Not to worry on the FDA they official down graded piracetam from a prescription drug to a supplement about a year ago.
Is this true? Can anyone confirm that Piracetam is now classified as a supplement by the FDA?
They shot down David Tolson's (Bulk Nutrition, Unlimited Nutrition) attempt to do the same in 2004 (just four years ago).
I smell bullshit!
The FDA now reversed
everything they concluded in 2004?
1] That Piracetam is authorized as an investigational new drug (IND).
2] That Piracetam wasn't a dietary supplement or food prior to being an IND.
3] That since the label makes representations that Piracetam is used to treat diseases it is by definition a drug.
These guys may have fooled a couple of investors, but I'm skeptical. What substance is going to be classified by the FDA as an investigational new drug and then a few years later reclassified as a dietary supplement? It is no longer a drug? And these guys shot themselves in the foot by listing all the disease that can supposedly be ameliorated by their can.
http://64.233.169.10...v...;cd=7&gl=us"Jan. 9, 2004:
FDA has carefully considered the information in your submission, and the agency has concerns about the evidence on which you rely to support your conclusion that a dietary supplement containing Piracetam will reasonably be expected to be safe.
Page 2 -
Mr. David Tolson
Your product is excluded from the definition of "dietary supplement" under 21 U.S.C. 321(ff)(3)(B).
Piracetam is an article authorized as an
investigational new drug (IND) for which substantial clinical investigations have been instituted in the United States, and the existence of such investigations has been made public. The results of at least two clinical studies conducted under authorized INDs were published in peer reviewed journals!'
In addition, there is no evidence that Piracetam was marketed as a dietary supplement or a food
prior to the authorization to investigate Piracetam as a new drug. Therefore Piracetam is
excluded from the statutory definition of a dietary supplement under 21 US.C. 321(ff)(3)(B).
In summary, Piracetam is not a dietary supplement under the Federal Food, Drug, and Cosmetic Act.Moreover, the product appears to be a drug under the Act and thus subject to the regulatory requirements of drugs. Under 21 U.S.C. 321(g)(1)(B), an article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of a disease in man is a drug. The information contained in your submission, namely the inclusion of a list of documents
setting forth diseases for which Piracetam may be an effective treatment, suggests that it is intended to treat, prevent, or mitigate diseases. See 21 CFR 101.93(g). These representations suggest that this product is
intended for use as a drug within the meaning of21 U.S.C. 321(g)(1)(B), and that it is subject to regulation under the drug provisions of the Act. If you intend to make claims or representations of this nature, you should contact FDA's Center for Drug Evaluation and Research (CDER), Office of Compliance,
HFD-310, Montrose Metro II,
11919Rockville Pike, Rockville, Maryland 20852."
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Only thing I can think is maybe evidence was supplied to the FDA that Piracetam was marketed in the past as a dietary supplement prior to the authorization to investigate Piracetam as a new drug and therefore Piracetam could be classified as a dietary supplement relying on the statutory definition of a dietary supplement under 21 US.C. 321(ff)(3)(B). But then it would have a duel classification as a IND and a dietary supplement, if that is even possible.
Edited by Rags847, 27 June 2008 - 06:23 AM.
