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FDA and Vitamins?

Hey All,

I was wondering if anyone had heard about the FDA classifying vitamins as drugs? I read about it somewhere else, but I've only heard of it on one site on the web, and am not sure how reliable that site is. It seems to me that if it's true, the implications for vegans could be enormous. If it's true, it seems to me that it's something that needs to be pounced on before it gets snuck through, and we're stuck with a big drug company monopoly. Thoughts? Anyone else heard of this?

Yes the FDA wants to regulate the vitamin industry here and in Canada.
Guess the US and Canada are one now?

It is a quiet topic and you do not hear much about it.

Dr Mecola posted a vblog about it a couple months ago.

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     The Robert Scott Bell radio show and rsbell.com often carry information related to this  and other alternative/natural foods and healing.   I'd go check it out myself but my computer has been running molassesly slow.             

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Why do you think that the FDA regulating vitamins would result in a big drug company monopoly?  I'm not following the reasoning there . . .

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All vitamin regulation means is that when you buy a supplement, it is what it claims to be.  There is a lot of conspiracy theory nonsense floating around on the internet about this.  The reason why people speak of a big drug company monopoly is that in theory it would force smaller supplement producers to go through the process of getting their products approved.

I think that supplement regulation is a good idea.  Many faulty, poorly-tested, or simply ineffective products are marketed under the umbrella of "natural" without having any criteria for judging their effectiveness.  I believe supplements are regulated in Europe, no?  People need to know what they are buying is safe and effective. 

Also, why would there be special implications for vegans? 

Anyway, just check your one source carefully.  Lots of tinfoil-hat-wearers out there.  ::)

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  Tin-foil-hat-wearers? I've actually seen one(!)  Has it been rumored to be a protection  against something, or something?
  Also, has anybody yet checked out the rsbell.com website? I checked it myself but my ram has been too weak to get to many of the more informative areas.  I believe it should have some good information/documentation to put in place some of the "conspiracy theorist" phobes.

  P.s.  And to Wabbit, what site was it that you were refering to?

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I think regulation of vitamins/herbal supplements would be great - there has historically been plenty that turned out not to be safe (ephedra?), or things classified as herbal supplements that really, really aren't (melatonin), but there are some complications. First, the testing/paperwork and such would cost the makers, resulting in higher prices. Some people buy these things only because they're cheaper than medicine medicine, so they'd lose some sales maybe. Also, how would these things be tested? Some things for sure would get grandfather standing, but other newer supplements/herbs/etc could potentially require animal testing if they apply the same rules as they do to prescription pharmaceuticals :( Bad news for vegans.

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why does the average American think government regulation is a good thing?
Can not really comment further with out really offending fellow vegwebbers.

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   Perhaps because they too often hear just one side of the arguement.  Perhpas also because caring people such as Kevin Trudeau and others who try to bring some alternative  information to the public often get threatened and/or sued, - or labeled as such and such by the very people they try to inform and protect!
why does the average American think government regulation is a good thing?
Can not really comment further with out really offending fellow vegwebbers.

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why does the average American think government regulation is a good thing?
Can not really comment further with out really offending fellow vegwebbers.

You can state your opinion like all of us have done above without offending anyone personally.

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   Perhaps because they too often hear just one side of the arguement. 

What is the other side?  I would love to hear it.  I have yet to hear any compelling evidence that vitamin regulation will bring on the apocalypse like some suggest. 

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    For starters, if I were to tell you that nearly 1/2 of the people working for the FDA were once employees of the pharmacuetical industry, and nearly 1/2 of the people working for the pharmacuetical industry were once employed by the FDA, would that be enough to raise suspicion of their motives?  Perhaps also some people here remember or have heard how chiropractic was once barred and disrespected and degraded by the med establishment as recent as the 1950s(?) 

   Perhaps because they too often hear just one side of the arguement. 

What is the other side?  I would love to hear it.  I have yet to hear any compelling evidence that vitamin regulation will bring on the apocalypse like some suggest. 

