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FDA says no more piracetam


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#91 Grapevine

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Posted 01 September 2010 - 05:34 PM

Right grape, you know more than what the head of the FDA in Atlanta is telling me. Think what you wish. You are focusing on the structure/function claim and not the bigger issue at hand. Avoiding the obvious statement by them that it is a drug in their eyes. This is just the start of their larger probe into piracetam. If that weren't true, why wasn't something said by Them about the other race tams? They went through my entire site looking at stuff but said nothing of oxi/ani? Because nobody is making it a script. I dotn care what you say, i'll take the word of David price of the FDA over a random internet poster who tells me all is well.


I'm not saying all is well, I'm saying you're making way too big a deal out of this for what is CURRENTLY happening. YOU are going to have to stop selling, and if people want to buy up your remaining stock, that's fine. Other vendors will continue to sell it, maybe it'll eventually become regulated, maybe it won't. I know I will be telling everyone I know that orders piracetam to get it from somewhere other than you, because there's no excuse for the hysteria you are creating. You need to be more careful about the claims you make-- you're throwing around terminology that you don't understand (I don't make any claim to be an expert on FDA legislation but I know the difference between something being banned completely and an isolated incident of the FDA telling a major vendor to stop selling an unregulated substance). It would have been completely acceptable if you had said "Hey guys, I got a letter from the FDA to stop selling this, I'm the biggest vendor so if you want to get my stock while it lasts, now's the time!" but you went to every single forum that might have had an interest in this saying "OH NO PIRACETAM IS ILLEGAL NOW IN 15 DAYS THEY ARE BANNING IT!"

Can you see why I might take issue with that?

Edited by Grapevine, 01 September 2010 - 05:36 PM.


#92 Mike M

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Posted 01 September 2010 - 05:55 PM

Six ways from Sunday this stinks of shady business practices from smartpowders / Mike M .

But I am even more disappointed in the ImmInst moderators for letting this and other disreputable practices continue. (yes FunkOdessey, Chrono I am speaking to you)

Calling out individual members for being suspect of very questionable vendor claims that have not been substantiated by one shred of verifiable evidence? Claims that have been marketed to nearly ever nutrition/supplement/body building forum known to man?

Shame on you. It should have been your job to be suspect of these type of things and caution prudence before stocking up on 10 years of piracetam!

I appreciate your retraction, well somewhat of a retraction... "I'm still confident he's telling the truth but maybe this is not as widepsread as I thought. "

What gives you confidence? That he has advertised his products and current 'promotions' here for a long period of time? That his prices are cheap?

That very suspect member profiles like '425Runner' and others use nearly every post to promote smartpowders, primaforce, or other affiliated vendor's product on here and many other forums???

Take a look! I see one very 'touching' post started by '425Runner' looking to overcome severe stage fright. Then two pages of concerned forum members trying to give ideas and solutions, asking for more information. Not one thank you, or followup by 425Runner to the thread he/she started! Yet 425Runner loves promoting Mike's companies every chance possible. Do a google search. Its not just here and not just nootropics.

Maybe this FDA ban its not 'as' widespread as you thought??? What does that mean exactly? Its a little widespread? Seriously, what shred of proof is there that distinguishes this 'ban rumor' from any other over the last five years? A vendor gets called out for labeling issues...supposedly?

See that's the problem. The continuous presence of vendors like smartpowders on this forum allows them to game the system. Most people roll in and out of here like the wind so they are in a disadvantage when faced with a vendor whose only goal is to promote products/prices and a generate a high ratio of good comments in order to bury any bad ones. Mike M is not a nutrionist, a chemist, a biologist, or even much of a body builder I assume. He is a professional internet marketeer and a very good one at that. He admits his primary job is to troll the forums. He has done this for a long, long time and he knows how forums work. He is well documented by myself and others...

http://www.imminst.o...wders-opinions/

So just pretend for a second! You have no moral code but making money. Your job is to sell snakeoil on snakeoil forums. You are in it for the longer term, its a career and you are smarter than the average bear.. You can't exactly sell arsenic laced snakeoil (can't have customers dropping like Melamine fed dogs) but what's a little rat scat, who's going to notice? Now go be devious in your pursuits! How friggin easy would it be to sell your product here or on any other similar forum??? Low prices would help, but with persistence, big talk, unsubstantiated bluster, a rolling set of methodically managed ghost/fake accounts and multiple company names/LLC's you could sell some serious snakeoil on a whole bunch of snakeoil forums!

