National agriculture regulators are meeting in Kentucky this week to hash out the issues that matter most to the country’s farmers and ag manufacturers. Included in that list: hemp.
On Wednesday, the National Association of State Departments of Agriculture (NASDA) voted to expand funding opportunities for the hemp industry. Specifically, members voted to “advocate for USDA to allow hemp to be designed as both a specialty crop and an agronomic commodity depending [on] its intended use,” NASDA announced.
And, the Plant Agriculture & Pesticide Regulation Committee heard from Kay Doyle, director of U.S. Public Policy and Public Affairs for Greenwich Biosciences, who until last year served on the Massachusetts Cannabis Control Commission. NASDA is hosting its annual meeting this week.
Greenwich Biosciences, now part of Jazz Pharmaceuticals, is the United States arm of GW Pharmaceuticals, the company behind Epidiolex, also known as the nation’s first cannabis plant-based medicine approved by the U.S. Food and Drug Administration. Epidiolex, which is cannabidiol-based, has been approved to treat rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, as well as tuberous sclerosis complex in patients one year or older.
Greenwich Biosciences has exported cannabinoids to more than 35 countries for research purposes, Doyle said on Tuesday, adding that the company has conducted more than 60 clinical trials related to cannabinoids.
During her presentation to agriculture regulators, Doyle gave a brief overview of delta-8 THC, and its similarities and differences with delta-9 THC, with which regulators are more familiar. The path to delta-8 THC, which can be converted from hemp-derived CBD, was paved by the 2018 Farm Bill that, among other things, legalized hemp, defined as cannabis plants with .3% THC or less.
Since then, the market has exploded with delta-8 THC products that are almost entirely untested and unregulated, and a state-by-state legal patchwork has emerged. Michigan “decided to regulate all THC isomers and have them sold by the cannabis licensees,” Doyle said, while states like Colorado, Illinois, Iowa, Massachusetts and New York, issued guidance to license holders indicating that they were not allowed to “synthesize intoxicating compounds.”
In a nutshell, much of the regulatory conversation around delta-8 THC comes down to definition. Take Oklahoma, where lawmakers amended legislation to cut delta-8 and 10 out of the state’s “definition of marijuana,” Doyle said.
“A lot of states are doing a lot of different things, and this sort of patchwork quilt of different approaches, even in neighboring states, is leaving both the consumer and the industry at a disadvantage, as well as putting the states themselves in a difficult position regarding enforcement. Do they have the resources to keep up with an industry that is relentlessly innovating to gain a market advantage?” Doyle asked.
The process to create delta-8 THC is part of the concern, Doyle said, because of the use of solvents.
“The chemicals that are being used to synthesize CBD to make delta-8 are creating byproducts that may not be safe for humans to ingest,” Doyle said. “And the process of synthesis itself needs to be done in a controlled and well-ventilated environment where workers can take adequate precautions to protect themselves from the fumes.”
“We should be concerned about making it available for human consumption until further research is done,” Doyle said. “Unfortunately, like many other cannabinoids, it hasn’t been extensively studied, so we don’t know very much about its safety profile.”
The cannabis industry itself is starting to do some of this research. The U.S. Cannabis Council, for which the Marijuana Policy Project’s Steve Hawkins is executive director, is a “strategic alliance” that includes both major advocacy orgs, large cannabis companies, and individuals who aim to “speak in one voice.” The Council worked with a private testing lab in California to test 16 samples of delta-8 products bought at shops and online vendors.
The group released a report in May that found THC levels ten times the .3% limit set by the 2018 Farm Bill. “More concerning,” Doyle said, is that seven of the 16 samples failed US Pharmacopeia standards for copper, chromium or nickel. The testing also found lead and residual compounds like methanol and acetone.
The conversation then turned to national regulation, and cannabis reform proposals before Congress, including a draft discussion bill called the Cannabis Administration and Opportunity Act (CAOA), for which the public comment window closed earlier this month. Doyle told the group of agriculture regulators Tuesday that “the FDA, due to its deep scientific expertise and the complexity of the cannabis plant, should be the primary agency to regulate the public health and safety impacts of this novel product.” The debate over who should oversee what in a national legalization scenario has proven to be among the most contentious, with many cannabis and hemp industry members explicitly opposed to the FDA having too broad a reach.
Doyle also called for a federal regulatory framework that would “encourage” the development of additional FDA-approved cannabinoid drugs, because, Doyle said “we’d like to have some more company in this space,” and for clear differentiation in “cannabinoid content between FDA approved medications and cannabinoid consumer goods.”
“Research into the therapeutic potential of cannabinoids is just beginning. The FDA is at a crossroads,” Doyle said. “They obviously must proceed carefully, especially in the way they regulate consumer goods so that it doesn’t just disincentivize the kind of research we and others would like to do to bring more FDA-approved medications to patients.”
Greenwich Biosciences has the largest lobbying footprint of any cannabis or cannabinoid-related company in the nation, as Cannabis Wire was the first to report. The company has been lobbying in all fifty US states, and the company has also outspent every other cannabis company or organization, according to a Cannabis Wire analysis of disclosure reports.
NASDA members approved the hemp policy amendment, put forth by Vermont Secretary Anson Tebbetts, Maine Commissioner Amanda Beal, New Jersey Secretary Douglas Fisher, Connecticut Commissioner Brian Hurlburt, and Delaware Secretary Michael Scuse.
NASDA members also elected new officers, including New York Agriculture Commissioner Richard A. Ball as president of NASDA for the next year.
