186 replies to this topic

[Mike M]

Here comes the big push. I got served today by the FDA with a warning letter. The letter outlines their stance that Piracetam is a Drug and not a nutritional supplement. I have 15 days to respond to this letter before they take action of seizure. I was informed this is a wide ranging inquiry and they're going after everyone that sells piracetam. I'm not sure I'm prepared for a fight with the FDA to be honest with you. While I think I have some ground to stand on, just not sure I want that battle. Gotta love the government.

[aLurker]

NOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOoooooooooooooooooooooooooooooooooooooooo!!!!!!!!!!
This makes me a sad panda. What kind of shelf life does Piracetam have? What is the best before date on your current inventory?

[Mike M]

As long as you keep the stuff away from heat it will last 3 years or so. If you really want it to last forever, just get a vacuum sealer and it will be fine.

[medievil]

Throw the warning letter away and reorder piracetam, i'm pretty sure they will just seize it if you dont respond without any further action.

Someone correct me when wrong, i'm not familiar with the US system, but i highly doubt they will do more then just destroying it when its just about a simple nootropic, thats how it works in belguim when the customs seize meds.

Edited by medievil, 30 August 2010 - 05:03 PM.

[Mike M]

I'm a retailer of piracetam. My last shipment was over 40 pallets of piracetam powder. I'm not an individual consumer. You don't screw around with the FDA in the US. They visited my broker in december, me in february and came back today to give me the terms. Not something you screw around with.

[aLurker]

Have they shown any interest in anything else or is it just the Piracetam? Will this affect anything else (like Aniracetam or Oxyracetam)?

[Mike M]

Nothing has been said about those at this time. The focus right now seems to be on piracetam.

[jackdaniels]

Was never the biggest fan of piracetam but this is truly absurd.

[Mike M]

Here is something they said:

Piracetam is not a vitamin, mineral, amino, herb or other botanical, or dietary substance for use by man to supplement the die by increasing the total dietary intake. Further, piracetam is not a concentrate, metabolite, constituent, extract or combo of any such dietary ingredient. These products do not qualify as a dietary supplement under section 201(ff) of the act

The act they are citing is: 201(ff)(1) of the act, 21 U.S.C. 321(ff)1.

[Animal]

Well this is only in the US so meh, there are plenty of European suppliers.

[Mike M]

Yeah, where do you think they get it from? Last month I sent 2k/kg out of the country to euro suppliers. Not that I'm the sole supplier, but with US demand going way down, the price will go way up. There was already a 20% increase in production cost moving forward. The most recent order I was quoting was considerably more expensive than my past orders. Even with a 30% increase in order size on my end.

[Introspecta]

Mike if i order 3 kilos on Thursday Will I be ok. Or is that too long to wait? Don't get paid until then. You said you have 15 days to respond. I just want to know if they have the right to do this. Then again i guess they do what they want. They are probably afraid of people getting too smart and catching on to there shady ways. I hate the U. S. government with a passion. Anything thats good they ban. But they can sell alcohol, tobacco, unhealthy foods that kill us, spray chemtrails, flouridate the water, who knows what else our government is doing. I think they banned tobacco shipments too because people were saving too much money. Like they don't make enough already. Selfish, greedy corrupt pieces of shit is what the united states government is. This country will not last another 100 years without a war.

[tritium]

Can you please post a scan of the letter?

[Introspecta]

Of all the supplements to be banned you'd think phenibut would be the first nootropic considering its the only one thats physically addicting. Piracetam? Seems so harmless. I've ingested kilos of the stuff,stopped for months with no adverse effects. Doesn't make any sense.

[Mike M]

I will see if I can get a scan of the letter emailed to me. I leave for Indy tomorrow and will be gone for 5 days. I'll drop it by the office and have them scan it. My day was supposed to be spent packing and getting ready, that went out the window.

This isn't some ploy, because if I were lying, it'd be way to obvious to prove and it'd ruin my long term reputation, which I'd never take a chance with.

[babcock]

Not a huge user of piracetam but I find this amount of control by the government on such a harmless supplement to be absolutely disgusting.

[synapse]

Piracetam is a derivative of the amino acid GABA and should not be considered a "drug".

[Mike M]

I'm going to make a fight for that, but you're dealing with a gray area. Not many want to fight with FDA, mainly due to costs. It's not worth 40k for me to prove it's legal, possibly, then never come close to making that amount of cash. I'm going to make a simple argument and see how they respond. If they push back, I'm done. BTW, no coupon needed, will have it a flat 20% off for everyone on piracetam.

[kismet]

You are a supplier and stand to benefit from making up or exaggerating your story. You (and others) have often alluded to the risk of an imminent ban on piracetam, etc (IIRC) What is really going on? Why no official FDA statement?

Can you please post a scan of the letter?

[synapse]

I would be willing to fight for it due to it's basis on an amino acid. An argument could further be made that piracetam can and does act as a supplement to the amino acid needs of the brain.