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The difficult thing about debating this issue is that there are many, many convoluted issues here that need to be teased apart:

- Should vitamins be regulated as drugs, period?
- What should the process be for this?  What are the guidelines?
- Who should be responsible for overseeing this process?
- Who should pay for the process?
- Over what time frame would the process occur?

fb, you addressed a couple of these--the cost to smaller companies of testing their products, and the animal testing aspect.  Unfortunately, animal testing is THE way right now.  That's a separate issue and a very sad one. 

The FDA is to pharmaceuticals as the USDA is to meat/dairy.  They're corrupt.  It sucks.  But I still think that vitamins need to be regulated.

I looked up the history of this, out of curiosity:

http://www.thedoctorwillseeyounow.com/articles/bioethics/nutraceut_7/ wrote:
Within the realm of alternative medicine, nutraceuticals represent one of the boldest challenges to government regulation. Historically, the FDA took the position that a product that made health claims was a drug. Beginning in 1976, vitamins and minerals were exempted from regulation as drugs, but only so long as they did not make health claims. Then, in the early 1980s, studies began to show that certain food ingredients, such as fiber, provided specific benefits to health. Food manufacturers wanted to proclaim these benefits to consumers without having to obtain drug approval. The FDA wrestled with this problem until Congress passed the Nutrition Labeling and Education Act of 1990. This law authorized the FDA to issue regulations permitting certain health claims for foods, which led the agency to allow claims associating low levels of calcium with osteoporosis, dietary fats with cancer and cholesterol with heart disease.

After passage of the FDA Modernization Act of 1997, a food could make a health claim without FDA regulatory authority so long as the claim was based on an authoritative statement by a governmental or quasi-governmental scientific body (such as the NIH or the Natinal Academy of Science ) and the agency was given advanced notice of the manufacturer's intent. This leeway did not apply to dietary supplements, however.

See, when a health claim is made, that claim needs to be backed up, period.

I think the LARGER issue here is educating people about a proper diet.  SAD is not conducive to good health, and people do not know how to eat in such a way that minimal supplementation is required.  As vegans, we have been educated so that we DO NOT CHOOSE meat and dairy even though government agencies would have us do so.

Still, I would like to know that anything I choose to take is legit.

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The difficult thing about debating this issue is that there are many, many convoluted issues here that need to be teased apart:

- Should vitamins be regulated as drugs, period?
- What should the process be for this?  What are the guidelines?
- Who should be responsible for overseeing this process?
- Who should pay for the process?
- Over what time frame would the process occur?

fb, you addressed a couple of these--the cost to smaller companies of testing their products, and the animal testing aspect.  Unfortunately, animal testing is THE way right now.  That's a separate issue and a very sad one. 

The FDA is to pharmaceuticals as the USDA is to meat/dairy.  They're corrupt.  It sucks.  But I still think that vitamins need to be regulated.

I looked up the history of this, out of curiosity:

http://www.thedoctorwillseeyounow.com/articles/bioethics/nutraceut_7/ wrote:
Within the realm of alternative medicine, nutraceuticals represent one of the boldest challenges to government regulation. Historically, the FDA took the position that a product that made health claims was a drug. Beginning in 1976, vitamins and minerals were exempted from regulation as drugs, but only so long as they did not make health claims. Then, in the early 1980s, studies began to show that certain food ingredients, such as fiber, provided specific benefits to health. Food manufacturers wanted to proclaim these benefits to consumers without having to obtain drug approval. The FDA wrestled with this problem until Congress passed the Nutrition Labeling and Education Act of 1990. This law authorized the FDA to issue regulations permitting certain health claims for foods, which led the agency to allow claims associating low levels of calcium with osteoporosis, dietary fats with cancer and cholesterol with heart disease.

After passage of the FDA Modernization Act of 1997, a food could make a health claim without FDA regulatory authority so long as the claim was based on an authoritative statement by a governmental or quasi-governmental scientific body (such as the NIH or the Natinal Academy of Science ) and the agency was given advanced notice of the manufacturer's intent. This leeway did not apply to dietary supplements, however.

See, when a health claim is made, that claim needs to be backed up, period.

I think the LARGER issue here is educating people about a proper diet.  SAD is not conducive to good health, and people do not know how to eat in such a way that minimal supplementation is required.  As vegans, we have been educated so that we DO NOT CHOOSE meat and dairy even though government agencies would have us do so.

