19 replies to this topic

[rashlan]

Relentless email :

Piracetam and Oxiracetam are very interesting materials. All research, over literally decades, document them to be exceedingly safe. While Relentless Improvement has received no FDA communications, other businesses have received letters in regards to these materials, and been asked to remove them from sale.

The FDA's position is that they are not nutritional supplements, and while I personally disagree, I simply do not have the resources available to fight their position.

Given current information, I feel I have no choice but to discontinue sales of both these items as well. To be forced to destroy an on-hand inventory by FDA order would be financially crippling for a small business like mine.

Existing Piracetam stock on-hand is limited, Oxiracetam has a greater quantity available, and is currently offered at discounted pricing.

***Now is the time for you to act and stock up on Relentless Improvement brand documented quality product. With long dated expiry and stable shelf life, you would be imprudent not to***

Piracetam expiry: April 2012
Oxiracetam expiry: March 2012

You now know what I know, and there is no other information available to relay in personal communication (phone/email).

Please order directly at the links below for best prices and service. When it is gone, it is gone "forever".

Edited by rashlan, 17 September 2010 - 02:13 AM.

[Deckah]

Yeah, off the product list on SP too. Well damn.

[niner]

Are all the racetam dealers folding because one of them got a letter about health claims? c'mon. Everyone better stop selling walnuts, too.

[maxwatt]

I had trouble finding shelled walnuts at Fairway last Tuesday. They had a bin of the shelled ones too. They keep quite a while in the shells, guess I better stock up.

[Recortes]

What's their new price?. In the website I see same price as before

[iago]

According to the letter sent to Smart Powders, the only racetam they're interested in is piracetam. Oxyracetam isn't mentioned. I wonder why RI mentions it.

[gwern]

According to the letter sent to Smart Powders, the only racetam they're interested in is piracetam. Oxyracetam isn't mentioned. I wonder why RI mentions it.

The racetams are all advertised pretty much the same way. If the FDA is offended by the advertising for piracetam, then the descriptions for oxiracetam are likely offensive as well. (Look at RI's pages for piracetam & oxiracetam; they literally copy each other about the benefits.)

[iago]

According to the letter sent to Smart Powders, the only racetam they're interested in is piracetam. Oxyracetam isn't mentioned. I wonder why RI mentions it.

The racetams are all advertised pretty much the same way. If the FDA is offended by the advertising for piracetam, then the descriptions for oxiracetam are likely offensive as well. (Look at RI's pages for piracetam & oxiracetam; they literally copy each other about the benefits.)

Yes, I figure the rest are on their way out too but for now the only one targeted specifically is piracetam.

Edited by iago, 18 September 2010 - 01:32 AM.

[FortFun]

Where is fort fun saying this i s all a marketing scam? Told you guys I wasn't lying

Oh that's funny, I see your letter is now posted finally. And what do you know, it says exactly what we thought it would say:

"The issues and violations cited in this letter are not intended to be an all-inclusive statement of the violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations.

You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action, without further notice, including, without limitation, seizure and injunction. Other federal agencies may take this Warning Letter into account when considering the award of contracts.

Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the corrections. Furthermore, please advise this office what actions you will take to address product that you have already distributed"

And we can see now why you never posted the full letter. Because if you did it would be easy to refute your false claims that Piracetam was the target because no other racetams where listed in it. It would also be easy to refute your claims of a piracetam ban because the letter clearly ask you to correct the violations, not quit selling piracetam.

You also continue to pretend you have the inability to read plain english, but the RI letter if legit, clearly states they have not received any warning from the FDA and the only businesses that have are yours.

How about you please post your response to the FDA as well as the rest of the information that was aked for to verify the claims that you have made regarding a ban.

[b]1) I see the warning letter you received is still not posted on the FDA website. For all we know it might never be. Can you please post the full letter now? I am especially interested in the standard language I quoted earlier that states it was not an all inclusive review of all your potential violations and that you need to insure that you don't violate the law further in other product labeling claims. You posting the full letter would help clear up whether or not you were lying in claiming that piracetam was the target of the investiation because none of the other ractems were listed in your letter. I'd also like to see exactly what they claimed would happen in 15 days.

http://www.fda.gov/I...s/ucm225605.htm

Edited by chrono, 20 September 2010 - 09:59 PM.
removed discussion only relevant to SP products

[niner]

Where is fort fun saying this i s all a marketing scam? Told you guys I wasn't lying

Mike, I thought you got a letter on claims. Doesn't that just mean stop the claims and everything's hunky dory? Did you actually get something that said racetams themselves were out?

