Contrary to decades of reefer madness propagated by our federal government, the Food and Drug Administration (FDA) now admits that marijuana does have accepted medical use. However, reports of the death of cannabis prohibition are exaggerated. No doubt, the conclusion of FDA’s scientific review of marijuana’s current Schedule I status is a welcome milestone in federal cannabis policy.
But while the Department of Health and Human Services’s (HHS) August 29, 2023 recommendation to the Drug Enforcement Administration (DEA) to reschedule marijuana based on FDA’s review will finally bring relief from the federal gross receipts tax levied on struggling state-licensed cannabis businesses, it also underscores the urgent need to both (1) continue pressing forward on descheduling efforts before critical momentum evaporates and certain industry stakeholders effectively settle for rescheduling without full decriminalization, and (2) demand that marijuana be exempted from existing categories of FDA-regulated products to preserve state medical and adult use cannabis markets.
Before proceeding, it’s important to remember that rescheduling would not apply the federal Food Drug and Cosmetic Act (FDCA) to marijuana for the first time—it applies right now, and like the federal Controlled Substances Act (CSA), would continue to apply after rescheduling. But absent any statutory authority permitting FDA to do otherwise, the FDCA would continue to apply after descheduling too, just as it does to hemp products. I previously noted this in “Cannabis Cannibalism: How Federal Rescheduling Could Consume the State-Licensed Industry Without Safe Harbors Under the Federal Food, Drug and Cosmetic Act,” available here.
However, moving marijuana from Schedule I to Schedule III will shift enforcement priorities (and the incentives to vigorously pursue these priorities) at both DEA and FDA. Indeed this has been the experience after the CSA’s prohibitions on hemp were relaxed beginning with the 2014 Farm Bill, and then scrapped under the 2018 Farm Bill which descheduled hemp by carving it out of the federal CSA’s definitions of “marijuana” and “THC.” Soon after, purveyors of hemp CBD products began receiving FDA cease-and-desist letters citing prohibited product claims and numerous grounds under the FDCA for prohibiting the interstate commerce in such cannabis products.