Here come the regulations 
Hveragerthi
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I have been discussing how making up claims for alternative medicine are leading to more and more regulation. It has already been in the works for a while, but new vague regulations are being pushed forward that can eliminate our access to many supplements. This is why I get so upset about the heavy censorship of the facts here on Curezone. Seems that as long as you are just making up wild claims you can post wherever you want since there are sheeple who will blindly follow. But heaven forbid you post scientifically validated information. Then you get banned from nearly every board. Just remember that when all these new regulations get passed who contributed to their formation. Those who kept promoting the proven quackery and those who censored the real facts about these quackeries and other proven medical facts.
Here is some of the newest regulations being pushed forward:
http://www.naturalproductsinsider.com/articles/2011/07/ndis-and-the-burden-of...
NDIs and the Burden of Proof
A Changing Burden of Proof?
Fast-forward to 2011 and the just-released draft NDI guidance. The crux of the issue is who should have the burden of proof when it comes to safety of a particular ingredient—the industry or FDA?
Here’s the breakdown:
First, the scrimmage line between new dietary ingredients and “old” ones has been moved, and industry is calling “off sides.” In the draft guidance, FDA stated the burden of proof should switch from FDA to the manufacturers of even long-time ingredients if the manufacturer changes the method of extraction, concentration or manner of production that changes the chemical composition or structure in any regard. It basically “freezes” the marketplace in time at October 1994. Any advances in technology of existing ingredients will flip the burden of proof to the other side. Likewise, use of an new dietary ingredient along with an old one will flip the burden of proof to the manufacturer to prove the safety of the old as well as the new ingredient in this new matrix.
In addition, there are apparently other issues that will remove ingredients from consideration altogether. If the ingredient has been the subject of an Investigational New Drug Application (that’s an IND, not to be confused with an NDI), that could remove it from being a dietary ingredient completely. Likewise, a synthetic version of a botanical substance cannot be a dietary ingredient either, according to the draft guidance, even if it is nature-identical to a plant material and the commercialization of the plant material is not commercially viable. No amount of safety data will escape that conundrum.
At the same time FDA’s new guidance is changing who has the burden of proof of safety, the level of that burden is shifting too—sort of like going from a preponderance of the evidence to “guilty beyond a shadow of a doubt.” The draft NDI guidance lays out what FDA expects from a manufacturer to satisfy this burden to demonstrate a reasonable expectation of safety, setting some pretty daunting standards for providing “chronic safe use” and even “intermittent safe use.” After all this time, it’s starting to look like the agency is trying to impose the food-additive burden of proof on the dietary supplement industry once again. With such high expectations from FDA to issue a “no objection” letter for an ingredient, one begins to think only the most scrupulous (or masochistic?) manufacturers will go to the trouble to file the NDI notification at all. When you set the bar too high, some folks won’t even try to jump it. That’s not an encouraging scenario for an industry whose reputation is already tarnished by companies who don’t bother to take on current regulatory burdens.
Surely this is not what Congress intended when it set up the NDI process in DSHEA 17 years ago. The differences between a reasonable “expectation” and “certainty” of safety were supposed to mean different burdens of proof for manufacturers. The dividing lines between old and new ingredients were supposed to carve out truly “new” ingredients for the higher safety substantiation, and ingredients with a history of safety were to get the benefit of the doubt. The rather remarkable safety profile of the dietary supplement industry, now evidenced over the past four years by the mandatory adverse event reporting law, demonstrates a strong safety track record in spite of whatever new concentrations, extractions and production methods have been employed since 1994. Shouldn’t that count for something in the allocation of proof?
Finally, the law sets up not one, but three ways for FDA to remove products from the market when the burden of proving safety rests with it. The scales that balance consumer access with consumer safety were pretty even before the NDI guidance came out. Now FDA seems to have tilted them too far in its direction. Maybe it’s time we put our thumb on the dish to balance them out once again. The burden of proof didn’t just change hands, it may have become insurmountable.
