CBD and other cannabinoids have taken the market by storm. Nevertheless, many consumers do not understand these products’ role in the complicated fight for the legalization of cannabis and cannabis-derived compounds. Despite the benefits these compounds could have for patients, the Food and Drug Administration’s lack of understanding and willingness to research these products keeps them from reaching their full potential.
FDA regulations heavily affect the sale and marketing of cannabinoid products in the United States. For example, no product containing hemp or cannabis derivatives may be sold as a “dietary supplement” under the Federal Food, Drug, and Cosmetic Act, because CBD is an active ingredient in a prescription medication the FDA has approved (the epilepsy drug Epidiolex). For the same reason, cannabinoids may not be added to food for humans or animals.
Without a clearer regulatory framework for cannabinoid products, clinical trials cannot be conducted prior to selling these products. Every day, innovators in the cannabinoid industry are finding new hemp and cannabis derivatives that could be used to produce products that benefit consumers’ health. However, without this necessary step of approval, trials cannot be conducted to determine the cannabinoids’ efficacy and safety.
Thirty-seven states, the District of Columbia, and several U.S. territories have legalized marijuana use for medicinal purposes, effectively overriding the restrictions put in place by the federal Controlled Substances Act and the FDA. Although this has allowed patients to access cannabinoid products, it also means the products they purchase generally have not been tested in rigorous clinical trials. If the FDA moves forward with establishing a regulatory framework for cannabis-based products, consumers will benefit from greater protection.
Recent activity at the FDA may indicate change is coming: The agency hired cannabis policy expert Norman Birenbaum, signaling a regulatory framework for cannabis-derived products might be on the horizon. Strides have been made in the past few years that have led to some limited hemp- and cannabis-based products receiving FDA approval. Given Birenbaum’s background working with cannabinoid regulation at the state level, his consultation with the FDA hopefully will bear fruit.
The next necessary step is to develop a clear regulatory framework for cannabis-derived products. Right now, only one cannabis-derived drug and two cannabis-related drugs have been approved by the FDA, but their use is restricted to specific circumstances. Beyond that, only three hemp seed products (not containing THC or CBD) are “generally recognized as safe” for consumption as food. These approvals do not keep up with consumers’ demand for hemp and cannabis products.
Cannabinoids represent a helpful form of relief for patients suffering from conditions ranging from epilepsy to HIV/AIDS. These compounds may even help cancer patients experiencing side effects from chemotherapy. The medicines the FDA has approved so far tend to target these particular conditions but have shown potential for other therapeutic uses in treating dementia, glaucoma, brain injury, and more.
However, the FDA still has not approved any drugs containing CBD other than Epidiolex or synthetic delta-9 THC other than Marinol and Syndros. As a result, cannabinoid products cannot be marketed to treat diseases or said to have therapeutic or medical uses. The FDA has stated an interest in facilitating research by companies looking to bring safe and effective cannabis-derived products to market. The agency must commit to this research for meaningful change to occur.
With a clearer regulatory framework, more cannabinoid products can go through trials and enter the market. That doesn’t mean the market will become a free-for-all with untested and unsafe products available for purchase. Under an effective regulatory system, new cannabinoids would still be required to undergo testing before they could be sold to consumers. As a result, patients would be able to seek out safe cannabis-derived products to treat a much wider variety of ailments.
One of the most common arguments for the federal legalization of marijuana and cannabinoids is people will buy the products whether or not they are legal. A clear regulatory framework would ensure any cannabis-derived products offered to consumers are thoroughly tested to ensure their safety. Continuing to outlaw cannabinoids will force consumers to seek products from unregulated, potentially unsafe sources.
Consumers will benefit significantly if the FDA establishes a regulatory framework for approving cannabinoids and other cannabis-derived products. Hopefully, under the guidance of Norman Birenbaum and other cannabinoid experts, the powers that be at the FDA can be encouraged to comprehend why it is essential to pursue such regulation—not only to provide patients with the treatments they need, but also to improve patient safety.
