 Posts |
|
|
Kil
Evil Skeptic
USA
13477 Posts |
Posted - 11/14/2003 : 20:54:58 [Permalink]
|
quote:
Sen. Dick Durbin:
My bill says that before a manufacturer can market a
dietary supplement containing a stimulant, the manufacturer
must prove the stimulant is safe. It also prevents
manufacturers from using the term "dietary supplement" to
mask dangerous drugs such as steroids. And it says makers
of dietary supplements must report serious negative health
consequences resulting from the use of their products.
Well, it's a start. I would like to see much tougher regulations, but I will not be complaining if this passes.
As Senator Durbin said:
quote:
The $18 billion-per-year, dietary-supplement industry says
these requirements are costly and unreasonable. Take, for
example, Project: FANS (Freedom of Access to Nutritional
Supplements), an organization funded by the supplement
industry that said my bill would "hold long-used
nutritional supplements, from calcium to Flintstone
vitamins, to a higher reporting standard than is currently
set for many prescription drugs." Or a recent
"investigative report" for Insight stating that my bill
"would give the Food and Drug Administration the authority
to remove from the market any dietary supplement it
chooses, including vitamins E and C" and would "require
exotic proof of safety from any dietary-supplement maker if
the agency has received so much as a single report of an
adverse reaction" [see "Regulating Vitamins," Sept. 16-29].
Nonsense. This isn't a higher reporting standard than
exists for prescription drugs or even over-the-counter
medications such as ibuprofen and cough syrup. Our laws
already require those drugs and medicines be proved safe
and effective before they legally are sold. Health problems
related to the use of such medications must be reported to
the FDA.
It will be tough getting rid of the DSHEA. I would at least like to see "all" dietary supplements to be "proved safe and effective before they are legally sold." Or at least, safe! Is that asking so much? Apparently, it is to the dietary supplement industry...
|
Uncertainty may make you uncomfortable. Certainty makes you ridiculous.
Why not question something for a change?
Genetic Literacy Project |
|
|
|
Dave W.
Info Junkie
USA
26022 Posts |
Posted - 11/14/2003 : 23:32:55 [Permalink]
|
Kil wrote:quote:
A couple of things. Come to think of it, I have never seen a bottle of St. Johns Wart with anything on the label but the ingredients. What it's used for is pretty much common knowledge.
Yeah, that's part of the problem. There is a "tag team" effort going on between the people who make and sell dietary supplements, and the people who write and sell popular-press books about "medicinal herbs" and other such things.
I could easily go on a rant here, myself. That the FDA has no jurisdiction whatsoever over books which purport to help people get and stay healthy is obviously a double-edged sword. No regulation, as is the case now, and all sorts of nonsense gets printed. Too much regulation, and it would be possible to create the kind of atmosphere in which real conspiracies to keep major health advances secret would be possible. There is, perhaps, a happy medium in which one would be prohibited from doing the alternative-medicine version of "shouting fire in a theatre," but I don't have a guess as to where it lies.
At any rate, with what we've got now, so long as it's not obvious that a SJW manufacterer is paying someone to write a book which praises SJW, neither the FDA nor the FTC will consider the book to be part of the "labeling" of the product, and thus many claims could be made for it without having to answer to any government health or consumer protection agency whatsoever. I'm not saying that that's what actually happens, just that it could, and there's not a damn thing to be done about it as the laws stand now.
quote:
As for Laetrile, I see what you mean. I must admit, I made an assumption about B17. I just did a search for it and you know what? I could buy it today if I wanted to. http://www.1cure4cancer.com/ Still, this has nothing to do with DSHEA. Maybe I should have used one of the hormones that are sold as dietary supplements, or Emu oil as an example. Oh well...
The hormones, especially. Steroids, one of the targets of Durbin's bill, are hormones.
Emu oil, on the other hand, doesn't fall under the DSHEA, either. In every instance I've ever seen, it's supposed to be used topically, and thus is not a "dietary supplement." Any health claims for emu oil (and there are a lot of them) would therefore be "new drug claims," and require the same full testing and approval process as any other drug. Fact is, however, that lots of people are selling emu oil using wording which makes it sound more like a moisturizer than anything else, and those fall under the "cosmetics" part of the Food, Drug, and Cosmetics Act.