I would never suggest that Mike M is using a similar business model, or that he has followed this model repeatedly in his career in the internet 'forum marketing' business. Instead I'd expect every member should expect the worst of vendors in an unregulated industry and question/verify everything. Especially if you are putting their products in your body. I guess what I would not expect is that moderators (especially here), would be asking members to set aside their thinking caps and assume that vendors claims no longer need to be substantiated.

Now I know I am picking on FunkOdessey. I am more than certain that he is a very nice guy and would never do a thing to hurt a flea. But I raise the issue to ask all moderators how long can this forum persist while allowing vendors to openly game the system? Why are vendors like Mike M continually allowed to break forum rules with no repercussions? Why are vendors even allowed to participate if all they they have to say is another announcement of their latest sale prices? If they can't talk about how to use their own product or about their products intended/expected effects then why are they here??? Vendors are not needed here to defend COAs, heavy metal analysis, etc. Imminst should have standards, trusted labs, etc. The vendor either complies or it does not. Its an A,B, or C level vendor according to set standards. End of story. Member credibility will speak for itself with respect to posting.

-fortfun

PS... And what a load of bull that Mike M doesn't stand to gain from this rumor. He claims 90% of the market right? After all his self generated publicity how many new people are now wondering what is so cool about Piracetam that its 'ban' is causing an uproar? What's going to stick...a rumor of a ban or some later quiet mea culpa that he over reacted to a GMP audit? His reputation taking a hit for a false rumor? Seriously? Give me a break. 6 months from now someone like me might bring it up again. He'd then accuse me of having some grudge. And then 10 noobs or ghost accounts would post comments praising how quickly he ships and how they were so impressed that he e-mailed them personally. I know the COA is 1.5 years old but who cares, Mike M can be trusted. He posts here all the time. Rinse/Repeat...

Heck even if he is right, maybe the guy controlling 90% of the market should be the one who is blamed for not doing a more methodical job of insuring product safety/integrity and for making sure his distributors don't make false claims? Maybe it will be better finding a piracetam bottle next to the aspirin at walgreens...I know I would be more comfortable using it.

I do know one thing...The FDA probably won't take too kindly to any two bit supplement vendor that misrepresented FDA actions in order to drive sales....



You really shouldn't miss your daily dose of meds. Don't look under your bed, the boogy man is there too. I'm just now leaving roswell, az as I'm actually a superior alien life form. Have mods do IP checks on any of those people. I post as me, that's it. Someone else that supports my business, I have no control of them. Just as many people say good things as bad things (like you). Do you have a voodoo doll of me? I can send you one if you want.

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#93 Mike M

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Posted 01 September 2010 - 05:57 PM

According to Price, everyone that is selling piracetam will be issued this same letter within the next 30-45 days. Sorry, I'm taking his word over yours. If the claims had anything to do with this, the same claims are made on the other racetams and they never mentioned them. It is a focused effort to eliminate the supply of piracetam so it can be made into script around the start of the year.

#94 Warrior

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Posted 01 September 2010 - 05:58 PM

Still awaiting letter. If it's posted I'll probably grab 3kg Friday.

#95 gcurrie

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Posted 01 September 2010 - 06:09 PM

Still awaiting letter. If it's posted I'll probably grab 3kg Friday.

http://www.imminst.org/forum/topic/43512-fda-says-no-more-piracetam/page__view__findpost__p__427800

Grab away.

#96 mTORC1

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Posted 01 September 2010 - 06:10 PM

Any USA citizens, can anyone call the FDA to find what exactly is going on?
A pissing contest won't get us any further.

Edited by mTORC1, 01 September 2010 - 06:10 PM.


