38 replies to this topic

[maxwatt]

http://www.santacruz...ies/01local.htm

The federal Food and Drug Administration is proposing to regulate a wide variety of alternative medicine products, from vitamin, mineral and herbal supplements to lotions and stones used by massage therapists.

The April 30 deadline for public comment has stirred up a storm of protest on the Web ....

Draft proposal [PDF] http://www.fda.gov/O...480-gld0001.pdf
Federal Register http://www.fda.gov/O...8fr/E7-3259.htm
Comment on the proposal http://tinyurl.com/376ul9

Does anybody trust them to get it right?

[Anthony_Loera]

Yeah, I got the news from the NPA through an email... but here's what the NPA says...

On April 16 we got this update:
==========================================
FDA Guidance on CAM: No Cause for Alarm…The association has recently heard from members concerned about a draft “guidance” document from the Food and Drug Administration (FDA) on complementary and alternative medicine (CAM) that some are claiming will, among other things, classify all dietary supplements as drugs. This is untrue and the document in question should not be cause for alarm. First, a “guidance” document is by definition not legally binding and does not change or create laws or regulations. Guidances, like the one in question, are usually issued to help explain how a law or laws are applied. In this case, the guidance clarifies how products used in CAM, such as foods and dietary supplements, are regulated under different provisions or statutes depending on their intended use and claims. Whether finalized or not, the draft guidance will not change current laws and regulations, such as the Dietary Supplement Health and Education Act. (www.fda.gov/OHRMS/DOCKETS/98fr/06d-0480-gld0001.pdf)

=============================================

So we are told, we should not worry... but I am still concerned because of the direction this is taking.. (baby steps in a directionis, is still... taking you closer in that direction ...)

RevGenetics is a part of the NPA that, among other things... lobbies against these kind of changes.

Anthony Loera

[zoolander]

It's to be expected considering the significant effects that some of these herbs/vitamins can have on normal physiology/biochemistry/molecular biology. The way that these regulatory agencies work is that if a compound can move the norm value significantly then it should be classified as a drug.

Make sense?

[Karomesis]

The April 30 deadline for public comment has stirred up a storm of protest on the Web ....

[lol] [lol] [lol] as it should. There are MANY shyster assholes selling the worst shit products ever found.

although I normally shun ANY govt interference in my personal and business matters, i welcome this intrusion for the simple reason that I HATE deceptive businesspeople [ang]

and all lies should be unwelcome, and destroyed as soon as the opportunity presents itself.

[mike250]

well I think it will also damage the good ones. I hope we don't come to a point where we have to get a prescription for some vitamins/herbs/supplements by doctors. I'm already going to order some stuff through unique nutrition because thats the only way I can get them through

[niner]

Karomesis has a point. It seems like any moron can set up a supplement operation, and quite a few of them have. Even the reputable supplement companies have done some things that are a little dodgy. I don't want anyone telling me I can't have something, but I wouldn't mind if product purity and potency were enforced better than they are today. And then there's [wis] efficacy. Of course, if you enforced efficacy, then none of this stuff would ever get on the market, or if it did, we wouldn't be able to afford it.

[Anthony_Loera]

It's to be expected considering the significant effects that some of these herbs/vitamins can have on normal physiology/biochemistry/molecular biology. The way that these regulatory agencies work is that if a compound can move the norm value significantly then it should be classified as a drug.

Make sense?

I am sorry, you have vitamins that (given the right amount) can be poisonous (ie Vitamin A) and good ol' fluoride which prevents tooth decay and used in most of our water supply ,can poison a person given enough of a concentration, then there is simple apple seeds... I guess these are all drugs if you think about there concentrations...

come on now... you will be opening a major can of slimy gooey worms on this one.

You are inviting the government the power to basically rule the manufacturing on most every product out there, and arbitrarily stop items from coming to market, or at the very least make it extremely difficult for small businesses to compete. I am sorry my friend, but I am all for making sure products are safe for human consumption and use... but please think about what you want the government to do.

I do find this a bit personal because of what my wife and I went through about 24 months ago regarding my wife's health and ambition to become a mother. I will say that after seeing 2 specialists that told us "It would be impossible..." to me and my wife's dream of having a child, it would have highly anger me if such a ruling or law was put in place at that time.

