Comment · Mon, August 29, 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
YungNO2 · 2 points
What caught my attention was this specifically : “If we have this very high burden of constantly refiling [NDINs] unnecessarily, you can imagine it will create a resistance [from industry] that over time will cause the system to break down,” Israelsen said. “And we haven’t even discussed how in the world will FDA staff and pay for all of this. They simply don’t have the resources to do it.” Their lack of resources and control fueled infallibility should be exloited to overload their petty system and expose (to the public) their obvious lack of efficency towards establishing safe and effective supplement regulation.
u/MisterYouAreSoDumb · Ceretropic & Nootropics Depot
Yes, it would be a mess. Furthermore, it is not going increase safety. There are ZERO reported deaths arising from dietary supplements every year. ZERO. Remember the FDA approved drug Vioxx? That killed 60,000 people before it was pulled from the market. Sixty fucking thousand deaths from a single FDA approved drug. Hundreds of FDA approved drugs are recalled every year due to unexpected side effects and deaths. In 2009 alone, 1,700 FDA approved drugs were recalled. Accutane was on the market for 27 years, before it was recalled in 2009 due to birth defects, IBS, and suicidal tendencies. Darvocet was on the market for 55 years before it was recalled in 2010 for causing serious heart toxicity. It caused over 2,100 deaths from 1981 to 1999! FDA approved pharmaceutical drugs kill hundreds of thousands of people every year. Dietary supplements kill zero.
Anyone that is still under the impression that the FDA is protecting them, and that having them more involved in supplements is a good thing, should just go back through the statistics for all drug related deaths and hospitalizations. This is about money and control, not safety. They have recently been trying to manipulate the public by putting out articles stating that dietary supplements lead to 20,000 ER visits a year. What they fail to also mention is that prescription drugs lead to 1.9 MILLION hospital visits a year, and 128,000 deaths! So dietary supplements only lead to 20,000 ER visits, and ZERO deaths, but prescription drugs lead to 1.9 million visits and 128,000 deaths. The EU estimates that prescription drugs kill about 200,000 every year in Europe. So just between the EU and US, there are about 328,000 deaths every year due to prescription drugs. There are ZERO for dietary supplements. Hmmm, I wonder what is the real threat to American's health and safety?!?