For State, Local, Territorial, and Tribal Health Departments

Overview
  • CDC, FDA, and state health authorities have made progress in identifying the cause of EVALI.
  • Emergency department (ED) visits related to e-cigarette, or vaping, products continue to decline, after sharply increasing in August 2019 and peaking in September.
  • National and state data from patient reports and product sample testing show tetrahydrocannabinol (THC)-containing e-cigarette, or vaping, products, particularly from informal sources like friends, family, or in-person or online dealers, are linked to most EVALI cases and play a major role in the outbreak.
  • Vitamin E acetate is strongly linked to the EVALI outbreak. Vitamin E acetate has been found in product samples tested by FDA and state laboratories and in patient lung fluid samples tested by CDC from geographically diverse states. Vitamin E acetate has not been found in the lung fluid of people that do not have EVALI.
  • Evidence is not sufficient to rule out the contribution of other chemicals of concern, including chemicals in either THC or non-THC products, in some of the reported EVALI cases.

CDC will continue to update guidance related to EVALI as appropriate.

Public Health Reporting
  • As of November 26, 2019, states were asked to only report hospitalized EVALI cases to CDC. Further collection of data on nonhospitalized cases will be at the discretion of individual state, tribal, local, and territorial (STLT) health departments.
  • CDC stopped the collection of data on nonhospitalized cases of EVALI for the following reasons:
    • Patients with EVALI may have similar symptoms to flu or other respiratory illness, and it might be difficult to distinguish EVALI from other respiratory illnesses.
    • Case finding and reporting of nonhospitalized patients could become more difficult and burdensome given the potential for large numbers of respiratory illnesses during the emerging flu season and may be of limited value to the ongoing investigation.
  • Healthcare providers are advised to report cases of lung injury of unclear etiology and a history of e-cigarette, or vaping, product use within the past 90 days to the STLT health department.
  • STLT public health officials should promptly notify CDC about possible cases of lung injury associated with use of e-cigarette, or vaping, products via evali@cdc.gov.
  • STLT health departments that need data collection tools, reporting guidelines, and case investigation forms should email CDC at evali@cdc.gov.
  • Consider conducting case-finding activities that use existing data sources (e.g., local poison control center, coroner and medical examiner’s office, and other applicable surveillance systems including syndromic surveillance). CDC has developed two working syndromic surveillance definitions (one version with specific symptoms and a second focused on use of e-cigarette, or vaping, products). The latter has been preset within CDC’s National Syndromic Surveillance Program’s BioSense/ESSENCE platform, however the symptom-based syndrome category is only available as a free-text query. Either of these could be used for case-finding within the platform. Contact NSSP@cdc.gov for more information.
  • Consider asking the medical examiner or coroner’s office and other pathologists to report possible lung injury cases, especially lung injury cases without an alternative, likely diagnosis. If individuals are identified after death or at autopsy who showed signs of lung injury, medical examiners and coroners are encouraged to report such cases to their STLT health department.
CDC 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 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 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 e-liquid and aerosol emissions 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.

This 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.

Primary Case Definitions

2019 Lung Injury Surveillance Primary Case Definition (CDC) – September 18, 2019

Download a printable PDF version of 2019 Lung Injury Surveillance Primary Case Definition (CDC) – September 18, 2019 pdf icon[PDF – 179 KB].

CONFIRMED CASE

Using an e-cigarette (“vaping”) or dabbing* in 90 days prior to symptom onset

AND

Pulmonary infiltrate, such as opacities, on plain film chest radiograph or ground-glass opacities on chest CT

AND

Absence of pulmonary infection on initial work-up. Minimum criteria are:

  1. A negative respiratory viral panel

AND

  1. A negative influenza PCR or rapid test, if local epidemiology supports influenza testing

AND

  1. All other clinically-indicated respiratory infectious disease testing (e.g., urine Antigen for Streptococcus pneumoniae and Legionella, sputum culture if productive cough, bronchoalveolar lavage (BAL) culture if done, blood culture, HIV-related opportunistic respiratory infections if appropriate) are negative

AND

No evidence in medical record of alternative plausible diagnoses (e.g., cardiac, rheumatologic, or neoplastic process).

