98 replies to this topic

[ak34]

Just thought I would post this here as opposed to under the suppliers section. Does anyone have anymore information on the recent events with the racetams? Relentless is saying they are no longer getting shipments past customs and they don't expect to in the near future. Can anyone say what the problem is here? They are not regulated by the FDA right?

[abelard lindsay]

Just thought I would post this here as opposed to under the suppliers section. Does anyone have anymore information on the recent events with the racetams? Relentless is saying they are no longer getting shipments past customs and they don't expect to in the near future. Can anyone say what the problem is here? They are not regulated by the FDA right?

Link?

[solracselbor]

Just thought I would post this here as opposed to under the suppliers section. Does anyone have anymore information on the recent events with the racetams? Relentless is saying they are no longer getting shipments past customs and they don't expect to in the near future. Can anyone say what the problem is here? They are not regulated by the FDA right?

Link?

you might find this interesting:

http://www.t-nation....iracetam_banned



Also would it be possible if someone could please verify the date and veracity of the article located withing this link:


http://www.textfiles...gs/notp_fda.txt

Which contains this non-official FDA notice:


P92-3 Food and Drug Administration
> FOR IMMEDIATE RELEASE
>
> The Food and Drug Administration announced today it has issued an import
> alert against unapproved mail-order drugs promoted by six overseas companies.
> Many of these drugs are illegally advertised in periodicals and through
> direct mail, as foreign versions of approved prescription drugs. The
> promotion and distribution of unapproved drug products within the United
> States is illegal.
> "In some cases, the drugs are counterfeit -- lacking any real similarity
> to the approved drug. The uncertain character and quality of these drugs
> constitute an unreasonable risk to the public health," FDA Commissioner
> David A. Kessler, M.D., said.
>
> The import alert instructs FDA field offices to automatically detain all
> imported unapproved prescription products manufactured by six overseas
> companies which have promoted their products in this country. The companies
> cited are Interpharm, Inc., of Nassau, Bahamas; Northam Medication Service
> International Pharmacy of Nassau, Bahamas; Inhome Services of Delemont,
> Switzerland; International Products of Hannover, Germany; Azteca Trio
> Internacional, S.A. de C.V., of Zona Rio Tijuana, Mexico; and Interlab of
> London, England.
> These companies have been promoting a wide variety of products purported
> to treat various conditions, including depression, high blood pressure,
> fungal infections, fatigue, chronic bronchitis and hair loss.
> -MORE-
>
>
> Page 2, P92-3, Import Alert
> Many of the ads for these unapproved drugs claim that people can save
> money on the costs of prescription drugs, but in reality the drugs may pose
> a risk to the patient's health. Dr. Kessler said so-called "foreign
> versions" of prescription drugs are often of unknown quality with inadequate
> directions for use.
> For many years FDA has permitted -- and will continue to permit -- its
> field offices to exercise discretion regarding the release for entry into
> the United States of small "personal-use" quantities of drugs sold abroad
> but not approved in the United States -- provided that the drugs do not pose
> unreasonable safety risks, that their use is not promoted in the United
> States and that they are for a serious condition for which there is no
> satisfactory treatment available in this country. The policy was designed
> to give FDA field offices discretion to release small quantities of
> medicines with which individuals returning to the United States may have
> been treated while traveling abroad and to allow individuals with serious
> conditions the ability to import, under certain limited conditions,
> personal-use quantities of unapproved drugs that they believe might be
> helpful in treating their conditions.
> Personal-use quantities are generally considered to be amounts for a
> patient's treatment for three months or less. Imports involving larger
> quantities are not permitted as they lend themselves to commercialization.
> FDA approves drugs on the basis of scientific data proving them to be
> safe and effective. FDA-approved labeling provides information on how and
> when the drugs can be used to maximize their effectiveness and minimize
> their harmful side effects. The manufacturing facilities and procedures for
> approved products are also carefully regulated by FDA to ensure product
> integrity.
> -MORE-
>
>
> Page 3, P92-3, Import Alert
> The unapproved drugs promoted by these overseas operations lack these
> safeguards and quality assurance standards.
> Consumers should also be aware that the acquisition and use of
> prescription drugs without the valid prescription of a physician or other
> licensed health professional may violate state or local laws. FDA warns
> that severe adverse reactions, including death, can result from the improper
> use of prescription drugs.
> Persons with questions about importation of drugs for personal use
> should consult with their local FDA district office or the FDA Imports
> Operations Branch in Rockville, Md., at (301) 443-6553.
> The Food and Drug Administration is one of the eight Public Health
> Service agencies within HHS.

