New Cannabis Schedule Proposal: Impact on Science
A new proposal to reclassify marijuana as a Schedule III drug doesn't make it federally legal in the USA, but it may help scientists. More still needs to be done.
Attorney General Merrick Garland has introduced a proposal to reclassify marijuana from a Schedule I to a Schedule III drug. This shift, following a recommendation from the Department of Health and Human Services, would reposition marijuana with substances like ketamine and Tylenol with codeine, acknowledging its lower potential for abuse and accepted medical use, contrasting sharply with its previous categorization as a Schedule I substance with drugs like heroin and LSD. The formal rulemaking process will begin upon publication in the Federal Register and includes a 60-day public comment period as mandated by the Controlled Substances Act (CSA).
DEA Definitions
Schedule I drugs, substances, or chemicals are defined as drugs with no currently accepted medical use and a high potential for abuse. Some examples of Schedule I drugs are: heroin, lysergic acid diethylamide (LSD), marijuana (cannabis), 3,4-methylenedioxymethamphetamine (ecstasy), methaqualone, and peyote.
Schedule III drugs, substances, or chemicals are defined as drugs with a moderate to low potential for physical and psychological dependence. Schedule III drugs abuse potential is less than Schedule I and Schedule II drugs but more than Schedule IV. Some examples of Schedule III drugs are: products containing less than 90 milligrams of codeine per dosage unit (Tylenol with codeine), ketamine, anabolic steroids, testosterone
Another big difference is that Schedule III drugs have a “a currently accepted medical use in treatment in the United States” and are legally available by prescription.
Supporters and Critics
This proposed reclassification has garnered support for its potential to ease research barriers and reduce tax burdens for cannabis businesses. However, it also faces criticism for maintaining regulatory control under the DEA, requiring cannabis dispensaries to adhere to stringent registration and reporting requirements similar to those of pharmacies. Critics have also expressed concerns about compliance with international treaties and the practical impact of the change, as marijuana will remain federally illegal. This complex transition process will involve review and possible adjustments by the Office of Management and Budget and an administrative law judge, with a potential for Congressional intervention requiring a supermajority vote.
How does this affect research?
Currently, scientists who want to conduct research on cannabis products (differentiated from hemp by containing >0.3% delta-9 THC on a dry weight basis), must apply for and be awarded a Schedule I research registration from the Drug Enforcement Agency (DEA). Getting the permit is not necessarily the greatest barrier. The part that leaves scientists the most frustrated is that as a Schedule I drug, they can only conduct research on Cannabis sources approved by the DEA. Until 2021, that source was limited to The University of Mississippi cannabis farm. In 2021, the DEA began accepting applications from additional growers.
Here is the kicker: in certain states where cannabis is current legal in state (not federally) and adults can walk into a dispensary and purchase and consume cannabis products with >0.3% delta-9 THC, federally funded scientists conducting research on cannabis are NOT allowed to study those same products! Here’s an excerpt from the NIH National Institute on Drug Abuse website:
Currently, federally-funded researchers cannot use federal or non-federal funds to obtain or handle cannabis or cannabis products that are subject to CSA regulation from a state dispensary. These materials and products continue to be controlled substances under federal law and no state dispensaries have applied or been approved by the DEA to supply cannabis for research.
What this means is that even researchers who are currently approved to conduct studies on the safety or pharmacological properties of cannabis are barred from studying the cannabis products that the public actually consumes, which are purchased in dispensaries. This has created significant gaps in our understanding of the safety of these products, particularly the risk of side effects like hyperemesis syndrome associated with the use of high-THC products.
The Takeaway
Moving marijuana to Schedule III within the DEA structure may not make cannabis federally legal, but it should ease these restrictions on scientists by allowing them to apply for Schedule III permits, which have more relaxed requirements than Schedule I permits.
Will the scheduling change allow scientists and clinicians to study the cannabis products that the public is actually using? No! There will still be limitations on approved sources of the drug for research. And that is a shame. We need to do more to bring the publicly available products into the lab and clinic for study.
Yours in health, Dr. Quave
What are your thoughts on research restrictions on cannabis? I’d love to know! Join the Nature’s Pharmacy community and add to the conversation with your comments below.
Cassandra L. Quave, Ph.D. is a scientist, author, speaker, podcast host, wife, mother, explorer, and professor at Emory University School of Medicine. She teaches college courses and leads a group of research scientists studying medicinal plants to find new life-saving drugs from nature. She hosts the Foodie Pharmacology podcast and writes the Nature’s Pharmacy newsletter to share the science behind natural medicines. To support her effort, consider a paid or founding subscription, with founding members receiving an autographed 1st edition hardcover copy of her book, The Plant Hunter.
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