As an aside, it's pretty obvious to me that the emu-oil market has been created due to the fact that emu burgers didn't sell all that well, and lots of people who bought emus are losing money just feeding the poor birds. A guesstimate, but I'd say that at least half the companies selling emu oil have the word "ranch" in their names, and very few of them do business in Australia. Also, about a year ago, a rancher in Texas let his flock go free because it cost him too much to feed the things. In response, the local sheriff actually created a "posse" to drive around and shoot the birds before they did too much damage.
quote:
I strongly doubt that most the crap that's on the shelves at Sav On or any supermarket would be so easy to sell, raw. It wouldn't be as convenient to use and there is the problem of dosage. Many of these "natural" products need to be heavily processed to be of any commercial value, and would not fit neatly in the produce or spice aisles. Just where would the hormones go? Next to the garlic powder? Of course, I suppose a person could shlep off to a herbalist, though the hormones may still be hard to find. And, it's so out of the way...
Yeah, but there are plenty of people who prefer to do it the hard way, anyway, even today. They know that many of the big-name pharmaceutical companies have also jumped on the supplement bandwagon, and want to be sure that those "poison pushers" aren't getting their hard-earned dough. So, they schlup out to GNC or even out-of-the-way places, buy in raw form, and do the measuring themselves. It's not like there's much in the way of dosage control on what one can find at their local Safeway - the stuff isn't regulated well enough.
But, my point wasn't about whether or not it would sell well, it was about whether or not there were any specific laws which would prevent SJW or any other herb from appearing on the same store shelves as the sage and thyme. Since without the DSHEA, SJW would be considered a "food," is there any outstanding reason why it wouldn't be classified as "Generally Regarded as Safe" (GRAS), like so many other things?
In other words, there's an $18-billion market to be had out there. If the DSHEA suddenly vanished next week, the maunfacturers would probably quit producing the stuff in pill form, and instead switch to ground-up herbs, at least for those things which really are all-natural. B-17, as you say, requires heavy processing, while SJW in pill form is probably nothing more than ground-up plant stuffed into a gelatin wrapper. Eliminating the DSHEA, in other words, will only eliminate some of the products on the shelves - those which require processing.
quote:
No one will ever be able to stop some schmuck from drinking so much carrot juice, for beta-carotene, that he turns orange. The thing is, that guy had to have some real dedication to his foolishness. He had to work at it. How hard is it to pop a pill?
Indeed. Nobody is going to be able to protect those who would truly like to do themselves harm. Banning the pill form of the stuff is only going to protect people from grossly negligent accidents.
Twenty-three years ago, or so, there was a B-12 fad. If you had problems with your memory, the "authorities" told us, you should take 500 mg of B-12 a day for a week. If you can remember your dreams after that, continue taking 500 mg. If not, up the dosage to 1,000 mg the next week. And so on, adding 500 mg per day, every week, until you can remember your dreams. Lots of people were doing this. And the cautionary tale arose of the one guy who was taking 25 grams (25,000 mg) of B-12 every day, who "fried his brain" and wound up a vegetable.
On the other hand, there's the story of the senior citizen who was brought to a doctor because his kids feared he was entering the first stages of senile dementia. After several missed diagnoses, the doctor learned that the man had been a vegetarian for 40 years, and a test for serum B-12 showed that he was woefully deficient. Plants apparently aren't a good source of B-12, but the body tends to keep a lot of the vitamin around. It took this guy 40 years to use up his "stores" of B-12, and he regained his mental faculties with the help of a low-dose B-12 supplement.
quote |
- Dave W. (Private Msg, EMail)
Evidently, I rock!
Why not question something for a change?
Visit Dave's Psoriasis Info, too. |
|
|
|
Kil
Evil Skeptic
USA
13477 Posts |
Posted - 11/23/2003 : 16:14:21 [Permalink]
|
quote:
DaveW:
I could easily go on a rant here, myself. That the FDA has no jurisdiction whatsoever over books which purport to help people get and stay healthy is obviously a double-edged sword. No regulation, as is the case now, and all sorts of nonsense gets printed.
