posted
What's the argument against having the FDA regulate these products the way they do everything else?
Posts: 21898 | Registered: Nov 2004
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posted
They passed a law a while back (and I remember ranting about it at the time, but you're a bit young to remember) that does not allow them to do so. (By considering such supplements to be "foods" not drugs -- which is both ridiculous and irrelevant.)
One of the most dangerous and idiotic laws passed in the last 20 years, IMO.
Posts: 32919 | Registered: Mar 2003
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quote:What's the argument against having the FDA regulate these products the way they do everything else?
Money.
Either, A) the FDA does not have the budget or manpower to handle these additional tasks, so can not be stretched. After all, it is more important to make sure the milk everyone drinks is healthy than the supplements only some gullible people take are healthy.
or B) The multi-billion dollar Supplement industry paid off our government employees--congressmen--so that they would be free from oversite.
Either way, the answer is money.
There is also a morality issue. Makeup was originally left off of the items the FDA regulates because at the time--1900 or so--, it was deemed only immoral women wore makeup. Today some of the same thinking applies, only fools use supplements instead of working on their health (diet and exercise, not fad pills and miracle cures), so those fools should suffer the results of their laziness.
Posts: 11895 | Registered: Apr 2002
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posted
or C) The cost of a full approval process (as for drugs) would mean that only large companies with potentially highly profitable supplements would be able to reach the market, so a political decision has been taken to allow these products which are assumed to be “safe” to be sold without testing.
I don’t know how things work in the USA, but this is the reason given in Europe. If herbal supplements had to go through testing similar to that required for drugs, they would disappear from the shelves as there would be no companies willing to pay for the testing and approval procedure.
I think there are efforts being made to improve the situation here, but I’m not very familiar with that area. I know more about pesticides, where “natural” pesticides have previously not been registered, but there is now a move to get companies to register them by producing a cheaper route to registration than the full approval process for other pesticides.
Posts: 169 | Registered: Aug 2005
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posted
Was it legal to have testosterone and estradiol in that product and still label it "natural"? I'm wondering if it was a problem of adulteration, which would be a bit of a separate issue from the safety of herbal supplements in general. And the FDA would have jurisdiction on the adulteration of herbal supplements just like it would have jurisdiction regarding the adulteration of food, right?
I agree with Rivka that it's an incredibly dangerous loophole that permits the sale of supplements without regulation. There's nothing inherently safe about natural herbs. If a substance derived from an herb passes safety and efficacy tests and is sold in exactly measured quantities, it's a drug.
As an aside, GHB was apparently sold as a natural supplement for some time until it was banned.
Posts: 3546 | Registered: Jul 2002
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quote:If herbal supplements had to go through testing similar to that required for drugs, they would disappear from the shelves as there would be no companies willing to pay for the testing and approval procedure.
posted
At least homeopathy is unlikely to cause cancer. But yeah, that would be at the top of the list of frauds.
Posts: 3546 | Registered: Jul 2002
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quote:If herbal supplements had to go through testing similar to that required for drugs, they would disappear from the shelves as there would be no companies willing to pay for the testing and approval procedure.
*world's smallest violin plays*
Pfft. Even tiny violins should only play for true statements.
Posts: 32919 | Registered: Mar 2003
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posted
Let's say that "supplements" were regulated. How would that work? Would we have to get FDA approval for every single ingredient that we might want to put in our food?
Posts: 16551 | Registered: Feb 2003
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posted
What do you think happens now? They are the Food & Drug Administration, neh?
The irony is that right now supplements actually have less oversight than straight "foods." Quoting from the page I linked above:
quote:In October 1994, the Dietary Supplement Health and Education Act (DSHEA) was signed into law by President Clinton. Before this time, dietary supplements were subject to the same regulatory requirements as were other foods. This new law, which amended the Federal Food, Drug, and Cosmetic Act, created a new regulatory framework for the safety and labeling of dietary supplements.
Under DSHEA, a firm is responsible for determining that the dietary supplements it manufactures or distributes are safe and that any representations or claims made about them are substantiated by adequate evidence to show that they are not false or misleading. This means that dietary supplements do not need approval from FDA before they are marketed.
posted
No. People who put stuff in our food would have to get FDA approval.
I don't buy the, "It would cost to much. We wouldn't get the stuff on the market."
Well, I have this Arsenic stuff that I believe will cure Sinus Headaches. Right now there is nothing that can stop me from selling it, spending 3 Million n marketing. Once the fatalities start rolling in, the Federal Government can ask me to take it off the market. If they prove a connection, by spending your tax dollars doing the research, they could even force me to take it off the market.
