New FDA ruling could jeopordize all supplements

I *DO* blame Pharma, actually - but not entirely: they didn't just fall into this position, they arranged it for themselves (I imagine it cost them a pretty penny - but I'm sure it's been profitable as can be) - I also blame government for being so ready & willing to arrange the playing field to Big-Whatever's liking.

"Citizens" are a fast-fading group here: unions & collective bargaining have been so beaten down that the capitalist ideal of cheap commodity labor is pretty much a reality, consumer's groups are completely toothless in terms of causing any real change in the way things run, voters really only get to choose between Tweedle-Dum & Tweedle-Dumber...or not playing at all, which suits the suits at the top just fine.

This is a major reason, I believe, that the recent elections went the way they did - there's been a lot of despair over the course of things, and not just these last 8 years (personally, I trace it back to the years immediately following WW2); whether any real improvement for real people is in the offing, only time will tell.

A big part of the problem is that there's no sense of real history remaining here: everyone has their favorite faiy tales, but few actually look back far enough & dig deep enough to really get a sense of what's happened in the long view. We're still a young nation, and our attention-span is sadly short; we've done alright as a nation, but as a people, things aren't going so hot - and haven't since the Nixon era. Eisenhower was about the last real non-ideological Republican we've had in top office, and he tried to warn us about how the post-war era was shaping up - but few listened.

Ah well: this is not getting the leaves off my lawn!
 
noobster said:
That's a very curious state of affairs. Not only from a legal point of view, but also culturally.

I can't really blame the pharma companies, they're just looking out for their interests. But politicians, voters, consumer groups and supplement companies just bending over and taking it is quite disconcerting. It will be interesting to watch how this develops.
Click to expand...

At the same time, do you really know whats in any bottle of a supplement you buy? the lack of regulation is in some ways appalling, and particularly the claims made in ads. No other sort of products are allowed to be sold like that....

But this ruling is definitely ass backwards
 
EasyEJL said:
At the same time, do you really know whats in any bottle of a supplement you buy? the lack of regulation is in some ways appalling, and particularly the claims made in ads. No other sort of products are allowed to be sold like that....


But this ruling is definitely ass backwards
Click to expand...

I couldn't agree more. Whoever expected that this industry would regulate itself must have been out of their mind. I only learned about the extent of this quite recently when I watched Bigger, Stronger, Faster. I don't think the average customer has the slightest idea of how unregulated the supplement industry is.

What's really disturbing is that the FDA didn't use this opportunity to look out for the safety of the customers. There's so much wrong with Section 912, it's distressing.
 
BodyWizard said:
FOLLOW-UP

I've been a student of nutrition and supplementation for more than 40 years; by a roundabout route, that's how I ended up here @ AM. There has been tension between the FDA & the ADA (dieticians) (and to a lesser extent, the AMA) on the one hand, and physiologists & nutritionists on the other, for many years.

The most recent - and in many ways, the most successful - bulwark against federal control of what we can eat & use for supplementation is DSHEA - the Dietary Supplement Health and Education Act of 1994 . A lot of the bros who were around FOUR YEARS AGO will certainly remember the preservation of DSHEA being a real big deal in this community; they may even remember this website: Invalid Link Removed

The outgoing administration is pushing through a bunch of 'midnight regulations', as happens, sadly @ the end of *any* administration; the purpose of these moves is to set in place ideological changes that couldn't pass legislative muster. In any event, they typically represent a big ol' F-U to the incoming administration, and are an end-run around due process in every sense (look! A *real* bi-partisan issue!!!)

For the last 8 years, the FDA has been increasing its efforts to smash the core of DSHEA- that is, the GRAS category; they have been working internationally through the Codex process to have everything considered effective classified as a drug - and therefore banned from non-prescription sale. Many OTC vitamins are no longer available OTC in many parts of the world for this reason.

With the end of the 43 administration comes also the end of Big Pharma executives in controlling roles @ the FDA (don't believe me: look it up) - and the end of their efforts to put any effective supplements under the control of the pharmaceutical industry.

Many fear (and I'm one of them) that the current round of midnight regulations will accomplish that very thing. If you use any kind of supplement, you should be concerned enough to contact your representatives and tell them to not let that happen - he!!, if you eat "vitamin-enriched "cereal (which is pretty much all cereal) with "vitamin-D-enriched" milk (which is practically all milk) - you'll be impacted.