Interestingly, and unless the below quote is wrong, B17 can be sold even as a banned substance. The rub for retailers is labeling. Because the FDA considered the proximity of books or pamphlets on the subject of B17 as a cure for cancer as labeling, it became too inconvenient to be sold in most places. But since B17 is banned, and SJW isn't, maybe the FDA would be hard pressed to be so hard-nosed about what it considers labeling.
quote:
http://home.bluegrass.net/~jclark/b17_legal.htm
Any individual that sells laetrile must not claim that it does anything in his place of business. Many health food stores in the past were raided and had to give up their supplies of B17 because the B17 was near books that claimed that the B17 was the answer to cancer... In other words, the books were near the B17 in the stores and was therefore considered "labeling" which is a term used by the FDA. Labeling according to the FDA is against the law and can be prosecuted.
quote:
DaveW:
Emu oil, on the other hand, doesn't fall under the DSHEA, either. In every instance I've ever seen, it's supposed to be used topically , and thus is not a "dietary supplement." Any health claims for emu oil (and there are a lot of them) would therefore be "new drug claims," and require the same full testing and approval process as any other drug. Fact is, however, that lots of people are selling emu oil using wording which makes it sound more like a moisturizer than anything else, and those fall under the "cosmetics" part of the Food, Drug, and Cosmetics Act.
And yet, at "Awareness 2000," Emu oil was being sold as a cure for everything, including cancer. On the table were bottles of Emu oil and pamphlets with claims of the miraculous healing abilities of Emu oil. Snake oil a-rama. It looks like they were breaking the law. But there they were, right out front for everyone to see.
quote:
DaveW
But, my point wasn't about whether or not it would sell well, it was about whether or not there were any specific laws which would prevent SJW or any other herb from appearing on the same store shelves as the sage and thyme. Since without the DSHEA, SJW would be considered a "food," is there any outstanding reason why it wouldn't be classified as "Generally Regarded as Safe" (GRAS), like so many other things?
In other words, there's an $18-billion market to be had out there. If the DSHEA suddenly vanished next week, the maunfacturers would probably quit producing the stuff in pill form, and instead switch to ground-up herbs, at least for those things which really are all-natural. B-17, as you say, requires heavy processing, while SJW in pill form is probably nothing more than ground-up plant stuffed into a gelatin wrapper. Eliminating the DSHEA, in other words, will only eliminate some of the products on the shelves - those which require processing.
The elimination of some products is a good thing. As I suggested in my previous post, it is my opinion that products that could be sold raw would not have the same appeal to the average consumer. If it's not in a bottle, with a recommended dosage (which is also so unregulated that the amount listed on the label cannot be trusted) the product would probably only appeal to those who are highly committed to improving their health, "naturally." The health food junkies will make their way to an herbalist or a health food store, but most of the people who shop in safeway will pass. As it is, whole aisle's are filled with these supplements and are as easy to buy as bread and eggs. The DSHEA has created this 18 billion dollar industry by making a guinea pig out of the average Joe. Fact is, most people assume that these products are necessarily safe or they couldn't be sold in the supermarket. They don't know that the manufacturer does not have to supply the FDA with research showing a product to be safe or effective before marketing. The law is not weighted toward consumer protection. The DSHEA was created to benefit the manufacturers of the product.
quote:
DaveW:And I'm not sure that the FDA regulations - even the DSHEA - make it allowable to put such things into soft drinks. To be added to a "food," a substance has to be an "approved food additive." Unless those soft drinks are billing themselves as dietary supplements, I think the FDA would consider them to be "adulterated" foods for having non-approved additives.
This seems to be a gray area for now...
quote:
http://pf.inc.com/magazine/19990601/799.html
Regulatory gate open to health claims--for now
The label on Bliss, a drink produced by Energy Brands Inc., based in Whitestone, N.Y., notes that it contains kava and St. John's wort and promises that those who consume it will discover "the eternal relaxation channel."
Without specifically saying their products remedy depression, relieve anxiety, or cure other ailments, the makers of drinks like Bliss nevertheless tout their supposed salutary effects.
So how far can companies go in waving the health flag before they run afoul of the Food and Drug Administration? Under federal law, a claim that an herbally enhanced drink can cure or prevent a disease, such as cancer, is illegal without the FDA's imprimatur. But under a statute enacted in 1994, the maker of herbal pills or capsules (known as dietary supplements) may assert a less specific health benefit--say, promoting better circulation or boosting stamina.
