Even though CBD products and other cannabinoids have received significant popularity in recent years, many consumers are unaware of the complex legal status they face being derivatives of a product that is still currently illegal on a federal level.
The way forward for these products to realize their full potential of providing relief to patients is for the FDA to approve them, opening the door for them to be available on a much broader scale.
Because of a lack of FDA approval, cannabis and cannabinoids are not approved to be marketed for treating any specific disease or condition. In other words, cannabis and its derivatives cannot be sold or described as a drug for specific illnesses, per the FDA. Therefore, this lack of approval presents a significant obstacle to the medical use of cannabis and cannabis products.
Currently, only one cannabis-derived product and three synthetic cannabis-related products are approved. However, these products are only approved for use in minimal, extreme circumstances.
For example, Epidiolex, which contains CBD, is used in patients with extreme seizure disorders; Marinol and Syndros, which include synthetic delta-9-THC, are used for treating nausea associated with cancer chemotherapy.
Given the current legal status of marijuana on a federal level, FDA regulations for hemp and cannabis products tend to be complex. For example, since a cannabinoid is present as the active ingredient of an FDA-approved drug, nothing containing this compound can be labeled and sold as food or nutritional supplements.
This puts non-approved cannabis-derived products in a tricky state where they cannot be marketed for their intended use.
To further complicate these matters, FDA-approved clinical trials are much more difficult to conduct with products involving drugs regulated under the Controlled Substances Act (CSA).
The FDA requires clinical trials for any new medicines to be conducted in a way that does not involve potential harm to participants. With many cannabinoids being under the umbrella of “marijuana” under the CSA, there are even stricter regulations on these trials.
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One of the most notable restrictions on clinical trials for cannabinoid products is that cannabis products and derivatives used in these clinical trials must be sourced from FDA-approved growers.
The National Institute on Drug Abuse (NIDA) Drug Supply Program is the primary source of marijuana for research purposes, with additional growers being allowed to apply with the DEA to produce and distribute marijuana for scientific research. However, this policy presents a significant obstacle to the expansion of clinical trials for cannabis products.
Opening up the door for more clinical trials will lead to more cannabinoid products receiving FDA approval — a tremendous first step toward allowing more people to receive the care and relief they need.
When a drug goes through the rigorous process of clinical trials to receive FDA approval, it is tested to ensure its efficacy and safety. As a result, consumers know that when they purchase an FDA-approved product, it is made to a particular standard and, therefore, is relatively safe.
Of course, this does not mean that every product that goes through clinical trials is safe in all circumstances. FDA approval is for specific uses of a particular drug, and even so, there are potential side effects that patients should be aware of.
Clinical trials are essential in understanding any possible adverse effects that a cannabinoid product may have. Some people may react differently to cannabis-derived products than most, and a controlled clinical trial is a safe way to figure that out.
Once cannabinoid products overcome this obstacle of going through clinical trials and receiving FDA approval, much of the stigma of using these products for medical purposes can be removed.
Unauthorized cannabis products can provide relief to consumers but, due to their current status, still possess that element of uncertainty and unpredictability. With FDA approval, consumers can approach cannabinoids as a legitimate treatment with their doctor’s prescription.
One of the most exciting outcomes of a clearer regulatory framework for cannabinoid products is that, as potential forms of treatment, they will be made available to more patients not served by currently available drugs. In states where medical marijuana has been legalized, patients have used it to treat various conditions, such as severe pain, nausea from cancer treatment, and more. FDA approval would allow cannabinoids to become a mainstream treatment.
The FDA has frequently expressed a willingness to support and invest in legitimate research for medical applications of cannabis, but few legitimate strides have been made until recently.
The hiring of cannabis policy expert Norman Birenbaum represents a commitment to establishing a clear regulatory framework for FDA approval of cannabis and cannabinoids. Under the guidance of a cannabinoid expert like Birenbaum, a brighter future can be paved for using these compounds to provide patient relief.
Jorge Olson is the co-founder and CMO of two publicly traded companies, Hempacco, (HPCO), and Green Globe International, (GGII). Olson was born in Tijuana, Mexico, without running water or electricity, hurdling buckets of water across a block several times per day. Now, Olson is the author of business and inspirational books, as well as an authority on consumer packaged goods, beverages, and wholesale distribution. His partners are super-entrepreneur Sandro Piancone, Cheech and Chong, James Linsey, and Rick Ross.
