View Full Version : Your Suppliments In Danger!
De_Franza
10-21-2004, 07:58
This is really just for US citizens, but anyone in the EU care to comment? seen any difference? heard anything about this? The news in the US is silent on this.
Anyway, I just read an article about this crooked plan to take most suppliments off the market, no doubt cooked up by "big pharma" and their lobby groups in Washington. see below...
{copied from William Campbell Douglass II, MD's "Daily Dose" newsletter}
{To start receiving your own copy of the Daily Dose, visit:
http://www.agora-inc.com/reports/rhb/codex}
...In the article, Dr. Wright explains how the European
Union (EU) Directive on Dietary Supplements could have
a huge impact on our health freedom. This directive,
which is part of a larger form of legislation called
Codex Alimentarius, severely restricts access to natural
health products in Europe - and the US may not be far
behind if we don't do something about it.
Dr. Wright urges you, as I do, to write to your senators
and congressmen to try and preserve your right to take
the vitamins and supplements you want. To locate your
senators, visit www.senate.gov. To locate your congressmen,
visit www.house.gov. You can also get help finding this
information at your local library.
Stand up and be heard!
Visit below to read the full article:
http://www.agora-inc.com/reports/nah/codex
redqueen290
10-21-2004, 19:30
They do realize that all this is going to do is have people buy them online from mexico? Outlawing something never gets rid of it. Not to mention, supplements are so good for you. I sometimes wonder about the people running our country.
Before we get out the pitch fork, the torch and match down to the city hall, let's be aware that the specific legislation (and related directives) has NOTHING to do with us here in the States. The enlightened European bureacrats think they know better what is good for their citizens. It is their citizens responsibilities to decide how they want to be governed.
There is no pending legislation in the US of that nature. We have no basis to complain.
De_Franza
10-22-2004, 07:57
One would think so Ken, except that the US has joined the WTO and therefore is bound to follow it's rules (although, when has membership in an international body affected US policy?). If you read the article, it explains how this works.
That's assuming this isn't alarmist bunk. Any comments from those in Europe? Has this been in your news? I"ve seen some fliers at health food stores here, but no media coverage.
Rasputin
10-22-2004, 10:06
...is FDA-mandated scientific studies of all supplements sold in the US, testing for:
Health Benefits vs. Claims
Side Effects/risks
Interactions with drugs and other supplements
Most effective dosages
and Contraindications.
Without a true double-blind test, it is impossible to rule out the placebo effect. Why pay hundreds of dollars or more a year for an herb or chemical that has no more effect than Lactose?
If a product is found to be GRAS (generally regarded as safe) but it does not have the claimed theraputic effect that is claimed by the manufacturer, it should be labeled along the lines of "this product has passed GRAS testing but has been shown in clinical testing to have no effect upon the human body". I think that would make your choice so much easier when browsing down the aisles at GNC, trying to decide upon what to spend your hard earned cash.
Right now, all they are required to say is "X Statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure or prevent any disease". In other words, all it says is "don't look at US, WE didn't certify that it works."
But, in reference to the OP, I think that the US's approach will persist over that of the EU. We tend to err on the side of the consumer being able to make their own decisions instead of the Government making them for us. Let's hope that that trend persists. The label should say "it works" or "it has been shown that it does NOT work" but let us buy it if we so desire.
Oh, and to open up another can of worms, I would like to see Homeopathy's strangle hold on the FDA dissolved. See http://www.quackwatch.org/01QuackeryRelatedTopics/homeo.html for more information.
One would think so Ken, except that the US has joined the WTO and therefore is bound to follow it's rules (although, when has membership in an international body affected US policy?). If you read the article, it explains how this works.
That's assuming this isn't alarmist bunk. Any comments from those in Europe? Has this been in your news? I"ve seen some fliers at health food stores here, but no media coverage.
I read it. It will be political suicide for any officeholder to implement that on the US citizens. I would love to see the Democrats try it. This country was founded on the basis that we didn't care to be tell what to do by the aristocratic tyrants in Europe and England. So, I would love to see some political hacks trying to bring back those stinking tea drinkers to tell us what we can or cannot pollute our bodies with! Remember the Boston Tea Party? :mad: :D
...is FDA-mandated scientific studies of all supplements sold in the US, testing for:
Health Benefits vs. Claims
Side Effects/risks
Interactions with drugs and other supplements
Most effective dosages
and Contraindications.
