The FDA and the DEA Are Butting Heads Over CBD
The DEA is resisting a recommendation that the cannabis-derived compound be moved to the least restrictive category of controlled substances.
A letter from the Department of Health and Human Services (HHS) to the Drug Enforcement Administration (DEA) reveals that medical reviewers at the Food and Drug Administration (FDA) and the National Institute on Drug Abuse (NIDA) believe the federal government should lift its ban on cannabidiol, a cannabis-derived compound commonly marketed as CBD.
HHS Assistant Secretary Brett Giroir sent the letter, which Marijuana Moment's Tom Angell obtained and published this week, to DEA Acting Administrator Robert Patterson, who has since retired, in May. "After reviewing the available information," Giroir writes, the FDA and NIDA "conclude that CBD and its salts [should] be controlled in Schedule V of the Controlled Substances Act." Drugs in Schedule V, which is the least restrictive category for controlled substances, have demonstrated medical value and are deemed unlikely to cause harm, abuse, or addiction. By contrast, drugs in Schedule I, where CBD currently sits as a component of marijuana, are supposed to have no recognized medical value and a high potential for abuse.
Giroir's letter also reveals that the DEA told HHS in April, 2018, that descheduling CBD would violate the United Nations Single Convention on Narcotics, a decades-old treaty to which the U.S. is a signatory. The DEA insists that CBD can be legalized only one product at a time, as particular preparations undergo clinical trials and receive FDA approval. Last month, for instance, the DEA put the CBD medication Epidiolex in Schedule V after the FDA approved it as a treatment for two severe forms of epilepsy.
The FDA, by contrast, has argued that CBD itself should be moved to Schedule V. In fact, the FDA report Giroir shared with DEA says that CBD should be descheduled altogether if the Single Convention is ever amended. Currently, the treaty requires signatories to regulate and control cannabis and all of its derivatives:
That recommendation speaks to the safety of CBD, which is marketed across the United States as a treatment for conditions ranging from stress to epilepsy. As far as I know, the FDA has never argued that a drug in Schedule I should be descheduled altogether.
In a fight between scientists and drug cops, however, the drug cops win. The Controlled Substances Act, passed in 1970, empowers the attorney general to disregard recommendations from HHS. If Attorney General Jeff Sessions' ongoing obstruction of cannabis research is any indication, it is likely that the DEA will, for the foreseeable future, resist a broad rescheduling of CBD.
"DEA will continue to support sound and scientific research that promotes legitimate therapeutic uses for FDA-approved constituent components of cannabis, consistent with federal law," Acting DEA Administrator Uttam Dhillon said in a press release announcing the rescheduling of Epidiolex. The agency patted itself on the back for that decision:
Marijuana and CBD derived from marijuana remain against the law, except for the limited circumstances that it has been determined there is a medically approved benefit. In those instances, such as here, the drug will be made appropriately available to the public for medical use.
The drug is already widely available to the public for medical use, both as a component of most cannabis products and as a concentrate that is probably similar to Epidiolex (although we can't know that for sure, thanks to the federal prohibition on studying the effects of state-legal cannabis products in humans). There is broad support across the global medical community for CBD's therapeutic value, and the World Health Organization released a report in June that found
CBD "exhibits no effects indicative of any abuse or dependence potential", "may be a useful treatment for a number of other medical conditions", and "is generally well tolerated with a good safety profile". It also found "no evidence of recreational use of CBD or any public health-related problems associated with the use of pure CBD".
To make matters slightly more frustrating, attorney Rod Kight argues that not all forms of CBD are covered by Schedule I, because not all forms of CBD come from marijuana:
It is true that CBD derived from marijuana is also controlled. This is because CBD derived from an unlawful source is itself unlawful. But that's just the beginning of the inquiry. There are legal forms of cannabis, including industrial hemp, non-psychoactive hemp, and the mature stalks of the plant, which are an exception to the definition of marijuana. (Additionally, CBD can be derived from sources other than cannabis.) When CBD is derived from a lawful source it is lawful.
Except law enforcers don't treat any form of CBD as lawful. That CBD products have proliferated as quickly as they have says more about law enforcement priorities and resources than any consensus among cops and prosecutors about the legality of CBD.
In addition to citing the Single Convention on Narcotics as a reason to keep CBD in Schedule I, the Justice Department (which includes the DEA) has used the treaty as an excuse for blocking cannabis research. In April, Sessions cited the treaty when explaining to Congress why he continued to sit on applications for new manufacturers of research cannabis. As I wrote at the time, Sessions seems to be intentionally misreading the treaty to suit his anti-pot prejudices. That excuse probably won't hold water much longer: We now know that Sessions' obstruction of cannabis research conflicts not just with the wishes of Congressional Republicans but with the scientific advice of HHS and the FDA.