#97 Jurence

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Posted 01 September 2010 - 06:17 PM

Go to the FDA website and do a search in public letters ... there is nothing to support this claim guys

#98 Grapevine

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Posted 01 September 2010 - 06:21 PM

Any USA citizens, can anyone call the FDA to find what exactly is going on?
A pissing contest won't get us any further.


Going to attempt to call them now-- I'm going to try to get in contact with this David Price fellow.


EDIT: It's Derek Price, not David. Left him a message.

Edited by Grapevine, 01 September 2010 - 06:59 PM.


#99 Mike M

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Posted 01 September 2010 - 06:41 PM

404-253-2277

Knock yourself out. Don't be surprised if you stir up a lot more crap than you expected. You're getting ready to call a high government official who deals with big issues all day. I'm sure he'll be SUPER excited to talk with you.

To the guy that pointed out the letter isn't posted on the FDA site, for the 50934th time, look at the date on my letter. It's from the 30th, the site isn't updated to that point yet. I have no control over when they do updates to their webpages.

#100 Grapevine

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Posted 01 September 2010 - 06:46 PM

404-253-2277

Knock yourself out. Don't be surprised if you stir up a lot more crap than you expected. You're getting ready to call a high government official who deals with big issues all day. I'm sure he'll be SUPER excited to talk with you.

To the guy that pointed out the letter isn't posted on the FDA site, for the 50934th time, look at the date on my letter. It's from the 30th, the site isn't updated to that point yet. I have no control over when they do updates to their webpages.



Hey, I'm just looking for some clarification on this that isn't coming from you. I'm perfectly willing to admit it if I'm wrong, but the letter you provided along with your hysteria-inducing posts just aren't cutting it for me.

#101 Mike M

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Posted 01 September 2010 - 06:56 PM

It's not a hysteria inducing post. I have 15 days to respond to them. In that response, they want to me write a full report on how I removed the items from my site that they asked about. They only singled out piracetam as an item that was a drug and had to be removed. They went on further to explain structure function claims within the label, which is a mute point when they consider it a drug and a NON DSHEA compliant item. When something isn't DSHEA compliant, it is ILLEGAL to sell as a supplement per the FDA. I will attempt to argue that it is a nutritional supplement and dshea complaint. That will be an unsuccessful attempt given the rules for being complaint. Unless someone can bring evidence of domestic purchasing prior to Oct 15th 1994, there isn't a lot that can be done. The FDA's stance is that piracetam is NOT legal to sell within the USA. This is why it is on a marked listed for importation and not getting into the country from most brokers. The only reason I was hit first is because of the quantity in which I import it. From here, they are going after the smaller guys with letters that will be a carbon copy of what you see posted. Their goal is to eliminate the distribution chain, it started at the brokers, now the suppliers and finally the retailers. The reason bb.com quit selling it back in November was due to the raid on their facility. Same thing for bulknutrition.com. That's why you stopped seeing these items sold. The DEA/FDA has been on this for over a year.

I have ZERo motivation to lie about this. Anyone with common sense business knowledge would know why. If I were getting out of the business, it would be different. However, having a limited supply item and cutting the margin by 20% is NOT a good business model. Most would raise it 20% or not even discount it. Do you really think with a ban coming in I'm going to sell less at full price vs 20% off? Even if I did, due to the margin, I could have sold it at full cost, sold half as much and made the same money as selling ALL of it at 20% off. What sense does that make?

Why don't you wait 48 hours for the site (fda) to update. You can read the letter for yourself and draw your own conclusions. When the FDA comes in and the officer that served me papers points to piracetam and tells me it is illegal to sell, then supplies me a letter saying the same, I'm more apt to believe them than you. If the FDA shows up at my door and starts giving me fines and penalties, telling them grapevine said it was ok is not a legit excuse.

ANYONE THAT FEEL THEY'VE BEEN TAKEN ADVANTAGE OF DUE TO THIS SITUATION CAN RECEIVE A FULL REFUND FOR ANY UNOPENED PRODUCT. I have ZERO issue with that. I've been honest about every aspect. If I wanted to call it a fire drill, I would have done it back in feb when they first visited me.