We went to a Chinese herbalist who holds a degree in China, but not a US degree as a doctor... he specializes (among other things) in herbs. Do I think he would have had the resources to test his all his herbs out in a laboratory simply because said he was going to use them to treat my wife, while the same could also be used for teas, or a food additive and not be 'tested' in that case? No, he is an old gentleman who has lived a long life, and simply wants to practice what he knows about herbs and help people, while making a bit of money to pay for a few movies here and there. If there was a 'law' in place then a whole slew of people would stop practicing some good natural therapies in the USA. I believe we would also all then pay premiums on the natural items we used.

The Chinese herbalist prepared the nastiest concoction I ever did imagine. These were not powdered herbs, no. They were pieces of plants, stumps or bark, really interesting stuff when you see these things before being cut and powdered. The herbs were then weighed, cut by hand, and mixed with others and handed to me and my wife in a brown paper bag. We were given directions on how to take the nasty things, and I really though it was crazy at the time... but my wife simply wanted to try something after we went to 2 drug wielding specialists (That are renowned docs in Florida I might add...) that could not give us a positive result, and said the word 'impossible' which made my wife cry. Boy did I want to slug the guy when he did that... it still makes me upset when I remember it.

So what would have we done without our simple Chinese herbalist if a law like this existed at that time? I believe we would still be without a child.

So again, think about what you are saying... and think about how this would affect all people, the herbal and natural products out there.

You start pushing for something like this, and you will be shooting yourself in the foot.
========================================================

I am sorry about my rant, but this really bugs me. Forget that I do business for RevGenetics, because even if I were to tell my partners to take over and leave... I would still hold these same thoughts about this.

Another argument against it, other than my personal one?

Sure...
You will be putting the current paradigm regarding health on it's head. Right now, in many countries we have 'home made' remedies that are being used daily to 'treat' everything from headaches and colds to stomach problems just to mention basic ones. What happens when you put a something like this into effect? What do you expect to happen, should we be 'enforcing' un-enforceable laws or rules? Do you want tax money to go to enforce the daily remedies we get from people? Are you making a person 'bad' in the eyes of the law because of a remedy? Should they be fined? Should police be strapped with this new layer of work? Currently a trademark take 6 months to a year and a half... do you expect people to wait any less to be approved for their remedy? When applying to the FDA for acceptance for a new drug, how long do you believe it takes to be approved? Correct me if I am wrong, but did you know that, If say a drug... hmmm let's call it 'no sneaze powder' was approved by company A, and a second company... called duh... company 'B' wanted to be approved, they have to go through the same process with the FDA and wait months (if not years) even though it was already shown that 'no sneaze powder' was fine by company 'A' ?

========================================================
Do you want these same things to happen to everyday vitamins, supplements and natural products? Each individual person going through the FDA process for 'herbs' that someone else has already shown to be ok for a headache? Yeah, it would be great for the government in fees, but really... should something like that be acceptable for individuals and natural herbs?

Look at the current red-tape, and the many unenforceable everyday laws we currently have, and you want to add more?

You may say something like... look at ephedra, we need to be protected because that whole ephedra fiasco will happen again and people will die. The fact is ephedra has been used for 5000 years, but because the labeled dosage in many of the supplements could be off by up to 10 fold, and there was no standardization (and no simple chinese herbalist there to personally cut it from 'ma huang' for you...) it really made things dangerous for some people, and was linked to the death of others. If we were a people that really cared about what we put in our bodies, we need to be proactive about it. Most of us know we don't eat a whole tube of toothpaste, swallow a ton of apple seeds, totally eat the heck out of vitamin A, etc...

What is the solution? The key is education and strict labeling of the products regarding overdosing, and other harmful effects. Then randomly testing the products, like the NPA Truelabel program does... not more 'rules' or 'laws', We would take those that don't test accurately off the market, which is basically what you have agreed to do with the NPA when you join them.

I could go on, but I really need to shift my mental energy... Seriously you really need to think about what you are asking. Go to your super market, walk down the aisles and think about all the products you would affect if this or something similar would ever become a law. Then think about it if this ever becomes some sort of law... should you report your grandmother to the authorities for that soup she made you to treat your stuffy nose?

========================================================
Ok, I am done now... again this is an issue we need to keep talking about, as I believe it's one of those that need to be understood a bit better. I proposed a simple solution (more labeling, more random testing), so please if you want to debate it... please propose a sane solution rather than argue without one...

goodnight everyone.

Anthony Loera
[:o] [:o]

Edited by Anthony_Loera, 21 April 2007 - 05:41 AM.

[lucid]

I wouldn't mind if product purity and potency were enforced better than they are today. And then there's whis.gif efficacy. Of course, if you enforced efficacy, then none of this stuff would ever get on the market, or if it did, we wouldn't be able to afford it.

