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FDA says no more piracetam


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#151 Ben

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Posted 08 September 2010 - 10:58 AM

A teaspoon full of product submitted for COA/Heavy Metals analysis 1.5 years ago makes me totaly confident that the rest of the 44,000+ kg is fit for human consumption.


How much would it cost me to have the product checked ? (I'm new to this)
Seems like such a big deal / risk.


FortFun makes really excellent points. I would not trust random mystery powder from a respectable shop on my high street, why would I trust it from "SmartPOWDAS!!!" ? And it is trust. Think about what you know factually as to the quality of any nootropic powder you buy over the internet. Well, you know factually that it comes from China (reassuringly, right?), but what else?

Please imminsters, don't all go now and buy SmartPowders perhaps soon unsellable items. Exercise a little judgment ffs.

#152 Revisiter

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Posted 08 September 2010 - 11:04 AM

No you're totally right revisiter. i'm not going to be the lone voice here questioning mike m / smartpowders as a distributor of racetam products. If you're confident the 'allegedly crap' product you bought is safe, is what Mike says it is, and does not contain any heavy metals or other impurities, and you are buying it regardless of any facts to the contrary about Mike's honesty and integrity....then I am sure you will be fine. I know based on Mike's love of discussion forum customer service he will make sure we all know that order 9256 gets delivered by the end of the week (maybe sooner! Its been chaos with the sale, ya know!)

Some of us here expect a little more from distributors that sell products that we put in our bodies. A teaspoon full of product submitted for COA/Heavy Metals analysis 1.5 years ago makes me totaly confident that the rest of the 44,000+ kg is fit for human consumption. I don't know what the fuss is about either.

I guess the good news is I don't have to worry about Mike M / smartpowders bull sh*tting the nootropics community anymore and none of you all have to hear me detailing what a total fraud I think he and his company are. Sounds like a win/win!

:)
fortfun

and btw..welcome to the forum!


Perhaps you are right, fortfun. Perhaps you are.

If indeed you are rightfully worried about how the products might be contaminated, you should anonymously buy one of Mike's product and test it out yourself, it'd put an end to all these wouldnt it? Sure, it'd cost a bit. I would, definitely, reimburse you the full amount if you could prove what you've been crusading about. Put your money where your mouth is.

But maybe the level of significance is too high, after all a teaspoon of 44000kg is what... a lottery shot that could go nowhere?

Nonetheless, you might be right all in all. By the end of the week I may be turning on what I've been saying due to my discontentment at Mike's delivery practices, or the end of the year where I realise I've been swallowing bucketful of crap.

From what I've read so far about this thread and some following ones, you've been giving Mike too much stick without that much of solid evidence of what you've been larking about. Like I've said, I would reimburse you if you were right, so you've got nothing to lose.

How bout it then, fortfun?


Oh and thank you so much.

Cheerios,
Revisiter

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#153 KimberCT

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Posted 08 September 2010 - 11:56 AM

You could if you excluded the fact the 'adverse events' with ephedra were well documented and monitored by the FDA (e.g. People died), that the FDA solicited public comment, repeatedly warned the public about the dangers, and then announced the ban well before implementation.

Other than that, you could compare the upcoming green tea ban to ephedra.

Yes, and it would still be far more appropriate than your comparison of green tea to piracetam.  :dry:



#154 Mike M

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Posted 08 September 2010 - 12:46 PM

Sorry if I don't pay much attention to fort, a person who's only posts on this board are aimed at slamming me directly, much like Ben-Au. Two guys, that hide behind a fake screen name. Everyone has an opinion. Nothing wrong with them not wanting to purchase from me. I wish they would have been there when the FDA showed up for a surprise inventory inspection yesterday. Halting all of my orders and work so they could inventory everything, I mean EVERYTHING that was there. Including all my now foods, optimum, etc etc. Was on the phone at length again with Mr. Price again. For those that think they are serious, just sit and watch what happens over the next 60-90 days to everyone else on their list.
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#155 FortFun

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Posted 08 September 2010 - 12:49 PM


LOL!

I thougt revisiter claimed he did not know what all the fuss was about???

Now revisiter is an expert on this topic?

Hey nooby! Let's not get confused, okay? Someone imports 176+ drums of piracteam from multiple chinese suppliers..how do you propose we insure its all safe?

Are you suggesting we all have to test it ourselves???? You did just say so...