Although that law doesn't cover what are known as "functional" or herbally enhanced foods and beverages, the many companies producing them claim nonspecific health benefits. Concerned about the trend, the FDA is reassessing how it regulates functional foods.
While federal officials sort out the law, it seems unlikely that the FDA will crack down on wellness-drink companies, says David Schardt, a researcher with the Center for Science in the Public Interest, based in Washington, D.C. Although he advocates tougher oversight, Schardt adds, "I don't think anyone should hold their breath.
quote:
DaveW:
Again, though, I don't believe the FDA is funded well enough to go after everyone. They start with the most dangerous, and continue to the most-outrageous. Stuff which isn't likely to kill you or cost you a |
Uncertainty may make you uncomfortable. Certainty makes you ridiculous.
Why not question something for a change?
Genetic Literacy Project |
|
|
|
Kil
Evil Skeptic
USA
13477 Posts |
Posted - 11/24/2003 : 15:55:23 [Permalink]
|
At the risk of being redundent..
quote:
DaveW:
But, my point wasn't about whether or not it would sell well, it was about whether or not there were any specific laws which would prevent SJW or any other herb from appearing on the same store shelves as the sage and thyme. Since without the DSHEA, SJW would be considered a "food," is there any outstanding reason why it wouldn't be classified as "Generally Regarded as Safe" (GRAS), like so many other things?
I understand what you are saying here. If it is "Generally Regarded as Safe" and the labeling is more complete with regard to potential dangers, I have no problem. My concern is consumer protection. How we arrive at putting the consumer first is fine with me. As long as we get there. All possible scenarios about what the dietary supplement industry could legally do if the DSHEA didn't exist is of little importance to me. That is why I keep pointing out that without the DSHEA some of these supplements would be much more difficult to buy and use, even if they will still be legal in some form. That works for me.
I am not focused (except as a sketpic) on health food fanatics or Andrew Weil-wellness addicts. In fact, it is their lives and far be it for me to keep them from practicing their religion of "natural" alternatives with a faith based commitment to any vaguely ancient Chinese medical treatment dished out with a healthy dose of pseudo-scientific explanation for how it works, no matter how crazy it is. Screw them. The Darwin awards must go to someone... |
Uncertainty may make you uncomfortable. Certainty makes you ridiculous.
Why not question something for a change?
Genetic Literacy Project |
|
|
|
Dave W.
Info Junkie
USA
26022 Posts |
Posted - 12/01/2003 : 12:55:18 [Permalink]
|
"Screw them," huh?  Of course, some of 'them' are the intended targets of consumer-protection laws. It's not like Weil, Chopra, and others like them got to where they were because they've got good data. They are, instead, doling out easy answers to complex questions and picking up a following with charm and "compassion." The worst of them are assuredly con-men, from whom the public largely needs protection (even the die-hard followers, who need protection from themselves). I'm not a terribly big fan of social Darwinism, as you might guess.
Anyway, on the funding point: the DSHEA mandates that the FDA examine product labels to ensure that they're within the law. Surely no company which decides to break the requirments laid out by the DSHEA is going to call up the FDA and turn itself in. One of the major failings of the DSHEA, therefore, was its utter lack of mandating any sort of funding mechanism, and the Harkin/Hatch bill appears to try to rectify that.
Even if all the money goes towards just a couple of people cruising the Internet all day, bookmarking product sites which violate the DSHEA (then emailing the URLs to the lawyers), that'd be a hell of a lot more consumer protection than what we've got now.
A few years ago, a friend of mine told me that the FDA told him to quit sending their main office complaints about fraudulent products. He was told to send them, instead, to the FTC (an even less well-funded organisation), and perhaps to the FDA field offices local to the "offense" (hard to do when some were overseas, but advertising to Americans). He found the whole exchange to be fairly disheartening, as it meant that the FDA was less amenable to hearing consumer complaints in general. In my opinion, it's exactly this sort of consumer "policing" of the marketplace for which the FDA needs more funds.
Perhaps both bills needs to be passed. It's not like they're contradictory. |
- Dave W. (Private Msg, EMail)
Evidently, I rock!
Why not question something for a change?
Visit Dave's Psoriasis Info, too. |
|
|
|
 |
|
|
|
Topic Locked
