Posted 23 February 2012 - 04:57 AM

Racetams cannot be classed as dietary supplements. Normally when you start making health/medical claims about a substance, it becomes a supplement in the FDA's eyes and regulated accordingly. However, if the substance cannot be considered a dietary substance, it becomes an unscheduled drug. So the second you start suggesting that your product is for human consumption, you open yourself up for an FDA audit for selling an unapproved drug.Health claims are what led the FDA onto Mike of SmartPowders.com. Google "Piracetam legality" and you'll find that all the discourse goes back to a PDF that he got. Compare that situation to CerebralHealth.com that only has a one-liner above its bulk racetams section about cognitive enhancement. Then you find Piracetam with a Wikipedia "Learn More" link and a "Buy" button.Bottom line: Not sure how you're going to market your smart pill in a way that makes no claims and survives the scrutiny of the FDA when it gets wind of you (ie when a competitor files a complaint about you).Of course, you'll notice American Piracetam vendors that make health claims all day, but that's just the nature of the supplement/pill market -- a bunch of people playing roulette with getting caught. Half the supplement industry doesn't even test for heavy metal contaminants like they should and the attitude is "catch me if you can".IANAL and you should be seeking legal counsel. Unless you want to spend hundreds of millions of dollars getting Piracetam approved for consumption, I wouldn't hinge my smart pill business on the hope that FDA never comes knocking.As far as I know, none of the big boy supplement marketeers are pushing a racetam mix, and this is really not a race you want to come in first.

Edited by Dobry Den, 23 February 2012 - 05:03 AM.