84 replies to this topic

[Saber]

Piracetam has always been a pharmaceutical drug. It doesn't occur naturally in our body and no natural food contains it. This is just the FDA doing their job. If you want it bad enough, you can import the pharmaceutical grade from UCB.
It's unfortunate that there's any regulation at all, yes.

[shawn]

Yet they find no problems with aspartame......sheesh.
And here I just find out about this stuff only to find that it may be unobtainable before I can order some.

[OneScrewLoose]

Any updates?

[SonofSocrates]

I have a question for the nootropics experts on here.

I work in R&D in the dietary supplement/nutraceutical/functional food industry. Its how I pay for my food, water and shelter.

How about some type of legal protection on my work like the pharma guys get? Then maybe companies will actually invest in research.

I mean I'm not a fan of our monetary system as a whole, but save a completely new system, shouldn't MY work be protected from someone ripping in off as soon as I go to market?

Are some rules aka regulations good? or are they all bad?

[Johann]

A while back, the World Bank was financing the construction of a new water system for some country down in South America. But some of the poorer people didn't want to stop using well water. So the govt passed a law that made it illegal to obtain your water from a well or even from a puddle in the front yard.

This is how all governments become in the long run. They protect the interests of their sponsors.

Here in the United States, there are restrictions on how many animals one can own,
what can be done with those animals, what kind of animals are allowed.

There are restrictions on food, water, drugs, the way you cut your grass, mandatory
carbon monoxide and fire detectors in homes.

Private businesses are forced to put in smoking bans and aren't allowed to use
trans fats in their cooking -- essentially private businesses are now partly owned
by government.

If you can't pay your taxes on your house, it gets taken away even though the house is paid off so there really is no such thing as private ownership of property
any more.

If you spank your child, the government will come take the child.

If you buy raw milk too much , you can go to jail.

Grow the wrong plant in your backyard, go to jail.

Go to Wal-Mart to buy some cough medicine, got to show your Identification Card and then you're entered into the database and must only buy one or two bottles max.

Got to Wal-Mart and want to buy some superglue -- got to show your Identification Card because some kids are using glue to get high.

Same thing goes with paint, razor blades, tobacco, insulin test strips.. etc etc

the list goes on and on and on..

Eventually everyone will need special permission to do anything.

[shawn]

It's a horrible make work program.

Eventually everyone will need special permission to do anything.

Isn't the reintroduction of slavery wonderful.

[Johann]

Except this is going to be Ultra Slavery. More intense than any previous type.

My late grandfather married my grandmother when she was 17. He would be
considered a child molester by today's twisted rulebook.

People used to buy and sell milk and eggs from and to their neighbors less than a hundred years ago. Those people now would be hauled into jail if that milk was not pasteurized.

People for thousands of years were able to grow their own plants as God intended. Now one can go to jail for growing marijuana and other plants that the GOVT doesn't allow.

oh and don't forget about mandatory recycling programs and mandatory health insurance coverage. Here in MA, if one doesn't buy health insurance, his tax refund will be withheld.

[synapse]

Except this is going to be Ultra Slavery. More intense than any previous type.

My late grandfather married my grandmother when she was 17. He would be
considered a child molester by today's twisted rulebook.

People used to buy and sell milk and eggs from and to their neighbors less than a hundred years ago. Those people now would be hauled into jail if that milk was not pasteurized.

People for thousands of years were able to grow their own plants as God intended. Now one can go to jail for growing marijuana and other plants that the GOVT doesn't allow.

oh and don't forget about mandatory recycling programs and mandatory health insurance coverage. Here in MA, if one doesn't buy health insurance, his tax refund will be withheld.

money and control- the great motivators of governments around the world.

[Mike M]

I haven't had an update on my end. I assume I won't till after new years.

[SonofSocrates]

Mike M, was really looking for your comments in particular. Not looking for a great debate on the subject, so no worries.

[425runner]

Well said! I couldn't agree more.......what happened to our freedom? All the government does is to control every aspect of our lives.

Except this is going to be Ultra Slavery. More intense than any previous type.

My late grandfather married my grandmother when she was 17. He would be
considered a child molester by today's twisted rulebook.

People used to buy and sell milk and eggs from and to their neighbors less than a hundred years ago. Those people now would be hauled into jail if that milk was not pasteurized.

People for thousands of years were able to grow their own plants as God intended. Now one can go to jail for growing marijuana and other plants that the GOVT doesn't allow.

oh and don't forget about mandatory recycling programs and mandatory health insurance coverage. Here in MA, if one doesn't buy health insurance, his tax refund will be withheld.

[Mind]

And to throw more cold water on everyone's spirits, isn't CODEX supposed to come into effect sometime soon?

[OneScrewLoose]

Yeah God forbid people have fire detectors in their homes...

[rwac]

Yeah God forbid people have fire detectors in their homes...

?

[SpawnMoreOverlords]

So any updates ? I ordered a kilo of primaforce piracateam a week ago because of this thread -_-;;

Edited by Pwnz0r, 05 January 2010 - 09:58 AM.

[Dorho]

[bump]

Any updates?

[magellan]

And to throw more cold water on everyone's spirits, isn't CODEX supposed to come into effect sometime soon?

yes

[chrono]

Do we think this will mean that piracetam will only be available by prescription, or will importing a 3 month supply be a viable option?

Edited by chrono, 31 January 2010 - 03:03 AM.

[OneScrewLoose]

I think this was a bunch of BS. I emailed bodybuilding.com back in December:

I've heard recently that the FDA has been investigating piracetam suppliers, and now considers it a drug. Is there any chance of Piracetam becoming illegal soon?

