Another blog post, this time with a slightly longer title!
Few people know that the term nootropic dates back to more than 50 years ago to 1964, when the research scientist who created the drug piracetam needed a word to describe pharmaceuticals that make you smarter.
I’ve used piracetam, or one of its sister compounds, almost every day for two decades. I found out about it from Steve Fowkes, Bulletproof Radio guest and research biochemist who ran the first newsletter on smart drugs starting in the 1980s. It’s still not FDA-approved in the US even though it’s prescribed in Europe.
Is piracetam legal?
The US government didn’t exactly ban piracetam.
Here’s how it works. To legally sell something for human consumption, a substance must be a food, a drug, or a supplement.
As it is, piracetam isn’t an FDA-approved drug. So, you then look at whether or not they will consider it a food.
The food category is further broken down into two sub-categories: foods and dietary supplements. Since piracetam doesn’t meet the requirements to be classified as a food, it would have to be accepted as a dietary supplement.
In order to be classified as a supplement, it would have to augment the diet and contain one or more of the following:
- Herb or botanical
- Amino acid
- A substance that increases total dietary intake of a nutrient
- A derivative of any of the above
Piracetam does not contain any of those, which leaves one possible avenue for FDA approval — it could be considered a food additive. In order for the government to accept it as a food additive, it has to be Generally Recognized As Safe (GRAS), which carries its own list of requirements. In short, qualified experts have evaluated it and decided that it is safe for its intended use.
So, it’s not that anyone decided piracetam is unsafe. It’s just that it hasn’t been tested and it doesn’t fit neatly into any of the required categories. So, if someone tries to sell piracetam for human consumption, they could get any number of recourse from the regulatory agencies — angry letters, fines, audits, or the whole operation could get shut down.