CBD in the USA
I’ve had the opportunity to attend several cannabis conferences and expos in the United States over the last year and many people who came by to talk to me would ask if they’re allowed to sell cannabidiol (CBD) products, both within and outside their home state. The move recently to approve GW Pharma’s Epidiolex®, in the U.S. is a significant one as it is an admission by the U.S. FDA that cannabis has medical value. On September 27, 2018, the Department of Justice and Drug Enforcement Administration (DEA) placed Epidiolex® on schedule V of the Controlled Substances Act, the least restrictive schedule of the CSA. This class is for medications with lower abuse potential. By classifying Epidiolex® as a schedule V drug, it will be made appropriately available to the public for medical use. All other marijuana products are currently classified as schedule I drugs, along with such illegal substances as heroin and cocaine.
Currently in the U.S:
- 9 States in the United States have completely legalized cannabis for medical and recreational use
- 29 States have legalized cannabis for medical use only
- 17 States have legalized cannabis with limited THC content for medical use
To combat this restriction, various States have enacted their own state-level regulations thereby allowing the possession and sale of CBD containing cannabis products.
CBD is an abbreviation for cannabidiol, a molecular component of the cannabis plant which is touted to provide therapeutic benefit to people suffering with various medical conditions such as epilepsy, pain, or insomnia. CBD as a molecule, regardless of being derived from cannabis or hemp, is also classified as a controlled drug in the same way as the cannabis plant.
Within various States, “CBD” is most often presented in the form of hemp oil, which contains CBD. Hemp, when harvested at the proscribed time, contains less than 0.3% THC. At least 35 States have already passed industrial hemp statutes which allow for the sale of hemp derived CBD products.
There are also 9 States which have completely legalized cannabis-derived CBD for recreational or medicinal use (Alaska, California, Colorado, Maine, Massachusetts, Nevada, Oregon, Vermont and Washington). (Note: the ballot for legalization of marijuana in Michigan will take place on November 6, 2018). These States are taking full advantage of the cultivation, processing and manufacturing of cannabis products, and often move product from State to State with the risk of being “caught” by federal authorities always in the distance. In fact, only federally licensed facilities conducting medical or research and development (R&D) work within DEA licence provisions are permitted to transport CBD products from one licensed facility to another (within a state, and interstate).
The import and export of hemp-derived CBD is possible by applying for permits through the United States DEA. Similarly, the import and export of cannabis derived CBD is possible for R&D and medical use, although much more difficult to achieve then hemp-derived CBD. Inter-state movement is only permitted among federally licensed sites (i.e., licensed under special R&D provisions). Movement of cannabis (as a controlled substance) for medical or R&D purposes would be governed the exact same way as any other inter-state controlled substance movement, provided that the companies are working under federal permissions. Federal permissions for cannabis and cannabinoids do exist and universities may be able to do testing with federal permissions. However, it should be noted that the manufacturing and distribution/sale of such CBD products, regardless if they’re derived from cannabis or hemp, is not an open market across State boundaries, despite popular notions to the contrary.
- To answer some comment questions:
Can I sell CBD products? Yes, if you’re located in a State that has legalized CBD derived from cannabis or has an industrial hemp statute that has been approved for CBD derived from hemp.
- Can I transfer CBD products between States? Yes, only if you are transferring product between federally licensed facilities conducting medical or R&D work with licenses issued by the DEA.
- Can I import/export CBD products from the United States? Only with an import/export permit issued by the DEA, primarily for medical and R&D purposes only.
As mentioned above, the FDA recently approved the drug Epidiolex®, a hemp-derived CBD based formulation, which became the first cannabis-based drug to be approved in history by the United States FDA for the treatment of two epilepsy disorders. There were adequate and well-controlled clinical studies that supported the approval of this drug. Although it is approved for the specific epilepsy conditions, there is a chance the drug will be prescribed for off label use when it becomes available in the fall. The reason why Epidiolex®, is considered a huge milestone for CBD based products in the U.S. is that it will likely pave the road for other pharmaceutical products containing CBD for specific therapeutic benefits. This could also remove barriers in the transportation of a CBD based products from state to state and also open up the possibility of exporting the product from Health Canada under the Special Access Program.
At CCI, we strive to stay ahead of regulations here and abroad on cannabis activities. Our eyes are set on the United States as states shift towards legalization of recreational cannabis. I would like to see increased dialogue between Canada and the US in terms of providing more opportunities to import/export CBD products as it will help increase the supply for Canadian companies since legalization occurred on October 17th, 2018. As well, Canadian producers are seeking more suppliers for diverse genetics and starters which are often found in States such as California and Nevada. At CCI, we aid those who are seeking clarity for cannabis licensing in the U.S and importing/exporting of cannabis from the United States and can help businesses small and large navigate the complexity of the regulated landscape. Contact our subject matter experts today to find out how we ca help move your cannabis business forward.
Written by Saira Saleem, Manager Licensing & Regulations Consulting, Cannabis Compliance Inc.