#156 FortFun

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Posted 08 September 2010 - 12:55 PM

Mike M: I wish they would have been there when the FDA showed up for a surprise inventory inspection yesterday. Halting all of my orders and work so they could inventory everything,

Yeah, I'm sure that had nothing to do with you lying about the FDA banning piracetam...like I stated in my first post in this thread..

"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.... "
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#157 chrono

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Posted 08 September 2010 - 01:43 PM

Some of these points about purity are valid concerns, and people should be aware of the risks involved in buying bulk powders. But the issue has been discussed here ad nauseam. No one is forcing anyone to buy from SP, and I don't think Mike has represented his COAs as being anything but what they are. There are several threads here about importing pharmaceutical piracetam, if in anyone's opinion the purity of bulk piracetam is too questionable.

And as Synapse observed, I think the SP e-mail message was slightly misdirecting in its implication that other retailers were already being affected by this. But it's nothing like the plot of sinister dimensions that some here are portraying it as.

Sorry if I don't pay much attention to fort, a person who's only posts on this board are aimed at slamming me directly, much like Ben-Au. Two guys, that hide behind a fake screen name.

Indeed, as I pointed out in the other thread, FortFun's entire post history contains nothing but attacks on your business. So FWIW, I don't think you should be expected to respond to it over and over, either. Everyone is perfectly capable of making up their own minds about what this user says, but as he seems so very concerned about Mike's motivations, I suggest that his own could use a little scrutiny. For instance, no mention is made of retailers who have much less (or no) record of purity for their bulk piracetam.

Ben makes a lot of good contributions here, regardless of his occasional criticisms of your business.
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#158 MonteCarloNOS

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Posted 08 September 2010 - 02:39 PM

Mike-

How much of the piracetam market do you think you wholesale to?

#159 FortFun

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Posted 08 September 2010 - 02:52 PM

Seriously Chrono?

No doubt I was very disturbed by what the community considered fact with respect to smartpowders / mike m . I am still concerned! So you state as a moderator, that Mike M /smartpowders should not be expected to address safety issues? That as a vendor with profit motive he has equal sway here? Even when documented facts say otherwise? What exactly do you mean by respond over and over? He has repeatedly made multiple statements that defy fact in this thread alone. That my own motivations should be questioned? Can you question anything I have brought up? Please state anything you consider inappropriate besides the fact that I have proven over and over again that a vendor is dishonest?

If this is where you are going then you are right...navigators need to be involved!

I really question your objectivity at this point. And I definitely don't trust my privacy in your hands.

Your role as moderator is to summarize and provide subjective summary analysis of all posts that you and the vendor obviously disagree with...your last post as an example???? Really? First I think you are dead wrong. Second, if you are right then you have 'for sure' lost my interest in this forum as a place for worth while discussion. You might as well say this forum is "FDA Approved"....no, sorry I mean "Chronos Approved"!!!

I know I upset you at the beginning of this thread. Sorry, you were not doing you job, that is a fact that you can not dispute. Too bad you left objectivity at the door. I am dumbfounded, your last post is beyond bizarre!

Please escalate to brokenportal and mind.

If your take in your last post is offical for immisnt then I will have nothing more to say or do here. Enjoy smartpowders, I guess you win in stifling discussion!

cheers,
fortfun
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#160 synapse

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Posted 08 September 2010 - 03:32 PM

FF-

I see Chrono recognizing that you may be making some valid points. I don't see him as necessarily trying to defend Mike M. in all of this (or anyone else for that matter). Being familiar with his post history on this thread and elsewhere, Chrono is open to differences of opinion and has made many valuable contributions to the fora here. Further, I don't get the sense that he is in any way attempting to stifle discussion.

#161 chrono

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Posted 08 September 2010 - 04:35 PM

Thanks, synapse. ;)

@Fortfun: Your assumptions about my duties as moderator are pretty inaccurate. I do not speak for ImmInst in an official capacity, and believe it or not, am allowed to express my own opinion. And despite what you seem to think, I am not required to agree with your analysis of this (or any) situation.

The only thing I've done in this thread is express an opinion contrary to yours, and point out a glaringly obvious pattern in your posting history, which is viewable to all users. I'm sorry if this is somehow stifling to you, but despite your sensationalist exaggerations, I haven't done anything objectionable here. Feel free to complain to someone if you disagree.

Edited by chrono, 08 September 2010 - 04:37 PM.