Without a true double-blind test, it is impossible to rule out the placebo effect. Why pay hundreds of dollars or more a year for an herb or chemical that has no more effect than Lactose?...
That is all good and every reasonable person would agree to it.
The problem is, we simply do not have the exact knowledge regarding those factors.
If we subjected supplements to the same standard used in our current drug approval, the result would be a blanket ban on 99% of the supplements. The time and money required to research and document these products would simply be prohibitive.
Right now, for the most part, there are contradicting evidences on the efficacy of most supplements. The FDA simply don't know, neither do the scientific community. Are we gonna say you are NOT allow to take shitake mushroom b/c we don't have the scientific knowledge on its efficacy, side effect and contra indication, etc? We have to consider the individual's rights. This country is different from the aristocratic Europeans.
On the other hand, I don't like to see the public being fleeced by unscrupulous merchants.
We want to have the information necessary to make the right decision. But the necessary information, takes a lot of resources, in terms of money and time. No private entity will provide the humongous resources needed to research and validate a product that will instantly be offered by 10 thousand competitors. Are we, as a nation of taxpayers, willing to commit the amount of resources needed to acquire the scientific knowledge that can help us decide if we should take ginseng, ginkoba, shitake mushroom or green tea? Are we willing to give up our rights to decide for ourselves and wait till the government decides that it has the necessary information to give a green light?
De_Franza
10-22-2004, 12:33
I read it. It will be political suicide for any officeholder to implement that on the US citizens. <snip> Remember the Boston Tea Party? :mad: :D
LOL! You and I are on the same page, then. Still, it seems creepily possible.
Rasputin
10-22-2004, 13:04
That is all good and every reasonable person would agree to it.
The problem is, we simply do not have the exact knowledge regarding those factors.
If we subjected supplements to the same standard used in our current drug approval, the result would be a blanket ban on 99% of the supplements. The time and money required to research and document these products would simply be prohibitive.
I do not feel that this would be the case. Were I to be placed in charge of this project by the FDA, I would mandate:
1. Require any untested supplement to be in compliance within 1 year from the date of the law.
2. Require that any company wishing to market a supplement "for the purposes of preventing, diagnosing or curing illness, or other health-based claims" in the USA subject that supplement to rigorous double-blind clinical testing, supervised by the FDA or an FDA-approved agency.
3. Food items will be exempt from this regulation, but they must not bear any packaging extolling their health affecting properties or making any claims which have not been proven by said double-blind testing.
4. Companies, based upon nonprofit or income level, would be offered cost-sharing assistance to help defray the price of clinical testing. This would be on a sliding scale. All companies would bear the cost of testing their products to some degree.
5. Any product which is shown in official clinical testing to be harmful to the health of the consumer at X dose but does also show clinical health benefit at preventing/curing Y problem will be required to state so on the label, such as "This product has been shown to cause hepatic inflammation at doses higher than 5mg/kg, but also has been shown to lower blood cholesterol (LDL)"
6. Any product which has not been shown to have any positive health benefit but does cause health problems in laboratory testing is a dilemma. Should we still allow it to be sold, with a vicious disclaimer on the bottle? Or should it be treated as a poison and simply disallowed? I confess that I do not know.
7. Any product which has not been shown to cure or prevent any of the claimed health problems but has no negative health impact should be allowed to be sold, with the label "This product has been proven in clinical testing to have little to no health impact whatsoever. Buy it if you like--it's your money".
You say that we do not have the resources to make it happen. According to the Nutrition Business Journal:
http://www.expoeast.com/press/09142004-1.cfm
the US Dietary Supplement industry reached $62.9 Billion dollars during 2003. Surely the money is there to have these products tested. We can start with the ones found to be used most often by the population and work our way down to the ones only rarely used. Eventually, it should be impossible to market a supplement and make claims about its health benefits unless they have been clinically tested, even if it takes 10 years.
Apparently, the FDA is starting to agree:
http://www.pharmacist.com/articles/h_ts_0176.cfm
So, in closing, I am not saying that the consumers will not be allowed to take ginseng, ginkoba, shitake mushroom or green tea, or any other supplement. But if someone tries to market them under the supposition that they offer health benefits, they should have to back it up with science. If they cannot, they should have to state on the package that it has been proven to have no health effect.