Edited by solracselbor, 20 November 2008 - 06:12 AM.

[ak34]

Just thought I would post this here as opposed to under the suppliers section. Does anyone have anymore information on the recent events with the racetams? Relentless is saying they are no longer getting shipments past customs and they don't expect to in the near future. Can anyone say what the problem is here? They are not regulated by the FDA right?

Link?

you might find this interesting:

http://www.t-nation....iracetam_banned



Also would it be possible if someone could please verify the date and veracity of the article located withing this link:


http://www.textfiles...gs/notp_fda.txt

Which contains this non-official FDA notice:


P92-3 Food and Drug Administration
> FOR IMMEDIATE RELEASE
>
> The Food and Drug Administration announced today it has issued an import
> alert against unapproved mail-order drugs promoted by six overseas companies.
> Many of these drugs are illegally advertised in periodicals and through
> direct mail, as foreign versions of approved prescription drugs. The
> promotion and distribution of unapproved drug products within the United
> States is illegal.
> "In some cases, the drugs are counterfeit -- lacking any real similarity
> to the approved drug. The uncertain character and quality of these drugs
> constitute an unreasonable risk to the public health," FDA Commissioner
> David A. Kessler, M.D., said.
>
> The import alert instructs FDA field offices to automatically detain all
> imported unapproved prescription products manufactured by six overseas
> companies which have promoted their products in this country. The companies
> cited are Interpharm, Inc., of Nassau, Bahamas; Northam Medication Service
> International Pharmacy of Nassau, Bahamas; Inhome Services of Delemont,
> Switzerland; International Products of Hannover, Germany; Azteca Trio
> Internacional, S.A. de C.V., of Zona Rio Tijuana, Mexico; and Interlab of
> London, England.
> These companies have been promoting a wide variety of products purported
> to treat various conditions, including depression, high blood pressure,
> fungal infections, fatigue, chronic bronchitis and hair loss.
> -MORE-
>
>
> Page 2, P92-3, Import Alert
> Many of the ads for these unapproved drugs claim that people can save
> money on the costs of prescription drugs, but in reality the drugs may pose
> a risk to the patient's health. Dr. Kessler said so-called "foreign
> versions" of prescription drugs are often of unknown quality with inadequate
> directions for use.
> For many years FDA has permitted -- and will continue to permit -- its
> field offices to exercise discretion regarding the release for entry into
> the United States of small "personal-use" quantities of drugs sold abroad
> but not approved in the United States -- provided that the drugs do not pose
> unreasonable safety risks, that their use is not promoted in the United
> States and that they are for a serious condition for which there is no
> satisfactory treatment available in this country. The policy was designed
> to give FDA field offices discretion to release small quantities of
> medicines with which individuals returning to the United States may have
> been treated while traveling abroad and to allow individuals with serious
> conditions the ability to import, under certain limited conditions,
> personal-use quantities of unapproved drugs that they believe might be
> helpful in treating their conditions.
> Personal-use quantities are generally considered to be amounts for a
> patient's treatment for three months or less. Imports involving larger
> quantities are not permitted as they lend themselves to commercialization.
> FDA approves drugs on the basis of scientific data proving them to be
> safe and effective. FDA-approved labeling provides information on how and
> when the drugs can be used to maximize their effectiveness and minimize
> their harmful side effects. The manufacturing facilities and procedures for
> approved products are also carefully regulated by FDA to ensure product
> integrity.
> -MORE-
>
>
> Page 3, P92-3, Import Alert
> The unapproved drugs promoted by these overseas operations lack these
> safeguards and quality assurance standards.
> Consumers should also be aware that the acquisition and use of
> prescription drugs without the valid prescription of a physician or other
> licensed health professional may violate state or local laws. FDA warns
> that severe adverse reactions, including death, can result from the improper
> use of prescription drugs.
> Persons with questions about importation of drugs for personal use
> should consult with their local FDA district office or the FDA Imports
> Operations Branch in Rockville, Md., at (301) 443-6553.
> The Food and Drug Administration is one of the eight Public Health
> Service agencies within HHS.

I don't have any links or information other than the fact that I've spoken with retailers and they are saying that is the case. Relentless I believe has had two shipments turned around. Racetams aren't regulated right?

