By Paul Armentano
A recently featured article in CBE, entitled “Implications of the MORE Act and Possible Federal Legalization of Cannabis,” opines that removing the cannabis plant from the federal Controlled Substances Act – as initially proposed by the Marijuana Opportunity Reinvestment and Expungement Act of 2019 – will reclassify it as a prescription-only substance.
Having spent more than 25 years studying cannabis policy and scheduling, I take issue with this interpretation.
Authors Tracy Gallegos and Neville M. Bilmoria opine: “[R]emoving cannabis from Schedule I of the CSA would mean that it could be treated as any other physician-prescribed drug. This means two things: (1) patients could now potentially avoid the plethora of various state medical cannabis laws and regulations and simply ask their doctor for a prescription; and (2) there could be a corresponding decrease, and ultimately the elimination of, state medical cannabis dispensaries in favor of local pharmacies potentially carrying cannabis as just another prescription drug on their shelves.”
Let me respectfully respond that this doomsday scenario would not be the result of descheduling.
In fact, substances available by prescription and obtained exclusively in pharmacies are those that have met two strict criteria. One, they have been determined by the US Food and Drug Administration to be clinically safe and effective treatments for a specific medical condition. Two, they are federally classified by DEA and HHS as Schedule II, III, IV or V substances. Removing cannabis from the CSA, a/k/a descheduling, would not amend its legal definition in such a way that it would meet either requirement.
Understanding the distinctiion between descheduling and rescheduling, a/k/a reclassifying a controlled substance to a lower category within the CSA, is pivotal. Substances categories in Schedules II through V primarily remain subject to strict federal, not state, regulations. This is why, for instance, the way controlled substances like opioids, anabolic steroids, and even prescription sleep aids like Ambien are regulated similarly in all 50 states and are not subject to a patchwork differing, state-specific policies.
By contrast, state and local governments are the primary regulators with respect to the creation and enforcement of policies governing to production, use, and sale of alcohol and tobacco. That is because neither substance is explicitly regulated by the federal Controlled Substances Act. In fact, neither alcohol nor tobacco are not included in the Act at all. This is why states and local governments possess a wide latitude to establish localized regulations for these products with respect to age limits, potency limits, hours of operation for retailers, taxation rates, and so on. State and local governments do not possess similar leeway with respect to the regulation of prescription medicines.
Just as the federal government’s decision to repeal federal alcohol prohibition nearly a century ago empowered states to be the primary decision-makers with respect to alcohol policy and enforcement, so too would the passage of The MORE Act eliminate the existing state-federal conflict and authorize states to establish their own cannabis laws in a manner that would be largely free from undue federal interference. Under such a descheduling policy, some states – at least initially – would no doubt continue to impose criminalization, just as some states continued to maintain statewide criminal restrictions on alcohol sales even after the repeal of federal alcohol prohibition. But states that wished to regulate the commercial cannabis market would be free to do so in a manner that they seem fit, and no doubt many states would choose this path.
That said, these state-specific schemes would not include the possibility of relegating the plant’s sale solely to pharmacies and/or exclusively to those patients who possess a doctor’s prescription because marijuana would still lack FDA approval as a medicine and, therefore, it would not be categorized as a Schedule II through V substance. By contrast, the unlikely scenario of Congress rescheduling cannabis from Schedule I to a lower category within the CSA could bring about such restrictions and take power away from the states – which is why NORML opposes such a federal policy change. This scenario, however, is highly unlikely because no substances lacking FDA approval currently exists in these categories, and the FDA is not likely to designate a botanical agent like cannabis as a medicine any time soon, if ever.
In conclusion, NORML advocates for the descheduling of cannabis, not the rescheduling of cannabis, for the following reasons:
- Many states have already established specific statewide laws and rules regulating cannabis production, taxation, and sales. Descheduling provides these states (and others) with the authority to continue to move forward with these regulations, while also authorizing those states that wish to continue to prohibit cannabis production and sales the flexibility to do so.
- Rescheduling is intellectually dishonest. Just as cannabis does not meet the strict criteria of a Schedule I controlled substance, it also does not meet the specific criteria that define schedules II through V.
- As a botanical plant, it currently lacks FDA approval and it is likely to continue to lack such approval going forward.
- It also lacks the abuse potential typically associated with substances categorized in Schedules II and III.
- Further, substances in these scheduling categories are only available to patients under the prescription of a physician – therefore making such a classification inapplicable to cannabis in those states that regulate its adult use.
- Rescheduling cannabis will not necessarily facilitate clinical research. The federal policies in place that make clinical trial work with cannabis more onerous than it is for other controlled substances — such as the requirement that all source material be purchased from the US National Institute on Drug Abuse (NIDA’s) University of Mississippi marijuana cultivation program — are regulatory requirements that are specific to cannabis, not to Schedule I drugs generally. Rescheduling cannabis to another classification does not necessarily change these regulations, at least in the short-term. By contrast, descheduling cannabis would allow private companies to develop their own specific and proprietary formulations of cannabis and allow them to legally test these products in FDA-approved controlled trials – with the goal of bringing such products to market.
- Congress has recently descheduled low-THC cannabis plants. In December 2018, Congress enacted legislation removing low-THC (below 0.3 percent) cannabis crops from the jurisdiction of the Controlled Substances Act. This change in policy established dual regulatory authority over the regulation of hemp to both the federal government (e.g., the United States Department of Agriculture) and the individual states. Descheduling cannabis altogether would be consistent with this existing policy and many of the state/federal regulations already established by this policy change.
The post Descheduling Cannabis Will Not Relegate Its Sale Exclusively to Pharmacies; It Will Empower States to Regulate Cannabis as They Seem Fit appeared first on Cannabis Business Executive – Cannabis and Marijuana industry news.