Still, I would like to know that anything I choose to take is legit.

Word.

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I think what I personally find disturbing about this has more to do with my lack of trust in the government to do what they are claiming to want to do: regulate some of the wild claims that are made about vitamins. I honestly don't think that they are capable of doing it (manpower required to enforce said law.) Visions of the phrase "acceptable levels of melamine in baby formula" float through my head. Whether or not the FDA is corrupt or in league with pharmaceutical companies is an additional matter. Furthermore, I also am not thrilled with the idea that the government wants to classify something that naturally occurs in food as a drug. At what point, then, do certain high-vitamin-containing foods become drugs?
It will most certainly raise prices for consumers at a time when many are cutting back, which will not help the smaller companies (read: companies that cater to the veg*n population)

But back to my original post: I had only heard of it from one source, and was unfamiliar with whether it was trustworthy. I was hoping that others had heard of the same issue to confirm or deny, so to speak. It sounds like people here have heard of this. That this has been kept fairly quiet, deepens my concern over said matter.

As far as my statement goes about it being important to vegans in particular, I thought that would be obvious: Vitamin B-12 will be classified as a drug.

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I know herbs and natural supplements cannot be regulated by the FDA because they cannot be patented-- they are NATURAL. They are not things that say your Dr. can prescribe. This is why stevia is being suppressed and in some places is not sold, because it cannot be patented by the govt, as it is a natural herb. Stevia cuts into nutrasweet and aspartame / splenda profits so therefore it is evil  :P

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Also, I saw that someone mentioned earlier something about how they would vaccinate their daughter with HPV, etc....I would definintely do research and know there are some good vw threads on vaccinnes....the HPV vaccinne in general is pretty controversial and vaccinnes are many of them NOT vegan btw, in addition to other issues... :-X

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The F in the FDA stands for food - they can and do regulate non-patent-able items. Doctors can prescribe natural (ish?) remedies, such as vitamins (B12 made from bacteria, for instance. But where to draw the line for "natural"...).

The issue of what constitutes a drug will always be... an issue. If you limit drugs to man-made compounds, that makes marijuana, morphine, codeine, cocaine, alcohol, and tobacco not drugs. If you extend it to whole plant products, that could include ginseng and ginkgo biloba, as well as whole plant foods identified to have a specific effect and consumed only for that effect. But then, that raises another issue - some plant foods Americans may typically only consume for drug-type benefits, whereas other people consume it just as food. Ginger doesn't quite fit this description, but it's close for some people.

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On the "what is a drug" note:

Some supplements come in very high doses - those used to naturally treat illnesses, for example, only work at pharmacological levels for these illnesses. When this is the case, I think it's extremely important that the people producing & selling them (not to mention using them!) know the products are safe, especially with respect to toxicity levels, adverse effects, etc just like anything else. I think this would also be beneficial if it ensured these products actually contained what they claim to - as it stands right now, some might just be placebos. who knows.

On the other hand, I'm generally suspicious about government regulations, especially when it comes to food and related industries/products - I certainly don't trust the Canadian (or US!) government to ensure that "food animals" are given the care and attention they require - most of us here know they don't - because the first priority is always profits, and it's hard to change the system when profit margins are so thin to begin with. I feel that if there's money to be made, that will be the #1 concern in this case, instead of transparency and the health of the people these natural vitamins & supplements will serve. It's really unfortunate that so many people feel like this.

I strongly feel transparency - or lack thereof - is one of, if not THE biggest problem in food production in North America. It is really disturbing that something as important as food, that people need to put into our bodies in order to live and be healthy, is something people know little about besides where to get it and how to make it. We all have the right to know where these things are coming from, and the fact that this information is so inaccessible is terrible. Regulation of vitamins, supplements & natural remedies etc would potentially help this - IF you trust the governing body(ies) that regulate them.

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I watch TV online.  Yesterday, during Brothers & Sisters "commercials,"  Wynonna Judd was hawking appetite suppressant (I think) and part of the pitch was that it was approved by the FDA, so that means it's safe.  bwuhahaha!!!

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