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- More on NDIs Hveragerthi
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This is a reply to # 1,870,124
http://www.naturalproductsinsider.com/news/2011/08/proving-an-old-dietary-ing...
Proving an Old Dietary Ingredient
FDA is likely to use it GMP (good manufacturing practice) inspections to check for new dietary ingredients (NDIs) that are on the market without FDA notification, according to Joseph M. Betz, Ph.D., Director,Office of Dietary Supplements (ODS) Analytical Methods and Reference Materials Program, at the United Natural Product Alliance’s seminar on FDA’s NDI Draft Guidance. He said if a company thinks its product contains an old dietary ingredient (ODI), which does not require FDA notification, he said it better be able to prove it.
Betz said analytical methods are one way to show an ingredient that is on the market now was sold before Oct. 15, 1994, and thus, an ODI. Such tests include indenty specifications, pattern recognition and solvent tests.
Betz walked the audience through a case example of Yohimbine (Pausinystalia yohimbe). He showed how researchers compare two or more extracts to determine if they are indeed the same ingredient.
He noted that when he was in graduate school in the late 1970s and early 1980s, he took meticulous notes on different botanical lab results; he said he also had bottles of products he found on health food stores, which shows they were sold pre 1994. He made this point to show there are ways to show an ingredient is an ODI, even if that means going through the basement of a former lab student.
ODS’s Analytical Methods and Reference Materials Program was created in 2002 to support analytical methods and reference materials that verify natural ingredient identity, as well as identify and measure contaminants. The government program provides grants to fund method development. Additionally, Betz noted the National Institute of Standards and Technology (NIST) has a Dietary Supplements Laboratory Quality Assurance Program that allows manufacturers to submit products for analysis for free. NIST will then provide feedback on the blinded results, including suggestions for method optimization.
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- Re: Here come the regulations Hveragerthi
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This is a reply to # 1,870,124
I see it took no time at all for the personal attacks to start again against me on the Webmaster forum. As usual the terms of service mean nothing.
But more importantly it shows how there are some that just do not get it. Our rights to supplements are going to be eliminated and soon can be taken away. The FDA has been unable to ban herbs and supplements outright, so they have been trying every other tactic they can to suppress our access to herbs ad supplements. First they tried to hide "riders" in bills that if passed in to law would have also included these hidden legislations. But those got exposed and stopped. So they are looking for new tactics. The newest is the NDI that will put most if not all small manufacturers out of business.
The language of the whole NDI thing is purposely vague so it can be interpreted as needed by the FDA. For example, as written now any herb or supplement or formula that is considered "new" must undergo very expensive testing to prove safety. But there is more to this. Even if the ingredients have already been proven safe their use in any other manner makes them "new" again. So let's say a formula has been marketed for 40 years with an excellent safety record. if the manufacturer changes anything, such as adding an herb, oil, etc. to improve absorption, or changes an herb to its extract then it is considered "new". But formulas are always being updated for various reasons. Better herbs come along. Or herbs get put on the endangered species list or just become too expensive or hard to obtain. If these are changed or left out of a formula then the product is considered "new" and must undergo the testing. For large companies this is great for now because it eliminates so much of their competition. But for small companies it is a nightmare. Let's say a company has 10 products, and each one costs $100,000 just for the testing alone to prove safety how is a small company going to afford this? This does not even include research and development, production costs and overhead. And this applies to ALL formulas or supplements from 1994 until present.
Even herbal extracts are subject to the same rules. If an extract of an herb was made after 1994 it must undergo these safety studies. So let's say that an was extracted to a certain concentration such as the coleus forskohlii extracted to 1% forskohlin. This extract would have to go under the testing. If the manufacturer decides to make an extract of 2%, 3%, 4%......... forskohlin then these "new extracts must all undergo the same safety testing separately.
And let's say you take something like vitamin C, which precedes the 1994 deadline. By itself this does not need the testing as long as the manufacturing process has not been changed. And let's say silica also does not require these studies since it also predates 1994. If you combine these two substances to make a collagen formula you now have a "new" product that now must undergo all the safety studies.
