Yes, You Can Help Shape Federal and International Cannabis Policy

By Amber Lengacher, Corey Cox, Shawn Hauser

Apr 30, 2020

It’s crunch time for the cannabis industry as closures and quarantine continue across the U.S. But as we collectively wrestle with feelings of helplessness and a range of uncertainties heading into election season, there are meaningful contributions that can be made.

In this special blog series, we’ll keep you updated on opportunities for you to help shape federal and international cannabis policy, wherever you are!

DEA is Accepting Public Comments on Proposed Rules for the Cultivation of “Marihuana” for Research Purposes

The United States Drug Enforcement Administration (DEA) recently announced it is accepting public comments on proposed controls to enhance the cultivation of “marihuana” for research purposes in the United States. These rules are purportedly designed to “enhance and improve research with marihuana and facilitate research that could result in the development of marihuana-based medicines approved by the Food and Drug Administration (FDA),” a request voiced by researchers for decades.

If these proposed rules are adopted without amendment, we anticipate the following key changes:

  • DEA will authorize additional persons to grow “marihuana” for use in federally sanctioned research, thereby providing alternatives to the stock currently supplied by the National Institute of Drug Abuse (NIDA).

  • In a claimed effort to comply with international treaty obligations, DEA will purchase and take title to all “marihuana” grown according to the new rules.

  • DEA will have the exclusive right of importing, exporting, wholesale trading, and maintaining stocks of “marihuana” with one clear exception: DEA’s exclusive right to these activities would not extend to FDA-approved drugs derived from or containing “marihuana”.

  • Authorized purchasers of “marihuana” for use in research, product development, and other purposes permitted by the Controlled Substances Act may only purchase stock from DEA.

The public comment period is open until May 22, 2020, and represents an important and timely opportunity to provide DEA with data and materials to inform its determination of how cannabis cultivation and disbursement for research should be regulated.

Potential comments could include:

  • General support of or opposition to DEA promulgating these rules.

  • Support for implementing a social equity component in the licensing structure.

  • Implementing a mandated licensure timeline for DEA to process applications (i.e., 60 days from submission).

  • Providing for an expedited dual-licensure process for individuals who wish to seek both manufacturing and research licenses from DEA.

  • Adding change-of-ownership guidelines for licensees.

  • Requirements that DEA pays and charges fair market value for stock.

  • Adjustments in the current requirement that the applicant must attest they have never violated federal law.

  • Suggestions for convenient inventory control systems that will more easily effectuate DEA’s “taking title” to research stock.

  • The requirement that DEA takes responsibility for the quality of the products produced. (Currently, the proposed rules say DEA is not responsible.)

  • A request for further clarification as to required “storage mechanisms.”

  • An appropriate number of licensed federal manufacturers. (Currently, DEA is considering up to 15 licensees; there are already 35 existing applicants).

  • Suggesting that DEA-licensed researchers be permitted to purchase research stock directly from state-legal dispensaries.

If the purpose of these proposed rules is as DEA states, then who better than licensed state operators to manufacture high yields and qualities of “marihuana” for research purposes? Current operators have been perfecting cultivation techniques and utilizing best practices in quality control and security protocol for years.

According to an August 27, 2019 letter to US Senator Brian Schatz of Hawaii, the FDA and US National Institutes of Health “support enabling researchers holding Schedule I [DEA] licenses for marijuana to obtain products from state-authorized dispensaries.” While DEA has resisted this position in the past, these proposed rules present a unique opportunity to set off a variety of positive changes in the way the US regulates “marihuana” at the federal level.

Your experience in the cannabis industry makes your comments invaluable to this rulemaking process.

If you would like more information on DEA’s proposed rules, including how it may impact your business, or if you would like to discuss submitting a public comment, please contact us.

From rallies and coalition formations to ballot initiatives and lobbying, the cannabis community got the industry to where it is today. The deadline for contributing your comments is May 22—less than a month from now! We hope to hear from you soon.

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