#102 synapse

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Posted 01 September 2010 - 06:57 PM

Does anyone know what company is trying to take piracetam to the prescription market? Are there any links to the clinical trials?

Even if a company is getting FDA approval to sell piracetam as a "drug", does not necessarily mean that piracetam would be banned from the OTC market. A similar situation occurred with galantamine. Johnson and Johnson got galantamine approved by the FDA to treat alzheimer's, but due to it's grandfathered status, galantamine remains on the OTC market.

Edited by synapse, 01 September 2010 - 07:00 PM.


#103 Grapevine

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Posted 01 September 2010 - 07:04 PM

Why don't you wait 48 hours for the site (fda) to update. You can read the letter for yourself and draw your own conclusions. When the FDA comes in and the officer that served me papers points to piracetam and tells me it is illegal to sell, then supplies me a letter saying the same, I'm more apt to believe them than you. If the FDA shows up at my door and starts giving me fines and penalties, telling them grapevine said it was ok is not a legit excuse.


This is like banging my head against a wall. I didn't say it wasn't illegal to sell (in the manner you are doing), I'm saying there's not a "ban" -- building off of what synapse said, it wouldn't be completely banned for sale if some company wanted to investigate it as a prescription drug. Also, I imagine you'd be cited for breaking some completely different rule if this were the case. I don't know, maybe not. I'm not going to bother looking it up at the moment because I don't plan on spending my whole day digging through FDA legislature. FFS, I'm not saying you're completely lying about everything-- the letter is obviously real. You just seem to be having a hard time following what I am saying.

#104 synapse

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Posted 01 September 2010 - 07:13 PM

Seems reasonable to suppose that someone sold piracetam prior to '94. Can anyone find anything? Otherwise, the GABA connection may be the best defense.

#105 Grapevine

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Posted 01 September 2010 - 07:31 PM

Seems reasonable to suppose that someone sold piracetam prior to '94. Can anyone find anything? Otherwise, the GABA connection may be the best defense.


I don't know about sales, but there are some pretty ancient studies out there, so that does seem quite reasonable:

1991: http://www.ncbi.nlm..../pubmed/1794001
1981: http://www.sciencedi...8b&searchtype=a

#106 synapse

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Posted 01 September 2010 - 08:04 PM

I would make the additional argument that the biological effects of piracetam are consistent with an amino acid. Toxicity is near zero and piracetam is involved in the synthesis of phospholipid cell membranes via protein supplementation.

Here is an interesting study discussing some of this: http://onlinelibrary...5.tb00268.x/pdf

Edited by synapse, 01 September 2010 - 08:09 PM.


#107 chrono

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Posted 01 September 2010 - 08:43 PM

I unapproved the posts in this thread wherein vendors advertised sales of their products (except Mike's posts about the FDA issues, where it's obviously implied). While I think this thread is an exception in some ways, if nothing else it generates a lot of noise from people with too much spare time.

For the moment, Smart Powders and Cerebral Health both stock bulk piracetam; some friends of mine also just bought some from NutraPlanet, whom I know nothing about. Relentless Improvement also sells it in pre-capsuled form. And pharmaceutical Nootropil (and various rebrandings) is available through several internet pharmacy sites.

Mike, whatever the 'big picture' is at the FDA, the letter seems to say that piracetam doesn't qualify as a dietary supplement under a certain law. It then goes on to say that it's considered a 'new drug' because of your advertising language, and hence can't be sold commercially. Might removing such language and dosing recommendations/etc be a solution for you?

#108 FortFun

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Posted 01 September 2010 - 08:43 PM

In plain english it says:

1.
A) Your firm is marketing Piracetam as a Dietary supplement
B) Piracetam you imported in 2004 was ruled to not be a dietary supplement
C) In order for your product to be a dietary supplement it has to contain one or more dietary ingredients
D) Since your product only contains Piracetam it can't be considered a Dietary supplement as you claim.
E) Therefore YOU violated the act by YOUR marketing claims

2.
A) The claims YOU made on your website and labeling charactherize your product as a drug (YOUR claims fit the definition of a drug)
B) The drug (as you claim it is by definition) is also qualified as a 'New' Drug because it is not generally recognized as safe when used according to YOUR instructions
C) YOU then sold this 'New' Drug without FDA approval
D) Therefore YOU violated the act again because of YOUR claims

But I'm pretty certain you know exactly was this says. You have been in this business for how long?

