A Florida-based research firm 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 has applied to the U.S. Drug Enforcement Administration to grow cannabis for federal research. There are only about 600 scientists across the country, including at least two in Maine, who have federal approval to study marijuana.
The University of Mississippi has had a monopoly over the cultivation of cannabis for federally sanctioned research for more than 50 years. But in 2016, with interest in cannabis research climbing, the DEA announced it would be opening up its marijuana cultivation contract to other growers.
“Although no drug product made from marijuana has yet been shown to be safe and effective in such clinical trials, DEA … fully supports expanding research into the potential medical utility of marijuana and its chemical constituents,” the agency said in its policy statement.
Allowing more growers would increase both the volume and variety of cannabis for research, which had been strictly limited because marijuana, a Schedule 1 drug, remains illegal under federal law. Scientists have long complained about the difficulty of conducting clinically valid research with such a restricted 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 supplier of medical pot, to launch Maridose.
They’ve set up shop in TechPlace, the business incubator facility at Brunswick Landing. For now, the roughly 2,200 square feet is more than enough to get them started, but Shain said he has plans for a larger facility at Brunswick Landing that he hopes will get underway next year.
Local DEA officials completed their final walkthrough of the Brunswick Landing facility on April 21, Shain said – he wanted it to be on April 20, also known as 4/20, the unofficial cannabis holiday, for poetic justice. But alas, schedules did not allow it.
Now, the company is just waiting on the final greenlight from the federal office, he said. Once granted, the company will be able to start custom-cultivating cannabis for research.
According to Shain, Maridose will get 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 won’t be sitting there with 50 pounds of cannabis, waiting to sell it to the researchers,” he said. “We’re not planning on growing mass generic strains. We will custom-grow the amount needed for the study.”
The amount Maridose will be able to grow is “minuscule” compared with what even a small commercial grower would harvest, Shain said, since the company’s customer base is limited to the 600 registered researchers. Maridose also plans to conduct its own research.
Shain wouldn’t get into specifics of what that research might entail but said the company plans to focus on areas such as opioid use replacement, pain management, arthritic and neuropathic pain, sleep and anxiety.
While Maridose will grow and work with cannabis, Shain stressed that it is not a cannabis company. It’s 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 such as the Maine Seed Capital Tax Credit program.
“Between the quality of life and all the incentives, it’s just a great place to do business,” he said.
A LONG TIME COMING
It’s been more than four years since Maridose submitted its application to the DEA, and six years since the administration announced it would be expanding its research cultivation program.
There were 37 applicants, including universities, research institutes, biotech startups and other cannabis-related companies.
But shortly after, then-U.S. Attorney General Jeff Sessions, a noted opponent of marijuana, put the DEA’s research expansion on ice. It was unknown at the time when or if the plans would continue.
But in 2019, the DEA resumed the process, providing notice of pending applications to the businesses that had applied. The agency also announced that due to the high number of applications, it would need to develop new regulations in order to approve them.
Those new regulations were published in the Federal Register in December 2020. Six months later, in May 2021, the DEA announced it had issued a memorandum of agreement to an unknown number of manufacturers with the intent of issuing a license.
To date, six entities have joined the University of Mississippi on the DEA’s list of approved “bulk manufacturer (marijuana) growers.”
Maridose intends 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 both three and 15 sites, but it did not commit to a number.
Those seeking authorization must meet strict criteria. The requirements include having adequate safeguards to prevent diversion of cannabis from the research facilities to the black market, as well as the ability to provide an adequate and uninterrupted supply to researchers.
The DEA wants licensees to have experience working with controlled substances but is reluctant to do business with applicants who are growing or working with cannabis, even in a state like Maine, where it’s entirely legal. Growing in a state market doesn’t violate state law, but it’s still a federal crime.
Shain has said he thinks that’s where his partnership with Tikun Olam gives him an advantage.
In 2006, Tikun Olam won Israel’s first license to grow and administer medical cannabis. U.S. researchers that use Maridose marijuana would gain access to clinical data collected from the 20,000 patients that have been treated with Tikun Olam’s marijuana.
GROWING RESEARCH
When the DEA announced its plans to expand the program in 2016, interest in cannabis research was already increasing. 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 – a 578 percent increase. In the same time period, the DEA raised the number of registered researchers from 371 to 595, a 60 percent jump.
That means there are more researchers registered to study cannabis than any other Schedule 1 substance in the country, the DEA said in a news release. It declined to provide an updated figure for the number of registered researchers 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-approved cannabis researchers in 2015 for a four-year project to develop gene sequencing tests that determine medically desirable cannabis strains at an early stage of plant growth.
The National Institutes of Health’s National Institute on Drug Abuse spent $111 million on cannabis research in 2015. Five years later, that figure had increased to $196 million.
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