--

Thanks for your email. I'm not entirely sure on the status of piracetam, but hopefully it is not banned soon. As of right now, it is still good to go, but that's definitely one to keep an eye on if the FDA is currently investigating it. If there is anything else we can help you with, please let us know! Thanks for choosing Bodybuilding.com and have a great day!

It's still available on their site.

[chrono]

I think this was a bunch of BS. I emailed bodybuilding.com back in December:

Bodybuilding.com is a retailer that carries Primaforce brand, which is owned by Mike M. If the FDA is investigating suppliers at the top of the supply chain, I don't think there's any reason why a retailer would know about it.

I don't think it's BS, but I think that the "end is near" tone of the warnings might be a little premature. Just because there's some kind of regulation on it doesn't necessarily mean there'll be no way to get it. I hope.

[Mike M]

Yeah this is real. Just had a visit from them.

[MrSpud]

Yeah this is real. Just had a visit from them.

What were they asking for? I noticed that they sent Cerebral Health a warning letter for making drug claims (see http://www.fda.gov/I...s/ucm198452.htm for details). Is it something like that or was some kind of contamination found (like when they find viagra analogues in sexual enhancement supplements) or are they going after Piracetam itself?

[chrono]

Thanks for the timely warnings again, mike. It's much appreciated. Are they just asking about piracetam, other racetams, or things in general?


I'm still a little confused about why it would be happening this way. Let's assume for a moment that UCB just finished a clinical trial concerning the Efficacy and Safety of Piracetam for MCI. And is going to start marketing it in the US, and because of its prescription status selling it in bulk on websites will no longer be kosher.

Why would they be "visiting" suppliers and collecting information? Why not just announce that it's going to become prescription, and say it will be illegal to sell after that point, instead of being all creepy uncle about it? Are they suggesting that it's already improper to be selling, for some wacky reason?

Then again, I have little concept of how things work in the world of FDA/supplements; it could be early in the process, yet.

Edited by chrono, 17 February 2010 - 06:40 AM.

[synapse]

Yeah this is real. Just had a visit from them.

What were they asking for? I noticed that they sent Cerebral Health a warning letter for making drug claims (see http://www.fda.gov/I...s/ucm198452.htm for details). Is it something like that or was some kind of contamination found (like when they find viagra analogues in sexual enhancement supplements) or are they going after Piracetam itself?

We did receive a warning letter from the FDA at Cerebral Health. They thoroughly went through our websites and basically said we could not mention any disease or medical condition even if they were testimonials from customers or quotes from doctors discussing ingredient efficacy. We responded immediately and removed any language that mentioned any medical condition. We have a pending patent that is scheduled to receive a final issuance sometime this year on a line of our products. We are carefully considering whether to pursue one of the most effective products covered by the patent for further clinical trials and FDA approval as a new drug for a medical condition. We are located in a lab facility with biotech companies pursuing FDA approval for neuroscience oriented applications and we may pursue a similar path on several of our products. For the time being, however, we are focused on the international OTC market.

[kismet]

We did receive a warning letter from the FDA at Cerebral Health. They thoroughly went through our websites and basically said we could not mention any disease or medical condition even if they were testimonials from customers or quotes from doctors discussing ingredient efficacy.

You should have never included them in the first place. I am glad you removed the unjustified and misleading claims after due warning.

So piracetam is still not banned?   I really hope this whole issue is not a canard to sell more piracetam...

Edited by kismet, 17 February 2010 - 03:08 PM.

[Mike M]

I have no structure function claim issue. They were looking for that however. All I know is they started at a supplier, got my info from there. No clue what the end game is here. I got very little info out of them. They asked for my manufactures, which is a bit odd, but whatever. They only asked about piracetam at this point.

[synapse]

We did receive a warning letter from the FDA at Cerebral Health. They thoroughly went through our websites and basically said we could not mention any disease or medical condition even if they were testimonials from customers or quotes from doctors discussing ingredient efficacy.

You should have never included them in the first place. I am glad you removed the unjustified and misleading claims after due warning.

So piracetam is still not banned?   I really hope this whole issue is not a canard to sell more piracetam...

There is extensive clinical research in regards to Galantamine and Alzheimer's (Galantamine is FDA approved for AD), but we still cannot say anything in that regard on the Cerebral Health websites. In regards to the racetams, there is considerable research showing its safety and potential efficacy for a variety of medical conditions. However, since the racetams are not FDA approved for any medical conditions, there can be no mention of such potential or implied efficacy on company websites.

We hope that the racetams are not removed from the OTC market and strongly feel that their safety profile is such that there is no need to make them prescription medications. However, if the racetams are removed from the OTC market, Cerebral Health will in all likelihood pursue clinical trials based on the patent filing mentioned above that covers racetam/choline donor combinations.

Edited by synapse, 17 February 2010 - 04:01 PM.

[chrono]

We hope that the racetams are not removed from the OTC market and strongly feel that their safety profile is such that there is no need to make them prescription medications. However, if the racetams are removed from the OTC market, Cerebral Health will in all likelihood pursue clinical trials based on the patent filing mentioned above that covers racetam/choline donor combinations.

If you guys are getting into trials, I hope you consider some that are aimed at healthy subjects as well. It receives so little clinical attention, and seems like a market that's woefully under-exploited.

[Mike M]

Just got another call from them. Having a meeting tomorrow so they can ask more questions and give me some paperwork.

[catfanatic1979]

Just got another call from them. Having a meeting tomorrow so they can ask more questions and give me some paperwork.

Mike, I think you need to call your congressman or whatever small government advocate you can find. I'm sure not too many people are aware and light needs to be shed on this. Fight it.

As for me, I'm stocking up. How long of a shelf life does this stuff have?

Edited by catfanatic1979, 17 February 2010 - 11:27 PM.