Two cannabis companies are accusing the Drug Enforcement Administration (DEA) of delaying approving applications for bulk manufacturing registration since it opened the process in 2018. MMJ International Holdings said its partner MMJ BioPharma Cultivation had submitted its application four years ago, but the process has been “delayed for years for reasons unknown.”
MMJ International Holdings, in collaboration with MMJ BioPharma Cultivation, has been manufacturing gelatin capsule medicines based on cannabis compounds with plans to investigate the products in clinical trials as potential treatments for multiple sclerosis and Huntington’s disease. The companies claim the DEA “has negatively impacted the progression of the drug development for patients” who suffer from the conditions.
The companies point out that the statutory mandate of the DEA is security and divergence and to facilitate the manufacturing of pharmaceuticals to help patients suffering from chronic diseases.
Elio Mariani, Ph.D., MMJ International’s executive responsible for research and development, described the delays as “unprecedented.”
Duane Boise, CEO of MMJ International, said that the company believes that their oral gel cap “will be FDA-approved as a safe and effective drug.”
“MMJ’s clinical trials will provide patient dosing, safety, and efficacy data to the FDA to prove that cannabis can treat essential tremors, a neurological disorder that causes involuntary shaking.” – Boise in a press release
MMJ International in 2019 was given DEA clearance to import cannabis-based products into the U.S. from Canada, a process that required the cooperation of multiple governmental agencies, including the U.S. Food and Drug Administration, the DEA, and Health Canada, the company said.
According to MMJ International, to date five approved entities are currently listed on the DEA website but none are manufacturing a pharmaceutical, such as MMJ International, with filings with the FDA to perform clinical trials.
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