What to know about FDA-approved cannabis-derived products
Dec 5, 2024
auto_awesome
Randy Easterling, a seasoned family practitioner and past president of the Mississippi Medical Association, dives into the world of FDA-approved cannabis-derived medications. He discusses their specific uses, such as Epidiolex, and navigates the complex regulatory landscape surrounding them. Listeners learn about the challenges in cannabis research, the legal status of THC and CBD in foods, and the importance of evidence-based studies, especially for vulnerable populations. This enlightening conversation sheds light on a rapidly evolving field.
The FDA has approved four cannabis-derived products, primarily for specific medical uses, following rigorous safety and efficacy trials.
Regulatory challenges and the Schedule I classification of cannabis significantly limit research opportunities and hinder the development of new cannabis medications.
Deep dives
Understanding FDA-Approved Cannabis Products
The FDA has not approved cannabis for treating any specific disease or condition; however, there are four FDA-approved products derived from cannabis or its compounds. These include Epidiolex, which is highly purified CBD used to treat pediatric epilepsy and certain seizure disorders, as well as Marinol and Syndros, variations of the cannabinoid Dronabinol used for appetite loss in AIDS patients and nausea from chemotherapy. Additionally, Nabilone (Sesamet) is approved for chemotherapy-induced nausea and vomiting. The rigorous FDA approval process requires randomized, double-blind trials to prove both safety and efficacy before any cannabis-related product can be legally marketed.
Research Challenges and Regulatory Considerations
The classification of cannabis as a Schedule I substance by the DEA has significantly hindered research and the development of cannabis-related medications. Researchers must obtain cannabis through a single federally sanctioned source, which complicates studies and limits the variety of cannabis used in clinical trials. Current ongoing trials are exploring cannabis's potential benefits for conditions like Tourette's syndrome and neuropathic pain, but regulatory hurdles remain a considerable barrier. Moreover, the FDA currently prohibits the sale of food products containing THC or CBD as active ingredients, yet consumer products like edibles often surface in the market, leading to potential confusion about safety and efficacy.
The U.S. Food and Drug Administration has approved cannabis-derived medications for several indications. In this episode, family practitioner Randy Easterling, MD, highlights the current regulatory status of FDA-approved cannabis-derived medications and their approved uses.
⭐⭐⭐⭐⭐
📺 Follow the AMA on YouTube: @americanmedicalassociation
🎥 Watch #AMAUpdate for the latest in health care news for physicians:
https://bit.ly/AMA_Update
📧 Subscribe to AMA Morning Rounds newsletter, with the news you need
every morning delivered to your inbox: https://bit.ly/AMA-MorningRounds
🎧 Listen to our latest podcast episodes now: https://bit.ly/AMA_Podcasts
📲 Download AMA Connect for news, podcasts, video updates and learning in
one place: https://apple.co/3URzNES
Get the Snipd podcast app
Unlock the knowledge in podcasts with the podcast player of the future.
AI-powered podcast player
Listen to all your favourite podcasts with AI-powered features
Discover highlights
Listen to the best highlights from the podcasts you love and dive into the full episode
Save any moment
Hear something you like? Tap your headphones to save it with AI-generated key takeaways
Share & Export
Send highlights to Twitter, WhatsApp or export them to Notion, Readwise & more
AI-powered podcast player
Listen to all your favourite podcasts with AI-powered features
Discover highlights
Listen to the best highlights from the podcasts you love and dive into the full episode