[solracselbor]

Well I just spoke to relentless improvement, where I was told the following:

"Dear _______,

It is a safe, non-toxic material, however it appears the FDA will no longer let it be sold as a supplement in the USA.

Kind Regards,
Pete"

Edited by solracselbor, 20 November 2008 - 04:55 PM.

[kismet]

Welcome to our world, a European nightmare for life extensionists may come true for you.
Still pretty strange that a completely harmless substance was banned.

[solracselbor]

Welcome to our world, a European nightmare for life extensionists may come true for you.
Still pretty strange that a completely harmless substance was banned.

Tell me about it.

Also, I have just spoken to a representative from American Nutrition who said that he is not aware of any piracetam "ban". In fact, the only reason why places are selling their stock quickly is becuase Piracetam, as of now, is in very high demand with low supply. He also said that they are expecting another shipment in 2 weeks. So, if they do recieve their shipment we may be able to nullify the "piracetam Ban" speculation.

[Centurion]

Welcome to our world, a European nightmare for life extensionists may come true for you.
Still pretty strange that a completely harmless substance was banned.

It works, that's why it was banned

[solracselbor]

Welcome to our world, a European nightmare for life extensionists may come true for you.
Still pretty strange that a completely harmless substance was banned.

It works, that's why it was banned

UPDATE:

Just spoke to a rep from Beyond-a-Century who told me that they have been having, as of now, no known problems with piracetam shipments.

So far, although the sample size is still small, it seems that only the big companies like relentless and BN are having this issue.

I suggest, if you would like, to call as many vendors of piracetam to inquire about this.


UPDATE # 2:

Vitacart.com is out of stock with piracetam. When I called they said their shipment is on backorder from a manufacturer in Colorodo. They are shipping to calfornia. Furthermore, the rep. stated that they have heard nothing about the FDA regualting piracetam, however the product may be stuck in customs right now. I dont know how customs and FDA are related, but if someone can explain this it would be appreciated. Additionally, the rep. stated that they are expecting their shipment in 3 weeks. In short, the rep. said their has been no mention of an FDA blockage of Piracetam.

Edited by solracselbor, 20 November 2008 - 05:23 PM.

[Centurion]

Welcome to our world, a European nightmare for life extensionists may come true for you.
Still pretty strange that a completely harmless substance was banned.

It works, that's why it was banned

UPDATE:

Just spoke to a rep from Beyond-a-Century who told me that they have been having, as of now, no known problems with piracetam shipments.

So far, although the sample size is still small, it seems that only the big companies like relentless and BN are having this issue.

I suggest, if you would like, to call as many vendors of piracetam to inquire about this.


UPDATE # 2:

Vitacart.com is out of stock with piracetam. When I called they said their shipment is on backorder from a manufacturer in Colorodo. They are shipping to calfornia. Furthermore, the rep. stated that they have heard nothing about the FDA regualting piracetam, however the product may be stuck in customs right now. I dont know how customs and FDA are related, but if someone can explain this it would be appreciated. Additionally, the rep. stated that they are expecting their shipment in 3 weeks. In short, the rep. said their has been no mention of an FDA blockage of Piracetam.

Unless youre rich, influential and have a doctor in your pocket, those in power will render piracetam beyond your reach. Increasing your IQ is cheating after all, and cheating is only for the elite

[medicineman]

Will this ban affect Europe?

[Centurion]

Will this ban affect Europe?

Indirectly yes, considering any bulk suppliers I have heard of are based in the US. Inside Europe the only source I have dealt with is QHI who ship out of Austria.

Shame, I was gonna place an order with bulknutrition on Monday! Now I'm not sure thats wise

[ak34]

Welcome to our world, a European nightmare for life extensionists may come true for you.
Still pretty strange that a completely harmless substance was banned.

It works, that's why it was banned

UPDATE:

Just spoke to a rep from Beyond-a-Century who told me that they have been having, as of now, no known problems with piracetam shipments.

So far, although the sample size is still small, it seems that only the big companies like relentless and BN are having this issue.

I suggest, if you would like, to call as many vendors of piracetam to inquire about this.


UPDATE # 2:

Vitacart.com is out of stock with piracetam. When I called they said their shipment is on backorder from a manufacturer in Colorodo. They are shipping to calfornia. Furthermore, the rep. stated that they have heard nothing about the FDA regualting piracetam, however the product may be stuck in customs right now. I dont know how customs and FDA are related, but if someone can explain this it would be appreciated. Additionally, the rep. stated that they are expecting their shipment in 3 weeks. In short, the rep. said their has been no mention of an FDA blockage of Piracetam.

