With new lab testing requirements for cannabis products that went into effect in California at the beginning of this year, licensed manufacturers have new hurdles to clear to bring safe and compliant merchandise to market in 2019. And many industry insiders are concerned about the addition of analytic testing for heavy metals, a new requirement included in the Phase-3 testing implemented by the state’s Bureau of Cannabis Control.
Jacqueline McGowan, the director of local licensing and business development at Sacramento lobbying firm K Street Consulting, told High Times that many in the business expected the new standards could be a challenge.
“We knew this was going to be an issue back in July of last year when we saw phase-2 testing standards go into effect and how that affected the marketplace,” says McGowan.
Of the more than fifty licensed cannabis testing labs in California, only a fraction are ready to perform the new tests, which also include screening for mycotoxins—poisons created by molds and fungi.
McGowan says that one her clients, Rebecca Kirk of CWG Botanicals in Oakland, was concerned about the possibility of vape cartridges not passing the new tests. Although her company, a cannabis cultivator, manufacturer, and distributor, had not yet produced any cannabis oil cartridges, she was in the process of product development. After obtaining eight different samples of cartridges, she sent them to a laboratory for independent analysis.
“What we do know, is that just about every cartridge out there has lead in it,” says McGowan.
McGowan said that it is difficult to find empty vape carts that are produced domestically.
“They all come from China,” she says. “There are a few that say that they are manufactured in the U.S., but in reality, they’re assembled in the U.S. The parts are still from China.”
McGowan adds that there are no BCC requirements ensuring that the hardware used for cannabis products be tested for safety.
“We’re going above and beyond the regulations in this project because we’re seeing failures for oil we know is clean,” said McGowan.
Josh Myers, the director of sales at the cannabis ancillary products supplier the Calico Group, said that “it’s absolutely true” that some vape cartridges on the market are contaminated with lead. He said that the Chinese manufacturers are “already well aware of this. Most of the manufacturers have already got on board, but there’s still a tremendous amount of product … that still has lead in it.”
Myers added that some California cannabis companies are having empty cartridges independently analyzed and are finding that about 5 percent are testing positive for lead.
Due Diligence is Key
Greg Magdoff is the CEO of cannabis testing company PharmLabs, which will begin Phase-3 testing for heavy metals at its lab in the Coachella Valley early next month. He also confirms that he’s heard from manufacturers whose vape cartridges have failed heavy metal tests even though the oil had passed before it was put inside. Magdoff says that companies should know that cannabis can be contaminated from the material it is contained in, including inks or paints used on wrappers and containers.
“It’s really important that people understand that these heavy metals can leach out from packaging, cartridges, etc. into the product,” Magdoff tells High Times.
He also cautions manufacturers eager to cut costs to closely consider their responsibility to consumers.
“If they decide to get a good deal and they’re getting hundreds of thousands of carts overseas, they have to do their due diligence, take one of the empty carts to a local lab and get a metals test– digest it down and see what’s in there,” says Magdoff.
Kirk tells High Times that some fellow manufacturers have shown her cartridge test results that have passed the new standards for heavy metals. But those tests were conducted on the oil inside, not the cartridge itself. Kirk says that terpenes are acidic and could be causing lead to leach from the cartridge into the cannabis oil.
“We honestly don’t know,” she says. “Is it now contaminated because it’s been sitting in there a year?”
Kirk is still looking for vape cartridges that she is comfortable using for her products.
“We’ve got to find something that gives us assurance that six or nine months down the line we’ve still got a clean product,” said Kirk. “We’re looking at a potentially great deal of liability.”
Toxic Metals Found in E-Cigarette Vapor
The danger is real. A Johns Hopkins University study released last year found that lead and other toxic metals had been detected in the vapors produced by some e-cigarette devices. Rich Able, a medical device marketing consultant, told Forbes that “the metals detected in this study have been associated with multiple adverse health effects under chronic conditions of exposure. Neurotoxins such as lead are linked to increased risk of cardiovascular and kidney disease. The other metals listed are even more nefarious to human organs.”
Able called for government regulation of e-cigarette devices to help ensure their safety.
“It is critical for manufacturers of these delivery systems to design, engineer and manufacture these devices to FDA medical device quality standards,” he says. “To continue manufacturing and marketing these devices to the smoking population without further diligence and clinical review is unethical and unconscionable.”
McGowan said that some businesses are hoping for a legislative fix to the problem.
“They’re planning on running a few different testing bills but I just don’t see how in the world they could ever get passed,” McGowan says. “They want to do bulk testing instead of final form testing, but that still means that we will have lead in our cartridges. I’m a consumer. I don’t want to smoke lead. And I don’t want our industry to suffer the consequences of negative headlines.”
In a memo to clients titled “Upcoming Extinction Events” that was published on social media, McGowan and K Street colleague Maximillian Mikalonis warn that sourcing safe vape carts will be a priority for manufacturers in 2019.“Once cartridges manufactured prior to December 31, 2018, sell out, manufacturers will face difficulty in sourcing hardware for vaporizer cartridges that can pass Phase-3 heavy metals testing. This will have a negative impact on manufacturer sales and the retailers that run out of cartridges for consumers. If only the illicit market has access to cartridges, expect a rough ride for legal cannabis sales,” they wrote.