• Log in with Facebook Log in with Twitter Log In with Google      Sign In    
  • Create Account
  LongeCity
              Advocacy & Research for Unlimited Lifespans

Photo
- - - - -

FDA approval is being sought for Piracetam


  • Please log in to reply
6 replies to this topic

#1 LifeMirage

  • Life Member
  • 1,085 posts
  • 3

Posted 26 August 2004 - 04:37 AM


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

Although most people if not all would see this as a good thing....it is not and heres why:

The FDA has strict guidelines for what they consider dietary supplements. (http://www.cfsan.fda...oview.html#what).

What is a "new dietary ingredient" in a dietary supplement?
The Dietary Supplement Health and Education Act (DSHEA) of 1994 defined both of the terms "dietary ingredient" and "new dietary ingredient" as components of dietary supplements. In order for an ingredient of a dietary supplement to be a "dietary ingredient," it must be one or any combination of the following substances:
a vitamin,
a mineral,
an herb or other botanical,
an amino acid,
a dietary substance for use by man to supplement the diet by increasing the total dietary intake (e.g., enzymes or tissues from organs or glands), or
a concentrate, metabolite, constituent or extract.
A "new dietary ingredient" is one that meets the above definition for a "dietary ingredient" and was not sold in the U.S. in a dietary supplement before October 15, 1994.

Piracetam does not meet any of these criteria, thus it would not be approved.

By trying to approve an unapprovable compound as a supplement, the FDA may choose to look more carefully at US suppliers and ban its sale as it is currently doing with andro.

I believe it is best to stay off the FDA radar.

#2

  • Lurker
  • 0

Posted 26 August 2004 - 05:53 AM

It was better for Piracetam being in legal limbo then now having to face scrutiny by the FDA. It will most likely be the case that Piracetam will not get dietary supplement status, and if it doesn't get that status I suppose it will be more difficult for people to order it in the US.

Freedom of supplement use, regardless of whether one considers it dietary supplement or not, it is important if nootropic use is to continue in any reasonable fashion. I suspect more nootropics will be targetted and eventually restricted or banned in one form or another, at least in the US.

sponsored ad

  • Advert
Click HERE to rent this advertising spot for SUPPLEMENTS (in thread) to support LongeCity (this will replace the google ad above).

#3 nootropi

  • Guest
  • 1,207 posts
  • -3
  • Location:Arizona, Los Angles, San Diego, so many road

Posted 26 August 2004 - 11:31 AM

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

Although most people if not all would see this as a good thing....it is not and heres why:

The FDA has strict guidelines for what they consider dietary supplements. (http://www.cfsan.fda...oview.html#what).

What is a "new dietary ingredient" in a dietary supplement?
The Dietary Supplement Health and Education Act (DSHEA) of 1994 defined both of the terms "dietary ingredient" and "new dietary ingredient" as components of dietary supplements. In order for an ingredient of a dietary supplement to be a "dietary ingredient," it must be one or any combination of the following substances:
a vitamin,
a mineral,
an herb or other botanical,
an amino acid,
a dietary substance for use by man to supplement the diet by increasing the total dietary intake (e.g., enzymes or tissues from organs or glands), or
a concentrate, metabolite, constituent or extract.
A "new dietary ingredient" is one that meets the above definition for a "dietary ingredient" and was not sold in the U.S. in a dietary supplement before October 15, 1994.

Piracetam does not meet any of these criteria, thus it would not be approved.

By trying to approve an unapprovable compound as a supplement, the FDA may choose to look more carefully at US suppliers and ban its sale as it is currently doing with andro.

I believe it is best to stay off the FDA radar.


Huh? And what is the motive behind this, really (I am implying David Tolson and Mike McClandwhatever)? Something smells fishy.

#4 peaceofmind

  • Guest
  • 12 posts
  • 0

Posted 26 August 2004 - 04:29 PM

Wouldn't it's dissaproval by the FDA automatically cause a ban on similar derivatives such as Aniracetam?

#5 ejdavis1

  • Guest
  • 92 posts
  • 0
  • Location:Washington, D.C.

Posted 26 August 2004 - 04:50 PM

Not automatically.

Edited by ejdavis1, 26 August 2004 - 05:16 PM.


#6 nootropi

  • Guest
  • 1,207 posts
  • -3
  • Location:Arizona, Los Angles, San Diego, so many road

Posted 26 August 2004 - 08:59 PM

What is this? A publicity stunt?

sponsored ad

  • Advert
Click HERE to rent this advertising spot for SUPPLEMENTS (in thread) to support LongeCity (this will replace the google ad above).

#7

  • Lurker
  • 0

Posted 27 August 2004 - 02:09 AM

Wouldn't it's dissaproval by the FDA automatically cause a ban on similar derivatives such as Aniracetam?


I suspect this would be a slippery slope. There are few places in the industrialized world where freedom of supplement use is in action to any large degree. It's getting to the point where substances are arbitrarily scheduled or banned because of the whim of officials in power. This is one area where I have views similar to libertarians.

I hope nootropi is right about this, that it is just a fuss over nothing. As I've said before I live in Canada, but the trend I see is worrying.




1 user(s) are reading this topic

0 members, 1 guests, 0 anonymous users