toldailytopic: Vitamins and supplements: should the government regulate more like pha

[Traditio]

No, that would be silly. The government regulates too many things, which should be left up to the individual to decide and fails to regulate other things because their power buddies do not want it regulated.

But surely, you think that the government should be able to hold supplements/vitamins to certain health standards (as in, they won't cause liver failure) and should ensure that they do what they're supposed to do (as in, metalonin advertised to act as a sleep aid doesn't actually act as a stimulant), right?

 

[lucy]

What kind of regulation do you want? If the FDA treats the supplement research in the same manner as they do for prescription medication, it is a loooonnnngggg process from "discovery" to "on the shelf" .

The stages are as follows:

1. Preclinical research - studies in animals to determine the pharmacokinetic (what the body does to the substance/drug) and pharmacodynamic (what the substance/drug does to thebody) They have to check
*toxicity levels (is there a level of toxicity or not),
*what levels of the substance are needed to be therapeutic,
* if it causes cancer
etc. The manufacture of the substance has to meet with the FDA to plan out the animal studies and agree on the design of the animal studies so that when they get to human testing, they will have worked out all the bad effects or non-effects of the substance .

2. Clinical development stage- this is the development how they are going to go about doing the human studies. The FDA regulates and sets the standards for the testing that the researcher has to follow. This involves LOTS of paperwork from the preclinical research proving that the stuff isn't going to harm the human subjects, etc.
Then you have to have a two phase study:
Phase I - they evaluate different dose levels in the person to find out what is the most effective dose. You don't want to take a whole bunch of the stuff is less is just as effective. You don't want to take too much if it is going to make you sick, either. Usually the researchers base their evaluation on the animal studies and from those studies they decide what doses they are going to try on the humans.
Phase II - This is where they take the drug/substance and try it out for a specific use on a specific disease or problem.
Phase III - Then you have to do a 3rd study. You only get to this stage if you have proven from the other studies that the stuff is going to be effective. These studies are to prove to the FDA that the stuff is safe and effective, and the FDA wants TWO of these kinds of research studies, and they both have to come out saying the same thing: the stuff is safe for XYZ and is effective for XYZ. They also want to know about mortality and morbidity outcomes (did anybody die of the stuff/get sicker from the stuff, or have weird side-effects from the stuff, etc.)

 

[lucy]

3. Once you get these phases done (and the FDA has to approve every step of the way, and you can't move on from one phase to the next unless the FDA says you have done enough research), then you can apply to the FDA for approval to market the stuff/drug. That takes about 10 months for standard approval.

4. Once you have the license for the product/stuff, you have to do Phase IV trials. This is where you have to make sure whatever you SAY the stuff is going to do on the label of the bottle, is REALLY what the stuff does. You also have to figure out what warnings you have to put on the label according to what your other studies found.

After that, the FDA may want to get a committee of experts to review all your research and they can also have a committee that keeps track of drugs already on the market to look for adverse reactions to the stuff.

All this can take years before the drug/stuff gets to the store where you can buy it.

Do you want that kind of regulation? Probably not.

 

[lucy]

I agree that there needs to be some kind of investigation as to whether these supplements are safe and effective, but I think having FDA in charge of it is going to raise the price of the supplements (you have to pay for all the years of research and the new marketing and the warning labels, and on and on...), and it will most likely mean that those supplements may not be available for use while they are under "investigation".

I do think the supplements ought at least be tested for purity (they have in 'em what they SAY they have in them), safety, (they don't have a heavy metal like Mercury in them- think of fish oil supplements), and that the supplements have the amount of the active ingredient they SAY they have in them. I think too, that there should be a reporting system so that if there are serious adverse affects that can be linked to a particular supplement, then the public would have knowledge of that information, and if the incidence of the adverse effect is of a significant level, then the supplement should be pulled off the shelf.

 

[lucy]

One more thought; There are already independent studies going on for some of the over-the-counter supplements. There is a site you can subscribe to (unfortunately I can't remember the name of it...) that you can then type in the supplement name and they will give you the research they have done on the substance.

Anybody out there know what is the name of that site ?

 

[nicholsmom]

But surely, you think that the government should be able to hold supplements/vitamins to certain health standards (as in, they won't cause liver failure) and should ensure that they do what they're supposed to do (as in, metalonin advertised to act as a sleep aid doesn't actually act as a stimulant), right?

Nope. I don't. But then I'm one of those lunatics who think that the FDA ought to be pared down to nearly nothing. They're more trouble then they're worth. Make them stick to new drug trials, get them out of the food industry altogether and let the states manage it. The states are closer to the product anyway. It also would be pretty cool to look at a package of meat and read "raised and processed in Indiana." :chuckle:

And stay outta my vitamins! Sozo, you can do your own research and I'll do mine :up:

 

[Newman]

http://www.ul.com/global/eng/pages/

Please check it out. Independent, third party (and these guys are even not-for-profit!) testers of consumer goods! We don't need the government to check things for us.