I'm almost positive the american nutrition and nuetracueticsrx are the same company, or at least managed by the same company. Vitacart uses nuetraceuticsrx as their bulk powder. Therefore, they are all related and waiting for the same shipment. I also spoke with nuetraceuticsrx today and he said he had not heard of the ban but said the same, just hi demand, low supply. I've even gone so far as to call the FDA to see what they say but I'm pretty sure I will not be getting a call back.

[Declmem]

I've contacted the FDA via email: industry@fda.gov

I will post their response here.

I called their 800 number but after 20 minutes on hold I figured I shouldn't waste any more peak time minutes.

If anyone else wants to contact them: http://www.fda.gov/comments.html

Edited by Declmem, 20 November 2008 - 06:45 PM.

[Mind]

The article about import restrictions listed above only deals with sources outside the U.S. Does that mean producers of bulk powder within the U.S. will still be able to distribute to our favorite retailers?

[solracselbor]

I had a chat with Suzanne from 4rx.com online pharmacy. She basically said that it is imported from india, and she wasnt sure if there were problems with shipment. I dont think she even understood the question.

Edited by solracselbor, 20 November 2008 - 08:39 PM.

[TheLorax]

Can anyone confirm the FDA ban of racetams? Is there a date when this will be drawn into effect? Has anyone placed any orders since the suspected ban?

[Declmem]

OK guys, so I just spent half an hour talking to a rep from the FDA, food and dietary supplements department.

They don't have a database of dietary supplements, but they do have a list of "approved" food and food additives, and piracetam was not on that list. In fact she could find nothing in her database on piracetam at all. According to her, this meant that it could not be sold on shelves as a food additive or dietary supplement. Nor could it be imported into the united states or legally sold to the US citizens online.

This is the search she was using: http://www.cfsan.fda...ms/wsearch.html

However, a brief search of the main FDA.gov site DOES turn up Piracetam, so it is in their records, just not as a food additive or supplement.

So, she referred me to the FDA's drug/medicine department, from which I am now waiting on a call back. I left a message briefly explaining the situation.

When I get a call back I will post any further info here.

[Declmem]

Oh, also, the FDA rep mentioned that if there was any ingredient in the piracetam that WAS restricted by the FDA, that might be the cause of its "ban".

So before I get a call back from the FDA, could someone please post a list of ingredients that goes into making Piracetam?

[ak34]

Oh, also, the FDA rep mentioned that if there was any ingredient in the piracetam that WAS restricted by the FDA, that might be the cause of its "ban".

So before I get a call back from the FDA, could someone please post a list of ingredients that goes into making Piracetam?

I am pretty sure piractam is just piracetam. this is from wikipedia:Piracetam's chemical name is 2-oxo-1-pyrrolidine acetamide; it shares the same 2-oxo-pyrrolidone base structure with 2-oxo-pyrrolidine carboxylic acid (pyroglutamate). Piracetam is a cyclic derivative of GABA

[Declmem]

Alright guys, here's the update.

Nothing solid, unfortunately.

The drugs department couldn't find any information on it either, except for a small article in 2002 saying it wasn't approved for use in the U.S., but according to the rep I talked to, that hardly means anything. She referred me back to the CFSAN (Center for Food Safety and Applied Nutrition) section of the FDA, but I had already talked to them and they weren't helpful so I'm kind of stuck.

To their credit, both reps took a LOT of time with me and genuinely tried to find more information. This last rep even went searching around online with me to find more info. But, no luck.

Apparently, piracetam is a very, very obscure drug/supplement. There may be some law hidden in the deepest vaults of the FDA, but I could not uncover it.

So, I guess the best I can do now is give you guys more information, maybe you'll have better luck.

Here's the direct email for the CFSAN: oco2@cfsan.fda.gov

If you want to reach CFSAN by phone, call this number: 1-888-463-6332. After pickup, dial 2, then 1, then 2 again into the phone menus.

Here's the best # to reach the drug/medicine branch of the FDA: 301 796 3400

Main contact page: http://www.fda.gov/comments.html

Supplement industry itself should contact them at this email: industry@fda.gov

Hope this helps! Sorry I couldn't get more info

Edited by Declmem, 21 November 2008 - 07:14 PM.

[solracselbor]

Alright guys, here's the update.

Nothing solid, unfortunately.

