NIDA Monopoly is Over: New DEA-Registered Cannabis Growers Can Supply Researchers with Product

By Shane Pennington

Nov 4, 2021

It seems like every day I read a new story about legislators, high-ranking federal officials, and frustrated advocates of marijuana research complaining that researchers still can't study the actual marijuana that people are using in the state-legal markets. That simply is not true.

Since 1968, the National Institute on Drug Abuse (NIDA) contracted operation based at the University of Mississippi was the only grower licensed by the U.S. Drug Enforcement Agency (DEA) to cultivate marijuana for research purposes. In 2016, Dr. Sue Sisley first applied to grow cannabis for research purposes when the Obama administration announced a plan to allow other growers to provide cannabis to researchers.

The DEA dragged their feet on this plan for years, so lawsuits were filed. Litigation against the DEA and Department of Justice that Matthew Zorn and I brought on behalf of Dr. Sisley and Scottsdale Research Institute (SRI) ended that NIDA monopoly in May 2021. Since then, the DEA has licensed four additional bulk manufacturers of marijuana. SRI received one of those licenses.

These new federally licensed marijuana growers can supply researchers with any marijuana product currently on the market. Claims to the contrary, while widespread, rest on the false assumption that because federal law prohibits DEA-registered marijuana growers from buying or otherwise acquiring marijuana plants/products grown/manufactured in violation of federal law, the newly-registered growers can't produce those plants/products for researchers.

That argument overlooks something critical: Marijuana plants grow from cannabis seeds, and cannabis seeds contain not more than 0.3% delta-9 THC, meaning they aren't a controlled substance under federal law. As a result, DEA's newly-licensed marijuana growers can:

  • Obtain the seeds from marijuana plants being grown and sold in state-legal markets;

  • Use those seeds to grow the same plants without violating federal law;

  • Sell the plants—the very ones being sold from state-legal dispensaries across the country—to DEA-registered researchers for use in research, including FDA clinical trials; and/or

  • Use the plants for their own studies and/or FDA clinical trials.

And that's not all. Federally licensed growers can also grow the marijuana currently being sold and used on the state-legal market using tissue cultures and other genetic material. Like cannabis seeds, such material isn't a controlled substance under federal law because it doesn't contain the requisite amount of delta-9 THC. The DEA's newly-licensed marijuana growers can therefore use tissue cultures and genetic materials to do everything they can do with seeds described above.

Nor are they limited to manufacturing whole-plant cannabis. Federally licensed growers are (some of them, at least) perfectly capable of manufacturing any and every type of cannabis-derived product currently on the market, including edibles, waxes, shatters, butters—you name it.

Believe it or not, this is just the tip of the iceberg. Consider IP, for example. The ability to produce state-legal marijuana products without violating federal law opens paths to forms of IP protection that simply weren't possible before. The possibilities are endless.

Please help spread the word: The NIDA Monopoly is over. We can study the cannabis people are using across the country under state law right now. People are investing resources in legislation and advocacy efforts designed to fix a problem that doesn't exist. Those resources could be—and really should be—supporting the important research efforts already underway.

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