FortFun posted this link, which answers my question clearly:

Your firm markets your piracetam products, "Smart Powders Piracetam" and "Primaforce Piracetam" as dietary supplements; however, both products are excluded from the definition of a "dietary supplement" under section 201(ff)(1) of the Act, 21 U.S.C. § 321(ff)(1). To be a dietary supplement a product must, among other things, "bear[ ] or contain[ ] one or more ... dietary ingredients" as defined in section 201(ff)(1) of the Act. Section 201(ff)(1) of the Act defines "dietary ingredient" as a vitamin, mineral, amino acid, herb or other botanical, or dietary substance for use by man to supplement the diet by increasing the total dietary intake, or a concentrate, metabolite, constituent, extract or combination of any dietary ingredient from the preceding categories. The only substance listed as a dietary ingredient on the labeling for your "Smart Powders Piracetam" and "Primaforce Piracetam" products is piracetam. Piracetam is not a vitamin, mineral, amino acid, herb or other botanical, or dietary substance for use by man to supplement the diet by increasing the total dietary intake. Further, piracetam is not a concentrate, metabolite, constituent, extract or combination of any such dietary ingredient. Thus, because your "Smart Powders Piracetam" and "Primaforce Piracetam" products do not bear or contain any dietary ingredients as defined in section 201 (ff)(1) of the Act, these products do not qualify as dietary supplements under section 201(ff) of the Act.1

So that would seem to settle it. Piracetam is a not a supplement. It's a drug. Mike is correct here. I guess y'all better get it while the gettin's good. I don't know if the FDA expects all vendors to be on top of all letters they issue. Does this mean that Gmen are likely to march into RI and seize inventory, or does RI get a letter and a chance to unload inventory? I think RI is being appropriately cautious here, and that I was mistaken in my earlier belief that this was only about health claims. Had this link been available earlier, we could have avoided a lot of confusion. Was this posted earlier and I missed it?

[Mike M]

It's posted in the letter that has been on the front of my site for 2.5 weeks now. Everyone just choose to look at the labeling excerpt instead. I imagine all vendors will be given a letter first. With no opposition, the FDA wanted me to recall all piracetam. I refuted that and luckily was able to have time to get rid of my inventory. I'm sure I'll be subject to spot visits to look for evidence that I'm still selling it. I imagine the FDA wants to make this easy on them. If they see everyone stop selling after getting a letter, there would be no reason to take more action than that. The Price guy has been good to deal with. He hasn't cocked an attitude, just the local field rep who is a blithering idiot. The fact that people think I would lie about this when it would only take a 5 minute phone call to verify, is funny.

[Grapevine]

It's posted in the letter that has been on the front of my site for 2.5 weeks now. Everyone just choose to look at the labeling excerpt instead. I imagine all vendors will be given a letter first. With no opposition, the FDA wanted me to recall all piracetam. I refuted that and luckily was able to have time to get rid of my inventory. I'm sure I'll be subject to spot visits to look for evidence that I'm still selling it. I imagine the FDA wants to make this easy on them. If they see everyone stop selling after getting a letter, there would be no reason to take more action than that. The Price guy has been good to deal with. He hasn't cocked an attitude, just the local field rep who is a blithering idiot. The fact that people think I would lie about this when it would only take a 5 minute phone call to verify, is funny.

FYI, I left Mr. Price a message and sent him an email. He didn't respond, and if I were still working for a newspaper I would have followed up with a couple more calls, but I'm not, so I figured I'd leave it alone, especially after seeing the FDA letters that if interpreted the way you interpreted yours, state that walnuts and cherries are drugs. They are in the middle of a crackdown on labeling-- you can find evidence of this in several news articles, and you were a victim of it. This is not a ban.

Sigh.

I've sent an email to a new contact at the FDA that I made a couple weeks ago (she's actually a lawyer that specializes in labeling, so if anyone knows what they're talking about, she should), so we'll see if she has any input on this.

EDIT: FFS the FDA letter you got quotes the offending labeling! Anyway, I realize you're dead set on telling me I'm wrong and refusing to reexamine your own understanding of the whole situation (I can easily see you misinterpreting whatever Mr. Price told you), so whatever. If I get any news on this from anyone that has a little more credibility than I do, I'll post.

Edited by Grapevine, 19 September 2010 - 08:44 PM.

[Mike M]

This is not a ban.

They see it as being illegal, like they have for the past 7 years. What part of the first paragraph are you incapable of reading?

EDIT: FFS the FDA letter you got quotes the offending labeling! Anyway, I realize you're dead set on telling me I'm wrong and refusing to reexamine your own understanding of the whole situation (I can easily see you misinterpreting whatever Mr. Price told you), so whatever. If I get any news on this from anyone that has a little more credibility than I do, I'll post.

Please tell me what part of this you don't understand: however, both products are excluded from the definition of a "dietary supplement" under section 201(ff)(1) of the Act, 21 U.S.C. § 321(ff)(1).

In the end, you've talked to nobody. So you know nothing more than when you started. You ignore the overly obvious first statement because you want to pay attention to a structure function claim. Trust me, I know a TON about that. The previous business I owned got raided by the DEA/FDA last year (search affordable supplements and dea on google). I know alllllllllllll about this. You can keep talking about the labeling, but it doesn't negate the fact they still say it is NOT A DIETARY SUPPLEMENT.

[Grapevine]

This is not a ban.

They see it as being illegal, like they have for the past 7 years. What part of the first paragraph are you incapable of reading?

