The Drug Enforcement Administration announced this week that it was now accepting comments on a Virginia-based biotechnology company’s application to import “marihuana extract” and “tetrahydrocannabinol.”
In a small notice published in the government’s daily Federal Register report, the DEA stated that Sanyal Biotechnology was looking to import cannabis extracts and THC to use in the organization’s research on liver diseases.
According to the DEA’s Diversion Control Division, Sanyal Biotechnology is the second company this year to request to import the two cannabis-based substances. The other company, Noramco, also requested permission to import whole plant marijuana.
We reached out to the DEA to find out more about the process of getting approved to import a federally controlled substance.
“Basically what they’ve done is ask to be a registered importer,” Special Agent Melvin S. Patterson of the Department of Justice’s Congressional and Public Affairs Office told Cannabis Now.
We asked Patterson how someone could import marijuana for research since the marijuana used in U.S.-backed studies must be provided by the National Institute on Drug Abuse’s University of Mississippi pot farm.
“I don’t know if that’s solely for marijuana extracts though, and this is for extracts, this is solely for extract to be studied,” said Patterson. “So NIDA is the sole provider of marijuana, and any hemp products, anything like that.”
Patterson also noted that companies have actually been approved for a license similar to the one Sanyal Biotech was requesting, but couldn’t put a number on the exact amount who have been approved.
He said that about two years ago, the DEA separated THC from other marijuana extracts in the drug code to simplify figuring out how many people were doing research on what aspect of marijuana, as in whole plant or extract.
Sanyal Biotechnology’s CEO Dr. Rebecca Caffrey told Cannabis Now that the company is applying for a DEA license so they can run a study for a Toronto-based company called Revive Therapeutics.
“They are testing out pure CBD as a treatment for liver diseases like NASH and autoimmune hepatitis,” Caffrey said. “The CBD they are using is pharmaceutical grade with no contamination THC in it. But the DEA still considers it Schedule I. So we have to have a license to use it in our lab and to import it into the U.S. from Canada.”
Caffrey added that Sanyal started the application four months ago, and are expecting it will delay their project a total of six months.
“It’s a pain,” Caffrey said. “My customer wants to pay me to run a study with harmless CBD that is equivalent to extraction from hemp, no THC. And I can’t obtain or handle it so I just have to wait.”
We asked Caffrey why she didn’t have to buy her marijuana from the NIDA farm to do research, and she explained that it’s because Sanyal isn’t conducting research on humans.
“We do preclinical research in special mice that develop diabetes and liver disease when they are on the SuperSize Me diet. So we have to go through all this mess just to do lab research,” she replied. “The company that has hired us to run the study is providing the CBD oil. They have it, but can’t ship it. We are just sitting on our hands, losing money.”
Caffrey says in the next phase of the application, the DEA will inspect their facility and look at personnel and security. After the DEA inspection, if Sanyal passes, they get the license. Then, they will have to apply to the VA Board of Pharmacy with that license number and get approval. Then, finally, they can run the study. “It’s a never-ending bureaucratic mess,” she said.
“We are researchers. We want to do the study and get results for our customer,” Caffrey said. “Instead we have mountains of regulatory paperwork and lengthy delays. If the government doesn’t speed up and streamline the process, we will lose business to companies in other countries, like Canada. CBD oil shouldn’t be Schedule I anyway.”
The application process won’t advance, however, until the comment period on the application closes — which the DEA set for the auspicious date of April 20. “Maybe someone at the DEA has a good sense of humor or maybe it’s just coincidence,” said Caffrey. “Pretty funny though.”
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