These are just a few of the possible scenarios that can arise from the NDI if allowed to pass, especially due to the vagueness of the wording.
So what is pushing these changes and giving the FDA the power to do this? Simple, all the outlandish, unproven claims being pushed by MLM companies and people, especially on the internet. So the FDA is using the excuse that they have to step in to protect the public from these outlandish and potentially dangerous claims.
Bottom line is that we can either work to police ourselves by stopping unproven and proven false claims or be prepared to lose ALL your rights to openly use herbs and supplements. Right now the NDI will only put small businesses out of business. But we know how rights are taken away, little by little. The gained power by the FDA means that in the long run even the big supplement companies will eventually be regulated out of existence if we do not put a stop to this!!!
The censorship here on Curezone is just contributing to the problem significantly. So again, when our rights and access to supplements are taken away remember who contributed to them being taken away.
- Re: Here come the regulations herbformind
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This is a reply to # 1,870,364So you're saying that if someone comes up with a new formula for a herbal product - it's supposed to be assumed, and not proven, that it's safe even when it's known that various substances can interact with each other differently?
I don't see how this is a bad thing for the public if it means more testing of various herbal formulas to be safe or not..
Frankly if you don't have the funds to prove your product is safe, you shouldn't have the right to sell something with the claims that it will help people in various ways, when you haven't tested it and made sure whatever you added that's new isn't causing a problem..
Hopefully what this will mean is less herbs in general, and maybe some people will wake up to the fact that their lifestyle is out of order and that's what causes most of their ailments in the first place, and to stop looking for the miracle pills they have to buy every month that fills the pockets of salesmen and won't help them anyway in the long run if they don't fix their lifestyle.- Re: Here come the regulations #67299
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This is a reply to # 1,870,398"Frankly if you don't have the funds to prove your product is safe, you shouldn't have the right to sell something"
Yeah because the amount of money you have on your bank decides whether or not your a capable healer, right? /snicker- Re: Here come the regulations herbformind
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This is a reply to # 1,870,402No because giving people health products which haven't been specifically shown to be safe or effective allows unwarranted quackery products to overflow the alternative health industry. /duh
- Re: Here come the regulations Hveragerthi
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This is a reply to # 1,870,413
No because giving people health products which haven't been specifically shown to be safe or effective allows unwarranted quackery products to overflow the alternative health industry. /duh
If something is shown to be quackery then the FDA can find ways to pull it off the market. They have done this enough times for things that were already proven safe and effective so they should have no problems doing this with quack medicines. unfortunately they do not do this with quack and deadly pharmaceutical drugs. Why? Because the FDA is in bed with the pharmaceutical companies and according to the ex-commissioner for the FDA Herbert Ley, the FDA officials are given high level job positions within these companies and other rewards for protecting the profits of the pharmaceutical companies. Along the same lines it has also been reported for over 4 decades that there are numerous FDA officials that own stock in the pharmaceutical companies they over see in violation of insider trading laws. So anyone thinking that the NDI regulations are being pushed for safety reasons are just fooling themselves.
The nutritional industry already has GMP standards in place for safety that in my opinion already exceed the standards required for many pharmaceutical companies.
- Re: Here come the regulations Hveragerthi
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- Re: Here come the regulations Hveragerthi
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This is a reply to # 1,870,402
"Frankly if you don't have the funds to prove your product is safe, you shouldn't have the right to sell something"
Yeah because the amount of money you have on your bank decides whether or not your a capable healer, right? /snickerUsually it is the "healers" with the most money in their accounts are the cons, which is why they are in it for the money, not to help people.
