Families whose children suffer seizures from epilepsy have asked legislators in several states to “legalize” cannabidiol (CBD), “medicinal” marijuana, and “whole-plant extracts” so they can use them to reduce their children’s seizures. The marijuana industry has been happy to accommodate, helping parents lobby legislators and, when successful, producing CBD products.
But none of these products is approved by FDA as safe or effective. All make unsubstantiated medical claims. Few contain what their labels claim. Some contain contaminants. Recently, the Centers for Disease Control and Prevention reported that 52 people in Utah were poisoned by an unregulated CBD product, which contained a synthetic cannabinoid. The agency warned regulations are needed to address “this emerging public health threat.”
This week, FDA approved Epidiolex to treat two forms of epilepsy in patients ages 2 and older. Epidiolex is an extract of marijuana called cannabidiol (CBD) that is purified and delivers a reliable, consistent dose. Clinical trials proved it reduces epileptic seizures. Now families have a choice. They no longer need to risk giving their children unregulated products that may harm their already fragile health.
Epidiolex
• FDA approved
• Proven to be safe
• Proven to reduce seizures
• A purified extract of marijuana that is 99% CBD, less than 1% THC, marijuana’s psychoactive ingredient
• Doctors prescribe.
• Patients buy at pharmacies.
• Likely to be insured.
• Likely moved to a lower Schedule CBD Products States Have Legalized
• Not FDA approved
• Not proven to be safe
• Not proven to reduce seizures
• Unpurified extracts containing up to 20% CBD, THC, other components. Some are contaminated.
• Doctors recommend.
• Patients buy at dispensaries.
• Not insured.
• Likely to remain in Schedule 1
Many media outlets are reporting that FDA’s approval of Epidiolex means CBD will be placed in a lower schedule of the federal Controlled Substances Act. But FDA Commissioner Scott Gottlieb clarifies, “This is the approval of one specific CBD medication for a specific use . . . based on well-controlled clinical trials evaluating the use of this compound in the treatment of a specific condition.” Just as Marinol, Cesamet, and Syndros, FDA-approved forms of THC, are in lower schedules but THC remains in Schedule I, Epidiolex is likely to be placed in a lower Schedule while CBD likely will remain in Schedule I.
Commissioner Gottlieb says FDA continues to support rigorous scientific research into potential medical treatments using marijuana or its components but is concerned about the proliferation and illegal marketing of unapproved CBD-containing products making unproven medical claims. FDA will continue to act to end such behavior, he says.
Action is certainly needed. Searching for CBD Oil on Amazon brings up 929 results. All unregulated.
