186 replies to this topic

[e Volution]

Cool, if anyone else finds other vendors offering discounts please post them!

I just recieved an e-mail from SmartPowders stating the following:

FDA bans Piracetam
The FDA has recently informed retailers and distributors that Piracetam is being marked as a drug. That it is not legal to sell as a dietary supplement. Smartpowders.com was informed of this on Monday August 30th, 2010. We have been given 15 days to respond to this letter from the FDA. During that time we will be running a sale to blow through our inventory. All piracetam products are now having additional 20% off until we run out! Discounts are taken at check out.
We will continue to update you as soon as we get more information. Here are the products affected: http://www.smartpowd...earch=piracetam

[gwern]

Maybe everyone should calm down a little bit.

If Mike is misinformed or lying or something like that, then some people will have bought piracetam earlier than they would have and in fewer larger orders, at a lower price than before (I don't see anyone accusing Mike of raising prices or not lowering them enough); economically, this leads to only minimal costs to those people (the opportunity cost, specifically). And Mike has already committed himself to a 40 or 50 day timeline for other retailers getting letters, so we'll know soon enough whether or not the problem is Mike's alone. It's not a very long time, all things considered.

But if Mike is correct that we're going to see most/all of the US retailers choked off, then he will have done us a great service in providing advance notice, since I don't see anything about any UK or foreign retailers being competitive with Mike's smartpowders.com (with shipping included and possible customs issues and whatnot).

And if Mike is neither completely correct nor incorrect, and only a few retailers get choked off, well, there aren't *so* many piracetam retailers that losing 2 or 3 doesn't imply major reduction in choice and presumably concomitant increases in price. I shouldn't need to draw a order-noorder/lying-nolying payoff matrix a la game theory for it to be obvious that piracetam users are better off ordering (and thus playing it safe).

[synapse]

I am curious what Pete's take on some of this is over at RI.

[pycnogenol]

This thread makes me very sad. First Altamont and now this.

[kurt]

I am curious what Pete's take on some of this is over at RI.

I know some time back he had a similar issue, but after that he continued selling it.

[synapse]

Coincidence? http://news.yahoo.co...ugs_advertising

[Neuronic]

I got the same email from Smart Powders today... of which another vendor must have leaked my address cause they have my email address and I have never bought from them.
Ironically I just read this post a few days ago and so I was worried at first when I saw the email. But I think the vendor read this thread, decided to send out a mass advertisement and have a sale.
No offense to Mike M, I hope you're wrong cause I think piracetam is the best poor mans med for narcolepsy. If you are right, thanks for the heads up!

[Pike]

though highly likely this is just as Mike says it is, i'll reserve my own speculations on the vendors until the FDA updates that letter website again to reflect up to the current date.

as for the whole issue itself, the concept of no longer being able to buy piracetam is becoming easier and easier to imagine.

[nito]

Well well...smartpowder website is now down and by the look of it on sale!

[newbieLLP]

Any USA citizens, can anyone call the FDA to find what exactly is going on?
A pissing contest won't get us any further.

Going to attempt to call them now-- I'm going to try to get in contact with this David Price fellow.


EDIT: It's Derek Price, not David. Left him a message.

Any luck?

[synapse]

Any USA citizens, can anyone call the FDA to find what exactly is going on?
A pissing contest won't get us any further.

Going to attempt to call them now-- I'm going to try to get in contact with this David Price fellow.


EDIT: It's Derek Price, not David. Left him a message.

Any luck?

I would try not to push it too much.

[chrono]

According to Price, everyone that is selling piracetam will be issued this same letter within the next 30-45 days. Sorry, I'm taking his word over yours. If the claims had anything to do with this, the same claims are made on the other racetams and they never mentioned them. It is a focused effort to eliminate the supply of piracetam so it can be made into script around the start of the year.

That will be strange when they get the same letter, since places like CH don't seem to make the same types of claims that this letter gave as the reason for asking you to desist. Several of us here have mentioned the possibility that, regardless of their motivation, it would make it more difficult for them if you removed the object of their legal justification. But as you're just repeating the same statement about their intent to bring this to prescription, I guess it's not worth trying to talk about. Maybe other retailers will have some luck with this tack.

Well well...smartpowder website is now down and by the look of it on sale!

The site is up. I think you probably had the wrong URL.

Edited by chrono, 04 September 2010 - 03:39 PM.

[FortFun]

"This letter is not intended to be an all-inclusive review of your products and their labeling. It is your responsibility to ensure that all of your products comply with the Act and its implementing regulations. You should take prompt action to correct this violation. Failure to do so may result in regulatory action without further notice. Such action may include, but is not limited to, seizure or injunction."

"Please respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific actions you are taking to correct this violation and to prevent similar violations. You should include in your response documentation such as revised labels or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, we expect that you will explain the reason for the delay and state when you will correct any remaining violations."