#162 soulfiremage

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Posted 08 September 2010 - 04:36 PM

The only thing I can add to this thread is my personal experience of Mike. It was nearly 2 years ago, I bought 2 x 500grams of Piracetam from him.

It took the usual USA to UK time to get here, his responses however to my emails were prompt, service was excellent. I spoke with him twice on messages; had no sense of nonsense.

I have finished both tubs of Piracetam now. It made a subtle and growing difference in the first few months and has been immensely helpful. If Mike happens to be selling it, when I have further funds available, I will be using his site again.

Note: Mike I did email you recently, but haven't heard back from you.

What my experience proves is simply that Mike and his product worked fine for me.

#163 Pike

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Posted 08 September 2010 - 05:41 PM

i was on the verge of giving fortfun credit for bringing up some valid points. then, i looked through his post history. fortfun, you might have better luck in convincing people of your viewpoints if you didn't come off so hostile... to everyone who disagrees with you. it might also help to post in topics that have nothing to do with smartpowders (i mean, really; there are more interesting topics than SP on this forum). that way, it wouldn't look like you're just some soandso who hides behind a false forum name and posts only to attack mike.




regarding the letter:

regardless of the small differences in what was posted and what the letter contained, the end result is essentially the same. i really don't feel like i've been "misled."

#164 TophetLOL

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Posted 08 September 2010 - 06:04 PM

<br />i was on the verge of giving fortfun credit for bringing up some valid points.  then, i looked through his post history.  fortfun, you might have better luck in convincing people of your viewpoints if you didn't come off so hostile... to everyone who disagrees with you.  it might also help to post in topics that have nothing to do with smartpowders (i mean, really; there are more interesting topics than SP on this forum).  that way, it wouldn't look like you're just some soandso who hides behind a false forum name and posts only to attack mike.<br /><br /><br /><br /><br />regarding the letter:<br /><br />regardless of the small differences in what was posted and what the letter contained, the end result is essentially the same.  i really don't feel like i've been "misled."<br />

&lt;br /&gt;&lt;br /&gt;&lt;br /&gt;<br /><br />Being swayed away from a otherwise valid argument due to emotion is exactly why this country is in trouble. It becomes a matter of how 'I' feel rather then the truth of the matter. If there is truth in something it really doesn't matter who it came from or what their intentions are.

It may seem that not many people agree with fortfun, but there are a lot more then you think. Since the ones who agree are unlikely to say anything, while the ones who disagree will.

Edited by TophetLOL, 08 September 2010 - 06:11 PM.


#165 Pike

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Posted 08 September 2010 - 07:45 PM

&lt;br /&gt;i was on the verge of giving fortfun credit for bringing up some valid points. then, i looked through his post history. fortfun, you might have better luck in convincing people of your viewpoints if you didn't come off so hostile... to everyone who disagrees with you. it might also help to post in topics that have nothing to do with smartpowders (i mean, really; there are more interesting topics than SP on this forum). that way, it wouldn't look like you're just some soandso who hides behind a false forum name and posts only to attack mike.&lt;br /&gt;&lt;br /&gt;&lt;br /&gt;&lt;br /&gt;&lt;br /&gt;regarding the letter:&lt;br /&gt;&lt;br /&gt;regardless of the small differences in what was posted and what the letter contained, the end result is essentially the same. i really don't feel like i've been &quot;misled.&quot;&lt;br /&gt;

&lt;br /&gt;&lt;br /&gt;&lt;br /&gt;<br /><br />Being swayed away from a otherwise valid argument due to emotion is exactly why this country is in trouble. It becomes a matter of how 'I' feel rather then the truth of the matter. If there is truth in something it really doesn't matter who it came from or what their intentions are.


what i might have given fortfun credit for has already been discussed, ad nauseum, in the nootropics forum. however, his entire being on this forum seems to be for the purpose of posting in SmartPowders threads; specifically for attacking mike. and while vendors of specific nootropic supplements might be worth discussion, it would make more sense to post in topics that aren't SmartPowders related. to exist on a forum just to attack an another company is enough to raise suspicion, for me, and to discredit how seriously i take you. as far as i know, it could just be some other vendor pointing out flaws in the company and hides behind another sign-on name because his sales practices are no better.


It may seem that not many people agree with fortfun, but there are a lot more then you think. Since the ones who agree are unlikely to say anything, while the ones who disagree will.


sure, that could very well be the case. but a headcount of who agrees and who doesn't agree with fortfun really isn't important to me or relevant. i'm simply giving my point of view.

