iRace, Medical Marijuana, Public Health

What does the FDA say about CBD and THC Products?

By: Colleen Beichner, iRACE FSUIntern
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This new series entitled Blunt Questions seeks to answer frequently asked questions from patients who use or are considering using medical marijuana.
Cannabis is now legal for medical use in 37 states and Washington DC and for recreational use in 19 states. Regardless of the various reasons people use cannabis, patients have questions that deserve thoughtful, evidence-based answers. 
One question that many patients have surrounds what it means for the Food and Drug Administration (FDA) to approve or issue warnings on cannabis and CBD products, administration methods, and how this may affect laws on the matter. This article serves as a brief overview on the topic and discuss the current policies of the FDA.
The FDA is responsible for the monitoring and approval of food, drugs, medical devices, radiation-emitting products, vaccines, blood, biologics, animal and veterinary, cosmetics, and tobacco products (FDA, 2022). It is important to note that the FDA is a federal agency, whereas medical marijuana is currently governed by individual states. In Florida, for example, the Florida Department of Health’s Office of Medical Marijuana Use (OMMU) is in charge of all regulations pertaining to medical cannabis in the state of Florida. Per the OMMU’s website, they are tasked with “writing and implementing the Department of Health’s rules for medical marijuana; overseeing the statewide Medical Marijuana Use Registry; licensing Florida businesses to cultivate, process and dispense medical marijuana to qualified patients; and certifying marijuana testing laboratories to ensure the health and safety of the public as it relates to marijuana.” As such, states are not required to consider FDA approval in their decisions on their respective cannabis and CBD laws as this is a federal agency (FDA, 2021).
FDA approval signals that a product has been proven safe and effective by the federal government for treatment under specific guidelines where required by law (FDA, 2022). This includes the quality of the drug, such as how potent it is, how pure it is, and whether the labeling is accurate or false (FDA, 2020). Additionally, once a product has been approved, the FDA continually monitors the safety and efficacy of these products and reviews concerns and complaints (FDA, 2022).
The FDA has approved four cannabis-related products including one cannabis-derived product and three synthetic cannabis-related drug products (FDA, 2020). All products require a prescription from a licensed healthcare provider (FDA, 2020).
Products approved by the FDA include: Epidiolex (cannabidiol (CBD)), and three synthetic cannabis-related drug products: Marinol (dronabinol), Syndros (dronabinol), and Cesamet (nabilone). 
- Epidiolex is a concentrated CBD product directly derived from the cannabis plant that was approved for the treatment of Lennox-Gastaut syndrome or Dravet syndrome in patients 2 years of age and older. CBD products do not contain delta-9- tetrahydrocannabinol (THC) and are therefore not psychoactive (CBD does not produce a “high” or have psychoactive intoxicating effects).

- Marinol and Syndros contain the active ingredient dronabinol which is a type of synthetic delta-9- tetrahydrocannabinol (THC). These products were approved for treating nausea associated with cancer chemotherapy and for the treatment of anorexia associated with weight loss in AIDS patients.

- Cesamet, contains the active ingredient nabilone, a synthetically derived chemical similar to THC. Cesamet, like dronabinol-containing products, is approved for treating nausea associated with cancer chemotherapy.
Currently, the FDA has not approved any administration devices for cannabis usage (FDA, 2019). Most recently, the FDA released a statement warning that vaping products containing THC have been linked to significant lung injuries and death (FDA, 2019). While vaping products obtained from unknown sources are significantly more dangerous, recommendations included avoiding vaping products for THC consumption generally, regardless of the source (FDA, 2019). Additionally, vaping products are not currently approved by the FDA. More research is needed to explore the different methods of usage and evaluate how these methods affect consumption patterns in order to create medically appropriate consumption methods. 

U.S. Food and Drug Administration (FDA). 2022. “What does FDA regulate?”.

U.S. Food and Drug Administration (FDA). 2021. “FDA Regulation of Cannabis and Cannabis-Derived Products, Including Cannabidiol (CBD)”.

U.S. Food and Drug Administration (FDA). 2020. “FDA and Cannabis: Research and Drug Approval Process”.

U.S. Food and Drug Administration (FDA). 2019. “Vaping Illness Update: FDA Warns Public to Stop Using Tetrahydrocannabinol (THC)-Containing Vaping Products and Any Vaping Products