- Re: Here come the regulations UserX
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This is a reply to # 1,870,680I think it will be like prohibition in the past here. The black market for all of the supplements will thrive. Many law officials will look the other way. Most will understand it is corruptness causing the problem. People will still get the supplements and natural herbs they want and need. The FDA will be revealed for what it really is, certainly not an advocate for health or anything people want or need. A legalized mob syndicate...evil
- Re: Here come the regulations Hveragerthi
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This is a reply to # 1,870,683
I think it will be like prohibition in the past here. The black market for all of the supplements will thrive. Many law officials will look the other way. Most will understand it is corruptness causing the problem. People will still get the supplements and natural herbs they want and need. The FDA will be revealed for what it really is, certainly not an advocate for health or anything people want or need. A legalized mob syndicate...evil
Yes, but it goes way beyond the FDA alone. For example, when Bush was in office a lot of people did not realize how much stock that the Bush family had in a pharmaceutical company, nor that his dad sat on the board of Eli Lily, nor the fact that 4 of his cabinet members also sat on the board of pharmaceutical companies. This is why the whole thing about banning cheaper pharmaceutical imports from Canada was such a farce. Most of these drugs were manufactured by American pharmaceutical companies then exported to Canada at cheap enough prices that the Canadian pharmaceutical companies were able to sell them back to Americans at a profit. So these are the same US manufactured drugs the US government were claiming were not safe even though they are being sold to American citizens by US pharmaceutical companies.
- Re: Here come the regulations UserX
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This is a reply to # 1,870,693Well,yes, but it is the same principle. It is a small portion of people doing these things. Kind of like anonymous, and all of us really. There is an awakening. People are sick of it. I don't think "render unto caesar's what is his" cuts it any more.
Legal, is a term that is being redefined in the hearts and minds of people. God given intelligence will put aside these evil doers no matter the lofty heights they falsely believe they rule from. Illusion, slight of hand, that is what we've been made to temporarily look at.
These agencies have no more authority than we allow them. Their time is up, they've been exposed.
I understand science, and the scientists will be on board with truth. Science will improve with no hindrances from political wish lists.
It is a mindset of realization of who has truth at the heart of their research. None of the heads of research do currently (researchers themselves do, but their hands are tied). Look at the ridiculous pink ribbon society, it just makes me sick!!!
- Re: Here come the regulations Hveragerthi
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This is a reply to # 1,870,701
It is a mindset of realization of who has truth at the heart of their research. None of the heads of research do currently (researchers themselves do, but their hands are tied). Look at the ridiculous pink ribbon society, it just makes me sick!!!
I agree. They have cures for breast cancer as well as other cancers but they do these stupid campaigns to make more money to pay executive salaries rather than to get these cures to the market.
Just think of all the good that money could really do such as to help fund our school system so we are not far behind other countries in education.
- Re: Here come the regulations UserX
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This is a reply to # 1,871,156Yes,you're so right. Every single thing I buy lately is pink. I went to Bread Company (Panera's its called elsewhere) and the box of stuff I bought was pink. Every company seems to endorse them. And why? What progress have they made? None!
And if you have a child with cancer, they try to force you legally to make them undergo chemo and radiation (the standard of care). If you want antineoplastin therapy, you are required to first undergo chemo, etc. So, the people have hardly any chance then, because they have effectively killed them already.- Re: Here come the regulations Mira528
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This is a reply to # 1,871,370That is so true.
I've even been asked to make donations for cancer research by grocery store clerks who are told to do so by management. This is so widespread. I think I'll stop buying anything pink!
- Re: Here come the regulations Hveragerthi
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This is a reply to # 1,871,370
Yes,you're so right. Every single thing I buy lately is pink. I went to Bread Company (Panera's its called elsewhere) and the box of stuff I bought was pink. Every company seems to endorse them. And why? What progress have they made? None!
The other day the local newspaper was all printed on pink paper. The whole thing has become so ridiculous. If they wanted a cure one of the many would already be on the market.
If people really want to do something beneficial with their money don't donate it to cancer research. Try donating to our schools or help out a family that is down and out. Beats going to corporate executive salaries for cancer societies that are not looking for, nor want, a cure.