Too stupid to worry about? Now that the election is over do you guys suddenly trust government regulators who are notoriously cozy w/ the industries they're supposed to regulate? The surest way to see the impossible happen is to assume that it can't.

Don't be a dork: call somebody in Congress & tell 'em NO.
Click to expand...
Great post- and yes- the bolded portion of this post is true- during the period of 2003-06- this was snuck in- pharmaceutical co. personnel do currently have controlling roles in the FDA (but not for much longer, it was finally recognized as a conflict of interest)

-how do you think the final rule (Title 21 CFR 111) got passed last year on DS? I agree with the rule from a QC and cGMP standpoint- and we are very strict about both, but the rule is very, very vague on some important issues....

guys and girls- this is really happening- and sitting there saying "no, this America, they can't do that" isn't going to help- write a letter or send an e-mail to your congressman- tell them that if this goes through- you and anyone you know will never vote for them again- because they are trying to take away your ability to think for yourself and make informed decisions regarding your own health....

do some research if you don't think we are telling the truth- I am not a big fan of magnetic bracelets, homeopathy, etc. either, but the message that the website is sending out is completely true- just read the proposed bill....
 
and the issues CFR 111 is vague on, could be VERY detrimental in the long run if interpreted the wrong way by the wrong people- see above statute
 
signed the petition, and hit fax too so they receive a hard copy.

i think whats most saddening about this is thinking about all of the legitimate companies just on this forum. countless hours spent here sharing research, reasoning, and results with not only consumers, but people who share common interests.

and its so disheartening and sad to see that during these times, when i see in my own town mothers and fathers trying to steal bare neccessities from the super market, and our government is concerned with the supplement/OTC industry. ****ing disgusting.

id love to write some letters and make some calls, unfortunately for the next 3 weeks im swamped with finas, papers, presentations, homework, holidays, etc. hopefully i can find some time to write my district rep.
 
I did the do on the link

However, this seems so over the top and vague in what it actually entails that it is somewhat ridiculous.

So, am i understanding this correctly that we're talking every possible supplement from vitamin to nut oil? So, walmart, cvs, walgreens, gnc, vitamin shoppe, smoothie kings, costco, sams, and every other retailer that is a part of the multi-billion dollar industry has to quit selling supps/vitamins/minerals/oils.

So, are we saying the raws or the finished product?

Crap seems like hogwash, but, I did do the do on the link for keepsake.
 
Well, on another note, there needs to be some type of regulation in terms of quality control, seriously!

This industry has, for lake of better words, gotten bigger than it's "britches"
 
if they ban anything it should be supplements that have no studies to show effectiveness or quality
 
hardknock said:
I did the do on the link

However, this seems so over the top and vague in what it actually entails that it is somewhat ridiculous.

So, am i understanding this correctly that we're talking every possible supplement from vitamin to nut oil? So, walmart, cvs, walgreens, gnc, vitamin shoppe, smoothie kings, costco, sams, and every other retailer that is a part of the multi-billion dollar industry has to quit selling supps/vitamins/minerals/oils.

So, are we saying the raws or the finished product?

Crap seems like hogwash, but, I did do the do on the link for keepsake.
Click to expand...

Well, the whole problem is how vague the ruling is. Basically it would cover every possible supplement, its a question of how whoever is running the FDA chooses to interpret the wording. So no, they wouldnt have to immediately quit selling supplements but the FDA could randomly pick different things to begin banning at their whim
 
I see it now.

Basically, it gives them a free head shot at whatever they decide to knock off at whatever time they feel the need.
 
hardknock said:
I see it now.

Basically, it gives them a free head shot at whatever they decide to knock off at whatever time they feel the need.
Click to expand...
Right, that's what I was saying the FAA did. They are in such light all the time though that they cant pull out that special tactic often, but against the little guy below te radar they can pick and choose what they go after, and how they choose to interpret the law that day.
 
Does anyone else think this is an arrangement for Big Pharma to get involved in the prescription vitamin game, like they already have in Europe?
 
Considering how hard (& for how long) the US has been working the Codex negotiations to adopt a pro-pharma position - including prescription vitamins - yes, I am reasonably certain they're trying to eliminate or cripple OTC vitamin sales.

Whatever they think they can shovel into pharma's maw before the clock runs out, basically.

