A Florida-based research company is in the final stages of obtaining a rare federal license to grow cannabis for medical research in Maine.
Maridose LLC is one of at least 37 companies that have applied to the US Drug Enforcement Administration to cultivate cannabis for federal research. There are only about 600 scientists nationwide, including at least two in Maine, who are state-licensed to study marijuana.
The University of Mississippi has had a monopoly on growing cannabis for federally sanctioned research purposes for more than 50 years. But in 2016, as interest in cannabis research grew, the DEA announced that it would open up its marijuana cultivation contract to other growers.
“While no drug derived from marijuana has yet been shown to be safe and effective in such clinical trials, DEA … fully supports the expansion of research into the potential medical benefits of marijuana and its chemical components,” the agency said in its policy statement.
Allowing more growers would increase both the volume and variety of research cannabis, which has been severely limited because marijuana, a Schedule 1 drug, remains illegal under federal law. SScientists have long complained about the difficulty of conducting clinically valid research with such a limited supply of the drug.
After reading the DEA’s announcement, Richard Shain, a former Procter & Gamble executive and product development specialist, teamed up with Tikun Olam, Israel’s largest legal grower and distributor of medical marijuana, to bring Maridose to market.
They have established themselves in the TechPlace, Brunswick Landing’s business incubator. Right now, the 2,200 square feet is more than enough to get it up and running, but Shain said he has plans for a larger facility at Brunswick Landing, which he hopes will be operational next year.
Local DEA officials completed their final tour of the Brunswick Landing facility on April 21, Shain said — he wanted it to be April 20, aka 4/20, the unofficial cannabis holiday for poetic justice . But unfortunately the schedules didn’t allow it.
Now the company is just waiting for the final green light from the federal agency, he said. Once approval is granted, the Company can begin custom cultivation of cannabis for research purposes.
According to Shain, Maridose will receive a contract from a specific researcher for the cannabis they want, and the DEA will then allow them to grow it for that person or team.
“We’re not going to sit there with 50 pounds of cannabis waiting to sell it to researchers,” he said. “We don’t plan on mass growing generic strains. We will individually grow the amount needed for the study.”
The amount Maridose can grow is “tiny” compared to what even a small commercial grower would harvest, Shain said, since the company’s customer base is limited to 600 registered researchers. Maridose also plans to conduct her own research.
Shain declined to elaborate on what that research might entail, but said the company plans to focus on areas such as opioid replacement, pain management, arthritic and neuropathic pain, sleep and anxiety.
While Maridose will grow and work with cannabis, Shain emphasized that it is not a cannabis company. It is a biotech research company and cannot sell cannabis to the public, he said.
Shain, who used to live in Maine, said he chose the state in part because of tax breaks like the Maine Seed Capital Tax Credit program.
“Besides the quality of life and all the incentives, it’s just a great place to do business,” he said.
A LONG TIME IS COMING
It’s been more than four years since Maridose submitted its application to the DEA, and six years since the administration announced it was expanding its research cultivation program.
There were 37 applicants, including universities, research institutes, biotech startups, and other cannabis-related companies.
But shortly thereafter, then-Attorney General Jeff Sessions, a well-known anti-marijuana advocate, put the DEA’s research expansion on hold. It was not known at the time when or if the plans would go ahead.
But in 2019, the DEA resumed the process and notified those companies that had applied of pending applications. The agency also announced that due to the high number of applications, it had to develop new regulations in order to approve them.
These new regulations were published in the Federal Register in December 2020. Six months later, in May 2021, the DEA announced that it had issued a letter of intent to an unknown number of manufacturers with intent to license.
To date, six companies have joined the University of Mississippi on the DEA list of approved “mass producer (marijuana) growers.”
Maridose wants to be next.
It’s still unclear how many permits the DEA intends to issue. In the rule published in the Federal Register, the agency included cost estimates for three and 15 locations, but didn’t commit to a number.
Anyone seeking approval must meet strict criteria. Requirements include adequate safeguards to prevent diversion of cannabis from research facilities to the black market and the ability to provide researchers with an adequate and uninterrupted supply.
The DEA wants licensees to have experience working with controlled substances, but is reluctant to do business with applicants who grow or work with cannabis, even in a state like Maine where it’s perfectly legal. Growing in a state market does not violate state law, but it is still a federal crime.
Shain has said he believes his partnership with Tikun Olam gives him an advantage here.
In 2006, Tikun Olam received Israel’s first license to cultivate and administer medicinal cannabis. US researchers using Maridose marijuana would be given access to clinical data collected from the 20,000 patients treated with marijuana by Tikun Olam.
When the DEA announced plans to expand the program in 2016, interest in cannabis research was already on the rise. Since then, it has only continued the upward trend.
Between 2017 and 2020, the agency increased its marijuana production quota from 472 kilograms to 3,200 — an increase of 578 percent. During the same period, the DEA increased the number of registered researchers from 371 to 595, a jump of 60 percent.
That means more researchers are registered studying cannabis than any other Schedule 1 substance in the country, the DEA said in a press release. It declined to provide an updated figure for the number of researchers registered and would not say how many of those were in Maine, but there are at least two.
Biologist Jean Doty and chemist Terry Morocco of the University of Maine at Farmington joined the ranks of DEA-licensed cannabis researchers in 2015 to develop a four-year project to develop gene sequencing tests that would identify medicinally desirable cannabis strains at an early stage of plant growth determine.
The National Institutes on Drug Abuse of the National Institutes of Health spent $111 million on cannabis research in 2015. Five years later, that number had grown to $196 million.