Despite the dearth of approved marijuana products, the term “medical marijuana” has become commonplace, and the term’s prevalence continues to increase as more states legalize the use of the marijuana plant and its active derivatives for medical purposes, and marijuana dispensaries continue to expand throughout the United States. As of 2017, 29 states and the District of Columbia have approved the use of marijuana for medical purposes. (Despite state laws legalizing marijuana for medical and/or recreational use, marijuana remains a Schedule I controlled substance its distribution and use remain illegal under Federal law.)
Studies on the potential of the marijuana plant or its extracts continue to expand and include, among others, treating pain, preventing seizures, and treating autoimmune disorders such as Crohn’s disease. However, despite assertions of efficacy, the U.S. Food and Drug Administration (FDA) has not recognized or approved the marijuana plant as a medicine, and to date, the FDA has only approved three products – Marinol® and Syndrox®, which include the active ingredient, dronabinol, a synthetic delta-9-tetrahydrocannabinol (“THC”), to treat nausea associated with chemotherapy and loss of appetite in AIDS patients; and Cesamet®, which includes the active ingredient, nabilone, a synthetically derived compound with a structure similar to THC, to treat nausea and vomiting associated with chemotherapy. These drugs are available by prescription only.
The FDA, an agency within the U.S. Department of Health and Human Services, is responsible for assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use and medical devices. Before a drug can be tested in people, a drug company or sponsor performs laboratory and animal tests to discover how the drug works and whether it’s likely to be safe and work well in humans.