Proposed Federal Framework for FDA‑Approved Cannabis‑Derived Drugs and State Cannabis Law Expansion

A > LA RELL ITAL CHAPTER IV_ U.S. Legal Landscape (1) FDA Approves Cannabis-Derived Pharmaceuticals The FDA will approve pharmaceutical-grade drugs derived from cannabis through the NDA process. FDA approval will require manufacturers to use cannabis varieties with particular chemical profiles and to demonstrate the ability to control the chemical consistency of those varieties during manufacturing. The DEA will place a narrow characterization of each FDA-approved drug on CSA Schedule II, IH, 1V or V, and will issue one or more registrations to manufacture the drug and the cannabis variety used to produce the drug. The FDA will improve and refine its botanical-drug review process in general and, in particular, as it relates to cannabis-derived drugs. The FDA, the DEA and DEA-registered cannabis researchers and manufacturers will cooperate to create a federal database of (i) each cannabis variety approved for use in producing an FDA-approved drug and (ii) the manufacturing controls required by the DEA and the FDA to cultivate chemically consistent plants of the variety in accordance with the CSA and the FDA’s drug approval. We refer to each cannabis variety in this database, together with its required manufacturing controls, as an “FDA-registered chemovar” (a chemovar is a plant variety characterized by its chemical content). (2) More States Adopt Medical Cannabis Laws More states will adopt medical cannabis laws, and the number and nature of qualifying medical con- ditions included in such laws will expand. Scientific research will improve the ability of the state-legal medical cannabis industry to develop products that target specific medical conditions. Companies will increasingly seek to differentiate such medical product offerings from recreational cannabis products. State regulators and industry leaders will seek to standardize testing, labeling and quality control pro- cedures particular to medical cannabis products and adopt cannabis-variety recognition and manufac- turing practices consistent with those for FDA-registered chemovars. (3) More States Adopt Recreational Laws More states will adopt recreational laws, typically after medical cannabis has been legalized for some period of time. States will establish agencies to comprehensively regulate both recreational and medical cannabis; some regulatory standards will apply across both categories but, increasingly, regulations will develop specific to each category. State regulators will learn from the recreational cannabis experience of other states and will seek to standardize regulations that allow adults to responsibly enjoy cannabis while protecting the health and safety of the general public. Recreational cannabis regulations will resemble federal and state alcohol and tobacco regulations, addressing issues such as product potency and warning labels, and restrictions on advertising and packaging that appeal to minors. © 2017 Ackrell Capital, LLC | Member FINRA/SIPC 87 HOUSE_OVERSIGHT_024723