Well with this point I agree. Supplement companies should be held to the same or higher standard food companies are held. They have to provide nutritional information beyond that provided in food and though I am a libertarian I would not mind a small amount of government oversight effectively mandating COA's for all supplement distributors.

That said, it looks like the free market has taken care of things reasonably well: Reputable supplement companies seem to put the ingredients they say in to their products. That said, many of them sell products which have not been thoroughly tested. It would be nice if there could be some sort of intellectual property laws that would encourage research into supplement benefits. However since there is not, maybe having the government provide funding to research the efficacy of supplements might not be a horrible idea... This makes me shudder though... government institutions are so inefficient. At this point it seems like the only way to get lots of funding for supplement research though. I'm not sure what I ultimately support here regarding gov' regulation of efficacy.

[zoolander]

Anthony I don't in any way want herbs and vitamins regulated. I was just stating how the govent agencies work. I live in a country that one of the tightest therapeutic goods administrations (TGA).

Some chinese herbs/roots and their western synthetic forms have been regulated by the FDA for some time now. This is not new. Lets use Ma huang as an example. Ma Haung/ephedra (it's synthetic form ephedrine) are highly regulated. In Australia they are Schedule III and you simply cannot import or use these compounds without a prescription.

[mike250]

Anthony I don't in any way want herbs and vitamins regulated. I was just stating how the govent agencies work. I live in a country that one of the tightest therapeutic goods administrations (TGA).

Some chinese herbs/roots and their western synthetic forms have been regulated by the FDA for some time now. This is not new. Lets use Ma huang as an example. Ma Haung/ephedra (it's synthetic form ephedrine) are highly regulated. In Australia they are Schedule III and you simply cannot import or use these compounds without a prescription.

wouldn't you think they have too tight of a therapeutic regulation.

[bacopacabana]

[lol]  [lol]  [lol]  as it should.  There are MANY shyster assholes selling the worst shit products ever found.

although I normally shun ANY govt interference in my personal and business matters, i welcome this intrusion for the simple reason that I HATE deceptive businesspeople [ang]

and all lies should be unwelcome, and destroyed as soon as the opportunity presents itself.

I would much rather rely on independent sources such as consumerlab, etc., than to launch yet another bureaucratic nightmare.

[bacopacabana]

Karomesis has a point.  It seems like any moron can set up a supplement operation, and quite a few of them have.  Even the reputable supplement companies have done some things that are a little dodgy.  I don't want anyone telling me I can't have something, but I wouldn't mind if product purity and potency were enforced better than they are today.  And then there's [wis] efficacy.    Of course, if you enforced efficacy, then none of this stuff would ever get on the market, or if it did, we wouldn't be able to afford it.

Stick to well known manufacturers who test their products. Avoid shopping for the lowest price on the internet.

As far as testing efficacy - you gotta be kidding.

We're living in a time period where the developments in biotechnology are nearly overwhelming, and yet the rate of new drugs on the market is decreasing. That's because of the cost of the FDA efficacy hurdle. Among the "new" drugs that are produced, many are mere copycats - small changes or isomers of previously accepted drugs that can get thru the pipeline quicker. Not the greatest landscape for the consumer.

I'm damn glad to have access, grey market though it may be, for products like ALT711.

[Anthony_Loera]

[lol]  [lol]  [lol]  as it should.  There are MANY shyster assholes selling the worst shit products ever found.

although I normally shun ANY govt interference in my personal and business matters, i welcome this intrusion for the simple reason that I HATE deceptive businesspeople [ang]

and all lies should be unwelcome, and destroyed as soon as the opportunity presents itself.

I would much rather rely on independent sources such as consumerlab, etc., than to launch yet another bureaucratic nightmare.

I agree, but I have to say, I would hope their pricing comes down regarding testing. I see that folks like Consumerlabs can charge almost 8x as much as a regular lab. I guess you pay a premium for services that include some advertising?

I would hope their pricing comes down some regarding the tests.

Anthony Loera

[Brainbox]

Some of the supplement companies are running awfull shady businesses. There are many more examples. The LM issue or viral marketing in general is just a tiny pain in the ass, but is essentially the same issue. It is an example of how certain supplement businesses are run. I'm not surprised that general measures are taken. Do I like them? No! Do I understand the rationale behind them? Yes. Do I think the government is overreacting? Yes. Do I think the media are overreacting? Yes.

But what else can be expected from a government? That they keep quiet like sitting ducks in such an environment? These people are payed for what they do. That's a fact of life to deal with.

