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FDA Sample Collection Criteria and Information for Vaping Related Incidents

CDC and FDA Product Sample Submission Information

  • CDC and FDA are working together to coordinate analysis of e-cigarette, or vaping, products to provide insight into the nature of the chemical exposure(s) contributing to the lung injury outbreak.
  • As of December 19, CDC and FDA are accepting case-associated product samples for aerosol or e-liquid testing if corresponding bronchoalveolar lavage (BAL) fluid samples are submitted to CDC (samples do not need to be submitted at the same time to meet this requirement). CDC and FDA will no longer be accepting isolated case-associated product samples.
    • In e-cigarette, or vaping, product use-associated lung injury (EVALI)-related death cases, CDC and FDA will continue to accept product samples for testing even if no BAL fluid sample is available for testing.
  • This change does not mean that the investigation has concluded. The extensive product testing conducted by both FDA and CDC to date has provided critical information regarding potential chemicals of concern. At this time, additional focused testing is needed for paired specimen testing (i.e., both product and BAL fluid samples) in order to continue to further inform the investigation.
  • Additionally, CDC and FDA are streamlining the sample collection process to reduce the burden on state partners. All product samples and corresponding BAL fluid samples will be submitted to CDC. CDC and FDA will coordinate sample testing and transfer to testing laboratories as appropriate.
  • CDC will conduct aerosol emissions testing of e-cigarette, or vaping, products. FDA is analyzing e-liquids for the presence of a broad range of chemicals. Analysis of both aerosol emissions and e-liquids will complement each other, and together will help improve our understanding of exposures among case patients associated with the lung injury outbreak.

The graphic below outlines the process for states to submit product samples to CDC for routing and testing in coordination with FDA. Upon receipt of product samples, CDC will determine whether sufficient liquid product is available to perform aerosol and e-liquid analysis and coordinate testing with FDA.

Product Sample Submission Guidance for Lung Injury Response
View full-sized imageThis graphic outlines the process for states to submit product samples to CDC for routing and testing in coordination with FDA. In the first box to the left, a clipboard with a checkmark is shown to help illustrate the first step in the process. In this step, states collect product AND BAL fluid samples and link both with a CDC case ID (samples do not need to be submitted at the same time). An arrow then leads users to the next box to the right to show the next step in the process, which is illustrated by an image of a computer receiving an email. In this step, states contact CDC to request submission of product and BAL fluid samples. An arrow then leads users to the next box to the right showing the third step, illustrated by a two people on a phone call speaking with each other. In this step, CDC reviews product and BAL fluid sample information and in consultation with FDA, instructs states on next steps. From here, the graphic points to the fourth box to the right, which contains two smaller boxes. The top box shows that product and BAL fluid samples arrive at CDC for testing. This box is illustrated with an e-cigarette, or vaping, product with an arrow to CDC. CDC will then send remaining sample to FDA for e-liquid testing. The bottom box in this step shows e-liquid testing at FDA. It is illustrated with an e-cigarette, or vaping, product with an arrow to FDA. The last step is shown in the box to the right. It is illustrated by computers linking with the cloud. In this step, agencies report data to the states. Additionally, both CDC and FDA will enter data from their testing in a secure repository to link epidemiologic, clinical, and product sample information to cases.
  • For information about collection and submission of e-cigarette or other vaping products, including e-liquids, associated with confirmed or probable cases for possible testing by FDA, contact FDAVapingSampleInquiries@fda.hhs.gov.
  • For information about collection and submission of e-cigarette or other vaping products’ e-liquids associated with confirmed or probable cases for possible aerosol emissions testing by CDC, contact IncidentResponse@cdc.gov.