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Piracetam and FDA


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#1 Mike M

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Posted 16 December 2009 - 11:58 PM


They're sticking their noses around. I know of some importers that got visits this week. This is the start of their regulation in this area. They've been very active in certain parts of the nutritional industry. I knew it would only be a matter of time before they came looking this way.

#2 DairyProducts

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Posted 17 December 2009 - 12:20 AM

They're sticking their noses around. I know of some importers that got visits this week. This is the start of their regulation in this area. They've been very active in certain parts of the nutritional industry. I knew it would only be a matter of time before they came looking this way.


Which parts of the nutritional industry have they been very active in besides nootropics? Are they interested just in piracetam or other nootropics as well?

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#3 Mike M

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Posted 17 December 2009 - 12:21 AM

I was told piracetam and pramiracetam were the two things they wanted to know about. Who they sent to, etc. They've been very active with pro hormones. Do a search for DEA and affordable supplements. They raided bb.com the month before that.

#4 DairyProducts

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Posted 17 December 2009 - 01:01 AM

I was told piracetam and pramiracetam were the two things they wanted to know about. Who they sent to, etc. They've been very active with pro hormones. Do a search for DEA and affordable supplements. They raided bb.com the month before that.


I assume you mean this story - http://www.kwch.com/....asp?S=11531266. Odd that they didn't want to know about the other racetams. When you say, "Who they sent to" do you mean what retailers they sent to or individuals who bought it online? It would be too bad if the federales came to a bunch of ImmInsters houses on Christmas.

#5 Mike M

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Posted 17 December 2009 - 01:46 AM

Yes, that story is independent of this. They wanted to know where this supplier sent their piracetam. They supply about 99% of the US. Most of the people selling piracetam buy through me at this point. Cut the head off.......

#6 acantelopepope

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Posted 17 December 2009 - 03:30 AM

Yes, that story is independent of this. They wanted to know where this supplier sent their piracetam. They supply about 99% of the US. Most of the people selling piracetam buy through me at this point. Cut the head off.......



So you'd better start selling everything at $5/kg then, eh Mike? Better to cut your losses and squeeze some profit out of the stuff than let the feds get it... am I right?

#7 Mike M

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Posted 17 December 2009 - 03:38 AM

That would be a great idea, considering I lose money on shipping, lose money on product as well! I'll be able to write down whatever loss comes from them, if it comes to that. I'm already one of the cheapest around. I'm not overly stocked at this point, so by the time the day comes, there won't be that much anyway. I simply won't reorder. Take the info however you want, just reporting what I know.

#8 exenium

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Posted 17 December 2009 - 03:52 AM

Would it be possible that FDA just does nothing about it? Or it's 100% sure they'll ban racetams..?

#9 Mike M

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Posted 17 December 2009 - 04:06 AM

Of course, there is no doubt they could do nothing. However, when the FDA comes to an importer and asks specifically about 2 items:

Where it came from?
How much did you bring in?
Where do you send it to?

Then grab copies of any/all information related to that, I tend to think it is for more than a scavenger hunt.

#10 JLL

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Posted 17 December 2009 - 10:06 AM

For everyone who thinks regulation only happens in Europe, think again.

#11 medicineman

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Posted 17 December 2009 - 10:29 AM

For everyone who thinks regulation only happens in Europe, think again.


Yea, I realized how much for granted I took the Kuwaiti pharmacy when I moved here from Europe.

#12 JLL

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Posted 17 December 2009 - 11:52 AM

For everyone who thinks regulation only happens in Europe, think again.


Yea, I realized how much for granted I took the Kuwaiti pharmacy when I moved here from Europe.


Sorry, I'm running a little slow today: do you mean that things are better in Kuwait or that they're worse?

#13 425runner

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Posted 17 December 2009 - 03:11 PM

I'm sure this is part of the FDA conspiracy! Thanks for the heads up, Mike. Better stock up before it's too late......

"Bill S.510, the so-called Dietary Supplement Safety Act, would greatly expand the Federal Food and Drug Administration’s (FDA) authority over dietary supplements and undermine the hard-fought victory the Nutritional Supplement Industry achieved with DSHEA, which sought to restrain the FDA’s historical abuse of discretionary authority over dietary supplements. And, despite its title, this Bill will provide the consumer with no more protection than current law provides.

If passed into law, this bill will, however, subject nearly all vitamins, minerals, herbal products and other supplements to a level of scrutiny that is unwarranted, unnecessary and costly. By questioning the safety of any dietary supplement that receives even one complaint, hundreds of products that have been safely and beneficially used could be removed from the marketplace. This Bill threatens not only manufacturers, suppliers and health food stores, but consumers’ rights as well".