As long as the supplement industry as a whole (I'm not only looking at the good ones here) is not able to take responsibility on their own, these regulations are inevitable. [ang]
Also users of supplements can have some influence here, but the problem is that the majority of them is ignorant.

[xanadu]

I'm against it for the simple reason that the federal govt is not to be trusted particularly under Bush. Or under anyone, for that matter. If they are going to be involved, I do not want to see anything more than a check for harmful contaminants or additions. Anything toxic or likely to be toxic in amounts used could be regulated. I can see them banning too powerful dosages, for example. If 5 of a pill could kill, that's way too strong even with a warning. Bush may be a lame duck but he is still capable of doing a lot more harm in the time remaining. Keep vitamins and sups free from the heavy hand of govt.

[wayside]

This means, for example, if a person decides to produce and
sell raw vegetable juice for use in juice therapy to promote optimal health,
that product is a food subject to the requirements for foods in the Act and
FDA regulations, including the hazard analysis and critical control point
(HACCP) system requirements for juices in 21 CFR part 120. If -the juice
therapy is intended for use as part of a disease treatment regimen instead
of for the general wellness, the vegetable juice would also be subject to
regulation as a drug under the Act.

By this rationale, every single thing you put in your body could be considered a drug.

Want a drink of water? That's a medical treatment for dehydration, sorry, you need a prescription.

Crazy.

[Brainbox]

Keep vitamins and sups free from the heavy hand of govt.

Agreed. It would help tremendously if we made a risk analysis and try to find out what the better arguments would be to accomplish that. Some lobbying (is this a right English term?) is required at different levels of government to try to give them a more balanced view on the matter. The fact remains that the core factor is that the supplement industry itself is partly responsible for these kind of developments.

[Brainbox]

By this rationale, every single thing you put in your body could be considered a drug.

Want a drink of water? That's a medical treatment for dehydration, sorry, you need a prescription.

Crazy.

Yes. But as far as I understand it are the unproven claims of health promoting properties used in marketing that are the cause of the issue.

Editted typing error

Edited by brainbox, 21 April 2007 - 06:38 PM.

[zoolander]

wouldn't you think they have too tight of a therapeutic regulation.

Yes. Totally.

But that's probably the way the agencies like to have it.

[wayside]

Yes. But as far as I understand it are the unproven claims of health promoting properties used in marketing that are the cause of the issue.

Maybe.

What we have now is certainly better than 100 years ago when anyone could sell anything claiming it cured everything. Could it be better? Sure.

But there are plenty of people who believe the FDA is just a pawn of big pharma, and things like this and the Codex Alimentarius are part of an effort to classify all vitamins, minerals, and supplements as drugs, and since only drug companies will be able to afford the necessary testing (and the necessary buying off of the FDA) only drug companies will be able to sell vitamins and supplements, or even better, their patented drugs that do the same thing.

Given the FDA's recent history it is hard to completely dismiss this as paranoid delusions. Any agency producing a report that says vegetable juice should be regulated as a drug has clearly gone off the deep end.

Even if the FDA is part of a vast conspiracy to get rid of vitamins and supplements, I don't believe they (or any government bureaucracy) can pull it off. Congress will feel enough pain to smack them down eventually, as happened in 1994 with the Dietary Supplement Health and Education Act.

[niner]

and the necessary buying off of the FDA

I guess a lot of drug companies are not paying off the right people, because a hell of a lot of drugs have been biting the dust at FDA lately, resulting in major hits to company profits and stock prices, or in the case of startups, complete flameouts of the company.

Any agency producing a report that says vegetable juice should be regulated as a drug has clearly gone off the deep end.

Haven't heard of this one, but if the "vegetable juice" was capable of causing lethal drug-drug interactions, would that change the picture?

[mike250]

Haven't heard of this one, but if the "vegetable juice" was capable of causing lethal drug-drug interactions, would that change the picture?

not really.

[Brainbox]

Yes. But as far as I understand it are the unproven claims of health promoting properties used in marketing that are the cause of the issue.

Maybe.

What we have now is certainly better than 100 years ago when anyone could sell anything claiming it cured everything. Could it be better? Sure.

But there are plenty of people who believe the FDA is just a pawn of big pharma, and things like this and the Codex Alimentarius are part of an effort to classify all vitamins, minerals, and supplements as drugs, and since only drug companies will be able to afford the necessary testing (and the necessary buying off of the FDA) only drug companies will be able to sell vitamins and supplements, or even better, their patented drugs that do the same thing.

Given the FDA's recent history it is hard to completely dismiss this as paranoid delusions. Any agency producing a report that says vegetable juice should be regulated as a drug has clearly gone off the deep end.