By then I've made my 10 Million in Arsenic sales, (Marketing Name--All Natural Cinesra.) and fold my company.
Posts: 11895 | Registered: Apr 2002
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posted
Port, the FDA does have to approve all food and all ingredients, and make sure that all ingredients are listed on all purchased food, (not on prepared food at restaurants). That is why you get those lovely lists of ingredients on the packages of all foods except produce.
That doesn't mean that the FDA needs to test every egg or spec of flour or grain of salt. They already know what those things are. You don't need an FDA form when you shake Paprika on your stew.
However, if there is some strange weed growing in your backyard that you think makes a yummy topping for frozen pizza, it would have to be tested to make sure that it won't kill people.
Then, when you sell your frozen "Portweed Pizza" you have to get FDA confirmation that it is Portweed you are putting on the pizza, and not some cheap oak leaves.
If you grind up the Portweed and sell it as medicine, you need FDA confirmation that the pill is the exact dose of Portweed that you say it is.
If you just want to sell a Portweed food supplement, you can put lettuce, oak leaves, or talc powder in the pills instead of the Portweed, as long as you have some miniscule amount of Portweed in some of the pills.
And if some pills are 2% Portweed, and others are 97% Portweed, well, who cares. maybe the people who are buying the Portweed Pills and who are not getting the steady amount of Portweed they think they are, but legally, you are doing fine.
Posts: 11895 | Registered: Apr 2002
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posted
I was trying to do research to see if the concerns in this thread apply to Canada (I was going to guess "yeah, we probably are just as at risk") when I came across this amusing source
quote: Through this foundation the FDA is seeking broad new regulatory power that it currently does not possess. This will include the authority to attack any dietary supplement (which are food ingredients) as unsafe based on its use of “Critical Path” technology. This means the FDA will use proteomics (the advanced study of proteins in biological systems) to assess changes in biomarkers (the change in the state of a protein at the molecular level) in order to establish whatever it wants to consider as a risk. The FDA can slant this technology, based on their own personal opinions, to make anything they want appear as a risk – including your favorite dietary supplements that you use to stay healthy. ... The anti-American FDA is actively seeking to undermine U.S. laws and harmonize our dietary supplement laws with Mexico and Canada. This is being done through the Trilateral Cooperation Charter – an illegal agreement set up with health regulatory agencies in Mexico and Canada. It is part of the campaign towards a North American Union, one which would be a catastrophe for health freedom in this country as dietary supplement laws in Canada and Mexico are far more restrictive than in the U.S.
Check out the description of the source at the top right of the page Thought it would be amusing, still looking for a (now, reputable) source for how this works in Canada.
Edit to add: Also found this...
quote: The Food and Drug Administration (FDA), in order to comply with standards dictated by supra-national organizations such as the UN‘s World Food Code (CODEX), NAFTA, and CAFTA, has been assuming greater control over nutrients, vitamins and natural health care providers to restrict your right to choose the manner in which you manage your health and nutritional needs.
I(Ron Paul) have been the national leader in preserving Health Freedom. ... I oppose legislation that increases the FDA‘s legal powers. FDA has consistently failed to protect the public from dangerous drugs, genetically modified foods, dangerous pesticides and other chemicals in the food supply. Meanwhile they waste public funds attacking safe, healthy foods and dietary supplements
posted
I have heard a few stories of unregulated stuff that do some good and would not be possible to obtain regulation. Phage for severe external infections is one thing that you will not get approval for buthas saved some lives. I don't think the evidence exists to argue the effective part of the FDA's safe and effective rules, but if the odds of you surviving are essentially zip, why not try it? Right now, the only way to get phage is through loopholes (it is a homepathic treatment). I got to agree with the dr who said, by the time he gets to the the patients, 90% are going to die, with phage it is more like 88%. Impossible to argue effective, but for those 2%, a miracle. (This doctor does every other technique he knows, charges nothing for the phage and makes sure the patients know that phage is extremely unreliable which probably also contributes to my favorable impression of its use in these cases).
Posts: 1001 | Registered: Mar 2006
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quote:Originally posted by Shigosei: At least homeopathy is unlikely to cause cancer. But yeah, that would be at the top of the list of frauds.
True. It's hard for sterilized water to do much of anything, but they should stop tricking people into buying it.
Posts: 3852 | Registered: Feb 2002
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quote:If you just want to sell a Portweed food supplement, you can put lettuce, oak leaves, or talc powder in the pills instead of the Portweed, as long as you have some miniscule amount of Portweed in some of the pills.
And if some pills are 2% Portweed, and others are 97% Portweed, well, who cares. maybe the people who are buying the Portweed Pills and who are not getting the steady amount of Portweed they think they are, but legally, you are doing fine.
