(EDIT- Apparently I'm incapable of paying attention to topic title character limits. Apologies, and also, :facepalm:.)
If you are not familiar with the background surrounding this debate, I suggest you read the thread FDA says no more piracetam.
I got a reply from my FDA lawyer contact this morning, and she has explained the issue further. Her reply:
This is really interesting. I can give you my thoughts after reading through the materials, though obviously with a caveat (and people wonder why lawyers are so hated!) -- I have not been retained by you or any other party as legal counsel in regard to this matter, therefore the following is merely my opinion and in no way constitutes legal advice, and should not be relied upon as such.
That taken care of, here is my general impression, although without all of the details about the company and its history, it's hard to fully evaluate the situation. Yes, this is a standard FDA Warning Letter, and yes, the owner of Smartpowders appears to be mistaken in taking the 15 day time frame as an effective date for a ban. However, that's not to say that anyone selling piracetam should carry on as usual.
Here's the deal -- there is no such thing as an "unregulated" product that is intended for human or animal ingestion. It is either a drug or it's a food (dietary supplements fall under the umbrella of foods). Normally in a Warning Letter, the issue is that the manufacturer is making claims about what the product can do that go beyond the scope of dietary supplements, thereby rendering the product an unapproved new drug. What FDA says in the letter above (it is now posted in full on FDA's website), and what is unusual about this situation, is that FDA has determined that piracetam is excluded from the definition of a dietary supplement. It is not eligible for sale under the food umbrella, therefore the only avenue that remains is that of a drug. Piracetam has not been "banned" per se, but it is not eligible for sale as a supplement. It would have to be approved as a drug in order to continue to be sold, and that is likely cost prohibitive for most manufacturers, as the application filing fee alone is over $1M.
This is not a new issue for Smartpowders. According to a footnote in the Warning Letter, it appears that Smartpowders filed a New Dietary Ingredient notification with FDA in 2004, informing the agency that it intended to sell piracetam as a dietary supplement. FDA informed Smartpowders at that time that piracetam did not fall within the definition of a dietary supplement, but the company went ahead with the product. They were pretty lucky to fly under the radar for as long as they did, but the new administration at FDA has really stepped up their enforcement of supplements, so it is not surprising that they were discovered.
As for the 15 day window, FDA did not state that the product would be banned after that time. Rather, they requested that the company submit a corrective action plan addressing each violation listed in the Warning Letter and that the plan be filed within 15 days -- standard procedure. However, because of the way FDA described the piracetam violation, it is highly unlikely that the company would be able to respond adequately other than to say it was removing the product from the market. Not a ban, but the product will not be eligible for sale unless it is approved as a drug, or unless the company successfully challenges FDA's classification of piracetam as beyond the scope of supplements.
So, piracetam doesn't fall under the definition of a dietary supplement. We knew this. However, given the new information here, I would assume this would extend to more nootropics than just piracetam, given part of the letter Mike received:
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.
I maintain that Mike was wrong to send out multiple emails and start threads across a variety of forums creating a lot of hype about how piracetam was "banned." He did a very poor job of explaining the situation and led people to believe things that were not true. Whether he is doing this intentionally or because he lacks the ability to fully understand the situation, I don't know. I now have a clearer understanding of why he is unable to sell it, hopefully this helps everyone else get a better idea of what's going on.
Edited by Grapevine, 20 September 2010 - 06:49 PM.