A small but growing segment of the medical marijuana market could be kept off shelves in Colorado as government regulators and the pot industry scramble to figure out how to safely produce and monitor cannabis nasal sprays, inhalers and suppositories.
Dubbed "non-conforming products" by the state Marijuana Enforcement Division and Colorado Department of Public Health and Environment, MMJ products that enter the body by inhaler or other means of nasal, vaginal or rectal administration would be taken off the shelves if emergency rules are adopted by the MED. According to the MED, MMJ nasal sprays cannot be sold to dispensaries after July 1 (sprays on store shelves before July 1 can still be sold), while other comforting products would be banned if or when the rules are adopted.
The rule changes were an attempt to get a regulatory grip on new, pharmaceutical-like deliveries of cannabis; products such as THC-infused nasal sprays and suppositories are being used to treat seizures, muscle spasms, chronic pain and other severe medical conditions. The new rules aren't permanent, however: The MED held an official rule-making hearing on Monday, July 9, when a working group of industry members, government and public-health officials, attorneys and other pot stakeholders refined the language before its final rollout, currently set for January 1, 2019.
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Although pot-infused nasal spray and suppositories may enter the body much as pharmaceuticals do, they're not tested and monitored by federal health and safety agencies; any MMJ product (besides GW Pharma's CBD drug, Epidiolex) falls outside the purview of the Food and Drug Administration, thanks to the plant's federally illegal status. This presents a health and safety risk to the public, according to Mike Van Dyke, director of the CDPHE's Environmental Epidemiology, Occupational Health and Toxicology Branch.
On July 9, Van Dyke, who helped write the current draft for the proposed regulations, told the working group that the original MMJ regulations from years past were written for products that could be smoked, vaporized or consumed orally, like edibles and liquids. Safely manufacturing nasal sprays and suppositories "requires a higher level of professionalism" than baking brownies or growing flower, he said, adding that heat combustion kills many contaminants in pot and that digestion offers a stronger guard against contaminated products than does rectal or nasal consumption.
"When you're squirting something directly into the nasal cavity, that's right in the blood-brain barrier," Van Dyke explained during the meeting. "A higher standard needs to be held for these." Part of that standard involves designating an intended use for the products, which includes risk assessment, heavy product testing and data-gathering to prove a medical product's efficacy. Such a process can take years and upwards of a six-figure R&D budget — something most cannabis companies can't afford.
"We sell about $20,000 a year of suppositories, so it just doesn't make sense for us to build a million-dollar research facility," explained Bob Eschino, founder of infused-product manufacturer Medically Correct. "These rules have to be off the table...[they would] require hundreds of thousands of dollars to make these products."
Cannabis companies making non-conforming products may have developed too fast for their own good. Multiple business owners around the meeting table told stories about large investments in research and development, with many products already going to market before the new rules were proposed.
The Marijuana Industry Group and Cannabis Business Alliance warned the group that if the rules as currently drafted actually take effect at the beginning of next year, their member companies could be forced to relocate to other states where marijuana is legal, and Colorado's MMJ patients might have to shift to buying from the black market.
Although CDPHE officials said there haven't been any reports of illness from the now-recalled products, they noted that their market presence was still very young. "The bar shouldn't be whether someone has died or gotten sick from using these," explained CDPHE Deputy Executive Director Karin McGowan. "We should be trying to prevent that in the first place."
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But industry members said they're also concerned with current language that allows the MED to deem any pot-infused product as "non-conforming" as it sees fit, as well as proposed limits to reintroducing terpenes into infused products.
While it looks like some form of FDA-style guidelines are looming for cannabis nasal sprays, suppositories and inhalers, there is still much work ahead before those rules are finalized. At the meeting, all parties seemed open to the idea of pushing back the January 1 rule implementation as they try to figure out a way to effectively test and research the products without hampering industry growth for several years at a time. "It's not by accident that we're sitting here in July. This is a working group, and we have a challenge in front of this," MED director Jim Burack concluded.
There will be several more MED rule-making meetings throughout the summer and into fall, tackling topics such as waste recycling, packaging and labeling, product development, distribution and more, with the next meeting set for Thursday, July 26. Anyone wishing to provide comment or proposed language can submit suggestions to the MED online.
Correction: This story was updated on July 16 to correct an erroneous statement that medical marijuana nasal sprays, suppositories and inhalers were recalled by the MED on July 1. Nasal sprays that were sold to dispensaries before July 1 can still be stocked and sold to MMJ patients, and other non-conforming products can still be sold until the new rules are adopted.