The Food and Drug Administration (FDA) is seeking any new information from the public to help unravel the mystery of what caused a recent outbreak of lung injury and deaths linked to vaping.
The lung injury, which public health officials have begun calling EVALI for e-cigarette or vaping product use-associated lung injury, has been most closely linked to vitamin E acetate, used as a dilutent in e-liquids containing THC. However, the FDA says it cannot tie the injury to any particular product or substance.
As of Feb. 3, the FDA has received more than 1,300 samples from 31 states and one territory with roughly 1,070 of those samples connected to patients. “Specifically, the FDA is analyzing samples submitted by a number of states for the presence of a broad range of chemicals, including nicotine, tetrahydrocannabinol (THC) and other cannabinoids, along with cutting agents/diluents and other additives, pesticides, opioids, poisons, heavy metals and toxins,” the agency said in a press announcement.
Thus, the agency has opened a docket to gather unpublished data or information that might bring them closer to a definitive cause – including information on specific chemicals, compounds, ingredients or combinations of ingredients that when inhaled or aerosolized, may be associated with EVALI symptoms. The agency is also seeking information on product design and potential ways to prevent consumers from modifying or adding substances to these products that are not intended by the manufacturers.
“We remain deeply concerned about these injuries and deaths and continue to work with other agencies, as well as state and local public health officials, on this complex investigation. National and state data from patient reports and product sample testing suggest vaping products containing tetrahydrocannabinol, 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,” said FDA Commissioner Stephen M. Hahn, MD.
“Our investigation has brought to the forefront the serious risks of using illicit, black market products. 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.”
Beasley Allen lawyers Joseph VanZandt and Sydney Everett, together with Mass Torts Section Head Andy Birchfield, are currently representing several individuals who are suing the top U.S. vape maker JUUL for the negative impact its products have had on their lives. They have also filed dozens of lawsuits on behalf of school districts nationwide, which seek to protect students and recover resources spent fighting the vaping epidemic.