I wonder if smartpowders / Mike M's warning letter from the FDA had similar language? It looks like most of the letters posted by the FDA do.

I wonder why Mike M did not post the full FDA letter? He stated earlier in this thread that we would see the full arguement of the FDA when he posted it here. It is quite clear that we have not, if his letter has similar language.

Wouldn't it make you a liar if you claimed that Piracetam was being banned by the FDA because it was mentioned specifically in your warning letter (along with several other products), yet your letter clearly states that this was not an 'all inclusive review' and it is your job to 'ensure that all of your products comply'???

Gotta give the FDA some credit for not wasting tax dollars providing smartpowders with a list of every product he is selling illegally. A legitmate vendor would take heed to the warning and evaluate their labeling claims from top to bottom following the clear language of the warning. A disreputable business would probably make some absurd claim in multiple e-mails and multiple forum posts that the FDA was banning Piracetam in an attempt to cover their bases by ditching product.

I mean it is the whole gist of his arguement for why grapevine did not understand the issue...

Mike M: "This is just the start of their larger probe into piracetam. If that weren't true, why wasn't something said by Them about the other race tams? They went through my entire site looking at stuff but said nothing of oxi/ani?"

Smartpowders / Mike M, please post the full letter. The suspense is killing me. lol. I'm pretty sure you're right that this is a start into a larger probe. Only my guess is that the probe is correctly aimed at you...not Piracetam.

Cheers,
fortfun

[longevitynow]

I hope the FDA does not ban Piracetam; I find it very useful for enhancing creativity and increasing divergent thinking. I love the fact that I have been able to get it for pennies on the dollar compared to what I was paying crossing the border to get 4-5 years ago. Although I had tried it in the past, I didn't notice all that much when I took it as the price kept my daily dose low. With higher doses with a little green tea or coffee, the creative ideas fly out of my mouth or pen.
To the point, many have said that perhaps MM, owner of SmartPowders, is creating a crisis to sell product. I hope for our sakes, the crisis ends up being mainly his crisis and not the total banning of OTC or over-the-internet, US based [not sourced] Piracetam.
I don't think MM is a bad guy, he seems more honest than most in the internet supplement business (but that may not be saying much). I think MM probably IS in a crisis; he did get a real FDA letter that suggests he might be in big doo-doo unless he either stops selling Piracetam or comes up with a good defense in the next 15 days.
I don't think he is making this up to sell more Piracetam, he is legitimately concerned that he, one of the biggest sources of Piracetam in the US, may be taken out of the game. Maybe it will still be legal, let's hope that it is just a problem of claims made that make it an unapproved drug. He is in a crisis because he does need to sell his current Piracetam; and because of the existing warning letters from the FDA, he, more than others, is more likely to get in trouble later on.
But as he is a major source of Piracetam, and probably the largest buyer, we may well see Piracetam prices go up significantly if he is out of the game (he buys so much that he can sell it cheaper than anyone else).
Yes, MM wants to sell product, but he has a particular need to sell it very quickly while other vendors don't (yet). He DOES have a crisis, and this may or may not be a crisis of Piracetam availability and price for the rest of us (we have to wait to see if it is MM or Piracetam that is the FDA's rifle scope).

[Cephalon]

I'm not sure about US competition law ... is it legit in the US to advertise a product stating it will be banned in near future? I think Mike is taking an extra risk with that. If the FDA is concerend about his was of advertisment (labeling issue) they will have their focus on his website.
In Europe he would get in real trouble with that (in terms of consumer protection - not that he sells a product that is not legit to sell as supplement, but putting pressure on the customer, making irrational buying decisions ....)
But I'm sure Mike knows what he does.
it would be interesting to have a feedback from cognitive nutrition as they have piracetam on sale now ...

[Grapevine]

Any USA citizens, can anyone call the FDA to find what exactly is going on?
A pissing contest won't get us any further.

Going to attempt to call them now-- I'm going to try to get in contact with this David Price fellow.


EDIT: It's Derek Price, not David. Left him a message.

Any luck?

Haven't heard anything. I sent him an email as well, figuring he'd be more likely to respond to that than a phone call, but I doubt I'm going to get an answer anytime soon (if at all). Probably should have introduced myself as a journalist.

