FDA to Release Files on Products Linked to Vaping Lung Injury

On February 15, according to foreign media reports, the U.S. Food and Drug Administration (FDA) released a public document seeking data and information related to products associated with lung injury linked to the use of e-cigarettes or vaping products (EVALI).

The document will be formally published on February 18 and is currently available for download.

This request for information responds to a congressional directive to collect public input that could help identify and assess additional actions the FDA can take to address the recent lung injuries associated with vaping products and help prevent similar incidents in the future.

The FDA is seeking unpublished data or information related to recent use of vaping products associated with lung injury, including information on specific chemicals, compounds, ingredients, or combinations of ingredients that may be associated with EVALI symptoms after inhalation or aerosolization, as well as product design and potential methods to prevent consumers from modifying products or adding substances not intended by manufacturers.

FDA Commissioner Stephan Hahn said that since last year, the FDA, the Centers for Disease Control and Prevention, and state health departments have been working to identify substances of concern and determine the cause of the outbreak of lung injuries associated with vaping products.

“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 indicate that vaping products containing THC, especially those obtained from informal sources such as friends, family members, in-person dealers, or online sellers, are linked to most cases and play a major role, and the presence of vitamin E acetate in vaping products is strongly associated with the outbreak.

“Our investigation has highlighted the serious risks of using illegal black-market products. As part of our efforts to reduce and prevent future outbreaks of injury, we are asking the public to provide additional steps the FDA can take to inform our regulatory work and address the illegal modification of these products.“