 

[Ktoyou]

But surely, you think that the government should be able to hold supplements/vitamins to certain health standards (as in, they won't cause liver failure) and should ensure that they do what they're supposed to do (as in, metalonin advertised to act as a sleep aid doesn't actually act as a stimulant), right?

I think they already require the ingredients listed. I think the government should mind more important things, such as cutting out much of the deadwood and reducing its expenditures.

 

[elohiym]

The government should stay out of the supplement business. Caveat emptor.

 

[mmstroud]

In addition to all the info provided by Lucy, don't forget that all of the FDA approved medications come with warnings that include everything from growing a third eye to spontaneous death if you take them! Yeah, the FDA does a great job!

Our family takes natural thyroid tissue and I was just recently able to order it (have NEVER been able to get it in the U.S. w/out a prescription) after about six months of a severe shortage because of threats by the FDA counterpart in England to start regulating supplements, at least those shipped to the U.S. Even then, I got it from Mexico - just a couple of weeks ago I finally got an email from my supplier in England saying that it was again available.

We also use stevia, a natural plant derivative, for sweetening ice tea and other drinks. It costs a dang fortune because the FDA is in bed with one of the artificial sweetener makers (can't remember which one right now) and has said that stevia will never be approved for use in soft drinks and the like. By all means, keep letting us consume products that, whether you believe they actually do or not, are reported as causing all kinds of problems, including cancer. In Japan, all diet drinks are sweetened with stevia. It's the only sweetener you can buy that doesn't affect blood sugar.

I'm with Knight and TomO and KtoYou and everyone else who says NO to regulation - please let us take some responsibility for ourselves. And don't think for a minute that regulation will create competition and drive prices down. ALL regulation drives prices up due to compliance costs, not to mention the cost to the taxpayer for the bureaucracy they'll have to create or expand.

 

[Newman]

I'm with Knight and TomO and KtoYou and everyone else who says NO to regulation

:wave2:

 

[Traditio]

Caveat emptor.

Can the buyer be expected to be well-informed when it comes to pharmaceuticals, supplements, etc?

 

[nicholsmom]

Can the buyer be expected to be well-informed when it comes to pharmaceuticals, supplements, etc?

Can you google & tell the difference between wikipedia and the mayo clinic?

 

[vnctblzn]

The TheologyOnline.com TOPIC OF THE DAY for April 15th, 2010 08:56 AM

toldailytopic: Vitamins and supplements: should the government regulate more like pharmaceuticals?

no. the government doesnt even have harder core drugs under control. better off regulating alcohol and nicotine.

 

[Nick M]

Not to mention.... this allows government more power over our own personal choices, I don't want Obama telling me what I can, or cannot take in my morning vitamin regiment.

Should the government tell you it is not ok to use Stanozolol over the counter? Especially teen boys, which would like do it? What about heroine?

Creatine (legal supplements) has dramatic and not necessarily good effects on the body.

 

[yeshuaslavejeff]

... ___ ...

 

[nicholsmom]

Should the government tell you it is not ok to use Stanozolol over the counter? Especially teen boys, which would like do it? What about heroine?

I think that the government ought to continue to regulate the drug industry. I don't think that anabolic steroids ought to be among those denied. They certainly ought to be by prescription only. This is a function of the government concerning legal and illegal actions because crimes are committed due to drugs like cocaine and meth. It is right on the borderline, though, of what I would consider to be their arena.

Creatine (legal supplements) has dramatic and not necessarily good effects on the body.

Buyer and parent beware then. It was completely ineffective in doing anything whatever for my husband when he tried it. But he has read many testimonials from folks that have great results from it.

If you are concerned about the performance enhancement supplements and drugs, Nick, you really ought to watch the documentary called "Bigger, Stronger, Faster" which does a decent job of covering all the pros and cons and comes to no recommended conclusion ("Just the facts, ma'am) so that you can decide for yourself.

 

[TomO]

Buyer and parent beware then. It was completely ineffective in doing anything whatever for my husband when he tried it. But he has read many testimonials from folks that have great results from it.

lain: Just out of curiosity has you husband tried the different forms of creatine. Creatine Monohydrate did absolutely nothing for me but Anhydrous had a dramatic effect.......I have no idea why it's the same thing as Mono it just has a water molecule removed.

Maybe for some reason I got better absorption with it? :idunno:

.....anyhoo, I've spoken to bunches of people who got no effect from one form but did from another. I've also spoken to people who just got no effect from it period. :chuckle:

One thing is for sure though, being as how there's like 15 different forms; finding the right one can be tedious and expensive. :think:

 

[Nick M]

I have no problem with prescription drugs, as long as the user knows. It isn't like Michael Jackson didn't know he was killing himself.

 

[Nick M]

It fills the muscles with water, that is where the creatine deaths come from. And muscle "gain". They get dehydrated.