[PRESS RELEASE] – WASHINGTON, Jan. 6, 2025 – MMJ International Holdings, recognized for its pioneering efforts in marijuana-derived pharmaceuticals, has made significant headway with the U.S. Food and Drug Administration (FDA) in developing a cannabis treatment for Huntington’s disease and multiple sclerosis. However, the company’s progress faces substantial roadblocks due to the Drug Enforcement Administration’s (DEA) persistent delays in processing cultivation applications, creating a stark contrast between the cooperation received from the FDA and the obstacles imposed by the DEA.
FDA Collaboration Highlights
Duane Boise, president and CEO of MMJ International Holdings, commends the FDA for its clear regulatory pathway that facilitates the development of marijuana-based medicinal products. The FDA’s structured approach has allowed MMJ to push forward with its investigational new drug (IND) applications, demonstrating a commitment to rigorous standards for safety, efficacy, and consistency in drug development.
“The federal government provided a very detailed regulatory pathway to move forward to prove the safety and efficacy of a marijuana product,” Boise said, underscoring the FDA’s support in its quest to secure pharmaceutical drug approvals.
DEA’s Delays Stifle Progress
Contrasting sharply with the FDA’s supportive stance, the DEA’s sluggish processing times have severely impeded MMJ’s ability to perform crucial clinical trials. These delays hinder the cultivation of specific cannabis strains essential for the company’s research, effectively stalling the development of active pharmaceutical ingredients (APIs) necessary for groundbreaking treatments. Boise expressed frustration over the blockade, saying, “MMJ has not been able to grow the specific marijuana plant cultivars needed for our API development due to significant delays in our DEA registration.”
Impact on Investment and Clinical Trials
The DEA’s inefficiencies have not only affected MMJ’s research activities but also have chilled potential investment opportunities. Investors hesitant to commit funds due to these regulatory uncertainties have further delayed the research timelines, leaving promising patient treatments in limbo. Despite these challenges, MMJ has successfully developed a soft gelatin capsule, now awaiting FDA approval, poised to advance to human clinical trials in Huntington’s disease once FDA cleared.
Legal and Regulatory Battles
Boise also highlighted the broader constitutional issues arising from the company’s legal challenges with the DEA, particularly criticizing the biased procedures in the administrative law judges (ALJs) process used by the DEA in enforcement actions. The recent Supreme Court ruling in Jarkesy v. SEC, reinforcing the right to a jury trial in cases involving federal agency enforcement, supports MMJ’s stance for a fair and impartial trial, challenging the DEA’s interpretative overreach.
MMJ’s Resolute Long-Term Commitment
Despite the setbacks imposed by the DEA, MMJ remains steadfast in its long-term commitment to navigating these regulatory challenges. “We are prepared for the long haul and will continue our efforts until the government acts in accordance with the law,” Boise said.
MMJ is hopeful that its ongoing legal battle will not only pave the way for its own research but also set a precedent for federal cannabis policy, advocating for more balanced and just regulatory practices.
While MMJ experiences substantial support from the FDA in advancing its drug development initiatives, the company’s efforts are consistently thwarted by the DEA’s delays, underscoring a critical need for alignment between federal agencies to truly support the development of innovative medical treatments.
MMJ is represented by Attorney Megan Sheehan of Rhode Island.
Despite the DEA’s policy, MMJ International is moving forward with the FDA on cannabis drug development for Huntington’s disease. Read More