- Re: Here come the regulations Mira528
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- Re: Here come the regulations UserX
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- Re: Here come the regulations Hveragerthi
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- Re: Here come the regulations UserX
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- Re: Here come the regulations Hveragerthi
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- Re: Here come the regulations UserX
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- Re: Here come the regulations herbformind
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- Re: Here come the regulations Hveragerthi
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This is a reply to # 1,870,398
So you're saying that if someone comes up with a new formula for a herbal product - it's supposed to be assumed, and not proven, that it's safe even when it's known that various substances can interact with each other differently?
That is why the formulators should know the chemistry behind the herbs or supplements before putting them together. But since you bring up the point of interactions do you also feel that any food combinations need to be tested for safety? For instance, do you advocate having every meal you consume tested for safety if they include spices, which are herbs? What about mixed alcoholic drinks since alcohol is also a drug? How about coffee with the interactions between creamers, artificial sweeteners, etc? Even pharmaceutical medications are not required to have safety studies between their interactions with other drugs or even their own safety. Look at the Phen-Fen fiasco, and how often drug adverse effects are not reported for years after their marketing if ever. And rarely are dangerous or deadly drugs ever removed from the market by the FDA. Maybe the FDA should focus on cleaning up the pharmaceutical industry before attacking the safer herbs and supplements.
I don't see how this is a bad thing for the public if it means more testing of various herbal formulas to be safe or not..Again, do you advocate that all your meals be tested for safety if they use spices or other plants in their manufacturing? Or what about if they use vitamin enriched bread or noodles in your meal? Do you want your meal tested for safety since you do not know the interactions between the nutrients added to the bread or noodles and the other ingredients in your meal? What level of paranoia are we willing to accept?
Frankly if you don't have the funds to prove your product is safe, you shouldn't have the right to sell something with the claims that it will help people in various ways, when you haven't tested it and made sure whatever you added that's new isn't causing a problem..Again, are food products tested for interactions? Alcohols?........... If you add a tea bag to a cup of hot water you are altering the chemistry of the herb in the tea bag. And there can be interactions with the minerals in the water or the dioxins from the teabag. Are you going to send out every tea you drink to get tested for safety spending $100,000 for reach analysis?
Hopefully what this will mean is less herbs in general, and maybe some people will wake up to the fact that their lifestyle is out of order and that's what causes most of their ailments in the first place, and to stop looking for the miracle pills they have to buy every month that fills the pockets of salesmen and won't help them anyway in the long run if they don't fix their lifestyle.Are you aware that foods by definition are drugs? So again, are you going to spend the money to test everything you put in your mouth for safety? Yet you need foods to stay healthy. And as I mentioned before, even pharmaceutical drugs do not have to be proven safe, nor even effective, to get FDA approval. If you take an over the counter aspirin or ibuprofen are you going to have these tested against every possible food, drink or medicine combination that you can combine with these to make sure there are no adverse interactions? So again, what level of paranoia are we we willing to accept?
- Re: Here come the regulations #67299
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- Re: Here come the regulations prettyangel
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This is a reply to # 1,870,364Hv, thanks for always posting valuable information such as this for us to learn. I completely get it. I also saw that this was crossed post in the personal conflict forum and the poster managed to make it all about you.Wow! This is actually serious. If the FDA can have this much control over herbs, the prices would be so high that it's almost as expensive as other drugs. What I really enjoy about using herbs is the good price and its high efficacy.
- Re: Here come the regulations grassman
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This is a reply to # 1,870,513Senator Dick Durban was the paid off deush that's trying to pass this unnecessary bill.
The pharmaceutical industry wants to take over the revenue stream of the supplement industry.
The same supplements will be available and they will cost 3-10 times as much as they do now.
Corporate greed through legislative control is the issue.And it needs to be stopped by letting your representatives know how you feel.
