BTS Research’s, Sam Abunadi President & CEO, urges the FDA to require “Clinical Trials” for Cannabis dose determination as a scheduled substance with not yet classified strands

With many cities and states now approving cannabis products, and without a doctor note, the American population at large is being invited to be a part of an uncontrolled drug influence clinical trial without a sufficiently regulated method to question the right dose determination hence consumers and non-consumers are subjected to possible danger.

Now that the cannabis is much more widely dealt with and accepted, many new industries are forging their way with little guidance from the Federal agency regarding how to handle a substance that is well known to be toxic and addictive to be allowed in the industry hands – more importantly as an FDA scheduled substance without current Federal oversight is a concern.

Many brave individuals and trend setters have embarked on either making their mark in the industry or by writing their respective expectation for the Cannabis Industry like the EPA, the Bureau of Cannabis Control, and the ISO 17025. But The FDA has not formed an official stance on the subject.

The fact that this industry most likely will never go away, and that Marijuana is now grown in fields and cropped all over the states. In addition to the international attention that has been met in Canada and other countries, the FDA should at this time, look at how the cigarette, Alcohol labels were historically established and how drugs doses determinations are studied – in combination.

With high concentration of the CBD and other extracts from the plant and with variation of the genetic crop and what the active material does, the brave few that have extracted these active ingredients and made it to the shops, have only their wits to go on besides the state recognized regulations. Why do so when the EPA has been studying crops for decades and we know that there is a variation from strand to strand.

When dealing with plants, it is commonly understood that crops undergo their own optimized growth path, which includes gene’s, pesticides and growing methods. Now, taking a crop that is known to be extremely influential and, in some cases, potent, and allowing it to be processed without acceptable set limits from the FDA is very risky.

The risk we are talking about spans from traffic accidents (just like in driving under the influence), to cognition, to the now diversely present active ingredients from Cannabis Water to cosmetic materials or foods. Soon, people will start preferring a Cannabis influencing beverage over a beer, wine or hard liquor.

To really be able to use the cannabis product safely, one should know how the cannabis will affect their behavior and their health. This can only be done with two primary mechanisms at minimum. 1) Identifying the strand that will be used and maintained and 2) to conduct adequate scale clinical studies that allow the streamlining of the dose determination.

With a significant undertaking of this scope, the FDA would have no choice but to consider allowing this industry into the “large pharma” hands and the clinical trials industry at large, who can and have the ability to conduct such tests. In addition, the FDA should require a clinical medical test for dose determination for all unclassified and determined dose levels or well-studied strands.