This is a misinterpretation. The FDA regulates supplements. It just doesn't regulate them using the same guidelines used for either food are drugs. Labels are required to be accurate and require ingredient labels and nutritional labels that a comparable to those on food.
Posts: 12591 | Registered: Jan 2000
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posted
I don't have much of a problem if you put some weird spice in your food...
My problem comes when you start saying the weird spice will cure hair loss, make you better in the sack, help you lose weight, etc... That's when it goes from being an additive or a suppliment and starts being a Drug. At least in my opinion.
Posts: 7085 | Registered: Apr 2001
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quote:Originally posted by rivka: They passed a law a while back (and I remember ranting about it at the time, but you're a bit young to remember) that does not allow them to do so. (By considering such supplements to be "foods" not drugs -- which is both ridiculous and irrelevant.)
One of the most dangerous and idiotic laws passed in the last 20 years, IMO.
I totally agree.
quote:Originally posted by Dan_raven:
quote:What's the argument against having the FDA regulate these products the way they do everything else?
Money.
or B) The multi-billion dollar Supplement industry paid off our government employees--congressmen--so that they would be free from oversite.
Either way, the answer is money.
Bingo!
When this law was being considered, the supplement industry conducted an expensive campaign to convince people that if the law was passed they would no longer be able to easily purchase their vitamins and other favorite supplements.
It was a stupid argument, when you consider the easy availability of so many FDA-approved over-the-counter medications. But the campaign was so convincing that even an otherwise very intelligent and well-informed friend of mine fell for it.
I was totally disgusted when the law was passed.
Natural and herbal does not equal safe and never has.
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We had a mommy end up in the ER on one of my other boards a few months ago because of Hyland's Teething Tablets.
Posts: 21182 | Registered: Sep 2004
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quote: Natural and herbal does not equal safe and never has.
The "children's" spin off of Doctor Who "The Sarah Jane Adventures" pilot special contained a product that advertised itself as "organic" (Which is good, right?).
SPOILERS: The character Maria questions this, asking what does it mean? Turns out, the "organic" element is a sentient alien life form.
posted
"A man I know ended up in the ER after taking St. John's wort along with his regular antidepressant."
St. john's wort outperforms placebos in not doing anything for depression. Makes it worse in a far larger number of cases then it helps heal depression. And yet, it can be marketed as an anti-depressent. Who the frock cares if the stuff won't reach the shelves if its regulated? That would IMPROVE the health of americans.
Posts: 4112 | Registered: May 2001
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quote:Originally posted by The Pixiest: I don't have much of a problem if you put some weird spice in your food...
My problem comes when you start saying the weird spice will cure hair loss, make you better in the sack, help you lose weight, etc... That's when it goes from being an additive or a suppliment and starts being a Drug. At least in my opinion.
If it's non-FDA-approved, you definitely cannot say your supplement cures or treats anything, or prevents any diseases. You have to stick to "promotes already healthy levels of..." or "supports healthy function of...." You can get into plenty of trouble if you start making overblown, inaccurate claims about your product.
Posts: 5957 | Registered: Oct 2001
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posted
I hate this stuff. I work in pharmaceuticals, and there's no good reason for this fake, harmful "medicine" to slip under the radar. There's a lot of labor, brains, and money that goes into real drugs, and you get results from that.
Posts: 1735 | Registered: Oct 2004
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quote:Originally posted by Ela: When this law was being considered, the supplement industry conducted an expensive campaign to convince people that if the law was passed they would no longer be able to easily purchase their vitamins and other favorite supplements.
It was a stupid argument, when you consider the easy availability of so many FDA-approved over-the-counter medications. But the campaign was so convincing that even an otherwise very intelligent and well-informed friend of mine fell for it.
Part of the campaign was a series of phone "surveys" -- and I got a call.
The survey was the first I had heard of the suggested law. But talking to me was clearly very frustrating to the telemar^H^H^H^H^H^H^H -- um, survey-taker. I kept refusing to fall for all the loaded questions, and disagreeing with all their oh-so-reasonable notions.
It was a lot of fun.
However, the fact that even after I found out more about the law and started yelping about it there was not much I could do was not fun at all. Posts: 32919 | Registered: Mar 2003
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quote:Originally posted by Joldo: I hate this stuff. I work in pharmaceuticals, and there's no good reason for this fake, harmful "medicine" to slip under the radar. There's a lot of labor, brains, and money that goes into real drugs, and you get results from that.
There is also a lot of good research going into studying the effectiveness of herbs in the academic community, though admittedly after the supplement companies make their millions. Hearing about the ineffectiveness or effectiveness of certain substances based on good double-blind studies from multiple sources have influenced what I buy.