Curezone is as it is but is insignificant in all things.It is all about the money.- Re: Here come the regulations herbformind
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This is a reply to # 1,870,586@grassman
your logic is dumbfounding, you say that things are the way they are because of greed and money yet you somehow believe that letting a so-implied corrupt government official know how you feel will influence him.- Re: Here come the regulations grassman
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This is a reply to # 1,870,589There is a way to influence career politicians and that is to threaten to not vote for them.
This is part of the political system and easy to implement.Corps have the money people have the votes.
- Re: Here come the regulations herbformind
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This is a reply to # 1,870,622the vast majority of votes a politician has is directly related with how much advertising and how much 'face' they show the public - in order to do that, they need money, money like they get from being 'greedy' and taking money from businesses with vested interests. as you can see, your tiny little ripple in the pond is not going to be heard since, whether he gets elected or not isn't decided by informed people who have complaints, it's made by the sheeple-mob who are influenced by the money-fed campaigns..
as you said, money and greed the problem (real problem though is human nature coupled with the current economic system, not like there is any guilt anywhere though as there is no free will (not been proven).- Re: Here come the regulations grassman
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This is a reply to # 1,870,637Civic responsibility is of the individual.
Sticking your head in the sand is an option that will achieve nothing.- Re: Here come the regulations Hveragerthi
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This is a reply to # 1,870,658
Civic responsibility is of the individual.
Sticking your head in the sand is an option that will achieve nothing.It is funny how people feel they have the right to vote and the right to free speech but have not figured out how to use those to enforce their right to protest and to have a government of the people for the people!
- Re: Here come the regulations herbformind
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This is a reply to # 1,871,158civic responsibility is a joke,
civilization has always rested on technology/science to propel it forward and to be more civilized
since the mob is mostly primitive, believing in supernatural gods, having faith, and heavily moralistic, they are led like sheep by more manipulative and organized minds funded by wealthy people..
your 'individuals must step up' cry has been heard since time immemorial and will never ever work because it ignores the cause-effect principle of human nature..
do you know how much time is wasted on dead-end rants like yours about how other people should do their duty and how you're a great person? if you want to change something as big as human greed you can't do it by cutting off one head or even a thousand as our environment will grow new heads to take their place until the environment itself is changed.. to do that we need scientific advancement. the only difference between us and our primitive ancestors is the tools and scientific principles we use to collect knowledge and harvest resources, organize resources, distribute them, etc.
of course, the majority of people will continue wasting time yelling at politicians instead of contributing in a real way, simply because misleading criticism like yours is spread as vastly as the medical 'miracles' here on cz
- Re: Here come the regulations Hveragerthi
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This is a reply to # 1,871,395
do you know how much time is wasted on dead-end rants like yours
Educating people about what is going on is hardly a dead end rant. There are those who prefer to stick their heads in the sand. The hear no evil, see no evil type mentality. Those people are likely to never be reached just like the "liver flushers" who still believe that those big squishy green stones are gallstones when they have been proven to be soap stones beyond any reasonable doubt. Not everyone is like that though. There are those who really want to know what is going on and want to do something to change it for the better if possible. But simply making it sound like life is black and white and nobody can change that is not going to help a thing. The reason this country and this world have been going downhill so bad is because of complacency: "Yes, our government is corrupt, but you cannot change it so live with it." "Yes, we are losing species of animals on a daily basis, but you cannot change it so live with it." "Yes, we are ruining our only habitat, but you cannot change it so live with it." "Yes, drugs are a major problem and affecting our kids, but you cannot change it so live with it." "Our schools are suffering from lack of funds while politicians are wasting trillions of dollars annually on worthless pork barrel projects like a 'bridge to nowhere', but you cannot change it so live with it.".............. Yep, let's just keep ignoring problems in the world since we cannot do anything to change it. Yes, I am being sarcastic.