2. Require that any company wishing to market a supplement "for the purposes of preventing, diagnosing or curing illness, or other health-based claims" in the USA subject that supplement to rigorous double-blind clinical testing, supervised by the FDA or an FDA-approved agency.
The supp on the market today, already has the statement "This product is not intended to diagnose, treat, cure, or prevent any disease." printed on the packaging. Anything that promises a "cure" will land you in hot water with the FDA and your DA.
3. Food items will be exempt from this regulation, but they must not bear any packaging extolling their health affecting properties or making any claims which have not been proven by said double-blind testing.
They are allowed to say carrot has a lot of vitamins that are good for your eyes. Can't they? Can they say 'An apple a day helps keep the doctors away"? Can't they say "People in China have long used ginseng to enhance their vitality and reproductive health"?
4. Companies, based upon nonprofit or income level, would be offered cost-sharing assistance to help defray the price of clinical testing. This would be on a sliding scale. All companies would bear the cost of testing their products to some degree.
With all due respect, I don't think you understand the amount of resources it takes to establish the efficacy of a herb supplement. Take ginseng for example. This has been researched by numerous institutions all over the world for decades. The result is inconclusive. Do you really think 'mom and pop' company has the brain power to pull this off with public dough? I see money down the toilet big time. Another federal pork project. Any idiot who wants to sell shitake mushroom is going to hop on the gravy train. Put that never-do-well brother in law of yours in charge of R&D and on government dough. Good lord! I don't think you understand the complexity and depth of what it takes to conduct such a research.
5. Any product which is shown in official clinical testing to be harmful to the health of the consumer at X dose but does also show clinical health benefit at preventing/curing Y problem will be required to state so on the label, such as "This product has been shown to cause hepatic inflammation at doses higher than 5mg/kg, but also has been shown to lower blood cholesterol (LDL)"
Fine by me, but it is again a matter of resources.
6. Any product which has not been shown to have any positive health benefit but does cause health problems in laboratory testing is a dilemma. Should we still allow it to be sold, with a vicious disclaimer on the bottle? Or should it be treated as a poison and simply disallowed? I confess that I do not know.
Any product with a detrimental toxicological profile, is pulled. Not for human consumption. That's been done.
7. Any product which has not been shown to cure or prevent any of the claimed health problems but has no negative health impact should be allowed to be sold, with the label "This product has been proven in clinical testing to have little to no health impact whatsoever. Buy it if you like--it's your money". You need to becareful there. It is a lot easier to establish scientifically that it has NOT been proven to have certain benefits, than to go all out to prove that it ABSOLUTELY has no benefit. Just because you can't find something, does not mean you have proven that it is not there.
You say that we do not have the resources to make it happen. According to the Nutrition Business Journal:
http://www.expoeast.com/press/09142004-1.cfm
the US Dietary Supplement industry reached $62.9 Billion dollars during 2003. Surely the money is there to have these products tested. We can start with the ones found to be used most often by the population and work our way down to the ones only rarely used. Eventually, it should be impossible to market a supplement and make claims about its health benefits unless they have been clinically tested, even if it takes 10 years.
It is the amount of sales reported. It is not the amount of money available to fund research.
Apparently, the FDA is starting to agree:
http://www.pharmacist.com/articles/h_ts_0176.cfm
That was 2 years ago. And you can see the result in the statements printed on every packaging of the supplement.
So, in closing, I am not saying that the consumers will not be allowed to take ginseng, ginkoba, shitake mushroom or green tea, or any other supplement. But if someone tries to market them under the supposition that they offer health benefits, they should have to back it up with science. If they cannot, they should have to state on the package that it has been proven to have no health effect.
I agree, with the exception that the correct statement is "This product has not been proven to do XYZ". But we already have the caveat emptor statement on every supp that says "This product is not intended to diagnose, treat, cure, or prevent any disease."
Rasputin
10-22-2004, 16:05
We agree that it would be nice if there were stricter testing of health supplements.
We agree that it would go against the credo of the American Way of Life to disallow products from being sold just because they have not been proven to work.
(I think) we agree that, although it would be costly and difficult to bring about, it would be beneficial if supplement manufacturers could be regulated just like drug manufacturers, so that the public could be more informed about the substances they are putting in their bodies.
