{"id":3125,"date":"2020-08-26T19:26:04","date_gmt":"2020-08-27T00:26:04","guid":{"rendered":"http:\/\/blogs.luc.edu\/compliance\/?p=3125"},"modified":"2020-08-26T19:26:04","modified_gmt":"2020-08-27T00:26:04","slug":"dea-proposes-new-rules-aimed-to-increase-federal-cannabis-research","status":"publish","type":"post","link":"https:\/\/blogs.luc.edu\/compliance\/?p=3125","title":{"rendered":"DEA Proposes New Rules Aimed to Increase Federal Cannabis Research"},"content":{"rendered":"

Joseph Baldwin<\/em><\/span><\/p>\n

Associate Editor<\/em><\/span><\/p>\n

Loyola University Chicago School of Law, JD 2021<\/em><\/span><\/p>\n

On Monday March 24, the Drug Enforcement Agency (DEA) proposed<\/a> amending the rules under the Controlled Substance Act to expand cannabis research in accordance with a 2016 policy statement. Among these changes includes directing the DEA to take title and physical possession of cannabis plants and increasing the number of entities permitted to manufacture cannabis for research.<\/span><\/p>\n

Federally manufactured cannabis <\/strong><\/span><\/p>\n

Since 1968, a single facility overseen by researchers at the University of Mississippi<\/a> (University) has continued to receive DEA approval to grow cannabis for research purposes via a contract with the National Institute on Drug Abuse (NIDA). In 1978, the Compassionate Investigational New Drug Program<\/a> took effect allowing the University to distribute cannabis to a small, federally approved list of people in the United States for research purposes under the supervision of NIDA.<\/span><\/p>\n

In 2016, the DEA published a policy statement<\/a> designed to increase the number of entities registered under the Controlled Substances Act (CSA) that manufacture cannabis for federally approved researchers in the United States. Following the DEA\u2019s policy statement, the agency received over 30 applications<\/a> from entities wanting to grow cannabis for research purposes.<\/span><\/p>\n

In 2018, the Department of Justice\u2019s (DOJ) Office of Legal Counsel (OLC) opined in a memo<\/a> that the DEA could not honor its 2016 policy statement because of the 1961 International Single Convention on Narcotic Drugs Treaty (Treaty) restrictions on the current cannabis licensing regime. To this end, because the DEA does not purchase or take possession of harvested cannabis plants at any point in distribution, permitting additional cannabis manufacturers under the current regime would violate the Treaty\u2019s requirement that a single agency monopolizes the cannabis supply chain.<\/span><\/p>\n

After three years, over 30 stalled applications, and two lawsuits<\/a>, the DEA has taken steps to establish a formal, legal pathway for expanded research into cannabis. Two significant changes are designed to bring the United States in compliance with the 1961 Treaty and increase the number of federally licensed cannabis manufacturers.<\/span><\/p>\n

International treaty compliance <\/strong><\/span><\/p>\n

The Treaty<\/a> obligates countries that permit cannabis cultivation for research to adhere to five requirements to maintain compliance with United Nation rules. Article 28<\/a> of the Treaty requires that if a party permits the cultivation of cannabis plants for the production thereof, it must apply the system of controls that cover the opium poppy located in Article 23(2).<\/span><\/p>\n

Article 23(2)<\/a>, made applicable to cannabis through incorporation of Article 28, contains five requirements for the supervision, licensing, and distribution of cannabis. They include: (a) designating areas and plots of land where cultivation is permitted; (b) ensuring only federally licensed cultivators are authorized to cultivate; (c) ensuring that each license specifies the cultivated land; (d) requiring all cannabis cultivators to deliver crops to the agency and ensuring the agency purchases and takes possession of the plants not later than four months after harvest; and (e) retaining exclusive rights to importing, exporting, wholesale trading, and maintaining stocks of cannabis.<\/span><\/p>\n

Currently, the DEA follows the first three requirements; under the newly proposed rules, the DEA would carry out the remaining requirements. Consequently, the DEA will retain sole ownership over all lawfully grown cannabis that is cultivated for research purposes, including cannabis stored at cultivation facilities. Therefore, because the DEA will now have to purchase all lawfully harvested cannabis, the United States is able to maintain compliance with the Treaty by monopolizing the cannabis supply chain. \u00a0<\/span><\/p>\n

Expanding research opportunities <\/strong><\/span><\/p>\n

According to the rule\u2019s economic analysis, the DEA posited two economic impact scenarios: one analysis calculating costs of three new federally approved growers and another with fifteen. Though, the DEA has said these numbers do not necessarily reflect the number of DEA registrants it intends to approve.<\/span><\/p>\n

Nevertheless, increasing the number of growers may increase the diversity of cannabis grown for research. Researchers have criticized the quality of cannabis after a study<\/a> indicated that federally grown cannabis is genetically more similar to hemp than commercially available cannabis. Other researchers<\/a> question the utility of studying cannabis that widely differs from what is commercially available. Including products that vary in quality and potency may produce more accurate research. Enhancing the accuracy of studies can facilitate potential developments in FDA approved medicines.<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"

On Monday March 24, the Drug Enforcement Agency (DEA) proposed amending the rules under the Controlled Substance Act to expand cannabis research in accordance with a 2016 policy statement. Among these changes includes directing the DEA to take title and physical possession of cannabis plants and increasing the number of entities permitted to manufacture cannabis for research.<\/p>\n","protected":false},"author":61,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[55],"tags":[],"class_list":["post-3125","post","type-post","status-publish","format-standard","hentry","category-pharma-industry"],"_links":{"self":[{"href":"https:\/\/blogs.luc.edu\/compliance\/index.php?rest_route=\/wp\/v2\/posts\/3125","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.luc.edu\/compliance\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.luc.edu\/compliance\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.luc.edu\/compliance\/index.php?rest_route=\/wp\/v2\/users\/61"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.luc.edu\/compliance\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=3125"}],"version-history":[{"count":0,"href":"https:\/\/blogs.luc.edu\/compliance\/index.php?rest_route=\/wp\/v2\/posts\/3125\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.luc.edu\/compliance\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=3125"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.luc.edu\/compliance\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=3125"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.luc.edu\/compliance\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=3125"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}