WASHINGTON D.C. / ACCESSWIRE / September 8, 2023 / Attorney Megan Sheehan representing MMJ BioPharma Cultivation last month filed suit against the DEA for "dragging their heels" for the approval of MMJ's API Bulk Manufacturing Registration to grow pharmaceutical marijuana needed to produce its medicine.
MMJ BioPharma Labs, MMJ International Holdings, MMJ BioPharma Cultivation are the leading Pharma cannabis companies that have FDA Investigational New Drug (IND) filings to conduct clinical trials in Multiple Sclerosis and Huntington's disease.
MMJ has completed manufacturing of its proprietary dose form, THC and CBD non-synthetic soft gelatin capsule developed from marijuana plant extracts. MMJ will be submitting for FDA approval to utilize its medicine in human clinical trials.
Duane Boise the companies President stated " while there is significant speculation of potential DEA rescheduling and federal legalization, we believe it is just meaningless noise. MMJ has been strictly following the federal laws currently in place and this insures MMJ's success."
WHAT DOES POTENTIAL SCHEDULING CHANGES MEAN? REALLY NOTHING
What does the DEA schedule change mean?
Schedule I classification means that marijuana has:
• High potential for abuse;
• No currently accepted medical use in treatment in the U.S.; and
• Lack of accepted safety for use under medical supervision. 21 U.S.C. § 812(b)(1).
Schedule III classification means that marijuana has:
• Potential for abuse less than drugs or substances in schedules I and II;
• Currently accepted medical use in treatment in the U.S.; and
• Abuse may lead to moderate or low physical dependence or high psychological dependence. Id. § 812(b)(3).
Last October President Joe Biden asked the Secretary of the Department of Health and Human Services ("HHS") and the Attorney General to "initiate the administrative process to review expeditiously how marijuana is scheduled under federal law." Statement from President Biden on Marijuana Reform, White House (Oct. 6, 2022). Media outlets report, and HHS and Drug Enforcement Administration ("DEA") officials confirm, that HHS has recommended rescheduling cannabis from schedule I to schedule III. Bloomberg News reports that the National Institute on Drug Abuse agreed with the recommendation. Riley Griffin, et al., US Health Officials Urge Moving Pot to Lower-Risk Tier, Bloomberg News (Aug. 30, 2023). By recommending that DEA reschedule cannabis in schedule III, HHS has determined that cannabis does have medical value.
Cannabis in schedule III would require a prescription issued by a DEA-registered, state-licensed practitioner. Legitimate handlers in the cultivation, manufacturing and distribution chain would have to obtain registrations with DEA like MMJ. Registrants would have to create and maintain inventory and transaction records, file certain reports and maintain adequate security. Schedule III placement would loosen registration requirements for researchers.
Tim Moynahan the companies chairman stated "Now that the DEA and HHS agreed that marijuana is considered to have a current accepted medical use MMJ's approval is imminent."
Dr. Elio Mariani, MMJ BioPharma Cultivation's CEO stated "MMJ has followed the FDA's directives and we feel confident that we have fulfilled the FDA's request that 1. MMJ's drug chemistry is known and reproducible; 2. that there is a preponderance of adequate safety studies; 3. that MMJ will be conducting well-controlled studies to prove efficacy; 4. that the drug is accepted by qualified experts; and the scientific evidence is widely available.
MMJ's scientific breakthroughs and new research are now underway and MMJ BioPharma Cultivation will ensure that schedule 1 DEA approved researchers will soon be able to obtain their specific cannabis strains for clinical trials.
MMJ is represented by Attorney Megan Sheehan of Rhode Island.
For more information on MMJ, please visit www.mmjih.com.
SOURCE: MMJ International Holdings
View source version on accesswire.com: