On October 26, 1881, outlaws calling themselves the Cowboys and lawmen engaged in a violent 30-second shootout in Tombstone, Arizona. The Gunfight at the O.K. Corral became famous for symbolizing the lawlessness of the American Old West.
While the standoff between the government and the CBD industry doesn’t involve shootouts per se, the current state of the market reminds me of those Wild West days.
The U.S. Food and Drug Administration (FDA) has its hands full dealing with the CBD bandits—opportunistic cowboys who are rushing to take advantage of the emerging market. They seem more interested in cashing in than focusing on quality and research to ensure safe and regulated products. And, unfortunately, the FDA isn’t enforcing its own rules or making stop orders more widespread.
A bad situation on the open range
The inaction is partly because the FDA, and the DEA, are outgunned. There are 28,000 cannabis businesses in the U.S. versus 25,000 combined men and women working at the FDA and DEA.
However, the government has options. The FDA could order a halt to all products sold until further notice. There is a precedent for this. In 2004, the FDA issued a final rule prohibiting the sale of dietary supplements containing ephedrine alkaloids (“Ephedra”) because such supplements present an unreasonable risk of illness or injury.
So why aren’t CBD products illegal according to the FDA?
In December 2019, the FDA stated that unregulated CBD may have the potential to harm users. The FDA noted that CBD can cause liver injury. There is an added risk of sedation and drowsiness.
Furthermore, studies of animals exposed to CBD show that it may cause male reproductive toxicity or damage to fertility in males or male offspring of women who have been exposed.
They don’t tell you these things when you buy a pack of gummies from the King of CBD or some other small shop in the city. They’re too busy counting out their cash without any repercussions.
More testing needed
Smart money says CBD lacks drug-like properties. That’s a quote often repeated by and from pretty smart top pharmaceutical industry people, life sciences analysts, and world-class medicinal chemists. The question is: Without regulation, what’s the incentive for companies other than GW Pharmaceuticals to take CBD through clinical trials? There is none. And that can be seen in the current FDA database of investigational new drug applications for CBD’s use for different disorders. Of the 96 applications filed in the United States, only 33 trials have been completed, and only 17 have been published with results. Most of all of the completed trials were studies either sponsored, performed, or supplied by GW Pharmaceuticals and/or GW Research Ltd and academia.
Again, if it says anything, it shows that many organizations in the CBD market don’t care about clinical trials or spending for legitimate scientific research. These organizations keep pumping up consumer confidence with unfounded claims. For instance, there have been claims that CBD is an alternative to opioids in treating pain. From this writer’s perspective, CBD offers a window regarding a mechanism of action in chronic pain, but it has a mountain to climb in being used as an effective treatment for chronic pain as CBD hasn’t passed any Phase 3 clinical trials to make that a reality. Moreover, as most clinical experts suggest, there is no standardized, double-blind cross over placebo-controlled trial done with CBD to reduce the use of opioids in pain management or reduce addictive cravings of opioids.
In research conducted by my organization, Kannalife, Inc., we showed that CBD and our leading drug candidate, KLS-13019 can prevent chemotherapy-induced neuropathic pain in an animal model. However, we found that CBD cannot reverse neuropathic pain, but our leading drug candidate KLS-13019 did reverse neuropathic pain, and more effectively in a much lower dose-response than morphine. Through our research, we have also found that CBD is highly inhibitory to all six known human opioid receptors, a factor that can shed further light on the probability of how CBD increases the risk of sedation and drowsiness (see: FDA findings and Epidiolex safety panel).
The shootout continues
As more and more organizations enter the market and make false claims, eventually consumers and the financial market will self-regulate. The CBD investment collapse in 2019 and further decay into 2020 is cleaning out and purging the market. Until regulators step in, consolidation and failure will do the rest.
Unfortunately, while that may have a modicum of a parallel to the statement that “Just take it because CBD never killed anyone”, it shouldn’t excuse the government or the FDA from policing the market rather than acquiescing to widespread public use of a relatively unknown compound of cannabis.
Therefore, until more research is conducted on CBD and more regulations are imposed, the CBD market will remain the Wild West.
Original Article: https://www.greenentrepreneur.com/article/349406