US FDA Seeks Input From Public to Prevent Repeat of EVALI Event

Today, the U.S. Food and Drug Administration 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, FDA Commissioner Stephen Hahn stated in a release.

“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.”

The FDA is seeking unpublished data or information related to the use of vaping products that are associated with recent lung injuries including information on specific chemicals, compounds,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.

Starting Feb. 18, 2020, you may submit responses to this RFI to Federal Register docket FDA-2020-N-0597 on regulations.gov. Comments should be submitted by April 20, 2020.