As long as we are disagreeing on the feasibility, that is pretty safe ground, since it is not up to us to design or implement these mandates.
Oh, and I don't think that each "mom and pop" company has to establish efficacy of their products. Rather, each product must be verified. Approach the problem from the opposite angle. For example, hundreds, maybe thousands of companies sell Ginseng. Establish one clinical study, 2000 participants. Half are the control, half receive the average dose as taken by those who take ginseng now. They are monitored for five years. At the end of those five years, the data is collected and evaluated.
The cost of the study is shared among every company who wishes to sell Ginseng, in proportion to their income from ginseng sales. When the study is paid for, the fee is removed. Unless the study is repudiated, ginseng no longer needs to be tested. Repeat for all other supplements, in order of their use, highest volume to lowest.
Maybe it is all a pipe dream. But I think it is worth trying. And I am not such a fatalist as to believe that just because something is difficult and/or costly it should not be attempted.
Anyone else want to add their two yen?
I would be ecstatic to have the information on the efficacy of each supplement. I would vote to increase the budget on R&D. (God know we spend money on countless of worthless crap.) We have the best research institutions in the world. It would accelerate our civilization forward, if we put more funding to work in all our research institutes.
Most of the supps today, are scams. People are buying hopes in nice little bottles. There are simply not enough scientific research to substantiate the majority of the claims. The imperfect solution we have for the imperfect situation we are in, is to let vendors make all kind of "suggestion" as long as they don't promise a "cure" and as long as they say none of their ''suggestion" has been evaluated by the FDA.
Who knows. May be we should require stronger language , such as " You are wasting your money on this crap, SUCKER!" on the package. :D
LOL! You and I are on the same page, then. Still, it seems creepily possible.
You are correct to be concerned. Western medicine needs to protect it's profits. They are losing patients right and left to homeopathy and chinese as well as other types of medicine.
There has already been a test case in the USA. The removal of Ma Huang for sale due to the deaths of people using it as a substitue for the drug methamphetamine. Those people improperly used a medicine and the sales were stopped. If you apply the same rules to the western pharmaceutical industry, doesn't that mean that most pharmaceuticals would be removed from the market?
I know for a fact right now governments want to force antidepressant makers to include a "increases the chance of suicide risk" message on their bottles. If people die because they suicided from taking a particular medicine, why is this medicine still allowed to be sold? Following the model of Ma Huang above, the medicine should be immediately banned for sale. Why aren't pharmaceuticals removed from market?
Money. Big money. Protecting the profits of large donors to political campaigns.
The law to force testing of supplements here in the USA? It would effectively stop distribution of natural medicines. Natural medicines are free to grow by anybody. Who is going to pay the FDA for testing? People using free or cheap herbal medicines do not donate thousands of dollars to political campaigns so they will get no protection from politicians.
......I know for a fact right now governments want to force antidepressant makers to include a "increases the chance of suicide risk" message on their bottles. If people die because they suicided from taking a particular medicine, why is this medicine still allowed to be sold? Following the model of Ma Huang above, the medicine should be immediately banned for sale. Why aren't pharmaceuticals removed from market?......
Things are not as simplistic as presented. There are tens of thousands , if not hundreds of thousands of patients who regained their lives, to various degree, and are therefore able to function, again, to various degree, as a result of these selective serontonin reuptake inhibitors. There are a few cases of extreme situation where the patients committed suicide while on these medications. These patients might have committed suicide, whether they were on these meds or not.
Who are you, to deny all those patients who benefit so much from these SSRI, the continued relief they have? Can you relieve their daily suffering? Do you know how much a positive impact the SSRI medications have on the lives of these mothers, daughters, sons, brothers, sisters, fathers?
It is one thing to be cynical about the political system. But one must not fail to taken into consideration the whole facts.
Before we get out the pitch fork, the torch and match down to the city hall, let's be aware that the specific legislation (and related directives) has NOTHING to do with us here in the States. The enlightened European bureacrats think they know better what is good for their citizens. It is their citizens responsibilities to decide how they want to be governed.
There is no pending legislation in the US of that nature. We have no basis to complain.
