Seeking input

The U.S. Food and Drug Administration has opened a docket to obtain data and information related to the use of vaping products that are associated with e-cigarette, or vaping, product use-associated lung injury (EVALI).

This request for information responds to direction from Congress to gather information from the public that could help identify and evaluate additional steps the FDA could take to address the recent lung injuries associated with the use of vaping products and to help prevent similar occurrences in the future.

The FDA is seeking unpublished data or information related to the use of vaping products that are associated with recent lung injuries including information on specific chemicals, compounds, ingredients or combinations of ingredients that when inhaled or aerosolized, may be associated with EVALI symptoms, as well as product design and potential ways to prevent consumers from modifying or adding substances to these products that are not intended by the manufacturers.

“Since last year, the Food and Drug Administration, the Centers for Disease Control and Prevention and state health authorities have diligently worked to identify substances of concern and characterize the outbreak of lung injuries associated with vaping products,” said FDA Commissioner Stephan Hahn.

“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.

“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.”