MMJ BioPharma Cultivation has begun preparations to ship THC and CBD from Canada. MMJ International Holdings is developing an oral drug product from natural whole plant extract derivatives from the marijuana plant containing THC and CBD. MMJ will be utilizing its new product for a FDA approved treatment of multiple sclerosis (MS) and Huntington's disease (HD). It is seeking the US Drug Enforcement Agency's approval to cultivate pharma-grade cannabis and extract for its clinical trials.
So who qualifies for the DEA license?
"To obtain a federal license, applicants must meet additional stringent guidelines, including demonstrating a case to meet the public interest, such as FDA fillings for the development of a pharmaceutical," the team with the company explains. "MMJ BioPharma Cultivation, an applicant being seriously considered for the DEA bulk manufacturing license, believes it is in the running."
MMJ BioPharma Cultivation is one of few that have applied to the DEA that meet the public interest use case because of its supply agreement with MMJ International Holdings who is in development of a cannabis-based drug to treat Multiple Sclerosis and Huntington's Disease. MMJ International Holdings has filed for clinical trials approvals with the FDA.
Other than Universities and Research institutes, Dr. Elio Mariani, CEO of MMJ Biopharma Cultivation, believes he has a fairly decent shot at obtaining a federal license to cultivate and extract pharmaceutical-grade medicinal marijuana.
"We meet the public interest requirement evidenced by our filings with the FDA, in our development of a cannabis-based drug to treat Multiple Sclerosis and Huntington's Disease. We have applied for the DEA bulk manufacturing license to continue our development of an FDA-approved pharmaceutical," says Mariani.
Why an Indian Tribe?
President of MMJ, Duane Boise said "the plan to cultivate on federally-protected Native American sovereign lands is unique and is progressing rapidly to completion for final approval from the DEA."
"MMJ Biopharma's endeavor is a mutually beneficial arrangement with the tribe as it serves the best interest of the tribe, many of whom will be employed. However, setting aside the employments benefits, under the U.S. Constitution Native American Indian tribes are recognized as semi sovereign nations, and a business venture with an Indian tribe offers multiple advantages. One being that the federal government has enacted a broad array of financial incentives to encourage investment in economic development projects in economically distressed areas in general, and on tribal lands specifically. These financial incentives will greatly benefit the tribal community."
"Other advantages include flexible regulatory environments and zoning. Tribes are generally exempt from local, county, and state zoning and land-use restrictions and state permitting requirements."
"The partnership with a Native American tribe is a carefully strategic maneuver on Boise's part. His nascent approach is a far cry from needing to be associated with a university - which is the only current viable opportunity for cultivating federally-approved cannabis thus far."
Within the next 30 days, the DEA is expected to release their amendments to the 2016 Obama policy statement. The new guidelines will supersede the current Obama policy in place and govern applicants seeking to become registered.
The 2016 policy statement provided information on how it intended to expand the number of registrations and described in general terms the way it would oversee those additional growers. Therein, DEA recognized the need to move past the single grower system and register additional growers.
Moreover, since the publication of the 2016 policy statement, "the Department of Justice, in consultation with other federal agencies, has been engaged in a policy review process to ensure that the marijuana growers program is consistent with applicable laws and treaties."
One such treaty, the 1961 Single Convention on Narcotic Drugs, while wholly ignored by Uruguay and Canada in their cannabis legalization process, does not apply to the Native American tribe.
According to the DEA's document, that review process remains ongoing; however, it has progressed to the point where the DEA has issued a notice of applications. Throughout the policy review process, the Department of Justice (DOJ) has also determined that adjustments to the DEA's policies and practices related to the marijuana growers' program may be necessary.
Currently, out of the 33 registered applicants, several are already disqualified. Time will tell which applicants will be approved.