Current status of FDA-approved cannabis or cannabis-derived compounds

September 6, 2019

There is much controversy regarding the use of marijuana for medical conditions and the regulations surrounding both cannabis and cannabidiol (CBD) products are both confusing and nuanced.

There is much controversy regarding the use of marijuana for medical conditions and the regulations surrounding both cannabis and cannabidiol (CBD) products are both confusing and nuanced.

As of this writing, cannabis and commercial CBD products have not been approved by the US Food and Drug Administration (FDA) for use in patients as they are concerned about safety and efficacy. Many state legislatures have sidestepped the FDA, permitting the use of marijuana and CBD for medical conditions with physician “approval.” There are now 33 legal “medical marijuana” states and Washington, DC; 10 legal recreational marijuana states and Washington, DC; and 17 states with “medical CBD” laws.

Last December, the Agricultural Improvement Act of 2018 was signed into law, which removed cannabis from the Controlled Substances Act. Previously, cannabis was a Schedule I drug, defined as drugs with no accepted medical use and high abuse potential, a category that includes heroin, ecstasy, peyote, and lysergic acid diethylamide (LSD). Congress, however, preserved the FDA’s authority to regulate cannabis and cannabis derivatives under the Federal Food Drug and Cosmetic Act and the Public Health Service Act.

In addition to Epidiolex, the CBD-only drug discussed in the article, the FDA has approved Marinol and Syndros, which contain the active ingredient dronabinol, a synthetic THC for treatment of anorexia associated with AIDS patients and nausea in adult and pediatric cancer patients who have not responded to antiemetics. Cesamet is another synthetic carbenoid, nabilone, with a structure similar to THC, and is FDA approved for treating nausea and vomiting associated with cancer chemotherapy in patients aged 18 years and older for whom other antiemetics are not effective. Sativex is an oromucosal spray contacting THC and CBD in a 1:1 ratio that is used overseas for treating pain associated with multiple sclerosis and is under consideration by the FDA for use in the United States.