As someone else said, their maybe more to this down the road. But none of this matches your house on fire story. Your deliberate misreading of this notice makes everything you you say suspect without further proof..

#109 chrono

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Posted 01 September 2010 - 08:49 PM

Does anyone know what company is trying to take piracetam to the prescription market? Are there any links to the clinical trials?

There's a link in this post. IIRC, it was a UCB trial.

#110 Warrior

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Posted 01 September 2010 - 08:50 PM

I see the letter nevermind. By the way, it appears if you removed the suggested benefit label it'd be fine.

#111 synapse

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Posted 01 September 2010 - 09:15 PM

Here is a link to all the clinical trials on piracetam: http://clinicaltrial...?term=piracetam

I do know the FDA is EXTREMELY particular about any claims whatsoever. As soon as any claim is made, it seems that the FDA construes it as a "drug" claim. I personally don't see a clear divide between "dietary supplements" and "drugs" as far as the FDA is concerned with the exception of the claim issue. Even prescription drugs supplement the diet in a way. Everything we consume effects our bodies. Both "food" and "drugs" alter biological function and have an impact on health. Even "air" could be seen as a "food", but as soon as you say "air" (or oxygen) is good for let's say treating or preventing asthma, then it becomes a "drug" (the domain of pharma).

Edited by synapse, 01 September 2010 - 09:18 PM.


#112 Warrior

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Posted 01 September 2010 - 09:33 PM

Here is a link to all the clinical trials on piracetam: http://clinicaltrial...?term=piracetam

I do know the FDA is EXTREMELY particular about any claims whatsoever. As soon as any claim is made, it seems that the FDA construes it as a "drug" claim. I personally don't see a clear divide between "dietary supplements" and "drugs" as far as the FDA is concerned with the exception of the claim issue. Even prescription drugs supplement the diet in a way. Everything we consume effects our bodies. Both "food" and "drugs" alter biological function and have an impact on health. Even "air" could be seen as a "food", but as soon as you say "air" (or oxygen) is good for let's say treating or preventing asthma, then it becomes a "drug" (the domain of pharma).


so do you think he will be able to sell if he just removes the claims listed?

#113 Mike M

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Posted 01 September 2010 - 10:32 PM

Here is a link to all the clinical trials on piracetam: http://clinicaltrial...?term=piracetam

I do know the FDA is EXTREMELY particular about any claims whatsoever. As soon as any claim is made, it seems that the FDA construes it as a "drug" claim. I personally don't see a clear divide between "dietary supplements" and "drugs" as far as the FDA is concerned with the exception of the claim issue. Even prescription drugs supplement the diet in a way. Everything we consume effects our bodies. Both "food" and "drugs" alter biological function and have an impact on health. Even "air" could be seen as a "food", but as soon as you say "air" (or oxygen) is good for let's say treating or preventing asthma, then it becomes a "drug" (the domain of pharma).


so do you think he will be able to sell if he just removes the claims listed?


Those same claims were made with then other race tams and they said nothing. That's my point.

#114 synapse

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Posted 01 September 2010 - 10:46 PM

Here is a link to all the clinical trials on piracetam: http://clinicaltrial...?term=piracetam

I do know the FDA is EXTREMELY particular about any claims whatsoever. As soon as any claim is made, it seems that the FDA construes it as a "drug" claim. I personally don't see a clear divide between "dietary supplements" and "drugs" as far as the FDA is concerned with the exception of the claim issue. Even prescription drugs supplement the diet in a way. Everything we consume effects our bodies. Both "food" and "drugs" alter biological function and have an impact on health. Even "air" could be seen as a "food", but as soon as you say "air" (or oxygen) is good for let's say treating or preventing asthma, then it becomes a "drug" (the domain of pharma).


so do you think he will be able to sell if he just removes the claims listed?


