The supply chain for cannabis products is but one example of the difficulty in providing safe and effective products for a rapidly growing industry (pun intended).
In 2018, cannabis products are entering the U.S. market, but there is little protection of public health. Cannabis products range from hemp used for clothing and rope to psychoactive for recreational use.
Hemp is used for clothing and natural ropes. It is not controversial, except that it is caught up with the DEA Schedule I regulations. Modern instrumentation can quickly demonstrate that hemp phenotypes do not produce significant THC or related psychoactive cannabinoids. There is little street value to hemp. Enlightened governance should recognize that hemp is benign and create a regulatory exception.
Medicinal cannabis products include cannabidiol. On June 25, 2018, the FDA announced approval of Epidiolex from GW Pharmaceuticals for the treatment of seizures with patients suffering from Dravet syndrome and Lennox-Gastaut syndrome. These are rare forms of epilepsy that begin in childhood. Morbidity is high.
There is a large body of mostly anecdotal examples reporting the beneficial therapeutic effects of medicinal cannabis. Cannabis diol (CBD), in particular, is recognized as an analgesic and often as a nonaddictive pain reliever. Thus, many see CBD as an off-label alternative to opiates.
Medicinal cannabis seems to be an attractive class of potential therapeutics that can be controlled using existing drug regulations and dispensed with existing prescription protocols.
The third segment is recreational cannabis, which contains high levels of psychoactive cannabinoids, such as THC. In the U.S.A., the federal government seeks to prohibit all cannabis including hemp and medicinal cannabis. A majority of the states are responding by legalizing medicinal cannabis. Many states are trying to draw a bright line between the existing black market supply chain and the regulated, taxed, and hopefully safer licit supply chain.
Case in point: California has developed an end-to-end supply chain based on licensed businesses regulated by a track-and-trace paper trail. Licensed nurseries must buy the seeds from a registered supplier. Licensed growers must buy their seedlings from licensed nurseries. Licensed processors (for drying, grinding, and packaging, etc.) must buy from licensed growers. Retailers, including dispensaries, can buy only from licensed growers or processors. The goal is to prevent unlicensed suppliers (black marketers) from supplying the licit market.
Interestingly, laboratories are responsible for procuring samples on site. Laboratories including staff may not have a financial interest in any stage of the track-and-trace supply chain. Hopefully, being independent will avoid potential problems of data fraud.
Thus, the cannabis world is divided into three parts or market segments. Each has unique market drivers. In the licit drug world, these are called critical quality attributes (CQA). These often take the form of the desired benefits such as euphoric high, linked to specifications (THC content), but in the reverse order.
For more information see https://www.americanlaboratory.com/Blog/351547-Stability-of-Licit-Cannabis-Products/.
Robert L. Stevenson, Ph.D., is Editor Emeritus, American Laboratory/Labcompare; e-mail: [email protected]