The FDA Wants the Public’s Data on Vaping-related Lung Injuries
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The US Food and Drug Administration (FDA) is seeking public comments related to e-cigarette, or vaping, product use-associated lung injuries (EVALI).
To bolster its investigation into the recent EVALI outbreak, the administration is looking for unpublished reports or information on the specific chemicals, compounds, and ingredients of suspected vaping products.
Calling all vapers
Like an epidemic outbreak, the vaping crisis burst across the US at the tail-end of the summer of 2019. By September 13, 6 people had died and 380 were suffering from lung injuries. Three months later, the tally stood at 48 dead and 2,291 injured.
Before long, vitamin E acetate, a thickening agent commonly used in the illicit vaping market, became the chief chemical suspect. And following the FDA’s own tests, the agency has confirmed that the acetate substance is “strongly linked to the EVALI outbreak.”
“National and state data from patient reports and product sample testing suggest vaping products containing tetrahydrocannabinol [THC], particularly from informal sources like friends, or family, or in-person or online dealers, are linked to most cases and play a major role, and that the presence of the compound vitamin E acetate in vaping products is strongly linked to the outbreak,” Stephen Hahn, the FDA’s commissioner, said in a statement.
Fortunately, the EVALI crisis seems to be abating. The proportion of hospitalized EVALI patients reported to the Centers for Disease Control and Prevention (CDC) declined from 58 percent on November 12, 2019, to 30 percent on December 3.
Now, to help prevent any future outbreak, the FDA has opened up a comment period that will last until April 20, 2020. Any member of the public with relevant data that aren’t available in published scientific literature can submit their findings either electronically or via post.
“As part of our efforts to mitigate and prevent a potential future outbreak of vaping injuries, we are asking the public for input on additional steps the FDA can take to inform our regulatory work and address the illegal modification of these products,” Hahn continued.
As of January 14, 2020, the CDC has found that 82 percent of patients admitted to hospital with EVALI reported using THC-containing products. A recent paper, authored by members of the FDA’s Forensic Chemistry Center, also discovered that THC and vitamin E acetate compounds can become linked with hydrogen bonds in e-cigarette liquids and aerosol.
But this close association between EVALI and THC shouldn’t be conflated with a direct cause, analysts warn.
“It's not the THC that's making people sick, and I think that's a really important distinction to make,” Dr Swetha Kaul, vice president of the board Of directors at the California Cannabis Industry Association, told Analytical Cannabis last October.
Despite being the largest legal cannabis market in the world, California has been struggling against an indomitable illicit marijuana trade. In 2019, it’s estimated that $8.7 billion of the total $12 billion made in cannabis sales went to the illegal market.
“Vitamin E acetate is very heavily used in the illegal vaping market; 20, 30, 60 percent of a cartridge could be vitamin E acetate,” Kaul continued.
“The safer option is to shop [for] legal, tested products. I feel like that's the messaging that might resonate,” she said. “Because if you just tell people to stop vaping, they're just going to ignore the entire message. So how about giving them a route where at least their chances of staying safe are higher and better?”