No published RCTs: RCT = randomized controlled trial. Peer-reviewed published RCTs are the gold standard to prove that something works. This is how Big Pharma goes about getting a drug approved by FDA. You can skip this by selling a compound as a dietary supplement (assuming you meet certain other requirements). In this case, you can make any claim you want w/o substantiation (evidence), much less proof of safety.
Answered 7/20/2014
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