Understanding how THC, CBD and all cannabis based products are regulated in the US can be a bit of a nightmare. Despite the increasing frequency with which the booming cannabis industry is in the news, the actual regulations determining how products are created and brought to market remain a blurry mess to many. CBD, even as a completely legal substance in all 50 states, could still be affected by different de-scheduling decisions. As the political movement for the de-scheduling of marijuana grows it’s important to understand some of the basic framework around our regulatory agencies and the many forms of the cannabis plant.
The most important legislation regulating the control and use of Marijuana, THC, CBD and Cannabis based products is the Controlled Substances Act or CSA, which was passed by the 91st United States Congress and signed into law by Richard Nixon.
The CSA put into place the scheduling of controlled substances, with five different classes. The Drug Enforcement Administration (DEA) and the Food and Drug Administration (FDA) are in charge of adding or removing substances from each class.
Class 1 controlled substances are those described as having the following characteristics according to the DEA:
- The drug or other substance has a high potential for abuse.
- The drug or other substance has no currently accepted medical treatment use in the U.S.
- There is a lack of accepted safety for use of the drug or substance under medical supervision.
No prescriptions may be written for Schedule I substances, and they are not readily available for clinical use.
Obviously, Tetrahydrocannabinol (THC, the psycho-active component of the Cannabis plant) is somewhat of an exception to this. Despite the fact that it is still Federally classified as a schedule 1 drug, it is legal in some states, and state Medical Marijuana laws allow prescriptions to be written for it.
There has been an ongoing debate on the de-scheduling of Cannabis. The main method for changing the classification of a controlled substance is by petitioning the DEA. The removing of cannabis from the class 1 status has been repeatedly proposed since 1972, when advocates first petitioned for its removal from the list of class 1 substances.
“The petition was ultimately denied after 22 years of court challenges, but a pill form of cannabis’s psychoactive ingredient, THC, was rescheduled in 1985 to allow prescription under schedule II. In 1999, it was again rescheduled to allow prescription under schedule III.
A second petition, based on claims related to clinical studies, was denied in 2001. The most recent rescheduling petition filed by medical cannabis advocates was in 2002, but it was denied by the DEA in July 2011. Subsequently, medical cannabis advocacy group Americans for Safe Access filed an appeal, Americans for Safe Access v. Drug Enforcement Administration in January 2012 with the District of Columbia Circuit, which was heard on 16 October 2012 and denied on 22 January 2013.””
Despite more recent attempts to petition for de-classification of the cannabis plant, the DEA refused to change its position as late as 2016. (“28 Legal Medical Marijuana States and DC – Medical Marijuana – ProCon.org”.)
This is despite a growing body of peer reviewed and published scientific studies showing the potential medical benefit of cannabinoids, both CBD and THC, and a growing market of food supplements containing just CBD, which is legal in all 50 states as long as THC content is below .3%.
So the news that has hit the internet in the last few weeks, centering on the FDA’s call for comments on the “beneficial” aspects of CBD, has garnered some understandable excitement. For those who have been using CBD to help support a variety of health needs for years and want recognition and easier access for this remedy, it may seem like a much welcome sign that the FDA is finally getting on board with CBD.
As wholehearted advocates for the fair treatment of and access to CBD, we do think it is important to point out a few key aspects of this latest development.
First, it is the DEA, not the FDA, that will have to officially change any classification status of a controlled substance under the CSA.
Also, the call for comments issued by the FDA is for an upcoming review by the World Health Organization and the United Nations, not for another appeal or petition to the DEA. That being said, the FDA will review all substances that the UN is reviewing, but, as reported by Herb, “The FDA will evaluate the drugs under consideration by the UN, but federal officials won’t make any recommendations whether they should be subject to international controls.“
Some are hoping that changes in review of CBD by the international community, namely the UN and WHO, would put pressure on US Federal agencies (the FDA and DEA) to change their classification of CBD, THC and the cannabis plant. And here is where things get even a bit trickier.
Although the Class 1 status of cannabis seems to many to clearly no longer fit, as more studies show it may indeed be a “beneficial” substance, and it has a relatively low “risk for abuse” compared to even Schedule IV drugs (which include Xanax, Valium and many Opiod painkillers) simply re-scheduling it as a class II or class III substance could provide some serious difficulties for those small cannabis companies that have pioneered in the industry despite the many roadblocks.
If the FDA and DEA agreed that cannabis had potential medical benefit, and were to re-schedule it as any lower class under the CSA, all products brought to market would have to undergo a full FDA clinical trial.
Clinical trials of class 1 substances are extremely difficult to carry out. First, the DEA must authorize the clinical research. Then access to the product for research must be approved by the National Institute on Drug Abuse. The only product available for this research is cannabis grown on the US government’s own cannabis farm, which is on the University of Mississippi campus. All transfers and research must then be overseen by the National Institutes of Health (NIH), and finally, review of the trial and oversight of the process is carried out by the FDA. Currently, only one company, GW Pharmaceuticals, has had access to the US government crop and has had approval for FDA clinical trials.
What this all means to many start-ups and small business owners in the industry is that if cannabis were to be re-scheduled as a Class II, III or even IV substance, both affording the expensive clinical research trials and gaining the agency approval needed to bring products to market would be impossible. Only those companies with the means and approved access would be positioned to sell cannabis based products.
Full de-scheduling of cannabis is thought by many advocates in the field to be the only way to preserve access to the market for small businesses. Many groups are currently working towards a full de-scheduling agenda, but the potential of this remains unclear.
Those small companies, including IrieCBD, have a holistic view of what the cannabis industry could be. We believe in whole plant oil that provides the Entourage Effect created when the natural terpenes and cannabinoids work together versus synthetic or isolated versions of CBD, THC or other naturally occurring compounds. We hold small business values dear, and therefore support a full de-scheduling of cannabis. Full de-scheduling is what would allow fair access to all able companies in the market, and would, we believe, provide the absolute best options for consumers, avoiding the monopoly by big pharmaceutical companies. We believe in the right of each individual to choose their own path to health, which is why we support all of us being informed on the issues that affect us.
Have your own story or opinion to share regarding access to cannabis based supplements? Feel free to email us at email@example.com . We’d love to hear from you.