TOPIC

THE FIX FOR ALL CANNABIS REFORMS

Scientific pilot programs are the mechanism the industry can use to secure substantial cannabis reform through executive action. The same process we outline below for medical marijuana, and the approach the DOJ and DEA should have taken, can be replicated for virtually any cannabis reform the industry and an administration want to pursue. Rinse and repeat. 

While the pilot programs are the mechanism, both state and federal governments should use the opportunity to thoroughly study the effects of these programs, with the goal of implementing the most socially beneficial and successful cannabis policies. 

First off, the AG should have just rescheduled "marijuana" and not scheduled products found in 41 different state legal programs. Second, the AG should have coordinated its final rule with HHS/FDA to ensure that DEA did not unilaterally implement regulations that are reserved for health experts. There are several mechanisms codified into US law and regulation which would have allowed the DEA and FDA to legalize state legal medical marijuana operators.

21 USC 811(d)(1) allows for the AG to reschedule a "drug" if it would better align the US with its International obligations. Drugs, and what constitutes a drug are controlled by the FDA. As such, the DEA can’t just create a new drug – classified as "state-legal marijuana" – without FDA input. It neither made sense legally nor rationally. DEA should have instead: (1) skipped the rescheduling hearing and issued a final order placing marijuana into Schedule III; or (2) canceled the current DEA rescheduling process, and commenced the 811(d)(1) scheduling order for "marijuana". Doing so would have gutted the petitioners’ arguments around NORML v. DEA, because HHS recommended Schedule III. That would have insulated marijuana in Schedule III and focused the argument exclusively on the state legal market gaining access to DEA registration.

That argument could then be dealt with separately. Once "marijuana" was rescheduled, then DEA would have several options for regulating state-legal medical marijuana markets. Both would require FDA participation. First, DEA could do what they are doing now, and allow state legal licensees to register with DEA. The second, is to waive registration requirements (as permitted by 21 USC 872(e)) entirely and permit the possession and distribution of state legal medical marijuana to those licensed under state programs.

As mentioned, FDA’s participation is key to any action intended to regulate state-legal medical marijuana programs. DEA could have worked with FDA on establishing a program by which each legal medical marijuana market would submit an Investigational New Drug (“IND”) application to the FDA for their state programs. FDA would then have authority under 21 CFR 312.10, to waive application requirements if it found that doing so would not pose a significant and unreasonable risk to human subjects. This implies that some reasonable risks are tolerated.

While some people may pause here and ask how FDA could satisfy that standard, I would counter “with studies showing people are drinking significantly less alcohol after consuming marijuana” (see Marijuana is Safer than Alcohol). Looking at the devastating effects of alcohol, including the 488 people who die each day from excessive alcohol use, this substitution sure seems like a public health benefit to us. By coordinating DEA and FDA under an IND, it would have legitimized DEA’s acknowledgement of state legal medical marijuana within the FDA drug framework and further insulated the rule from judicial challenge. There are numerous statutory and regulatory pathways for conducting research. And each of those pathways can lead to different legal commercial markets (i.e. establishing scientific pilot programs for medical, or adult-use, or social equity, or intoxicating hemp beverages).

What DEA should have done is first ensured that marijuana remained in Schedule III by simply moving the substance under the initial rescheduling proposed rule. Then DEA and FDA should have worked together to implement scientific medical pilot programs under INDs aimed at researching the state legal medical market, patient results, and the effects of legalization on society as a whole.

Importantly, all of this can be coordinated and executed at the executive agency level, without the need for Congress.

ADULT-USE

Applying the same principles as discussed above with medical marijuana, the executive branch can direct the DEA and FDA to conduct pilot programs on adult-use markets in the United States.

INTOXICATING HEMP

Applying the same principles as discussed above with medical marijuana, the executive branch can direct the DEA and FDA to conduct pilot programs on intoxicating hemp. These pilot programs can study the differences between the same product sourced from hemp and marijuana or simply study the use and consumption of intoxicating hemp in jurisdictions that allow it.

SOCIAL EQUITY

Applying the same principles as discussed above with medical marijuana, the executive branch can direct DEA, FDA, and, say, the Small Business Administration to coordinate and support pilot programs around the country to study and determine how best to implement a federal program.

INDUSTRIAL HEMP

The same scientific pilot programs can be implemented for industrial hemp, but it is also another avenue to access substantial investment. While subsidies must go through Congress, the next administration could relocate a portion of Department of Defense funds to commence a cannabis research project. The DOD has broad discretion over funds it receives from Congress, so this could theoretically subsidize a new hemp industry that could compete with bog oil, cotton, plastic, pharma, etc. We already know that hemp can be a sustainable replacement for many products that are harmful to our environment. All that is needed is funding and support to help this industry grow at a rate that can compete.