#166 Mike M

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Posted 09 September 2010 - 12:54 AM

Focusing on the label claim is pointless, when their position is that piracetam is a drug. The reason you don't see it listed as a "ban" is because to them, it was banned years ago. That it is NOT legal to sell in the USA, period. They've made their ruling on this, just like they did in 2003 when I submitted my letter to them about getting approval for it. They responded then with the same information.

Focusing on the label claim is like focusing on a scratch to a person that has a gun shot wound in the head. The scratch doesn't matter when something more pressing is around. So fort, why don't you call Mr. Price and ask him what the FDA's position is on Piracetam? I talk to him about every other day right now. Please call him, ask him whatever questions you wish, then I'll post what his response was to you next time I talk to him.

If I have so much to hide and I'm lying through my teeth, why would I ask you to do such a thing on a public forum where I could be proven wrong?

#167 MoodyBlue

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Posted 09 September 2010 - 01:31 AM

To support your claim Mike, I point out that the law concerning nootropics, or smart drugs, in the United States appears to be the same for all American citizens, whether they are merely a consumer or a vendor of those drugs. And that is that anyone in the USA is allowed to have enough quantiy of the nootropic drug in their possesion which will last them for as long as 3 months and no more. That's why I always wondered how US vendors were getting away with handling the relatively large quantities of nootropics compared to consumers. Apparently, all US consumers should be making their purchases for nootropics from foreign vendors like QHI, etc. I read "Smart Drugs II'' back in the early 90's, and it stated that at that time it was illegal to sell them in the US, though they could be purchased in Canada and Mexico. I'm surprised, Mike, that the FDA didn't come after you for Aniracetam, Oxiracetam, Pramiracetam, Phenibut, etc..

#168 chrono

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Posted 09 September 2010 - 02:09 AM

To support your claim Mike, I point out that the law concerning nootropics, or smart drugs, in the United States appears to be the same for all American citizens, whether they are merely a consumer or a vendor of those drugs. And that is that anyone in the USA is allowed to have enough quantiy of the nootropic drug in their possesion which will last them for as long as 3 months and no more.

What you're referring to is the FDA's personal importation policy, which applies to all drugs (or at least in theory, all those not available in the US), not nootropics specifically. I also don't think it would apply to vendors per se, as I don't think you're allowed to resell under this law. Furthermore, I don't think that all nootropics can be classified as 'drugs' as it pertains to this rule, as many do technically fall into the dietary supplement category.

#169 synapse

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Posted 09 September 2010 - 11:50 AM

Focusing on the label claim is pointless, when their position is that piracetam is a drug. The reason you don't see it listed as a "ban" is because to them, it was banned years ago. That it is NOT legal to sell in the USA, period. They've made their ruling on this, just like they did in 2003 when I submitted my letter to them about getting approval for it. They responded then with the same information.

Focusing on the label claim is like focusing on a scratch to a person that has a gun shot wound in the head. The scratch doesn't matter when something more pressing is around. So fort, why don't you call Mr. Price and ask him what the FDA's position is on Piracetam? I talk to him about every other day right now. Please call him, ask him whatever questions you wish, then I'll post what his response was to you next time I talk to him.

If I have so much to hide and I'm lying through my teeth, why would I ask you to do such a thing on a public forum where I could be proven wrong?


Mike M-

Is the FDA allowing you to sell your remaining stock? Or are you just taking your chances? Will you be discontinuing all of the racetams (and anything else that might fall into the category you mention)?

You mention the 2003 letter. Is this the David Tolson letter? Is he an associate of yours? I am a bit surprised that you continued offering piracetam even after the FDA rejected the letter. Is this part of the reason you sold Bulk Nutrition?

#170 KimberCT

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Posted 09 September 2010 - 06:38 PM

Interesting... just got an email from Cognitive Nutrition saying they are running a 35% off sale on piracetam.

I wonder if it has anything to do with this FDA meddling.



#171 Humanescence

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Posted 09 September 2010 - 06:49 PM

Given the fast sellout + 3 month stock limit per person, it should be a concern that customs may seize big orders.

What are the risks of a total vs. a return to shipper ?

Is anyone with experience on this suggest an optimal package size/weight for shipping to Canada.

ThankYou.

#172 Mike M

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Posted 09 September 2010 - 06:55 PM

Interesting... just got an email from Cognitive Nutrition saying they are running a 35% off sale on piracetam.