Here's the link http://www.govtrack....d?bill=s111-510

Edited by 425runner, 17 December 2009 - 03:22 PM.


#14 Thorsten3

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Posted 17 December 2009 - 08:40 PM

I'm sure this is part of the FDA conspiracy! Thanks for the heads up, Mike. Better stock up before it's too late......

"Bill S.510, the so-called Dietary Supplement Safety Act, would greatly expand the Federal Food and Drug Administration's (FDA) authority over dietary supplements and undermine the hard-fought victory the Nutritional Supplement Industry achieved with DSHEA, which sought to restrain the FDA's historical abuse of discretionary authority over dietary supplements. And, despite its title, this Bill will provide the consumer with no more protection than current law provides.

If passed into law, this bill will, however, subject nearly all vitamins, minerals, herbal products and other supplements to a level of scrutiny that is unwarranted, unnecessary and costly. By questioning the safety of any dietary supplement that receives even one complaint, hundreds of products that have been safely and beneficially used could be removed from the marketplace. This Bill threatens not only manufacturers, suppliers and health food stores, but consumers' rights as well".

Here's the link http://www.govtrack....d?bill=s111-510


beginning of the end Mike? Does this mean nowhere to buy piracetam in future??

#15 kismet

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Posted 17 December 2009 - 09:38 PM

Would it be possible that FDA just does nothing about it? Or it's 100% sure they'll ban racetams..?

Well, last year there were already threads and rumous about a possible ban (or was it the year before that one?!) IAC I see several "the world is ending" threads every year. Either this is the same thing or this is a great hoax to increase racetam sales. I'm really not sure at this point...

For everyone who thinks regulation only happens in Europe, think again.

For everyone who thinks lack of regulation is a good think, look at the US. Just ask actual health experts and doctors or Aubrey's coauthor (if I understood correctly) what their opinion is about the wild-wild-west of supplements...

OTOH, Aubrey, does raise some interesting points about *over-regulation* (mostly in the pharmaBiz, though), and I think it's indeed ridiculous to condemn either over- or under-regulation w/o looking at it on a case by case basis.
OTOOH, our supplement market sucks despite rather heavy regulation (or to put it the other way round: we're as "good" as you are). Maybe it's not a regulation thing; the supplement market place may inherently attract lots of scum wanting to make a quick buck at the cost of others. (only if the market place is going to suck anyway I prefer the wild-wild-west w/ easy access to supps..)

I just wanted to say that I'm somewhat disappointed by the useless (political) cheap shot you took (esp. using the word "regulation" in your post even though this post is about "supplement regulation") -- you did not even use a smiley. It's not as easy as your post implies, it never is. And living in Europe I find the statement pretty inflammatory, 'cause you know, our system does not suck as much as you think.

Edited by kismet, 17 December 2009 - 10:19 PM.


#16 rwac

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Posted 17 December 2009 - 10:36 PM

For everyone who thinks lack of regulation is a good think, look at the US. Just ask actual health experts and doctors or Aubrey's coauthor (if I understood correctly) what their opinion is about the wild-wild-west of supplements...

OTOH, Aubrey, does raise some interesting points about *over-regulation* (mostly in the pharmaBiz, though), and I think it's indeed ridiculous to condemn either over- or under-regulation w/o looking at it on a case by case basis.
OTOOH, our supplement market sucks despite rather heavy regulation (or to put it the other way round: we're as "good" as you are). Maybe it's not a regulation thing; the supplement market place may inherently attract lots of scum wanting to make a quick buck at the cost of others. (only if the market place is going to suck anyway I prefer the wild-wild-west w/ easy access to supps..)


You seem to be agreeing with his point, somewhat.

What sort of regulation do you think makes the supplement market not suck ?

Edited by rwac, 17 December 2009 - 10:37 PM.


#17 pamojja

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Posted 17 December 2009 - 11:34 PM

And living in Europe I find the statement pretty inflammatory, 'cause you know, our system does not suck as much as you think.

I strongly disagree..

Was diagnosed with a PAD one year ago and the only 'treatment' offered: statins, on account of high cholesterol, and aspirin for its blood thinning effect.

After some investigation I found that the prescribed Simvastatin, though reducing Cholesterol for about 30%, only decreased total mortality by a mere 3% within 5 year trials.

On asking my internist how I could lower cholesterol also with diet I only got the silly answer: that I could eat as much veggies I wanted to, but this wouldn't change anything about my cholesterol at all :-(

After much more education I learned that cholesterol is but one risk factor of many for arteriosclerosis, or modified by some others:

25(OH)D vitamin D3 levels
omega-3 level
thyroid TSH, T3, T4
fibrinogen
c-reactive protein
homocystein
glucose
hormons
lipoprotein(a)
...