- Re: Here come the regulations wellnessforall
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This is a reply to # 1,871,395A view of Healthcare Reform and the Future Of Health Care
We need to have a system of medicine based on keeping people healthy through education and empowerment. And that means teaching young and old that they can maintain their health and prevent disease through foods, nutrition, and healthy lifestyle choices. To provide the public the incentive to make proper choices it needs, on an individual basis, to see the positive and negative effects of these choices. The technology to provide to each person regardless of their state of wellness a “yardstick” to measure health change between “Time A – (the present) and Time B – (after intervention) that is not related to disease is available NOW.
New analysis methods that measure changes in an individual’s wellness will reduce the number of people developing degenerative conditions and thus effectively reduce the disease burden in our society.
Conventional clinical tests are designed to identify individuals within the population who are already in a diseased state for drug treatment qualification. Clinical tests were not developed nor validated with the goal of helping individuals maintain or retun to wellness.
The restoration of balance is fundamental to all indigenous healing practices. We can use modern Science to supplement our societies lack of healers.
- Re: Here come the regulations Hveragerthi
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- Re: Here come the regulations herbformind
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- Re: Here come the regulations Hveragerthi
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- Re: Here come the regulations grassman
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- Re: Here come the regulations
- Re: Here come the regulations grassman
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- Re: Here come the regulations herbformind
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- Re: Here come the regulations Hveragerthi
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This is a reply to # 1,870,513
Hv, thanks for always posting valuable information such as this for us to learn. I completely get it. I also saw that this was crossed post in the personal conflict forum and the poster managed to make it all about you.Wow!
That is Sundragon, who is a Moreless supporter. In fact I am positive that this is the same poster that used to post under the name Justin before getting banned multiple times for the constant personal attacks. He just keeps making up new accounts and new names to come back and make up claims about me. He was even posting his garbage on the comments page of my YouTube videos. Then he tried to claim he was not the same poster as Justin even though he was using the same exact wording in his attacks.
Oh well, there is only a small handful of Moreless supporters that are going to take his serious. I think most people know his M.O. well enough to not take his seriously.
This is actually serious. If the FDA can have this much control over herbs, the prices would be so high that it's almost as expensive as other drugs. What I really enjoy about using herbs is the good price and its high efficacy.
And people don't realize that the more power that is given to the FDA just means even more regulation in the future to the point that the whole alternative medical industry in the U.S. can be regulated out of existence.
I wonder if the big herb companies supporting this have thought this through. For example, if an herb they use gets taken off the market due to an endangered status like lady's slipper was they would have to provide all new safety studies since removing the herb or substituting for it constitutes a change. Or if the FDA decides to ban more herbs commonly used in formulas this would also require all new testing. This can get very expensive very quick for the big companies as well.
And just handing the FDA this power is just going to lead to the FDA gaining more and more power over the industry over time. But unfortunately some people just will not get it until it is too late!
- Re: Here come the regulations grassman
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- Re: Here come the regulations herbformind
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- Re: Here come the regulations #140908
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This is a reply to # 1,870,124Interesting... This has been a lively topic of discussion with the "sciency" types too!
http://www.sciencebasedmedicine.org/index.php/alpha-brain-whats-wrong-with-th...
- Re: Here come the regulations Hveragerthi
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This is a reply to # 1,874,876
Interesting... This has been a lively topic of discussion with the "sciency" types too!
http://www.sciencebasedmedicine.org/index.php/alpha-brain-whats-wrong-with-th...That is not a discussion, it is a bash fest against the supplement industry by people who have no clue what they are talking about. For example, when they are making fun of the claims on labels they even added this one:
"Love it. Don’t forget “gluten free!”"
So they think it is funny that some people out there have Celiac disease or other gluten sesitivities? I guess they must also think it funny if a label states "peanut free" since even traces of peanuts can cause deadly anaphylactic reactions in some individuals.
Then this old myth popped its head up again:
"The evidence needed to demonstrate safety and efficacy, and the evidence needed to obtain FDA approval as a drug, are not materially different…"
They were actually talking about they feel herbs and supplements should be on par with the FDA's drug approval process. Well if that's the case then herbs and supplements should be allowed to make any unfounded claims just like is done for pharmacetucial drugs and any safety testing showing dangers of the substance can be withheld to get approval and for that matter we would nto even have to know how the substance works to get approval. That is what the FDA allows the drug companeis to get away with.
