DEA Considering MMJ BioPharma Cultivation Marijuana Grow License on Tribal Lands
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.
ST. PETERSBURG, Fla., Oct. 29, 2019 /PRNewswire-PRWeb/ -- MMJ BioPharma Cultivation, the premier medical cannabis research company, announced that it 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. MMJ BioPharma Cultivation, an applicant being seriously considered for the DEA bulk manufacturing license, believes it is in the running.
Why?
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 medicanal 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.
Why MMJ is a preferred investment opportunity?
Primarily because the MMJ BioPharma Cultivation strategy is federally legal once the DEA license is issued.
Also investment in "New Markets Tax Credits" are available for investors that make capital investments on Indian reservations, providing tax credits of up to 39 percent of the entire amount of the investment. The tax credit is spread over seven years, 5 percent of the investment for the first three years, and 6 percent of the investment amount can be claimed the next four years. MMJ as the employer can also receive a tax credit of up to 20 percent of wages and health insurance for qualified employees living on the Indian reservation. Another significant opportunity is that the MMJ BioPharma Cultivation businesses can claim depreciation at twice the normal rate for locating equipment and buildings on tribal lands.
Next steps:
On October 18, 2019, in case #11-1920 the D.C. Circuit Court issued an order, stating its view that the DEA was now moving forward through the regulatory process for applicants. The D.C. Circuit's order emphasizes that the Court expects DEA to act on the pending applications, and that a previously filed writ of mandamus petition may be renewed "in the event of significant delay."
The DEA stated in its Federal Register notice that it "anticipates evaluating the applications and, of those applications that it finds are compliant with relevant laws, regulations, and treaties, granting the number that the agency determines is necessary to ensure an adequate and uninterrupted supply of the controlled substances at issue under adequately competitive conditions."
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.
SOURCE MMJ Bio Pharma Cultivation
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