Actually there is. Has everyone forgotten the bill S.722 introduced by Senator Durbin of Illinois. It is still in comittee
Alex Fowler
10-28-2004, 16:37
Governments banning supplements like ephedra and the like because a handful of idiots go overboard with them is the exact opposite of what our Founding Fathers wished for our country. As far as I'm concerned, you should be able to do whatever you want as long as it doesn't directly affect other people...hell, if you want to do lines of coke off a hooker's *** while playing Russian Roulette for money in the basement of some restaurant in Chinatown, that's your business, not mine or the government's.
The problem is when the idiot ends up at the ER of the county H, the taxpayers, ie you and I, will have to ante up.
Rasputin
10-28-2004, 22:41
Governments banning supplements like ephedra and the like because a handful of idiots go overboard with them is the exact opposite of what our Founding Fathers wished for our country. As far as I'm concerned, you should be able to do whatever you want as long as it doesn't directly affect other people...hell, if you want to do lines of coke off a hooker's *** while playing Russian Roulette for money in the basement of some restaurant in Chinatown, that's your business, not mine or the government's.
And that would be fine by me, but I would still like it if a company sells a supplement which is designed and/or marketed to affect one's health, that we could be more informed as the the scientifically proven results of ingesting such a product. If it can be proven to do something, disclose that information. If it can be proven that it does NOT have that effect (based on said clinical trials), then they should have to say it right on the bottle: "Don't bother taking this for X, because FDA-sponsored clinical testing has proven that it has no effect on X".
You know, Zinc and Goldenseal for the common cold, St. John's Wort for Depression, Acidophilus for bowel distress, etc. We know what they are claimed to do, test them and let us all know. If we still want to buy them, at least we know that, at least according to this study, it did not help the test subjects.
But I am and always have been in favor of being able to buy just about any product. I still think they should pass GRAS testing, but the potential to poison the unwary is just too high to ignore.
kodanjaclay
10-28-2004, 23:19
Ok.. this is a topic I am very familiar with... probably more so than anyone here.
First thing you have to know is that the Elixir of Sulfanomide circa 1936 was used as a type of cough/cold medicine. Ethelyne Glycol was used as a solvent and killed several hundred people. This spawned the FD&C Act of 1938. That act was responsible for the beginning of what we call cGMP, or current Good Manufacturing Processes. Those processes apply only to pharmaceuticals currently. The impact is that each formulation must be created to exacting standards... the results must be checked and re-checked. Adverse incidents must be reported to the FDA. Now enter neutraceuticals. They are not made to GMP standards. They are also not regulated. Consequently, if you have a supplement that contains 100 IU of ingredient X, you cannot be sure. Part of the ephedra incident is that in a statistically large part of the population there will be an adverse reaction, irrespective of dosage. Further, it is a silent killer. This is part of the threat of ephedra, you might think you're taking 100 milligram when instead you're actually taking 500 milligrams. One of the things that has been found is through both government and laboratory testing, is that supplements may contain little of ingredient x, or conversely a large dose. Meaning, you don't know what you are taking. The FDA does not want to ban all supplements contrary to popular thought, and pharmaceutical companies are not worried because it is a different market. In fact, some are getting into neutraceuticals. What the FDA and HHS want to do, is to subject supplements to rigorous testing to ensure that what you are taking is what you believe you are taking.
Now, how do I know this? I work with these regulations day in and day out. A few dollars more is a small price to make sure you are breathing after you take the product.
i'm all for a standard if it says 1000 mg of X per serving then of course there should be exactly that anything else is false advertising.i just don't want to worry about the government taking my supplements from me.on a side note.i can't see the reason why marijuana a drug that no one has ever died from in the history of existence,is illegal while tobacco products and alcohol are.i mean sure it is legal under the circumstance your in X state with Y condition.so what are the medical benefits of tobacco?i personally believe the govt makes it harder and harder to be a law abiding citizen every day.where is this freedom we were promised?its certainly not the freedom to make your own decision and to put whatever you want into your body.its not the freedom to be responsible for your own actions.last time i checked i didn't need a big brother to baby sit me and make my decisions for me.anyway this is getting really close to sounding like a manifesto.[/ranting tangent]
kodanjaclay
01-04-2005, 07:16
Actually there is a goode deal of evidence illustrating the negative effects of marijuana on brain function. You should do more research. If you had, you would also know that during the Viet Nam war, drugs were seen, particularly Marijuiana, as a source of civil disobedience, and that that is the reason it was barred. It is interesting to note that Marijuana is a schedule one druge which means highly addictive and little or no medicinal value; however, there appears to be a strong case for the medicinal value of this drug.