There is a lot of empty-headed faith in both the FDA-approved pharmaceuticals prescribed by your doctor and in the less-regulated substances peddled by well-meaning natural food stores, and even the food regulated by the FDA.
The key is to be skeptical of everything you're putting into your system no matter where it comes from. Research it, read studies you find on Google Scholar. Find consumer groups that try to find out who's pulling the wool over your eyes about which substances and eating practices.
Posts: 106 | Registered: Dec 2003
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I don't know if there is anything wrong with cloned animals in fact, but it seems that for such a new technology, with only a couple generations of animals tested, 6 years of tracking is a little quick to move this into the public food supply.
I think herbal supplements should be regulated as food at least, and as drugs if the companies make significant and specific health claims about their products. Just make sure to cast the skepticism in all directions, especially since the FDA does not have a flawless record by a long shot.
Posts: 106 | Registered: Dec 2003
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If herbal supplements had to go through testing similar to that required for drugs, they would disappear from the shelves as there would be no companies willing to pay for the testing and approval procedure.
*world's smallest violin plays*
I agree with you. I don't think companies would pay for testing of herbal products that they could not patent, but I don't think that is a bad thing.
There would probably be a few useful things lost, but since we have no way of knowing which are useful, then that is not a major problem.
There would be a lot of useless but basically harmless things removed - a good thing.
There would be some dangerous products removed. - a very good thing.
Since we have no way of knowing what is good, useless or harmful the small disadvantage of removing from the market something that is useful for some people (but we don’t know who) is easily outweighed by the advantage of removing dangerous products. That doesn’t alter the fact that products would disappear from the market and only the larger companies would pay for the testing required.
Posts: 169 | Registered: Aug 2005
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posted
First, let me just say that Temposs has the right of it more than any of you.
Second, IME, there are plenty of herbs known to be very safe and helpful in the Chinese herbal catalog. Dong Quai is one, it's very safe for long-term use, and plenty of women I know swear by it for easing PMS. Chinese licorice is another one. There's no clear line in herbal tradition between herbs that can be eaten daily as foods, and herbs used only for healing specific problems. Regulating either of the herbs I mentioned above would be wholly retarded and laughable. Some probably could be regulated, and we'd be better off, but I don't think the difference would be huge.
Again, Temposs has the right of it. Re-cog-NIZE.
Posts: 3354 | Registered: May 2005
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posted
The problem as I see it is that many of the herbal supplements on the market have not been studied for either effectiveness or safety. Secondly, since there is no regulation or inspection, you have no way of knowing for sure that the bottle you have paid for has the active parts of the herb as advertised. Spot checks by independent sources have shown that some of these herbal supplements are mostly filler, with very little active ingredient. Companies can claim whatever they want, whether it's true or not. That's why regulation is needed.
The bottom line is that you have to be an informed consumer and find out all the pros and cons of the herb or supplement you are planning to take - the therapeutic action it is supposed to have, the side effects, and how it will interact with any other medications or supplements you might be one. Many of these natural medicinal herbs are not benign!
Posts: 5771 | Registered: Nov 2000
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quote:Originally posted by mr_porteiro_head: A woman I know ended up in the ER after taking a shower.
How'd that happen?
She slipped and fell on the built-in porcelain soap holder, which broke and cut into an artery in her leg.
Posts: 16551 | Registered: Feb 2003
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quote: Natural and herbal does not equal safe and never has.
The "children's" spin off of Doctor Who "The Sarah Jane Adventures" pilot special contained a product that advertised itself as "organic" (Which is good, right?).
SPOILERS: The character Maria questions this, asking what does it mean? Turns out, the "organic" element is a sentient alien life form.
Food for thought, perhaps?
Or should that be "thought for food"?
Posts: 12591 | Registered: Jan 2000
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quote:Even as a libertarian, I'd have no problems with the FDA cracking down on them.
I don't think "libertarian" is the best term for someone who is OK with the idea of government agents deciding how we're allowed to treat ourselves. That's the *opposite* of libertarian.
Posts: 544 | Registered: Mar 2007
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quote:Even as a libertarian, I'd have no problems with the FDA cracking down on them.
I don't think "libertarian" is the best term for someone who is OK with the idea of government agents deciding how we're allowed to treat ourselves. That's the *opposite* of libertarian.
Don't get me wrong. If you KNOW it doesn't do anything and you take it anyway, that's fine. The gov't should have no business in stopping you.
What the gov't should crack down on is the Fraud.
If you're buying a "supplement" with "claims not evaluated by the FDA" You're getting ripped off.
Posts: 7085 | Registered: Apr 2001
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