EDIT: FFS the FDA letter you got quotes the offending labeling! Anyway, I realize you're dead set on telling me I'm wrong and refusing to reexamine your own understanding of the whole situation (I can easily see you misinterpreting whatever Mr. Price told you), so whatever. If I get any news on this from anyone that has a little more credibility than I do, I'll post.

Please tell me what part of this you don't understand: however, both products are excluded from the definition of a "dietary supplement" under section 201(ff)(1) of the Act, 21 U.S.C. § 321(ff)(1).

In the end, you've talked to nobody. So you know nothing more than when you started. You ignore the overly obvious first statement because you want to pay attention to a structure function claim. Trust me, I know a TON about that. The previous business I owned got raided by the DEA/FDA last year (search affordable supplements and dea on google). I know alllllllllllll about this. You can keep talking about the labeling, but it doesn't negate the fact they still say it is NOT A DIETARY SUPPLEMENT.

I didn't say it was a dietary supplement.

[Grapevine]

Also, Mike, I seriously just want to know what you think of this letter and the following quote, as it has very similar wording to the letter you recieved:

http://www.fda.gov/i...s/ucm202825.htm

Because of these intended uses, your walnut products are drugs within the meaning of section 201 (g)(1)(B) of the Act [21 U.S.C. § 321(g)(B)]. Your walnut products are also new drugs under section 201(p) of the Act [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective for the above referenced conditions. Therefore, under section 505(a) of the Act [21 U.S.C. § 355(a)], they may not be legally marketed with the above claims in the United States without an approved new drug application.

[Mike M]

There is a HUGE difference. One, you just said it isn't a dietary supplement, in regards to piracetam. THAT HAS BEEN MY ENTIRE POINT. If it is not a dietary supplement it is not legal to sell, period, end of story. The walnut thing is simply a structure function claim. Walnuts are OBVIOUSLY legal to sell, but an individual product can be ruled to not be based on its claims. This is very basic stuff. Comparing the two, is just apples and oranges.

If there was solid proof that piracetam WAS a dietary supplement, then there would be ground on just changing a label to handle this issue. However, there is no proof that piracetam IS a dietary supplement .

[Humanescence]

Why not sell piracetam as piracetam. ? Like it is what it is.

Things that are not supplements or drugs get sold/brought everyday.

I may me missing an obvious part but please refresh my mind.

[Grapevine]

Why not sell piracetam as piracetam. ? Like it is what it is.

Things that are not supplements or drugs get sold/brought everyday.

I may me missing an obvious part but please refresh my mind.

You're missing Mike's disinterest in acknowledging the word "accordingly" in the letter he got.


Accordingly-- adverb
(conjunctive) In natural sequence; consequently; so.

Consequently indicates a connection between two things, the latter of which is done on account of the former.
Accordingly marks the connection as one of simple accordance or congruity, leading naturally to the result which followed.

-- from http://en.wiktionary...iki/accordingly if you want to read more. Yeah, I know it's not exactly the OED.


As in, "Accordingly, piracetam is considered a drug." According to his labeling. Ac. Cord. Ding. Ly.

Edited by Grapevine, 20 September 2010 - 05:47 AM.

[chrono]

I went ahead and deleted everything in this thread not relevant to how the FDA's letter impacts RI, and future vendors. As I mentioned elsewhere, every new thread discussing another retailer dropping piracetam is not going to turn into a re-hash of the closed Smartpowders/FDA thread. SP is no longer selling piracetam, and Mike's business practices and the purity of that product are not relevant to RI's letter.


I'm wondering why RI is being so proactive about removing these products. As niner asked, would the FDA be justified in holding them to warnings issued to another specific vendor? The issue of claims does seem (to me) to be central to this, and I guess selling it in capsules makes it pretty clear it's intended for human consumption. But I have to wonder why RI removed oxiracetam, as well; are dietary supplements subject to some form of the 'analogue act," such that oxiracetam would be thought to be included in the FDA's statement?

Edited by chrono, 20 September 2010 - 10:09 PM.
added link

[Grapevine]

I went ahead and deleted everything in this thread not relevant to how the FDA's letter impacts RI, and future vendors. As I mentioned elsewhere, every new thread discussing another retailer dropping piracetam is not going to turn into a re-hash of the closed Smartpowders/FDA thread. SP is no longer selling piracetam, and Mike's business practices and the purity of that product are not relevant to RI's letter.


I'm wondering why RI is being so proactive about removing these products. As niner asked, would the FDA be justified in holding them to warnings issued to another specific vendor? The issue of claims does seem (to me) to be central to this, and I guess selling it in capsules makes it pretty clear it's intended for human consumption. But I have to wonder why RI removed oxiracetam, as well; are dietary supplements subject to some form of the 'analogue act," such that oxiracetam would be thought to be included in the FDA's statement?

Judging by the information I got from my FDA contact, I would say this is the case. I posted it in a separate thread, but since it's unlikely oxiracetam/other nootropics fall under the definition of dietary supplements, they too would be a problem to sell.