[kbtoy]

First of all. Christ are some of you a bunch of nit picking nancies or what? I didn't examine every single word in every single post like some of you but I'm pretty sure Mike never came out and said himself that piracetam was going to be banned. All he said was served a letter that was going to require him to respond and probly he'll have to stop selling it. IDK if any of you are into BB'in or working out at all but I do and the same thing happened with some OTC steroids recently. And the thing was they didn't go after every supplier, they hit the biggest one and seized products charged them with selling unapproved drugs and so forth. Did the ban on those happen right away no but everyone took notice and stopped selling them for the most part and the banned them a little later. And it was the same deal with that stuff too, guys being paranoid and crying saying it was all a scam to sell more product. If you feel that way about what Mike is doing don't buy it, there's no need to come on here writing novels about how it's all a conspiracy, you could probly get your point across in a few sentences, and how you've been tracking Mike McCandless for years. If you had you would probly know what other companies he's sold and for how much, and then you would probly know he's not hurting for cash. The thing is if Piracetam is on the FDA's radar chances are it's gonna happen.
Secondly I don't understand what you guys would have Mike refer to Pira as except a dietary supp, would you have him call it rat poison? B/C no the FDA would never catch onto that.
IMO if you are having doubts about it don't buy anything it's as simple as that.

[hmm...]

I've read through this FDA warning letter and also the letter directed to David Tolson that referenced Unlimited Nutrition as a potential distributor of piracetam. Changing his label will not solve his problem. He did not inform the market through the FDA that he was selling piracetam. It clearly states in the letter that by law, suppliers have to provide premarket notification for the introduction of new dietary ingredients into interstate commerce. Consequently Mike was never approved to sell the stuff.

Tolson's 2003 application for piracetam was rejected by the FDA as the FDA did not consider it a dietary supplement. The FDA took the stance that piracetam was considered a "investigational new drug." At that time, piracetam was never sold as a dietary supplement, and the research surrounding it (including the articles the 2003 application referenced) involve using piracetam to cure, treat and prevent specific neurological conditions.

Everyone should also note that since the billion-dollar Belgium pharmaceutical company UCB Pharma makes Nootropil (aka piracetam), the FDA will unlikely consider piracetam a "dietary supplement." In the US, only drugs can claim to treat, diagnose, prevent, or cure diseases.

The letter that Mike got further elaborated on what the FDA considers a dietary supplement. By law, it is 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.

His appeal will not win folks. Plus, it's not like he has the resources, legislative clout/influence or history big tobacco has.

So to make it clear, piracetam is not being "banned" by the FDA. The FDA has never allowed its use. It may be considered for use in the future as a drug, but certainly not a supplement. If Mike had informed the FDA that he was about to sell piracetam, the FDA most likely would have rejected his application.

Edited by hmm..., 06 September 2010 - 12:33 AM.

[FortFun]

kbtoy: "I'm pretty sure Mike never came out and said himself that piracetam was going to be banned."

lol. Well then kbtoy you would be pretty wrong. Great job muddying the waters though! I guess you did not read any of the multiple e-mails and forum posts on multiple sites where Mike M specifically stated that the FDA was banning Piracetam.

It seems your take is always... aw shucks guys, I didn't read any of the details but I'm pretty sure what Mike M / smartpowders meant to say was blah blah blah.

Remember the last time you jumped in to defend his lack of posted CoAs?

kbtoy: "I kind of understand that but what do business ethics have to do with quality of product? To tell everyone the truth I envy Mike, I wish I had started a company like his at 23. I'd like to start a company like his now. Plain and simple I'm satisfied with his products."

http://www.imminst.o...ntry331468</em>

I guess you missed the part about him importing 44 pallets of piractam from a broker in China. What's that, probably four drums per pallet maybe 1000 kg per pallet....44,000 kg of piracetam at a minimum??? And I'd bet dollars to donuts that broker sourced that much piracetam from multiple suppliers in China. Plus he stated he just bought up the last USA supply...from wherever that may be. He used to claim he was discriminate in buying Piracetam, guess that's out the window as of two weeks ago.

And all we have is a single COA from his long time lab contract dated a year and 1/2 ago??? (that he refused to post for months until it became a problem for him here)

But your right kbtoy, what do business ethics have to do with anything... I'm sure the product is safe. Did you hear there's a sale going on?


(edits in bold)

Edited by FortFun, 06 September 2010 - 06:12 AM.

[FortFun]

hmmm.. - Can you please post a link for us to the David Tolson letter from the FDA that you mentioned reading?

Much appreciated.

fortfun

[Pike]

I've read through this FDA warning letter and also the letter directed to David Tolson that referenced Unlimited Nutrition as a potential distributor of piracetam. Changing his label will not solve his problem. He did not inform the market through the FDA that he was selling piracetam. It clearly states in the letter that by law, suppliers have to provide premarket notification for the introduction of new dietary ingredients into interstate commerce. Consequently Mike was never approved to sell the stuff.

Tolson's 2003 application for piracetam was rejected by the FDA as the FDA did not consider it a dietary supplement. The FDA took the stance that piracetam was considered a "investigational new drug." At that time, piracetam was never sold as a dietary supplement, and the research surrounding it (including the articles the 2003 application referenced) involve using piracetam to cure, treat and prevent specific neurological conditions.

