Comment · Mon, November 1, 2021 · ND Owner
Tongkat capsules vary in weight. How significant is this?
What they were answering
Temporary_South_9122 · 1 points
Yeah, I’m not surprised. It’s not regulated by
The FDA so god knows where they are being made. But nootropics depot is pretty reliable.
u/MisterYouAreSoDumb · ND Owner
We are absolutely regulated by the FDA. We have thousands of regulations we need to follow, and our facility is inspected by FDA inspectors. Capsule content amounts and variance are absolutely part of the FDA regulations. The FDA states that you need to be at or above(within reason) label claim on your products, and that those capsules need to meet USP's capsule variance specs. They let you dictate your processes on how to achieve that, but they regulate to ensure they are.
I think the reason people have the misconception that supplements are not regulated by the FDA is because of efficacy. The dietary supplement industry doesn't need to prove ahead of time that a product has a certain effect. Drugs have to prove efficacy before they are approved. Dietary supplements are still regulated for safety and to prove they are what they claim to be, though. Also, the FTC does regulate claims for dietary supplements. It's just a different government agency than the FDA. The FTC goes after supplement brands all the time for making unsubstantiated claims. The FDA is often times a part of those lawsuits, but the FTC leads the way in the US on unsubstantiated claims. They recently did it to that bullshit Prevagen supplement being pushed everywhere.
So we are absolutely regulated by the FDA, and we do need to ensure our claims are valid and substantiated. It's just a slightly different process than drugs. The FDA regulates supplements for safety and to ensure they are the things they claim to be. The FTC regulates for claims.