That being said, Budoseek! has an anti-drug policy and this is not the forum for such tangents.
In regards to neutraceuticals, what people fail to realize is basic chemistry. Some supplements react very strongly with others. Why is this important? Because on a fundamental level medicines are basically poisons that can control certain things in the proper dosage. Exceed that dosage and you are looking for problems.
In regards to a tobacco debate, once again you are obviously not aware of drug history. Drugs were typically accepted with open arms UNTIL society misused them. Exstacy for example, was hailed by psychtherapists because its unique effects on the body's seratonin levels allowed patients to open up, and assist them in their job. One enterprising patient decided she liked the effects so much she gave some to a chemist friend who reverse engineered it, and next thing you have is X everywhere. You have to remember that government is not pro-active, it is almost always reactive. When something like that has been made illegal, it is usually due to the actions of those who use the product. Another interesting side note here is that enforcement efforts typically are based on what society perceives as the risk. One more comment... are you familiar with carcinogens? Are you aware that there are more carcinogens in marijuana smoke, than in cigaratte smoke? My personal feeling is that unless you were born breathing it, you probably should not be. That includes any illicit, current or future, product, tobacco, Kilz or the like.
I am for "medicalization" of marijuana. If you are really in a lot of pain or whatever, b/c of aids or cancer, go to your doctor to get a shot of marijuana extract. ;)
I also support "medicalization' of all other hard drugs. If you are an addict, go get yourself registered at your local government clinic. No question asked. Addicts can get fix, free of charge. That will spare the society of a lot of criminal enterprising. Taking the profits out of the drug trade will destroy the drug trade. Right now it is a $40billion annual business. Everyyear, 900 tonnes of cocaine are produced, with 800 tonnes shipped to the US and 100 tonnes to Europe. If people think we are winning the drug war, they are just kidding themselves. How many of the 800 tonnes of cocaine got seized? How many of the $40 billion money laundering got bursted?
i'm not supporting the use of it just the legalization of it.i would only advocate its use in terms of medicinal purposes.but that doesn't mean we should make criminals out of people who use it otherwise.a rapist is a criminal, someone that decides to use marijuana is not anymore of a threat then an alcoholic would be.which apparently is legal. i don't believe this is far off subject as marijuana is an herb and could be a suppliment if it were legal.but anyway i'll shut up about the whole subject that first post was my first penny and this is the second adding up to my whole 2 cents on the matter.
kodanjaclay
01-04-2005, 21:30
Um. Night shade is a plant, Shrooms are a fungi, and so forth. Does that make them safe?
There is no need to legalize marijuana because THC can be derived and that is the ingredient which is responsible for the high and therapeutic effects. At any rate, this would be a matter for your congressman, and is not appropriate for a Budoseek! forum. If we can get back on topic and away from illicit drugs great, otherwise, I'll close the thread and submit it to the webmaster for review. It is irresponsible of us to be saying anything in a public forum that puts an illicit drug in a positive light.
yamatodamashii
01-18-2005, 23:10
Master Clay:
I'd really like to believe you; I've never been very taken with government conspiracy theories (well, maybe Big Oil...). However, I've ready the FDA's April 12 statement banning the sale of products containing ephedrine alkaloids ( http://www.fda.gov/bbs/topics/NEWS/2004/NEW01050.html ), and I read no proviso for re-introducing a properly manufactured product.
Also, there is a sizable annual death toll related to aspirin use; yet I haven't read any information about a move to ban aspirin sales?
kodanjaclay
01-19-2005, 05:29
Jason,
I'm not trying to be rude, but it really doesn't matter what you believe. That alkaloid was banned because in normal healthy people it was causing heart fialure and extreme over-heating. In some cases after one dosage.
Aspirin is a pharmaceutical product. All drugs are essentially poisons that have various effects based on dosage. The effects are known and the models are accurate. Through repeated testing aspirin has been shown to be safe, useful and effective.
You have to remember that unlike supplements all pharma products have to go through various clinical trials and so forth, including testing on humans. Neutraceuticals have no such requirement. The only parts of the CFR that has been enforced to date were labelling requirements and adverse event reporting.