Remember, though: US pharmcos have been selling prescription vitamins for years. They're absolute crap - though made to the highest standards, of course - that could never compete w/ open-market offerings. Pre-natal vitamins are a classic example: I forget now exactly what form of iron was prescribed for my then-wife, but I remember looking at the label & it was a very-low-bioavailability form of iron. And for the cost of that one month's supply, I could have bought her a vastly better iron supplement, a high-quality multi-vitamin, a high-quality multi-mineral, and enough vitamin c keep her levels stable for 3 months....

Let 'em compete, I say - and let 'em fail, fair & square - in a real open market. May the best product - and the health & wealth of the people - win!
 
I find it hard to believe they'll just ban Centrum and Kirkland brand fish oil just like that. They could care less about pissing off the gym rats, but the last people they want to piss off is your health conscious baby boomers.

Plus, with all the inventory in major retailers now, this would be a kick in the nuts for all the retail outlets stocking them.
 
RobInKuwait said:
I find it hard to believe they'll just ban Centrum and Kirkland brand fish oil just like that. They could care less about pissing off the gym rats, but the last people they want to piss off is your health conscious baby boomers.

Plus, with all the inventory in major retailers now, this would be a kick in the nuts for all the retail outlets stocking them.
Click to expand...

you just stop the interstate shipments of them. the DOT can enforce that easily enough, so it wont affect exsting inventory... and remember the vagueness allows them to enforce how they see fit. So maybe they allow Centrum Silver to continue to be sold but stop MST's MVP365 because its got Krebs Cycle intermediates in it and those sound scary....
 
EasyEJL said:
you just stop the interstate shipments of them. the DOT can enforce that easily enough, so it wont affect exsting inventory... and remember the vagueness allows them to enforce how they see fit. So maybe they allow Centrum Silver to continue to be sold but stop MST's MVP365 because its got Krebs Cycle intermediates in it and those sound scary....
Click to expand...

Jesus. Nothing beat arbitrary enforcement standards.
 
Yeah, thats where my beef with it comes. People have problems with the Codex Alimentus, but you certainly can't say its not detailed and specific :D its so detailed and specific it numbs your brain
 
EasyEJL said:
Yeah, thats where my beef with it comes. People have problems with the Codex Alimentus, but you certainly can't say its not detailed and specific :D its so detailed and specific it numbs your brain
Click to expand...
try reading the new rule on DS- 770 pages of pure excitement- there is a new twist at every chapter....




j/k it sucks and will make you pass out....
 
question is how will this affect the so called "research chemicals?" if so,...say goodbye to SERMS,...... im sure if passed this will include SERMS as well regardless if its considered "research chem"... theres still studies on them, so then i guess we are screwed even more
 
brk_nemesis said:
question is how will this affect the so called "research chemicals?" if so,...say goodbye to SERMS,...... im sure if passed this will include SERMS as well regardless if its considered "research chem"... theres still studies on them, so then i guess we are screwed even more
Click to expand...

I'm guessing they'd go after research chems before vitamin C...
 
BodyWizard said:
I
"Citizens" are a fast-fading group here: unions & collective bargaining have been so beaten down that the capitalist ideal of cheap commodity labor is pretty much a reality, consumer's groups are completely toothless in terms of causing any real change in the way things run, voters really only get to choose between Tweedle-Dum & Tweedle-Dumber...or not playing at all, which suits the suits at the top just fine.
Click to expand...

The above needs to be framed and posted.
The private run corporations (including the FDA , IRS, USDA and others) have been running the political scene for years.
And the people are suffering because of it.
I see third world in the future for this nation if something is not changed by us.
I am also writing my reps about this matter.
 
Invalid Link Removed

Someone at work sent this to me because they know how I love my supps. I came back at them with a huge long arguement about the situation, and sent them the initial link posted by the OP, and they didn't even respond....it's interesting to see how much the mass media hype machine really effects people and what they believe in.

The funniest part of that article was when they stated that vitamin deficiency is rare in America. Laughable.
 
Gutterpump said:
Invalid Link Removed

Someone at work sent this to me because they know how I love my supps. I came back at them with a huge long arguement about the situation, and sent them the initial link posted by the OP, and they didn't even respond....it's interesting to see how much the mass media hype machine really effects people and what they believe in.