It's really hard to say. I personally think the FDA is doing whatever they can to intimidate companies in the supplement industry in the hope that perhaps they will just go away. There are larger political forces at work attempting to repeal the Supplement Act including Senator John McCain. I sense they are doing whatever they can by law to protect their big pharma interests to keep the campaign funds flowing in hopes of re-election. Artificially created "drug" categories are further ways for the FDA to protect the interests of big pharma and keep the money in the hands of those constituents that are favorable to their political agendas. Unfortunately, both democrats and republicans are taking handouts from big pharma and physician unions making the issue particularly difficult to navigate.

Edited by synapse, 01 September 2010 - 11:15 PM.


#115 yowza

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Posted 01 September 2010 - 11:25 PM

I just recieved an e-mail from SmartPowders stating the following:


Posted Image

FDA bans Piracetam
The FDA has recently informed retailers and distributors that Piracetam is being marked as a drug. That it is not legal to sell as a dietary supplement. Smartpowders.com was informed of this on Monday August 30th, 2010. We have been given 15 days to respond to this letter from the FDA. During that time we will be running a sale to blow through our inventory. All piracetam products are now having additional 20% off until we run out! Discounts are taken at check out.
We will continue to update you as soon as we get more information. Here are the products affected: http://www.smartpowd...earch=piracetam



#116 synapse

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Posted 01 September 2010 - 11:34 PM

I have a bit of an issue with the first sentence of this announcement because to my knowledge no other retailers or distributors have been in fact notified of such a ban.

#117 chrono

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Posted 01 September 2010 - 11:49 PM

Those same claims were made with then other race tams and they said nothing. That's my point.

Right, but our point is that the letter states your marketing language is the ostensible reason for asking you to stop selling this product. Removing that reason might make it harder for them to make this case. It might not matter what their motivation is (i.e. new prescription status) if you remove the legal objections by which they can easily stop you from selling it.

And to prevent this from happening in this way to the other nootropics you've mentioned, prudence would seem to suggest that you proactively remove such claims from your site.

#118 yowza

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Posted 02 September 2010 - 12:42 AM

I followed the link and see that Piracetam is being offered at some pretty good prices...

Run into a little hardship from the FDA, why not roll with the punches to stay afloat...? As a retailer, SmartPowders offers great prices in good quantity and from what I can tell there's no overabundance of filler material making them attractive to buy from.

Plus, the distributor is very courteous and professional.

Edited by yowza, 02 September 2010 - 12:48 AM.


#119 MoodyBlue

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Posted 02 September 2010 - 01:53 AM

I unapproved the posts in this thread wherein vendors advertised sales of their products (except Mike's posts about the FDA issues, where it's obviously implied). While I think this thread is an exception in some ways, if nothing else it generates a lot of noise from people with too much spare time.

For the moment, Smart Powders and Cerebral Health both stock bulk piracetam; some friends of mine also just bought some from NutraPlanet, whom I know nothing about. Relentless Improvement also sells it in pre-capsuled form. And pharmaceutical Nootropil (and various rebrandings) is available through several internet pharmacy sites.

Mike, whatever the 'big picture' is at the FDA, the letter seems to say that piracetam doesn't qualify as a dietary supplement under a certain law. It then goes on to say that it's considered a 'new drug' because of your advertising language, and hence can't be sold commercially. Might removing such language and dosing recommendations/etc be a solution for you?


For your information, chrono--as well as anyone else's, there is at least one other site which sells bulk nootropic powders, including the controversial nefiracetam. I haven't bought anything from them yet, because I just recently found out about them. Here's the bulk nootropics page: http://www.ktbotanic...199fd1861c62b2d.

Edited by MoodyBlue, 02 September 2010 - 02:33 AM.


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#120 yowza

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Posted 02 September 2010 - 02:52 AM

ANYONE THAT FEEL THEY'VE BEEN TAKEN ADVANTAGE OF DUE TO THIS SITUATION CAN RECEIVE A FULL REFUND FOR ANY UNOPENED PRODUCT.


It's this sort of regard that one doesn't see in most businesses.


Thanks for the link moodyblue.

Edited by yowza, 02 September 2010 - 03:10 AM.



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