Due do the really bad side-effects and mere symbolical reduction of total mortality with statins, I suggested to my internist to prescribe me Niacin instead - which has been savely used in the 'wild-wild-west' of supplements for a half century and the reduction of high cholesterol.

After searching in his data-base he indeed could prescribe Niaspan to me, with the cleavage that I would have to pay it myself: 1,- € per 1 gram!

No question, I went for LEF's Niacin, which is available by its European distributor for a mere 0,04 € per 1 gram!!!

An other example D3, not recognized by my GP as a risk factor and having to pay for its test myself. However, I haven't been able to find any reasonable priced OTC product with more than 400 IU, in dry base only - and 10 times this dose would be for 0,24 €.
LEF's alternative for 4000 IU - 0,03 €

I don't even know the price difference of such supplements as menaquinone-7 or tocotrienols - as I simply haven't found them in local pharmacies yet (haven't been to Vienna's since, so maybe you, kismet, know it better? - doubt it though, else were you wrote you're getting yours from the States too..)

All in all, even while getting most supplement shipped from the states, this less toxic treatment with supplements still costs me about 200,- € per month. With the result that my cholesterol got lower about as much as the Statin would have promised; and after a half year my walking distance - strongly shortened by claudatio intermittens - has doubled!

If you would have been affected with such a serious disease which could be easily and much more safely treated with supplements - as calcification of arteries now appears to me - you would agree that our 'regulations' rather are prohibitions and do suck..

Even if all supplements I successfully use in my case, would be available or allowed here, its total price would still be prohibiting for me.

And in two weeks time comes 'Codex Alimentarius', which will prohibit the OTC sale of Niacin by January, 1st within the EU above mere 10mg doses.

I don't know other than call that pharma-fascism, because by then I'll only have the option to get it from my physician with a redicolous price dictated by Merck.

Welcome to our brave new world.

kind regards...

#18 Mike M

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Posted 18 December 2009 - 06:27 AM

Was told by supplier that FDA came back and said piracetam/pram is now considered a drug

#19 rwac

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Posted 18 December 2009 - 07:01 AM

Was told by supplier that FDA came back and said piracetam/pram is now considered a drug


In your opinion, did the priorities of the FDA change recently, or has this been coming a long time ?

#20 JLL

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Posted 18 December 2009 - 10:16 AM

I just wanted to say that I'm somewhat disappointed by the useless (political) cheap shot you took (esp. using the word "regulation" in your post even though this post is about "supplement regulation") -- you did not even use a smiley. It's not as easy as your post implies, it never is. And living in Europe I find the statement pretty inflammatory, 'cause you know, our system does not suck as much as you think.


Regulation is regulation is regulation.

There's nothing funny about it, so why use smileys? And I do think our system sucks hard. You're welcome to disagree of course.

If there is such a problem of "wild west supplement markets", I don't see how the government could ever solve it. The way these things are solved most efficiently are through the market itself; you hear bad news of a supplement company, supplement company loses customers, goes broke. That's how most things work, despite what the government says.

It's OUR OWN responsibility to find out which supplements are good or bad to take, not someone else's. If I decide to take something which is harmful, that is my choice and my problem. You seem to have the idea that people are too ignorant to be trusted with their own health -- but what is the alternative? If they are ignorant and make foolish choices, so be it. It's their life, not yours. You have your own life; make the best of it and let others make their foolish choices.

Why? Because the alternative is much, much worse: instead of you being in control of your own choices, the bureaucrat will have you on a leash. And do you really think the people who make decisions, say, regarding which supplements we can buy and in what quantities, have your best interests at heart? Of course they don't. They have their best interests at heart.

I really feel that everyone who argues that too much regulation (from government) is bad but some degree of it is good are missing the whole point. It's when you accept the idea that regulation -- that is, the state telling you and me what to do and what not to do -- that you have lost the battle. The idea of something being "minimally regulated" is ridiculous in the larger context, because nothing ever stays minimally regulated. State regulation (and states in general) are like a tumor that will keep on growing. You would shave off a part of the tumor, I would cut it off.

That said, I truly hope that I'm wrong in all this, and that Codex Alimentarius will prove to be a false alarm, and that piracetam (and pyridoxamine) is an exception rather than the rule.

But if history tells us anything, it's that government power always tends to expand.

#21 spacetime

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Posted 18 December 2009 - 04:37 PM

That would be a great idea, considering I lose money on shipping, lose money on product as well! I'll be able to write down whatever loss comes from them, if it comes to that. I'm already one of the cheapest around. I'm not overly stocked at this point, so by the time the day comes, there won't be that much anyway. I simply won't reorder. Take the info however you want, just reporting what I know.