Since you chose to look up the FDA's website, and that I commend you for by the way - research is always good- look up 21 CFR 210,211 and 58. While alot of this may not make sense to you in how it applies, these are called predicate rules and currently no supplement is made to these standards. These are typically what is referred to as cGMP requirements, save for the industry standards, but it will give you an idea of what is to come. What the neutraceutical industry is not telling you, nor those with the conspiracy theory crap, is that industry actually meets with the FDA to help keep the FDA up to date on standard industry practice. The FDA, nor HHS, is involved in pharma developments, so they have to be told what is happening. Then evidence must be presented. This is usually done as part of the NDA orANDA process. Make sense?
kodanjaclay
01-19-2005, 05:30
I forgot. Banned products do not get re-introduced unless evidence supporting their safety and efficacy is introduced and reviewed. Since that has not happened, what does that tell you?
Dennis Monk
01-19-2005, 09:34
someone that decides to use marijuana is not anymore of a threat then an alcoholic would be.
Both are dangerous behind the wheel of a 3000 pound vehicle. I deal with "today's youth" quite a bit more than I did 10 years ago and many of them think that although they would never drink and drive, it is not a big deal to drive after smoking marijuana. Thoughts like this tend to get people killed. As far a decriminalizing marijuana goes, slippery slope there. The next thing will be cocaine, then heroin and so on and so on. THC extract is available to those that truly need it. It really is not realistic anymore to give granny a prescription for Mexican Red Hair to treat her glaucoma.
jakmak52
01-19-2005, 10:38
Anyone hear of a product called "Newt", if so, what's your experience or thoughts on it.
...... That alkaloid was banned because in normal healthy people it was causing heart fialure and extreme over-heating. In some cases after one dosage.
Aspirin is a pharmaceutical product. All drugs are essentially poisons that have various effects based on dosage. The effects are known and the models are accurate. Through repeated testing aspirin has been shown to be safe, useful and effective.
You have to remember that unlike supplements all pharma products have to go through various clinical trials and so forth, including testing on humans. Neutraceuticals have no such requirement. The only parts of the CFR that has been enforced to date were labelling requirements and adverse event reporting.
Since you chose to look up the FDA's website, and that I commend you for by the way - research is always good- look up 21 CFR 210,211 and 58. While alot of this may not make sense to you in how it applies, these are called predicate rules and currently no supplement is made to these standards. These are typically what is referred to as cGMP requirements, save for the industry standards, but it will give you an idea of what is to come. What the neutraceutical industry is not telling you, nor those with the conspiracy theory crap, is that industry actually meets with the FDA to help keep the FDA up to date on standard industry practice. The FDA, nor HHS, is involved in pharma developments, so they have to be told what is happening. Then evidence must be presented. This is usually done as part of the NDA orANDA process. Make sense?
Thanks. Very informative, as always.
De_Franza
01-19-2005, 18:13
Both are dangerous behind the wheel of a 3000 pound vehicle. I deal with "today's youth" quite a bit more than I did 10 years ago and many of them think that although they would never drink and drive, it is not a big deal to drive after smoking marijuana.
That's a shame. I'm not proud to say I probably thought the same way once, though. There were a few nights where I was surprized I made it home, in retrospect. Actually, I wasn't thinking at all at that time was really the problem.
As far a decriminalizing marijuana goes, slippery slope there. The next thing will be cocaine, then heroin and so on and so on.
I'm not so sure. I mean, RPG's and most military weapons aren't allowed on the streets, but people still have their guns. I'm not sure the slippery slope arguments are always sound. If one thing at an extreme side of a class of things is outlawed or legalized, it doesn't necessarily follow that the whole class of things will be too. It's a matter of where the line is drawn. remember prohibition? People wanted their booze back, clearly the public felt alcohol was ok, but coke, heroin, etc. Still (rightfully IMO) illegal. I believe hard drugs will never be legalized even if marjuiana is.
Still, drunk drivers kill a lot of people every year.
Bad Karma
01-19-2005, 19:27
Let's not forget tobacco products, either. I've always felt that tobacco products are worse than marijuana. Definitely more addictive. I think there're more social/economic motivators than medical worth/value behind a great many things on and NOT on the market.
