Colo.'s draft rules on cannabis inhalers, suppositories draw lively debate


Colorado’s first step toward regulating some of the newest ways to ingest marijuana and cannabis got off to a lively start Monday when a working group of state regulators, industry professionals and community activists met in Golden to debate just how that would work.

The group included regulators from the Colorado Department of Public Health and Environment, the attorney general’s office, and the host agency, the Marijuana Enforcement Division of the state Department of Revenue.

The newest delivery methods aren’t really all that new, according to industry representatives, and aren’t intended for getting the marijuana buzz. These methods are designed to help those who are medically fragile — those with cancer or multiple sclerosis, for example — or suffer from other medical conditions for which marijuana or cannabidiol (CBD oil) is useful but where smoking, vaping or ingesting edibles isn’t possible.

The rules specifically deal with suppositories — vaginal and rectal — as well as eyedrops or nasal inhalers. Those products also raise concerns for anti-marijuana activists who worry that they will too easily get into kids’ hands.

But anyone choosing to use some of these products to get high will be rather disappointed, the industry reps pointed out, since suppositories, which got a lot of the attention Monday, don’t produce the marijuana buzz.

“These products are for patients who need them,” said Bob Eschino of Incredible Edibles. He told Colorado Politics that “it’s not something you sell. It’s something you educate the public about and when you need them, it’s good” that these products are available.

It’s more of the same for eyedrops. The product is being touted as a way to treat glaucoma, not as a way of getting high. Cannabis has long been used for reducing eye pressure, one of the problems for those who suffer from glaucoma. Eyedrops may be the newest pathway for treating ocular pain and pressure from glaucoma, according to Project CBD, a California nonprofit that promotes research into the uses of medical marijuana.

THC-infused nasal spray can also be used to halt seizures in young children, although inhalers are also promoted as a way to get a quicker buzz. And that’s a concern for the anti-marijuana group SMART Colorado, said Henny Lasley, a member of Monday’s working group. A teacher might not be able to tell the difference between a marijuana nasal spray and one designed for a child with asthma, she said during Monday’s meeting.

All of these products were legal to purchase in Colorado until July 1, said Marc Graboyes, president of Next Frontier Biosciences, which makes cannabis products for treating chronic pain and other medical conditions.

Graboyes, a member of the working group, told Colorado Politics that state regulators a year ago adopted rules for “intended-use categories” of marijuana products. That’s the products already regulated by the state: vaping, smoking, edibles and cannabis products applied to the skin, like salves and patches. Manufacturers were required to discontinue making “non-conforming products” as of July 1, while state officials came up with rules this summer that would go into effect on Jan. 1, 2019. That applies to the inhalers, eye drops and suppositories.

The meeting pointed out the growing conflict between Amendment 64, which said marijuana would be regulated like alcohol, and the growing class of cannabis products used to treat medical conditions, something akin to what is regulated by the federal Food and Drug Administration.

Representatives of the Colorado Department of Public Health and Environment raised public health and safety concerns for those products. Miek VanDyke of CDPHE pointed out that cannabis that is ingested, smoked or vaped has a much lower risk for the public. Heating the products, as with smoking and vaping, destroys bacteria, he said. Squirting cannabis into a nasal cavity or into the eyes doesn’t provide that same level of protection.

As for suppositories, he said those products will sit in the “main orifice” for a while, an area of “very sensitive tissue.” The state needs a strong minimum health and safety standard for those products, he said.

The rules could eventually require cannabis manufacturers to set up or retrofit high-cost facilities for making those products, and that’s just not practical, said Eschino, Graboyes and Kristi Kelly of the Marijuana Industry Group. That would take years — possibly as many as 10 to 15 years — and cost millions of dollars for products that aren’t in high demand.

“I sell $20,000 in suppositories a year,” Eschino explained. “You’re asking me to build a multimillion-dollar clean room.” He added that he would have to do the same in every state, since marijuana products can’t be shipped across state lines. “The products are not massive in the market but they’re important for those who need it.”

Making these products more difficult to come by will also drive those who badly need them to  the black market or to make them at home without cleanliness standards, Eschino told Colorado Politics.

There’s an economic development issue as well, Graboyes told the group, “Scientific innovation will move out of Colorado” and to other states if the rules are not fairly designed.

To have all the rules in place by Jan. 1 is likely too fast for the industry, Kelly said, asking that regulators consider a phased-in approach, with the first phase for companies already manufacturing those products. “No one is adverse to testing or product development. We just want it in a way that is practical and fair.”

“We are committed to compliance,” Graboyes said. But “it’s unlikely we can comply with these (proposed) rules in a cost-effective manner.”

As the market is changing and maturing, these different delivery methods will come up, Eschino explained. “We just need to have guidelines and rules we can actually follow.”

Monday’s discussion was the first of three meetings on the draft rules; the formal rulemaking hearing will take place on Oct. 16.

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