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.
Epilepsy Foundation Supports Appropriations Provision to Protect State Medical Cannabis Laws
On November 17, 2017, the Epilepsy Foundation and 11 organizations representing the epilepsy community, sent a letter to leaders of the Senate and House appropriations committees urging them to include a provision in the appropriations bills that would prohibit the Department of Justice from using funds to prevent states from "implementing their own state laws that authorize the use, distribution, possession or cultivation of medical marijuana." This provision would help ensure safe and reliable access to medical cannabis and CBD through protection of the state-regulated programs, which were established pursuant to state laws. It has been included in previous appropriations bills and it is a priority to many in the epilepsy community, especially the more than a million individuals living with epilepsy who do not have seizure control even with currently available FDA-approved therapies. Read the letter below.
Epilepsy Community Group Letter - DOJ Appropriations (Nov. 17, 2017)
Epilepsy Foundation Reacts to DEA December 2016 Final Rule Concerning CBD
On December 14, 2016, the Drug Enforcement Administration (DEA) finalized a rule that was proposed in 2011 related to the status of extracts of cannabis. The rule explicitly defines CBD as a separate category on the Schedule I controlled substances list as “Marihuana Extract.” Practically, this rule results in no change to the status quo because the DEA was already defining CBD products as Schedule I under the marihuana listing. Further, this rule will not impact the Food and Drug Administration’s (FDA) treatment of CBD products currently in the pipeline.
Federal law continues to treat cannabis and CBD as illegal, Schedule I controlled substances. However, the Department of Justice enforcement policy per an internal memorandum (the Cole Memo) states that federal prosecutors should prioritize eight enforcement areas, which do not include basic possession and use – these issues are left to state and local authorities to manage under state laws. While this has not meant that the DEA does not get involved in states, it has left states like Colorado, California, and others open to instituting the growing and dispensing of cannabis or CBD programs in their state. It is possible that this policy will change under the Trump administration.
DEA Final Rule on CBD
DOJ Cole Memo
Epilepsy Foundation Reacts after DEA Announces it Will Not Reschedule Cannabis to Improve Access for Research
On Thursday, August 11, 2016 the Drug Enforcement Agency (DEA) announced it would not reschedule cannabis, but would expand the number of sites that can grow cannabis for research. The Epilepsy Foundation is disappointed with the announcement because removing cannabis from Schedule I in the Controlled Substances Act would have lifted federal barriers to cannabis research. This would have paved the way for new treatments as well as much needed information that can help families make informed choices about medical cannabis.
We are encouraged that the DEA is considering expanding the number of sites that can grow cannabis for research and will closely monitor the implementation of the proposed expansion. We are concerned that the criteria could be too burdensome and may not allow for the meaningful expansion of growing sites. Currently it is difficult for scientists and researchers to organize clinical trials involving cannabis because it is a Schedule I substance and only the National Institute for Drug Abuse (NIDA) can cultivate cannabis for medical research.
While the DEA acknowledged some promise for CBD for epilepsy and seizures, they looked at a limited number of studies -- none in epilepsy or children, and none published since 2013. Recent studies and preliminary findings from clinical trials involving cannabis have shown minimal side effects or abuse potential for CBD when used to treat uncontrolled seizures.
The Epilepsy Foundation will continue to advocate for removing federal barriers to cannabis research and policies that promote innovation for the nearly one million people living with uncontrolled seizures.
Epilepsy Foundation Press Release on DEA Rescheduling Announcement
DEA Denial of Petition to Initiate Proceedings to Reschedule Marijuana
The Epilepsy Foundation strongly supports federal cannabis legislation that would lift federal barriers to cannabis research and create safe, legal access to medical cannabis in the states.
CARERS Act Group Letter (July 2016)
Epilepsy Foundation Speaks at Senate Briefing on CARERS Act
On June 21, 2016, Americans for Safe Access (ASA) held a briefing to express their support of the Compassionate Access, Research Expansion, and Respect States (CARERS) Act (S. 683). The Epilepsy Foundation was proud to participate in this hearing, as Senators Gillibrand (NY) and Booker (NJ) spoke, along with state and local advocates for this issue. Bea Duque Long from our Government Affairs team spoke about the importance of changing federal law to protect individuals and families in states with medical cannabis programs.
We have urged the Senate to bring the CARERS Act up for a vote in committee and move it to the full Senate. The CARERS Act would remove federal barriers to research and help protect and improve state cannabis programs.
The Epilepsy Foundation led a group of organizations representing individuals living with chronic and rare health conditions in an April 27, 2016 letter to the Drug Enforcement Administration (DEA) expressing broad support from the patient community for removing federal barriers to cannabis research.
Epilepsy Foundation Leads Letter in Support of Rescheduling Cannabis
Moving cannabis from Schedule I in the Controlled Substances Act (CSA) would pave the way for greater research and new treatments. Currently it is difficult for scientists and researchers to organize clinical trials involving cannabis because it is a Schedule I substance and only the National Institute for Drug Abuse (NIDA) can cultivate cannabis for medical research. There are also additional costs and infrastructure requirements due to the Schedule I status that can limit innovation and investment in medical benefit research.
In April 2016, the DEA announced it would make a determination on the Food and Drug Administration (FDA) recommendation on the scheduling of cannabis. This announcement was included in a letter from the DEA, the Department of Health and Human Services (HHS), and the Office of National Drug Control Policy (ONDCP), sent to the Senate in response to a 2015 letter.
Group Letter on Cannabis Rescheduling (April 2016)
Epilepsy Foundation Press Release for Group Letter to DEA on Cannabis Rescheduling
Action on Medical Cannabis in 114th Congress
Congress was very active on the issue of medical cannabis during the 114th session. One of the biggest developments for medical cannabis on the federal level has been the 2015 introduction of the Compassionate Access, Research Expansion, and Protect States (CARERS) Act (S. 683), which would reschedule cannabis to lift federal barriers to cannabis research and protect individuals in states with medical cannabis programs. This was the first Senate compassionate access bill ever introduced.
Soon afterwards, the House introduced a companion bill, H.R. 1538. In April 2015, Representative Griffith introduced the Compassionate Access Act (H.R. 1774) which would require that cannabis be rescheduled and help improve access to cannabis for research purposes. The American Academy of Neurology (AAN) has endorsed H.R. 1774, truly speaking to the importance of more research on medical cannabis.
Also, Representative Scott Perry (PA) reintroduced the Charlotte’s Web Medical Access Act of 2015 (H.R. 1635) to reschedule CBD in order to improve access and protect individuals and families who are using this CBD oil. Along with this reintroduction, a Senate companion version, S. 1333, was introduced for the first time ever.
Food and Drug Administration Sends New Letters Warning Companies Inappropriately Marketing CBD
The Food and Drug Administration (FDA) has issued several more warning letters to companies that have inappropriately marketed products containing cannabidiol (CBD). Many of these companies have misrepresented the current science on CBD and many of the products contain little to no CBD. You can view the list of companies that were issued warnings here. Please keep in mind that not all companies that advertise CBD products were tested and consumers should always be careful when purchasing CBD products for the treatment of epilepsy and uncontrolled seizures.
These warnings reinforce the need for safe and legal medical cannabis programs in the states. It is important that each state that is interested in allowing the use of CBD or medical cannabis, also allow for cultivation, production, and distribution of these products within a formal program with strong safety regulations. We urge legislators to work to make CBD and cannabis a safer treatment option where consumers can be confident that the product they are purchasing contains the stated level of cannabinoids.