Foundation Submits Comment to FDA on Cannabis and Cannabis-Derived Products
Only July 12, 2019, the Foundation submitted comments to the U.S. Food and Drug Administration (FDA) in response to their request for data and information on regulation of cannabis or cannabis-derived products, following a public hearing held in May, where the Foundation also testified. The Foundation urges the agency to allow these products – particularly those with therapeutic levels of CBD – to remain available and accessible for those in the epilepsy community who rely on CBD, while creating a regulatory framework that ensures that there is consistency in available products, manufacturing, safety, testing, and labeling standards, and increases the availability of important information such as potential side effects and drug interactions so that consumers and practitioners may be better informed.
In late 2018, the Agriculture Improvement Act (Farm Bill) federally legalized hemp including hemp-derived CBD with 0.3% or less THC by dry weight. At the same time, that legislation specifically preserved the FDA’s responsibility over such products. Since the passage of the Farm Bill, the FDA has been taking an Agency-wide, integrated, and collaborative approach to addressing the regulation of products made from CBD that fall under their jurisdiction. The Foundation is encouraged by the FDA’s public process regarding regulations on cannabis and cannabis-derived compounds, including cannabidiol (CBD). Decisions and regulations will take time.
Foundation Testifies at FDA Public Hearing on Medical Cannabis and Cannabis-Derived Products
On behalf of the Foundation, Jacqueline French, M.D., chief medical and innovation officer of the Epilepsy Foundation and professor of neurology at NYU Langone Health's Comprehensive Epilepsy Center, testified at a U.S. Food & Drug Administration (FDA) public hearing about the importance of allowing CBD products to remain on the market and the need for robust regulations to ensure consistency and safety in available products. The hearing was the FDA's first step toward developing a framework to regulate CBD products after legislation was enacted to federally legalize hemp including hemp-derived CBD with 0.3% or less THC by dry weight in late 2018.
Currently, more than one-third of people living with epilepsy do not achieve seizure control with available medications. There are also many people living with significant side-effects from their current treatment. The Foundation believes that more research is needed to understand the effectiveness of CBD in treating epilepsy and seizures, however if individuals –in consultation with their healthcare team – feel that the potential benefits of CBD outweigh the risks, those individuals should have access to safe, consistent and regulated CBD products.
The Foundation will also be submitting comments to the FDA and will continue to monitor the FDA’s decisions and regulations regarding CBD products which are expected to take awhile.
President Trump Signs Farm Bill into Law, Legalizing Hemp and Hemp-derived CBD
On December 20, 2018, the President signed the 2018 Farm Bill, H.R. 2, into law. Of importance and promise to the epilepsy community is that part of the farm bill legalizes hemp and hemp-derived cannabidiol (CBD) by changing the definition of hemp to include any cannabis plant or product derived from the cannabis plant that contains less than 0.3% THC by dry weight. It also amends the Controlled Substances Act to exempt hemp as a Schedule I substance. This essentially will allow states to regulate the production and commerce of, as well as research related to CBD.
However, this does not mean that all hemp-derived products, including CBD, are medically appropriate for all people with epilepsy. As of now, Epidiolex is the only FDA-approved CBD product to treat epilepsy and is specifically indicated for seizures associated with Lennox-Gastaut and Dravet syndromes. The farm bill does not change existing laws surrounding state medical cannabis programs. Individuals who purchase treatments through a medical dispensary and via a recommendation from their physician are still required to follow the regulations set forth including registration, renewal of medical cards, and other requirements decided by each state.