The drugs department couldn't find any information on it either, except for a small article in 2002 saying it wasn't approved for use in the U.S., but according to the rep I talked to, that hardly means anything. She referred me back to the CFSAN (Center for Food Safety and Applied Nutrition) section of the FDA, but I had already talked to them and they weren't helpful so I'm kind of stuck.

To their credit, both reps took a LOT of time with me and genuinely tried to find more information. This last rep even went searching around online with me to find more info. But, no luck.

Apparently, piracetam is a very, very obscure drug/supplement. There may be some law hidden in the deepest vaults of the FDA, but I could not uncover it.

So, I guess the best I can do now is give you guys more information, maybe you'll have better luck.

Here's the direct email for the CFSAN: oco2@cfsan.fda.gov

If you want to reach CFSAN by phone, call this number: 1-888-463-6332. After pickup, dial 2, then 1, then 2 again into the phone menus.

Here's the best # to reach the drug/medicine branch of the FDA: 301 796 3400

Main contact page: http://www.fda.gov/comments.html

Supplement industry itself should contact them at this email: industry@fda.gov

Hope this helps! Sorry I couldn't get more info

Wow, great job.

I think the fact that they cant find anything about piracetam being held at customs due to a recent FDA regulation at the current time, serves as evidence that a "U.S. Piracetam" ban is probably unlikely at this time. Maybe RI is just trying to get people to buy more by instilling the fear that they will no longer be able to obtain the supplement. We'll see in a week or two. As for now, I think it will be interesting to continue searching for more information.

[Declmem]

It could be something unrelated to the FDA, like some new procedures implemented by customs. The fact that piracetam couldn't be found at all in any of the FDA's official databases isn't a good sign. It could be that customs is now searching imports to make sure they are approved supplements/food additives, and if not, they are rejected. This is impression I got from the person at CFSAN.

But, we didn't talk about customs, so this is just speculation. They're not allowed to speak on subjects that are outside their departments. I asked for its regulatory status or any information they had on it, and they didn't have any :(

[StrangeAeons]

I would imagine what they're worried about is because of its appearances and consistency somebody could sneak a more illicit substance in, in a similar container; of course, this is just lazy because it can be tested pretty easily-- but to do this on a case by case basis might be expensive. I would imagine if my theory were true than we would start to see a more unilaterally harsh stance on mysterious white powders being imported. Anybody encountered this yet?

[solracselbor]

Any updates guys?

[Mixter]

Know your rights, know the DSHEA bill:

http://www.cfsan.fda...s/dietsupp.html

As far as I am familiar with the legislation, this means that
anything that is not a prescription-only medical product but
not FDA approved either, may be sold with a label
"not approved by the fda, not intended to cure or prevent any illness".

There have been recent attempts to repeal DSHEA, but so far unsuccessful.

[solracselbor]

Know your rights, know the DSHEA bill:

http://www.cfsan.fda...s/dietsupp.html

As far as I am familiar with the legislation, this means that
anything that is not a prescription-only medical product but
not FDA approved either, may be sold with a label
"not approved by the fda, not intended to cure or prevent any illness".

There have been recent attempts to repeal DSHEA, but so far unsuccessful.

Very Nice! Thanks for this!

[ak34]

Nutraceuticsrx looks like they now have a rep. on the forum. You can find him/her under the suppliers section (just joined today looks like). They offer racetams and i've spoken with them on the phone a few times and they say that racetams are fine. Hopefully we can get them to respond here.

[NutraceuticsRx]

Welcome to our world, a European nightmare for life extensionists may come true for you.
Still pretty strange that a completely harmless substance was banned.

It works, that's why it was banned

Customs and the FDA work together. All shipments coming into the US go thru customs. If it is food related like dietary supplements a certificate of prior notice has to be submitted to the FDA.
The FDA has to clear all imports on food, drug and unfortunatly nutritional supplements.

[ak34]

Welcome to our world, a European nightmare for life extensionists may come true for you.
Still pretty strange that a completely harmless substance was banned.

It works, that's why it was banned

Customs and the FDA work together. All shipments coming into the US go thru customs. If it is food related like dietary supplements a certificate of prior notice has to be submitted to the FDA.
The FDA has to clear all imports on food, drug and unfortunatly nutritional supplements.

Sooooooooo, what is going on? You guys say that there is no problem with the racetams and will have aniracetam in 2 to 3 weeks. Just trying to clarify what is going on. If you will not have it, not really a big deal as it seems no other retailors will either.