Everyone should also note that since the billion-dollar Belgium pharmaceutical company UCB Pharma makes Nootropil (aka piracetam), the FDA will unlikely consider piracetam a "dietary supplement." In the US, only drugs can claim to treat, diagnose, prevent, or cure diseases.

The letter that Mike got further elaborated on what the FDA considers a dietary supplement. By law, it is 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.

His appeal will not win folks. Plus, it's not like he has the resources, legislative clout/influence or history big tobacco has.

So to make it clear, piracetam is not being "banned" by the FDA. The FDA has never allowed its use. It may be considered for use in the future as a drug, but certainly not a supplement. If Mike had informed the FDA that he was about to sell piracetam, the FDA most likely would have rejected his application.

and you read this letter... how? a link would be appreciated. a link to both letters you read would be even better.

you'll have to forgive my skepticism, but for someone who registers 3 days ago and then makes this their first post...... it arouses some suspicion.

[m86]

http://www.fda.gov/o...5-01-vol160.pdf is what hmm... was referring to, IIANM. It's also the second result on Google for 'tolson FDA'.. though I am quite certain it has been referenced elsewhere before.

[hmm...]

yeah just google search for it

Tolson Letter:
http://www.fda.gov/o...5-01-vol160.pdf

Mike's Letter:
http://www.smartpowd...A-piracetam.pdf

The rationale behind the FDA's decision is right there. It's hard to argue with it. Piracetam is not a part a dietary ingredient that you need. Research is still being done on its mechanism of action. You can try to argue that it stimulates acetylcholine or NMDA glutamate receptors, but then you would fail because it's really not a derivative or precursor to acetylcholine (like choline) or glutamate, which are already on the market as supplements. Plus, the research of it affecting specific neuronal receptors makes it look more like a drug (like SSRIs, MAOIs, tricyclics, etc). It's not used a supplement in Europe, where it is a drug and all the research from PubMed investigates piracetam on specific conditions (like childhood seizures or Alzheimer's).

I don't know why the FDA has started this. Perhaps UCB Pharma wanted to shut it down. Maybe Mike was getting too big. Just type in "piracetam" on google shopping and 90% of the listed items are from him (Primaforce). Doesn't he also own/be part of 1fast400?


Also, if you notice in the first Tolson letter, one line says that the FDA decision is confidential for 90 days and then it gets put up on the web.

Edited by hmm..., 06 September 2010 - 07:17 PM.

[Mike M]

Won't matter anyway I will be out by friday of the powder. You guys can debate things till you are blue in the face. I spoke to the FDA Thursday at length. You guys keep thinking you know it all. Don't like me, don't buy from me. The only thing that will be left in stock next week will be piracetam caps. Have fun, no need for me to post anymore on this thread.

[FortFun]

FDA Bans Green Tea!!!

FDA labels Green Tea as a new drug!

"The therapeutic claims on your website establish that the product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease. Your Lipton Green Tea 100% Natural Naturally Decaffeinated product is not generally recognized as safe and effective for the above referenced uses and, therefore, the product is a "new drug" under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C.
§ 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective."

http://www.fda.gov/I...s/ucm224509.htm

http://news.yahoo.co..._drinks_warning

Better get it now before they run out of green tea powder! I heard unilever only has some green tea capsules left.

Nice scam on the nootropics community mike m /smartpowders. Hope you're proud of yourself.

[KimberCT]

FDA Bans Green Tea!!!

FDA labels Green Tea as a new drug!

"The therapeutic claims on your website establish that the product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease. Your Lipton Green Tea 100% Natural Naturally Decaffeinated product is not generally recognized as safe and effective for the above referenced uses and, therefore, the product is a "new drug" under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C.
§ 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective."

http://www.fda.gov/I...s/ucm224509.htm

http://news.yahoo.co..._drinks_warning

Better get it now before they run out of green tea powder!  I heard unilever only has some green tea capsules left.

Nice scam on the nootropics community mike m /smartpowders.  Hope you're proud of yourself.

I could make a contrary point by replacing the above "Green Tea" with "Ephedra".

[FortFun]

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.

[Revisiter]

I dont understand what's all the fuss over this.

Mike just thought it'd be responsible as a distributor to inform everyone that piracetam may be banned, well at least from his side, and that he's having a 20% sale on all piracetam products. Now I may be wrong and slept through economics 101 but unless Mike's putting baby powder into his piracetam or some other crap, what he's doing is very inconsistent with what you're accusing him of, isn't it? Though it may be possible that he's trying to get out of the industry by selling all his warehoused, allegedly "crap" product, I'm still buying, regardless.



PS Mike : you mind checking order 9256? It's been processing for days

[FortFun]

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!

Edited by FortFun, 08 September 2010 - 09:19 AM.

[Humanescence]

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.