But you can make it up on volume or at least go broke trying :)

So they plan on classifying it as a drug so big pharma can sell it? I'll try to contact a few suppliers and see if they have been visited by the FDA. I would think there would be more reports than just this single instance. You have vested interest so this may be nothing more than a ploy to try and offload your current stock.

#22 kismet

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Posted 18 December 2009 - 06:26 PM

I am sick of political bullshiting. There's no way to talk to people if ideology becomes involved (and I don't think there are any issues involved we haven't discussed ad nauseam); so let's get back on topic, is the piracetam issue real this time around?

Edited by kismet, 18 December 2009 - 06:29 PM.


#23 OneScrewLoose

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Posted 19 December 2009 - 12:07 AM

Are there any set dates for taking it off the market?

#24 Mike M

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Posted 19 December 2009 - 02:07 AM

That would be a great idea, considering I lose money on shipping, lose money on product as well! I'll be able to write down whatever loss comes from them, if it comes to that. I'm already one of the cheapest around. I'm not overly stocked at this point, so by the time the day comes, there won't be that much anyway. I simply won't reorder. Take the info however you want, just reporting what I know.



But you can make it up on volume or at least go broke trying :)

So they plan on classifying it as a drug so big pharma can sell it? I'll try to contact a few suppliers and see if they have been visited by the FDA. I would think there would be more reports than just this single instance. You have vested interest so this may be nothing more than a ploy to try and offload your current stock.



Search through 1000's of posts that I've made over multiple message boards under the name 1fast400. I have never claimed something to happen like this. I have very little to gain if I lie about this. If I lie and nothing happens, I'll look like an idiot. Why would I risk that on an 18.00 product?

http://clinicaltrial...how/NCT00567060

THAT is why this is being listed as a drug. Study was completed the and company is pushing to get all the nutritional suppliers from carrying it. Take my words for whatever they are, but you won't find an instance of me making random crap up and posting it.

#25 Viscid

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Posted 19 December 2009 - 02:18 AM

That would be a great idea, considering I lose money on shipping, lose money on product as well! I'll be able to write down whatever loss comes from them, if it comes to that. I'm already one of the cheapest around. I'm not overly stocked at this point, so by the time the day comes, there won't be that much anyway. I simply won't reorder. Take the info however you want, just reporting what I know.



But you can make it up on volume or at least go broke trying :)

So they plan on classifying it as a drug so big pharma can sell it? I'll try to contact a few suppliers and see if they have been visited by the FDA. I would think there would be more reports than just this single instance. You have vested interest so this may be nothing more than a ploy to try and offload your current stock.



Search through 1000's of posts that I've made over multiple message boards under the name 1fast400. I have never claimed something to happen like this. I have very little to gain if I lie about this. If I lie and nothing happens, I'll look like an idiot. Why would I risk that on an 18.00 product?

http://clinicaltrial...how/NCT00567060

THAT is why this is being listed as a drug. Study was completed the and company is pushing to get all the nutritional suppliers from carrying it. Take my words for whatever they are, but you won't find an instance of me making random crap up and posting it.


Alright you got me, I'm stocking up.

#26 meursault

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Posted 20 December 2009 - 06:56 PM

But piracetam was first synthesized and sold decades ago...wouldn't its patent have expired by now?

Edited by czukles, 20 December 2009 - 06:56 PM.


#27 Invariant

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Posted 20 December 2009 - 07:21 PM

But piracetam was first synthesized and sold decades ago...wouldn't its patent have expired by now?


Sure, but even pharmaceuticals that are off patent are still pharmaceuticals. You'll need a prescription to get it.

#28 Mike M

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Posted 20 December 2009 - 10:09 PM

Here are my suppliers exact words:

Investigator told me today that FDA consider Piracetam as a unapproved drug, not a dietary supplement. They are doing investigation on that and will give me the answer next week.

#29 donkey

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Posted 21 December 2009 - 05:15 PM

Search through 1000's of posts that I've made over multiple message boards under the name 1fast400. I have never claimed something to happen like this. I have very little to gain if I lie about this. If I lie and nothing happens, I'll look like an idiot. Why would I risk that on an 18.00 product?

http://clinicaltrial...how/NCT00567060

THAT is why this is being listed as a drug. Study was completed the and company is pushing to get all the nutritional suppliers from carrying it. Take my words for whatever they are, but you won't find an instance of me making random crap up and posting it.


Wowza, you know, I don't know anything about anything, but that study was dosing 9600 mgs? That's quite a handful of capsules, professor!

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#30 esaka

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Posted 21 December 2009 - 10:29 PM

So would it be illegal if oxiracetam and choline was ordered to Canada yesterday???


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