[synapse]

I'm going to make a fight for that, but you're dealing with a gray area. Not many want to fight with FDA, mainly due to costs. It's not worth 40k for me to prove it's legal, possibly, then never come close to making that amount of cash. I'm going to make a simple argument and see how they respond. If they push back, I'm done. BTW, no coupon needed, will have it a flat 20% off for everyone on piracetam.

Incidentally, it may well be worth the 40k to put up a fight. I will fight it if the FDA questions us on it.

[Mike M]

You are a supplier and stand to benefit from making up or exaggerating your story. You (and others) have often alluded to the risk of an imminent ban on piracetam, etc (IIRC) What is really going on? Why no official FDA statement?

Benefit how? I benefit by cutting my profit margin? I've told nothing but the truth about my visits with the FDA, which will be proven when I post a scan of this letter from them. You'll see where they visited me in Feb and being served today. It would be business suicide to make a big deal of this now, get a temporary increase in business and then lose the trust of your customers. I've been doing this for over 10 years, I'm not dumb.

If you don't believe me, that's fine. Don't purchase it, see where things stand in 4 months and then you can decide if I'm full of it. I'd press you to go through my entire post history and see where I've lied about anything. I told people when I got the first visit that it would be months before something happened.

[Mike M]

I'm going to make a fight for that, but you're dealing with a gray area. Not many want to fight with FDA, mainly due to costs. It's not worth 40k for me to prove it's legal, possibly, then never come close to making that amount of cash. I'm going to make a simple argument and see how they respond. If they push back, I'm done. BTW, no coupon needed, will have it a flat 20% off for everyone on piracetam.

Incidentally, it may well be worth the 40k to put up a fight. I will fight it if the FDA questions us on it.

Not for me. While long term it would be, I have other projects. Yes, I sell a lot of piracetam, but by no means would I go out of business if it stopped tomorrow. Would it suck, yes. I've been involved in tons of litigation over the past 10 years. Sometimes it's just not worth it to deal with it. I have a PHD throwing a letter together now for defense. We'll see what they say and go from there.

[synapse]

The fight would be worth it for me and my company without doubt. The entire Synaptine line and pending patent is based off of the racetam and choline synergy. I am prepared to discuss the matter with VCs if necessary to pursue the pharma route, but I personally prefer to stay in the OTC market. However, even in the worst case scenario I would be willing to offshore Cerebral Health to protect our product lines. If the US doesn't want our tax dollars, we will take them somewhere else.

Edited by synapse, 30 August 2010 - 08:30 PM.

[Mike M]

The letter should be up on here tomorrow. You can see their full argument and go ahead and prepare. Whatever argument they are making with me, they'll make with others. Of course, if you want to supply any evidence, such as prior to 94 piracetam being sold, feel free to forward on haha

[Animal]

You are a supplier and stand to benefit from making up or exaggerating your story. You (and others) have often alluded to the risk of an imminent ban on piracetam, etc (IIRC) What is really going on? Why no official FDA statement?

Can you please post a scan of the letter?

Especially if his intention is to discontinue selling Piracetam anyway, it would be a great way to clear stock.

[Mike M]

You guys are too paranoid. There is no way I'll sell my stock of inventory if not successful in defending this. I have over 10k/kg in stock with more on the way that I can't defer. I will have to destroy product no matter what. I will have to sell inventory at near costs just to help recoup SOME funds. TRUST ME, this is not what I want on any level. Why would I want to discontinue something I'm selling so much of? Makes no sense.

[synapse]

You guys are too paranoid. There is no way I'll sell my stock of inventory if not successful in defending this. I have over 10k/kg in stock with more on the way that I can't defer. I will have to destroy product no matter what. I will have to sell inventory at near costs just to help recoup SOME funds. TRUST ME, this is not what I want on any level. Why would I want to discontinue something I'm selling so much of? Makes no sense.

I hope that you not crying wolf here Mike. You have posted similar "piracetam ban" messages in the past and I can see why some of the members may be a little suspicious. If you strongly felt that piracetam was going to be banned in the past, it's difficult to reason why you would buy 10,000 kgs.

[Warrior]

We all know the FDA is slow to actually move, even when the decision to move is made. Reminds me of the recent prohormone and 17a Hormone ban this year. We knew it was coming, but there was not imminent enough threat to actually stop producing. Then one day we woke up and it was over.

If I thought the FDA was planning on banning but had not yet made the step, I'd continue production. We have been suspecting the hormone ban in the bodybuilding community for over a year and even know which were to be banned. But as referenced it took a year to actually occur.

[synapse]

The FDA is a joke! They have basically become the tools of big pharma and the American physician's association. The notion that natural substances cannot help with medical conditions is a flat out lie. Almost all medicines are naturally derived in one form or another.

The US market is only one game in town and getting smaller seemingly everyday. The FDA can overegulate the supplement industry to death to help appease their big pharma lobbyists, but naturally based medicine will live far longer that the US FDA.

Edited by synapse, 30 August 2010 - 09:43 PM.