I wonder if it has anything to do with this FDA meddling.



Wait, are you saying I might have been telling the truth! Say it ain't so!

Synapse, none of that had anything to do with me selling bulk. David used to do side work for me, he wrote articles. You're surprised I continued to sell it even though you've been selling it as well? Am I missing something here?

#173 synapse

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Posted 09 September 2010 - 07:21 PM

The FDA went through the Cerebral Health website with a fine tooth comb and while they did say some things about marketing language, they said nothing in regards to the actual ingredients (ie. Piracetam). I removed any "drug" type language from the website within 48 hours and sent back a response letter with the changes I had made. The FDA reviewed the site and product labeling for a second time and still had some issues and then I promptly addressed those issues (again within approximately 48 hours). Since my second response letter, I have not heard from the FDA. At no point did they say anything about the actual compounds themselves.

I have been taking a closer look at several of the recent FDA warning letters and it looks they are hounding just about everyone- from the makers of Lipton Green Tea to the makers of Snapple and even Pfizer for not adequately reporting adverse reactions from Lipitor.

#174 chrono

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Posted 09 September 2010 - 07:22 PM

You're surprised I continued to sell it even though you've been selling it as well? Am I missing something here?

I think he was referring to your implication that you'd already been told it was unacceptable to sell:

The reason you don't see it listed as a "ban" is because to them, it was banned years ago. That it is NOT legal to sell in the USA, period. They've made their ruling on this, just like they did in 2003 when I submitted my letter to them about getting approval for it. They responded then with the same information.



#175 synapse

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Posted 09 September 2010 - 07:34 PM

Exactly chrono. I am just surprised that if there was a ban, then why didn't the FDA say anything when they went through the Cerebral Health website so meticulously. At the time, there was also a product on the website called Synaptine Zen with Hydergine. They didn't say anything in regards to the hydergine, but I pulled the product from the website because there seemed to be some ambiguity about the OTC status of hydergine.

#176 synapse

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Posted 09 September 2010 - 07:44 PM

The further and further I delve into all of this, the more I realize how utterly confusing all of the FDA regulations have become. Not even Big Pharma seems to be able to fully comply with the complexity of all the regulations. Further, during a time when the US economy is seriously struggling, you would think the government would be trying to help businesses thrive rather than running them into the ground. While I have found my local inspector to be helpful, the FDA does not seem particularly interested in helping companies survive or prosper. I would hope that government and industry could work more collaboratively together..

#177 KimberCT

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Posted 09 September 2010 - 08:33 PM

Further, during a time when the US economy is seriously struggling, you would think the government would be trying to help businesses thrive rather than running them into the ground.  While I have found my local inspector to be helpful, the FDA does not seem particularly interested in helping companies survive or prosper.  I would hope that government and industry could work more collaboratively together..

 

 :laugh:



Edited by KimberCT, 09 September 2010 - 08:38 PM.


#178 Mike M

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Posted 09 September 2010 - 09:00 PM

Exactly chrono. I am just surprised that if there was a ban, then why didn't the FDA say anything when they went through the Cerebral Health website so meticulously. At the time, there was also a product on the website called Synaptine Zen with Hydergine. They didn't say anything in regards to the hydergine, but I pulled the product from the website because there seemed to be some ambiguity about the OTC status of hydergine.


That's because they have no clue what they are doing or why. Everyone within the FDA is given an order from someone above them and they follow it with no objection. I asked the guys that keep coming here if they have any clue why they are here. They simply said no, we just follow orders. That's why they are incapable of doing their job correctly.

#179 synapse

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Posted 09 September 2010 - 09:13 PM

I tend to agree Mike. Perhaps this will only effect piracetam although they may eventually get around to cracking down on more. I am not quite convinced they even really know what piracetam is or how it's made. I just hope that a defense can be made based on the fact that piracetam is a derivative of GABA. This may also hold for the other racetams. The problem, unfortunately, is that you would have to have a pharmacologist testify to this fact. Yet, how would the FDA dispute this?

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#180 Mike M

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Posted 09 September 2010 - 10:29 PM

Nobody is going to defend this against the FDA because nobody is making enough money from it to justify it. If they came after you, I doubt you're making enough profit to justify a 40k outlay, not even knowing if you'll be successful. Do you really expect a fair fight against someone as powerful as the FDA? That guy won't be me. I don't care about piracetam enough, especially when they don't care about the others, to waste time/energy/money to fight them.


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