Court Orders DEA To Respond To Medical Marijuana Company's Request For Bulk Manufacturing Registration

The Ninth Circuit Court of Appeals ordered the DEA on Monday to respond within 30 days to the suit arguing the agency has been “dragging their heels” for the approval of the medical marijuana company’s API Bulk Manufacturing Registration.

What happened: Cannabis researcher MMJ International Holdings Corp (MMJ) sued the DEA over a bulk manufacturing application that was submitted almost five years ago and never processed. In August, the company filed a petition for a writ of mandamus in the US Court of Appeals for the District of Columbia Circuit.

Now, the court is ordering the DEA to take action and respond to the request.

Why it matters: MMJ’s president Duane Boise previously told Benzinga that the DEA’s years-long inaction goes directly against the Control Substance Act, negatively impacts MMJ and ignores its effort to help people suffering from Huntington’s Disease and Multiple Sclerosis through clinical research.

MMJ has completed manufacturing of its proprietary dose form, THC and CBD non-synthetic soft gelatin capsule developed from marijuana plant extracts. MMJ has submitted its proprietary formulation to the FDA for approval to utilize its medicine in human clinical trials.

The request for a writ of mandamus, a court order instructing a government official or agency to fulfill their official duties, came after MMJ's attorney Megan Sheehan of Sheehan & Associates sent a warning letter to DEA deputy assistant administrator Matthew Strait and DEA regulatory chief Ricardo Quintero.

Arguments on which the request was based include 1) legal standard; 2) the DEA’s failure to comply with the timeline requirements; 3) relief being proper under the Administrative Procedures Act; concluding with 4) that writ of mandamus is a proper vehicle for relief under these circumstances.

What’s next: The DEA has 30 days or less to respond.

Photo: Benzinga edit with image by Wesley Tingey and GreenForce Staffing via Unsplash.