MMJ International Holdings has submitted to the FDA for approval of its soft gelatin capsule to be used in clinical trails for its Huntington Disease Study. MMJ has received an Orphan designation from the FDA. Once FDA approved the company will be one of a very few with federal authorization to sell its medication.

WASHINGTON, DC / ACCESSWIRE / August 28, 2024 / As the U.S. federally illegal cannabis industry, valued at $32.1 billion, approaches the Labor Day holiday weekend, it does so under the cloud of significant regulatory uncertainty. Last year, there was optimism as federal health regulators recommended marijuana be classified as medicine-a landmark moment in cannabis reform, but not really. However, this year, hopes have been dashed by U.S. Drug Enforcement Administration (DEA) chief Anne Milgram's notice in the Federal Register, which announced a planned December 2 hearing to discuss rescheduling marijuana. This delay means that the industry may not see marijuana rescheduled until 2025 or much later.

DEA Administrator Under Fire: Hypocrisy and Hindrance in Marijuana and Psychedelic Research

The government has been sued by MMJ BioPharma Cultivation, a company that has meticulously followed federal guidelines to develop a THC-CBD soft gelatin capsule for use in FDA-approved clinical trials. This suit highlights the significant ambiguities in the Controlled Substances Act (CSA), President Biden's Medical Marijuana and Cannabidiol Research Expansion Act, and the DEA's regulatory standards. A key point of contention is the legislative requirement that the U.S. Attorney General must approve or deny a marijuana research or manufacturing application within 60 days or request additional information. Critics argue that the DEA has deviated from the CSA's original Congressional directive to target drug trafficking and promote pharmaceutical development-opting instead to prosecute physicians, delay applications for bulk manufacturing registrations, and obstruct researchers based on increasingly vague and shifting standards.

DEA: An Agency at Odds with Itself

In a recent appearance on 60 Minutes, DEA Administrator Anne Milgram compared ketamine to the opioid epidemic, while her agency simultaneously blocks several companies from advancing legitimate pharmaceutical research. Milgram's public statements stand in stark contrast to the DEA's behind-the-scenes actions, which many argue are obstructing the development of drugs intended to assist patients in need.

MMJ BioPharma Cultivation's Legal Challenges

Duane Boise, President of MMJ BioPharma Cultivation, along with MMJ Biopharma Labs and MMJ International Holdings, leads companies at the forefront of pharmaceutical cannabis research. These companies have made significant progress in developing treatments for debilitating conditions such as Multiple Sclerosis (MS) and Huntington's Disease (HD). They have filed FDA Investigational New Drug (IND) applications to conduct clinical trials and have even received an orphan designation from the FDA for their work. However, despite these advancements, the DEA's prolonged delays in processing their application to cultivate strain-specific cannabis have severely hindered their progress, delaying the potential delivery of innovative treatments to patients.

Biden-Harris DEA's Shifting Standards and Resistance to Psychedelic Research

The case of MMJ BioPharma Cultivation it underscores a troubling trend in the government's shifting standards for what constitutes acceptable activities under the CSA. Historically, the CSA targeted drug traffickers-those who prescribed controlled substances without medical justification. However, in recent years, the government has broadened its interpretation, prosecuting entities like MMJ based on evolving standards that go beyond what state laws require. This evolving application of standards creates uncertainty and imposes a chilling effect on pharmaceutical research, forcing entities to navigate both state laws and unpredictable federal expectations.

The DEA is also embroiled in a legal challenge over its denial of psilocybin use for terminally ill patients under Right to Try (RTT) laws, which allow these patients to test investigational drugs that have not yet received full approval. The DEA argues that RTT laws do not grant it the authority to waive requirements for Schedule I substances like psilocybin. However, this stance has been met with skepticism from judges. The outcome of this case could have significant implications for the use of psilocybin in palliative care and potentially open the door for broader access to Schedule I substances for therapeutic use.

Industry Frustration and Stock Market Impact

The cannabis stock market reacted swiftly to the news of the delayed hearing, with significant drops in share prices for major operators like Green Thumb Industries, Curaleaf Holdings, Trulieve Cannabis Corp., and Verano Holdings Corp., reflecting the market's disappointment. Notably, all these companies are still operating in violation of the Controlled Substances Act at the federal level.

"It is incredibly disappointing to see the DEA drag their feet on an issue which has been a clear White House priority," said U.S. Rep. Earl Blumenauer, co-chair of the Congressional Cannabis Caucus. Despite the frustration, some industry observers are pessimistic, fearing that rescheduling may never occur.

FORWARD LOOKING

The Biden-Harris administration's DEA faces mounting criticism for its inconsistent policies and actions, which are seen as hindering vital research into new treatments for conditions like MS, HD, and mental health disorders. As the cannabis industry navigates the uncertainty surrounding marijuana rescheduling, companies like MMJ International Holdings continue to push forward with groundbreaking research and clinical trials. While regulatory hurdles remain, the progress made in cannabis reform and the growing recognition of marijuana's medicinal value signal that change, though slow, is inevitable. The next few months will be crucial in determining the future landscape of cannabis regulation in the United States.

Milgram's public statements, juxtaposed with the DEA's restrictive actions, paint a picture of an agency at odds with itself-one that claims to prioritize public health while simultaneously obstructing access to innovative treatments that could save lives. As legal and public pressure mounts, the DEA may be forced to reconsider its approach, potentially leading to a new era of drug policy in America.

MMJ is represented by Attorney Megan Sheehan and Associates.

CONTACT:
Madison Hisey
media@mmjih.com
203-231-8583

SOURCE: MMJ International Holdings