Even if the FDA is part of a vast conspiracy to get rid of vitamins and supplements, I don't believe they (or any government bureaucracy) can pull it off. Congress will feel enough pain to smack them down eventually, as happened in 1994 with the Dietary Supplement Health and Education Act.

I agree with you completely. Also with others that we need the freedom. The FDA is indeed also a conservative organisation that tries to keep things simple regarding their view. And that view is that pharmaceutical companies guarantee a good basis for scientifically proven medication.

The fact that the world did change and the real situation is not matching anymore with the view the FDA still has, well, they have to wake up first to realise the full impact of that. In the meanwhile they try to model the world to their view. In short, if supplements are becoming scientifically effective, they must be declared medicine and hence need regulation.

Unfortunately, that's the way it works, this is reality.

If in the meantime some supplement companies are conducting very shady businesses, they give the FDA the extra arguments to act now in stead of later, since these shady companies are posing a huge risk to society. This protection is the core-business of the FDA. As always, the story has different angles to look at.

Edited by brainbox, 22 April 2007 - 08:49 AM.

[luv2increase]

No one is dying or becoming seriously ill due to supplements. People are dying and becoming seriously ill from pharmaceuticals. Am I the only one who see the irony in this?

Why do they want to pick on supplements if they are doing no harm?

It is because they (Pharmaceutical "Industry") are losing out on the consumer health market. The FDA is getting pressured probably from Glaxo-Smith Klein, Pzfizer, etc... to do this.

It doesn't have anything at all to do about the FDA looking over our health. It is a business. It is all about the money.

I will move out the the dam country if they take my supps away.

The USA is being more of a police state every year. It will be scary what things will be like in 20 years! It will be like what North Korea is now here in our own backyards of the good 'ole USA.

[Brainbox]

Am I the only one who see the irony in this? 

No. Grumbling around ain't gonna do anything right. Just trying to be devils advocate.

[xanadu]

When supplements are against the law, I will simply be a lawbreaker. I will not give them up. I already use at least one illegal supplement that has been proven to help prevent alzhiemers and other diseases.

The FDA and government in general has become so corrupt that we can not believe anything they say anymore without proof. They have lied to us so many times they have lost damn near all credibility. Horrible noxious compounds like aspartame are legally added to our foods without warning. Other harmful substances like msg, olestra and so on are added to food whether we like it or not. Harmless and helpful herbs and substances like stevia are forbidden because they would cost big business money. The health and well being of the public are no longer top of the list of their priorities, if they ever were. Bush in particular has been awful in politicizing government agencies.

[wayside]

Haven't heard of this one, but if the "vegetable juice" was capable of causing lethal drug-drug interactions, would that change the picture?

I quoted before from the FDA document, here it is again:

This means, for example, if a person decides to produce and
sell raw vegetable juice for use in juice therapy to promote optimal health,
that product is a food subject to the requirements for foods in the Act and
FDA regulations, including the hazard analysis and critical control point
(HACCP) system requirements for juices in 21 CFR part 120. If -the juice
therapy is intended for use as part of a disease treatment regimen instead
of for the general wellness, the vegetable juice would also be subject to
regulation as a drug under the Act.

IOW, whether something is a "drug" is based purely on what claims are made about it, not whether it is safe or dangerous, or even if it does what is claimed.

Your supplement helps keep you healthy? No problem.

The same supplement helps lower blood pressure? Sorry, now it is treating a disease, it is a drug.

It's not a big leap at all to think the FDA will decide all supplements are "drugs", and try to regulate them as such.

It's not a big leap either to see the day where supplements can never be anything other than "promoting optimal health", and sellers (or anyone!) will not be allowed to say anything about them, even with the "These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease." disclaimers you see everywhere.

[PWAIN]

It seems to me that the FDA is having trouble with definitions and are trying to come up with a standard. They are saying, "how do we define what is a drug?" and are comming up with "used to treat something" which seems reasnable at first glance. The problem is that with the vegetable juice, it indicates that this is an incomplete definition.

What the FDA really needs to do is go away and think some more. They need to come up with something better that includes traditional use, it's use as or as part of a food, dangerous side effects and interactions and ultimately a bit of common sense (what is the difference between pornography and art).

If this really grates you, the best thing is to write to every pollitician that you can think of, every lobby group, mags, newspapers and current affairs program. Don't waste time here, changing peoples minds here won't change a thing.

I am not American so I cannot do the above but I am affected by it as without the US, sups will be obscure and hard to source.