I think about all these restrictions we impose on drugs (medicines), but when it comes to supplements, and I think vitamins, it's a hit and miss as to what you are consuming (quality and quantity). There are also some loop holes in getting things out on the market prior to FDA approval, unless I'm mistaken, again. I keep thinking about the last miracle weight loss pill that they had to rush of the shelves. Can't remember the name of it, though. Fen-Fen?
Peace
just recently we (at the gnc i work at) had to pull arginine 1000 mg tablets off the shelves but i have no idea why just yet.its probably something stupid like it was labeled wrong or whatever.have any of you heard about NO2 and other nitric oxide products getting banned for use by military?anyway just because something is illegal doesn't mean its going to stop it outright to me it just creates a dangerous underground market for it.just like there was during prohibition.you notice there aren't shoot outs or anything nowadays over some smuggled whiskey.i could go rant in little circles about all the hypocrisy in america nowadays.i can't help but getting the feeling that the government is just trying to protect us from ourselves.like they're the parents putting the plastic plugs in all the outlets for us.people are always going to make stupid decisions.at any rate if nothing else is going to be legalized i still find the sheer idea of restricting and banning sports supplements is absolutely ubsurd.its almost offensive.why don't they just make unprotected sex illegal and fatty foods and running fast and having sharp objects or firearms or anything else.it just seems like the first few bricks in these walls being built around us until we're left in this child proof world where we can't make personal decisions about ourselves with out prior government approval.yeah i'd say that was a good rant. :D
kodanjaclay
01-20-2005, 05:41
Bad,
You have to remember that FDA is still a pseudo-political body. There are cases when in order to solve an issue, trials have been rushed, and approval obtained too early. Then there is also misleading information provided to FDA and so forth. FDA is not perfect, but the protection exists. In this case, you could have Fen Fen (which I'm thinking is actually phen phen but could be way off) Dalcon or a host of other drugs. Remember that what I do stemmed from the 1938 FD&C Act which was the result of the Elixir of Sulfanomide incident. Basically, the cutting agent used in this cough syrup was ethelyn glycol... better known as anti-freeze. It could a bunch of people, mostly kids. Unfortunately though, we live in a reactive society, so if something is on the market, we will typically wait until there is ample evidence so as to ban it. This is what has caused problems, in my opinion, in neutraceuticals.
J4D3,
mislabelling can be as toxic as adulterated product. Its not stupid. Now when something is banned there will be a certain subculture that chooses to risk its welfare in indulgence. That does not mean that the act of banning a product is silly, it means there are people out there who believe it can't happen to me. I like to put idiots like that in the thinning the herd category. After all, when you have both clinical evidence to say that something may kill you, and bodies to back it up, its foolish to think it won't happen to you.
Don't make the mistake of putting Prohibition in the same category as regulation. One was a "moral experiment" conducted by politicians and one is a matter of public health instituted by experts in the field who have analyzed data and associated adverse events. And to be honest, and I'm really not trying to be offensive here, so please don't take it that way, I can tell by what you say that you are not well educated enough in this area to know whether neutraceutical regulation is an absurdity or not. You are not analyzing data, and apparently are not doing any research. For example, a vasodilator like NO2 can cause a dangerous drop in blood pressure. Are you aware of that? That alone would be reason for the military to ban it because when you are military, you are government property. that means there is a vested legal interest in you. Further, protection of the people is one of the reasons that government exists. Following the logic you presented, I suppose you'd like to get rid of NIH the CDC and not regulate any pharmaceutical product? And yet, the same people who say things like this, are among the first in line to scream and file suit when a loved one dies because someone did not do their job. Do you really feel that someone who works in a GNC, plays on a team, or some other career that does not analyze data, is in a better position to determine the safety and efficacy of a product than someone who is a PhD and is looking at clinical data? Or someone at HHS or FDA that notices a trend appearing from adverse events? What you are not considering is that each of us, while a part of the world at large, is also virtually an insular society in ourselves and if we don't feel the burn, we tend to disbelieve what can happen. Following the logic you have presented, that is akin to knowing that AIDS exists, but not taking precautions to minimize exposure to a possible contagion. Or in the case of a product requiring aseptic manufacturing, not wearing tyvex gowns simply because you can't see a gram negative bacterium or some other pyrogen or contaminant. Think about what you are saying.
Powered by vBulletin® Version 4.1.10 Copyright © 2013 vBulletin Solutions, Inc. All rights reserved.