The FDA’s Department of Health and Human Services announced yesterday it would reopen its public comment period regarding its recommendations to the United Nations on altering the status of cannabis and its derivatives in international drug treaties.
The FDA’s recommendations matter because the UN is considering a recommendation from the World Health Organization to put cannabis in a less restrictive category. But the move comes on the heels of continued delays, discord, and jockeying on the global front about whether cannabis should be considered as having medical value.
Some background: Currently, cannabis and cannabis resin are listed on Schedule IV of the 1961 Single Convention on Narcotics Drugs, the global drug control treaty. Unlike in the United States, where Schedule I is the most stringent of categories, Schedule IV is the most restrictive tier of the international treaty and includes dangerous substances with extremely limited or no medical value.
In January, the World Health Organization’s Expert Committee on Drug Dependence recommended that cannabis be removed from Schedule IV and be solely listed in Schedule I (which includes opium, coca leaf, cocaine, and fentanyl), effectively acknowledging its medical utility.
Then, in March, the FDA gave the public just fourteen days to provide input on these recommended changes, just ahead of a United Nations’ Commission on Narcotic Drugs meeting in Vienna. The Commission—which is comprised of representatives from fifty-three countries and has the power to vote on whether and where a drug should be listed in international drug control conventions—was scheduled to vote that month on the recommendations from WHO’s Expert Committee on how to classify cannabis.
In a statement issued at the time, the FDA indicated that its short submission period was “needed to ensure that [it] may, in a timely fashion, carry out the required action and be responsive to the UN.” That same month (and only days ahead of the United Nations’ Commission on Narcotic Drugs meeting in Vienna), the UN’s International Narcotics Control Board, which oversees compliance with international drug conventions, released its annual report. That report simply disregards the Expert Committee’s January recommendations, and concludes that there is “often little or no scientific evidence to support the effectiveness of many of the purported medical uses of cannabis.”
Back then, the UN Commission was still debating whether to postpone voting on the recommendations until a meeting slated for December, or during its 63rd session in March 2020. If voting was deferred to a later date, the FDA promised, the agency would reopen its comment period.
Ultimately, the Commission opted to postpone the voting, but it did not specify until when. In a brief statement in March explaining its decision, the Commission indicated the postponement was done to give Member States “more time to consider the recommendations.”
As a result, the FDA said yesterday it has reopened its portal for an additional thirty days, so as to “allow adequate time for interested persons to submit comments.”
When the public comment period once again comes to a close, the agency, in collaboration with the National Institute on Drug Abuse, will consider the comments. Then, the FDA’s Department of Health and Human Services will recommend to the Secretary of State what position the United States should take when voting at the UN.
How will that go? One possible hint: In a previous statement, the FDA signaled that the Commission is not obligated to follow the WHO recommendations and could ultimately: “control the drug substance in a schedule other than that recommended” or “reject the recommendations entirely.”
According to the Knowmad Institute, an international “Think & Do Tank” that promotes drug policy reform, the Commission is expected to vote on the WHO’s recommendations during its 63rd session in March 2020.
Notably, the Commission’s membership will be renewed on January 1, 2020. In addition to the United States, the Commission will include Canada and Uruguay, which have legalized cannabis for medical and adult use, as well as countries like Colombia, which focuses solely on the former, and Mexico, which is poised to regulate both.