The Surprising Reach of FDA Regulation of Cannabis, Even after Descheduling

Abstract

no currently accepted medical use in treatment in the United States"; and (3) "[t]here is a lack of accepted safety" for use of the drug or other substance under medical supervision. 8 Tetrahydrocannabinols (THC) and cannabimimetic agents (compounds that mimic the effects of cannabinoids) are also listed in Schedule I. 9 Manufacturing, distributing, dispensing, or possessing with the intent to do any of the foregoing is allowed under the CSA only for individuals who have been issued a so-called "Schedule I license." 10 These licenses are rare and hard to come by. 11 The Department of Justice (DOJ), and more specifically, the Drug Enforcement Agency (DEA) generally enforce the CSA. 12 Their actions with regard to illicit trade in drugs are usually perceived to be straightforward criminal prosecutions: "Miami Vice"-or "Cops"-style drug busts. 13 There is a misperception that such enforcement is not available in states with recreational or medical marijuana laws, at least with regard to state law-compliant cannabis enterprises. 14 The reality and risks associated with marijuana and its cannabinoids, ACP believes that it is time to review the evidence to determine whether reclassification is appropriate."). 8. § 812(b)(1)(A)-(C); see also infra Part II. 9. See § 812(c); § 812(d)(2)(A). 10. § § 821-823; Synthetic Drugs, Real Danger: Hearing Before the Subcomm. on Crime, Terrorism, Homeland Sec. & Investigations of the H. Comm. on the Judiciary, 114th Cong. 4 (2016) (statement of David Earl Nichols, Ph.D., Adjunct Professor of Chemical Biology and Medicinal Chemistry at the University of North Carolina at Chapel Hill, NC) ("Obtaining a Schedule I license is not a trivial matter. .. . [T]he investigator must have a strong personal belief that something useful will be discovered by their research that is of sufficient importance to justify the regulatory demands of a Schedule I license. To wit, a researcher must submit an application to the DEA that includes the investigator's scientific credentials, the description of the laboratory, a precise description of the work to be carried out, listing the specific substance to be used, and a calculation of how much substance will be needed and for how long. If the DEA determines that the. .. license is justified, there is then an inspection of the storage facility. .. to ensure that the controlled substance cannot be easily diverted. .. . Inventory and use must be documented, and there is a license fee for most non-public institutions.").

The legalization of cannabinoid products and standardizing cannabis-drug development in the United States: a brief report

“…Indeed, federal regulation and pharmaceutical drug development of cannabis, hemp, and cannabinoid products is an often complex and poorly understood issue. 6,7 The current state and federal cannabinoid and medical cannabis laws are surely overdue for an overhaul, as cannabis is shackled by its Schedule I status in the United…”

“…It can easily take 10 to 12 years for a single new chemical entity to be approved, with costs exceeding 1 billion dollars. 7 These exorbitant costs can be substantially higher for botanical products, given their complexity. Following CBD's movement through the gold-standard drug-approval process, other nonintoxicating cannabinoids found in the cannabis plant could follow similar pathways.…”

“…Investigators would no longer face as many inherent barriers to conducting research, including the frustrating difficulty in obtaining raw materials or the substantial, suffocating regulatory burden. 7 Legalization might also create the same low levels of abuse and risk as seen with other standardized cannabis-based drugs. 13 For example, the cannabis-based drugs Marinol, Epidiolex, and Sativex each have generated a low substanceabuse risk profile and very little, if any, evidence of diversion.…”

“…13 Pharmaceutical grade cannabis products face significant challenges for meeting the expectations of regulators, investors, and customers. 7 These myriad issues would probably be mitigated by providing market access to properly standardized products, since each of these national public health issues tends to cling to associations with illicit cannabis produced and consumed outside of state legal programs.…”

Natural polyphenols in preclinical models of epilepsy

“…However, at that time, there were few preclinical or clinical studies defining the efficacy and safety of this plant product in epilepsy. With persistent research and more preclinical/clinical evidence, cannabidiol (one of the active ingredients present in Cannabis plant) has been recently approved by U.S. Food and Drug Administration for the treatment of Lennox–Gastaut and Dravet syndromes (O'Connor & Lietzan, ).…”