The funniest part of that article was when they stated that vitamin deficiency is rare in America. Laughable.
Click to expand...
What a load of crap, that article is... Here's some powerful reasoning for you...
This week, researchers reported the disappointing results from a large clinical trial of almost 15,000 male doctors taking vitamins E and C for a decade. The study showed no meaningful effect on cancer rates.

Another recent study found no benefit of vitamins E and C for heart disease.
Click to expand...
This means they are useless? Dangerous? Because they don't seem to cure heart disease? Just this random fact thrown out in the first few paragraphs of an article is supposed to convince me of what, really? Yup, no reason to supplement with E or C. H*ll, it doesn't even cure heart disease or cancer...
 
Gutterpump said:
Invalid Link Removed

Someone at work sent this to me because they know how I love my supps. I came back at them with a huge long arguement about the situation, and sent them the initial link posted by the OP, and they didn't even respond....it's interesting to see how much the mass media hype machine really effects people and what they believe in.

The funniest part of that article was when they stated that vitamin deficiency is rare in America. Laughable.
Click to expand...

Well considering the low-bioavailability mess big pharma puts out, its true that those vitamins are a waste of money.
 
haha well as far as supplements that have "studies"

muscletech is pretty much screwed as their wording is alwasy like

"in some study"

"an ingredient in our product was studied"
 
RobInKuwait said:
I'm guessing they'd go after research chems before vitamin C...
Click to expand...
true,.. and in addition to the public using them that means any lab the uses them for research( im sure there are at least "some",...lol) are screwed too. Thats why i dont quite think this will pass,...... there will be alot of ppl and businesses affected by this,.... and our economy doesnt need anything else to bring it down anymore at the moment.
 
That seems counter-intuitive? You'd think ones that haven't been studied shouldn't be shipped? Then again, an uneducated populous can't rebel. Lame.
 
I don't find this surprising in the least. Our prescription drug costs are ridiculous. I was written a prescription of a proton pump inhibitor and it still costed like $60 a month w/ insurance -so I never even refilled it. I can live with heartburn once in a while and keep my $720 a year.

I spend more on fish oil, vitamins, etc than I ever have on pharmaceuticals - so I can see from my perspective how the pharmaceuticals would try to tap into that.

I am not a big fan of government regulations, but a little regulation would go a long way for the pharma industry to control prices.
 
I would leave this ****ing country. No ****ing doubt in my mind. Jesus this is ****ing insane!
 
So does anyone actually have a copy of the proposed legislation? This may just be a case of someone misunderstanding the language in the bill, no offense intended. I believe as the 1994 law came first it would also have precedent in the case that someone attempted to use this against supplements, but I could be wrong on that.
 
Someone needs to keep their bitch ass in check.

Bunch of spineless corrupt greedy ass mutherfuckers....

I guess crime does pay.....they have proven that.....

But hey, don't steal, the government doesn't like competition.....
 
haven't heard anything yet....
 
Whatever happened to civil liberties and the 'land of the free'? Isn't this the focal point of the United States? The US government is so hypocritical when money is involved.
 
FDA Scientists Revolt Against Corrupt Food and Drug Administration Officials

Maybe we can still get some help from inside the FDA

http://www.naturalnews.com/024910.html

The letter from the FDA's own scientists goes on to say, "It is evident that managers at CDRH have deviated from FDA's mission to identify and address underlying problems with medical devices before they cause irreparable harm, and this deviation has placed the American people at risk."

Congressman John, Dingell, chair of the committee which received the letter, went on to charge that these FDA bureaucrats "approved or cleared medical device applications in gross violation of laws and regulations..."
 
Gutterpump said:
Whatever happened to civil liberties and the 'land of the free'? Isn't this the focal point of the United States? The US government is so hypocritical when money is involved.
Click to expand...

All government is corrupt. EVERY goddamn gov, is corrupt.

Money is the root of all evil.
 
Ubiyca said:
All government is corrupt. EVERY goddamn gov, is corrupt.

Money is the root of all evil.
Click to expand...
bump

although I would have said addiction to or greed for.
at least other governments tell you what freedoms you lack.
had to sign a similar petition for some of the folks i buy online herbs for my family from.
the fda was trying to shut them down because of the health claims.
so they had to change their site even though , the stuff worked.
 
You must log in or register to reply here.
Back
Top