Comment · Fri, August 26, 2016 · Ceretropic & Nootropics Depot
Picamilon FDA ruling - Declaration of Dr. Cara Welch
Original post in this thread
YungNO2 · 71 points
So, as you all know (or should know since this is possibly the biggest nootropic community in the world and our industry is currently under attack in the US specifically) the FDA is trying to ban Picamilon as a dietary ingredient, with the help of Dr. Cara Welch
It is of my personal opinion that they have targeted a somewhat less popular substance in the nootropic market (Picamilon), which is completely harmless, has human studies on the net indicating extremely good tolerability and a low incidence of adverse events (in Russian), for the sole purpose of setting a precedent in order to ban and regulate our wide selection of beloved nootropics into oblivion.
I have issues regarding the legality of the definition used to qualify Picamilon as a synthetic drug. If Picamilon were truly a new substance all together, would it not have the effects of a new subtance rather than simply enhance the effects of 2 very well known and approved ingredients (Niacin and GABA). If the net effects of Picamilon are simply the pharmacol…
What they were answering
Direct reply to the original post — see the thread post above.
u/MisterYouAreSoDumb · Ceretropic & Nootropics Depot
Ohh, it's under a lot more attack than just that, believe me. I've been going through the regulations lately, and it is worse than you think. Did you know that a natural compound is considered adulterated if you use anything other than water or ethanol to extract it? Did you know that a supplement is considered adulterated if the extract uses the plant at a different life cycle than what is used in food? So if you use unripened apples to make an extract, that is against regulations. If you use mycelium of a mushroom, that product is adulterated. If supplements have always used roots, but you use leaves, then it is adulterated... Did you know that if a company files a new drug application on a natural compound before it is marketed as a supplement, that natural compound can never be used as a supplement again? It's considered a drug, merely because someone filed a new drug application; even if they later withdraw that application... It's not just about being natural. There are a ton of other considerations that go into it. The only reason the FDA has not completely taken over the supplement industry is because of lobbying, and support from a few select representatives and senators. The FDA is trying their hardest to regulate all supplements like they do drugs. Did you know the FDA just recently opened a new division for supplements, so they can have direct funding, instead of sharing it with the foods division? This is a fight that is just beginning, and it is anyone's guess where it will end up.