DENVER – Colorado’s Marijuana Enforcement Division held a public hearing Tuesday to discuss proposed final rules on banning certain additives in marijuana vaping products amid a nationwide outbreak of severe lung illnesses linked to both nicotine and marijuana vape products.
The changes proposed by the MED include banning certain ingredients that some health officials have postulated have caused many of the lung illnesses when they were used in black-market or over-the-counter vape cartridges.
"I think this is a very dynamic and innovative industry. It’s moving very quickly," said Shannon Gray, the marijuana communications specialist for the Marijuana Enforcement Division. "We as regulators are always trying to stay ahead of the innovation and put rules in place that protect public health and safety but don’t diminish what this innovative and overwhelmingly responsible industry is trying to do."
The ingredients that would be banned in Colorado-approved vaping cartridges under the proposed rule change would be: Polyethylene glycol (PEG); Vitamin E Acetate; and Medium Chain Triglycerides (MCT Oil).
Vitamin E acetate is a preservative which Dr. Tyrell Towle says is appropriate for use in topicals, like lotions and creams, but is not appropriate to be inhaled. Dr. Towle is the director of chemistry and extraction at MedPharm, a company that creates some of these products.
MCT Oil, meanwhile, is commonly a product of refined coconut oil, which Dr. Towle says is also fine for skin use and even to eat but not safe for inhalation.
The third ingredient, Polyethylene glycol, is used in medicinal preparation, particularly new medications that are coming out. They can be used to cut down the cannabis oil in vaping products to create cost savings.
Dr. Towle says none of these ingredients are necessary to create a marijuana vaping product.
"It is totally possible to not only load but vaporize from cartridges without using any of these additives, and so in the interest of consumer health and public health, these substances need to be banned until further research can be done," he said.
Gray says the suggested ban on these ingredients comes from the state's Department of Public Health and Environment. Limiting these ingredients should not affect the potency of the product. Gray says there's also room for more regulations down the line if the CDPHE determines that other ingredients are dangerous for consumers and need to be banned or limited in some way.
Marijuana products in Colorado are already prohibited from containing any toxic additives or any additives that make the product more addictive, more appealing to children or misleading to patients or customers.
The ingredients that the MED is proposing banning are used to thin-out cannabis oil in some products, and other states have said they have found the ingredients in some black-market devices where marijuana is not legal recreationally.
When New York health officials pointed to vitamin E acetate as possibly being responsible for the lung illnesses there in early September, the Colorado Department of Public Health and Environment said it was treating those findings as a lead but not a final answer. Still, at least one major Colorado marijuana dispensary chain said it was banning products with some of the thinning agents.
“We are aware of the discovery of vitamin E oil as a common ingredient in some of the samples that were tested from cases of this illness in other states. We are aware that Vitamin E acetate may be used as a thickening ingredient in vaping liquids, but we do not have much information on what happens when vitamin E acetate is actually vaporized and inhaled,” said CDPHE Director of the Disease Control and Environmental Epidemiology Division Dr. Tony Cappello.
Researchers have been studying the effects of the thinning agents for a couple of years, and have found that some of the ones the MED is proposing banning have carcinogenic effects when heated to certain temperatures.
Stephen Cobb, who works with another vape product group, Kebar LLC, agrees that more regulations are needed in the industry, particularly in light of the recent illnesses. However, he asked for some clarification on some rules.
"We don't even fully understand the scope of what's happening in terms of these vape-related illnesses, and so we need to be careful about broad-sweeping actions that we take now that might not even have a significant effect on the safety for consumers," Cobb said.
He also believes there could be unintended consequences to banning or limiting some of these ingredients, like encouraging manufacturers to move on to another chemical that might not be necessarily safer.
He supports the ban on Vitamin E acetate if it's an additive, but says it is naturally occurring in more plant oils, and so there might be a need to differentiate the two in order prevent processing problems that would be a burden to businesses.
At Tuesday’s meeting, officials and the public also discussed adding labeling to vape devices that would say “Not approved by the FDA.” The FDA has approved only one cannabis-derived product at this time, Epidiolex, which is only available through prescriptions.
"This is a step in the right direction to make sure that we are following FDA guidelines where possible," Gray said.
Cobb, on the other hand, says the FDA labeling might seem reasonable at face value, but the list was detailed for medical products that include some ingredients that might not apply to vaping products at all while not listing the cutoff for those that do.
Ultimately, Cobb thinks this is an FDA problem and that nationwide regulatory structure will need to happen eventually.
As of last Wednesday, Colorado had seen nine cases of the lung illness and seven hospitalizations. All nine cases involved people living along Colorado’s northern Front Range. Three of the patients had used marijuana products only; three had used nicotine products only; and two had used both types of products.
"I want them to hold manufacturers to the highest standard possible, because that’s what we hold ourselves to. But I also don’t want to be restrictive and just wipe out a class of products from the market. I think there’s a happy middle ground, and as always with legislation, getting the details right is really important," Cobb said.
Industry officials who spoke with our partners at The Denver Post said they were generally unsurprised at the new proposed changes, with more than 1,000 people sickened by the illness, which is linked to at least 18 deaths nationwide.
Should the proposed rule changes move forward as-is after Tuesday’s public hearing, the State Licensing Authority will make the final decision on whether to officially approve them in November. Should that be the case, the rules would go into effect Jan. 1. If the rules are approved and a company is found to be in violation, the penalty would be a fine, suspension of their license or even a revocation of the license altogether.