By Dr. Amanda Reiman (Ph.D., MSW), Chief Knowledge Officer, New Frontier Data
This week, the DEA announced that they support the recommendation of the Dept. Of Health and Human Services to move cannabis from Schedule 1 to Schedule 3. After reviewing the scientific evidence of the use of cannabis for medical purposes, the HHS determined that cannabis does have accepted medical value, and that it has a higher safety profile than medications currently Schedule 2, thus making the recommendation of moving it to Schedule 3. This is a historic move because, as a Schedule 1 substance, cannabis had no accepted medical value, and was deemed too dangerous to use, even under the care of a doctor. This designation was in opposition to the reality that millions of people are currently using cannabis for medical purposes under state-sanctioned programs. Cannabis was categorized as a Schedule 1 drug as part of the Controlled Substances Act of 1970. Shortly after the act was passed, groups like the National Organization for the Reform of Marijuana Laws (NORML) began petitioning the federal government to move cannabis out of Schedule 1. For decades, the federal government refused to review the case of rescheduling under the claim that there was not enough research on cannabis to conduct a thorough review of its medical utility. However, cannabis research has progressed in the past 50 years, and last year, HHS Secretary Xavier Becerra directed his agency to review this research. This review resulted in the Schedule 3 recommendation.
The DEA then had the opportunity to accept or reject this recommendation after their own review. And, this week, after 8 months, the DEA returned an acceptance of the HHS recommendation. So, what happens now? First the White House Office of Management and Budget will review the recommendation. If they approve it, there will be a public hearing where experts and the public can weigh in on the move from Schedule 1 to Schedule 3. Barring any major objections with merit, cannabis will then be rescheduled to Schedule 3. There are three major changes that will come with this new designation. First, the famed 280e tax law which prohibits cannabis companies from claiming business tax exemptions open to other businesses would no longer apply as they only impact businesses selling Schedule 1 and 2 substances. Secondly, THC-based cannabinoid medications, such as Sativex, would have a legal pathway for FDA approval. Once approved, these medications could be prescribed by a doctor and would be covered by insurance. They would also be available in all 50 states, even in states with no medical cannabis program. Finally, rescheduling would address barriers to researching cannabis. Previously, researchers could only access cannabis for research from the federal government’s supply. This meant that the government had strict control over what research was allowed. While there have been moves to end this monopoly on cannabis for research purposes, rescheduling would open new avenues for researchers to obtain cannabis and conduct studies on its medical value, as well as its impact on human health and functioning.
What rescheduling does not do is change the legal status of cannabis on the federal level. State cannabis programs would still be illegal federally, and it remains to be seen how the Feds will treat the sales and production of non-FDA-approved cannabis products now that an FDA pathway will exist. States can hope for a carve out for state legal programs with a labeling requirement indicating that products sold in dispensaries are not approved by the FDA. This would be like other herbal supplements. Rescheduling will also not allow for interstate commerce and would not impact those in jail for cannabis. Many reform organizations say that rescheduling does not go far enough, and that cannabis should be de-scheduled, often pointing out that alcohol, a substance with higher risk than cannabis, is not a controlled substance. But the federal government has spoken. Discussions should focus on ways to reconcile the newly realized medical pathway with the current state legal cannabis programs. Smoking cannabis flower will likely never be approved by the FDA, but millions of Americans currently rely on cannabis for medical purposes, and they should be considered and protected.