How many times have we heard the drug companies state they do not know how the drug works? Well, if they have not figured that out then how do they know if this same compound is not having adverse effects on the body elsewhere since it has not been thoroughly studied? Ironically, we can go to Medline and look up various herbs and supplements and their chemistry and exactly how they work are clearly stated. So the pharmacetucial drugs are the real fraud.
And how many FDA approved drugs have class action suits against them after numerous people were either killed or injured? Where were the safety studies to warn people of these dangers? It was over 30 years before the drug companies finally started admitting that Premarin could increase the risk of cancer even though the alternative medical industry had been pointing that out all along. Gee, the drug companies had a estrogen from horse urine that is 3,000 times more powerful than the body's own estrogen and they, nor the FDA, could figure out that this would increase the risk of cancer for over 30 years?!!!! Same for the nonsteroidal anti-inflammatory drugs (NSAIDs). Again, for over 30 years no mention of the fact that they could cause heart attacks or strokes. Although even common sense should have told them this fact since they clearly knew about the fact that NSAIDs could cause liver or kidney failure even with a single recommended dose. How? By cutting off the blood supply to these organs since NSAIDs constrict blood vessels:
http://mountainmistbotanicals.com/info/NSAIDs.html
And what increases when you also reduce the blood supply to the heart? Increased risk of heart attack. And what happens when you decrease the blood flow to the brain? Increased risk of stroke. So these risks were well known by the drug companies all along, but were deliberately hidden from the public:
http://mountainmistbotanicals.com/info/nsaids_and_heart.htm
Just as today they don't mention anywhere in the Physician's Desk Reference (PDR) or on drug inserts that coumadin (Warfarin) increases the risk of strokes:
http://curezone.com/forums/fm.asp?i=1656833#i
Nor do they tell people that the blood thinner Heparin can cause deadly blood clots:
http://curezone.com/forums/fm.asp?i=1595721#i
And of course the public is not being told that cholesterol lowering statins can cause heart failure. Nor that pharmaceutical antidepressants cause suicidal behavior. Nor that the bisphosphonate drugs given to osteoporosis patients significantly increase the risk of bone fractures and can cause deterioration of the jaw bone. Or that the "AIDS drug" AZT and its analogues completely collapse the immune system, unlike HIV, leading to the syndrome AIDS?:
http://curezone.com/forums/fm.asp?i=1553836#i
And it is not limited to "drugs" when it comes to the FDA turning a blind eye. Does the FDA require a warning label to tell diabetics that "no-calorie" sweeteners like aspartame (Equal, Nutrasweet) raise blood sugar? Or that the packets of these sweeteners contain the sugars dextrose and maltodextrin that also raise blood sugar?
Yet the drug companies can make unfounded claims about their drugs such as the NSAID aspirin can reduce heart attacks:
http://mountainmistbotanicals.com/info/aspirin-and-heart-attacks.htm
Then there is the manipulation of drug testing to make the drugs appear effective, which has been seen numeorus times especially when it comes to chemotherapy drugs:
http://curezone.com/forums/fm.asp?i=1502611#i
In fact, medical fraud to get pharmaceutical drugs approved is so rampant:
http://curezone.com/forums/fm.asp?i=1612150#i
And unfortunately, the FDA's role in this case is to protect the profits of the pharmceutical companies as well as their own profits instead of the public:
http://mountainmistbotanicals.com/info/fda-regulating-herbs.htm
The fact remains that herbs and supplements are more heavily regulated than pharmaceutical drugs. If pharmaceutical drugs were held to the same standard as herbs and supplements then nearly every pharmaceutical drug on the market to day would have to be banned for public use and the FDA would be pursuing the companies aggressvely for thier fraudulent claims.
- Re: Here come the regulations Hveragerthi
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- More on NDIs Hveragerthi
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