PROBABLE CASE

Using an e-cigarette (“vaping”) or dabbing* in 90 days prior to symptom onset

  • AND

Pulmonary infiltrate, such as opacities, on plain film chest radiograph or ground-glass opacities on chest CT

  • AND

Infection identified via culture or PCR, but clinical team** believes this infection is not the sole cause of the underlying lung injury OR Minimum criteria to rule out pulmonary infection not met (testing not performed) and clinical team** believes infection is not the sole cause of the underlying lung injury

  • AND

No evidence in medical record of alternative plausible diagnoses (e.g., cardiac, rheumatologic, or neoplastic process).

FOOTNOTES

* Using an electronic device (e.g., electronic nicotine delivery system (ENDS), electronic cigarette, e-cigarette, vaporizer, vape(s), vape pen, dab pen, or other device) or dabbing to inhale substances (e.g., nicotine, marijuana, THC, THC concentrates, CBD, synthetic cannabinoids, flavorings, or other substances).

**Clinical team caring for the patient.

Notes: These case definitions are meant for surveillance and not clinical diagnosis. These case definitions are subject to change and will be updated as additional information becomes available if needed.

Out-of-Hospital Case Definitions

2019 Lung Injury Surveillance Case Definition for Out-of-Hospital Deaths (CDC) – October 4, 2019

Download a printable PDF version of 2019 Lung Injury Surveillance Case Definition for Out-of-Hospital Deaths (CDC) – October 4, 2019 pdf icon[PDF – 65 KB].

  • This case definition is ONLY meant to be used to determine case status for individuals who die outside of the hospital or prior to hospital admission (e.g., at home, in route to the hospital, or in the emergency department), for whom chest imaging and clinical evaluation outlined in the primary 2019 Lung Injury Surveillance Case Definition  have not been performed. This case definition is NOT intended to be used to classify case status for surviving individuals or for individuals who die in the hospital, for whom chest imaging and clinical evaluation were performed.
  • This case definition integrates pathologic findings from the microscopic review of lung tissue specimens. As medicolegal jurisdiction allows, autopsies should be considered for deaths among persons with a history of using e-cigarette, or vaping, products, who had antecedent respiratory or gastrointestinal symptoms, or are suspected of having possible lung injury associated with use of e-cigarette, or vaping, products.
  • Fixed tissue specimens from autopsy can be sent to the CDC Infectious Disease Pathology Branch for histopathologic review and other testing. Refer to the guidelines for specimen submission.
  • This case definition is being used for public health surveillance purposes only and should not be used for clinical diagnostics or forensics. Persons meeting this case definition will not be counted separately; they will be included in the total count of confirmed and probable cases in conjunction with confirmed and probable cases that meet the primary Lung Injury Surveillance Case Definition (available on the State and Local Health Department page of CDC’s Lung Injury response website.

CONFIRMED CASE

History of e-cigarette product use, or vaping,* in the 90 days prior to death

AND

Pathologic evidence of acute lung injury (e.g., diffuse alveolar damage, acute fibrinous pneumonitis or bronchiolitis, or organizing pneumonia often with vacuolated or foamy macrophages and/or pneumocytes)

AND

Absence of pulmonary infection** (e.g. influenza, S. pneumoniae, Legionella, and other infectious diseases, including HIV-related infections as appropriate, as evidenced by microscopy, immunohistology, microbiology***, or molecular testing)

AND

No evidence of alternative plausible diagnoses for the lung injury in medical record or at autopsy

PROBABLE CASE

History of e-cigarette product use, or vaping,* in the 90 days prior to death

AND

Pathologic evidence of acute lung injury (i.e., diffuse alveolar damage, acute fibrinous pneumonitis or bronchiolitis, or organizing pneumonia often with vacuolated or foamy macrophages and/or pneumocytes)

AND

A positive result on testing for pulmonary infection** (e.g., influenza, S. pneumoniae, Legionella, and other infectious diseases, including HIV-related infections as appropriate, as evidenced by microscopy, immunohistology, microbiology***, or molecular testing), however medical examiner or other forensic pathologist believes infection is not the sole cause of the underlying lung injury

AND

No evidence of alternative plausible diagnoses for the lung injury in medical record or at autopsy

FOOTNOTES

* Using an electronic device (e.g., electronic nicotine delivery system (ENDS), electronic cigarette, e-cigarette, vaporizer, vape(s), vape pen, dab pen, or other device) to inhale substances (e.g., nicotine, marijuana, THC, THC concentrates, CBD, synthetic cannabinoids, flavorings, or other substances). This definition also includes “dabbing,” which involves superheating substances that contain high concentrations of THC and other plant compounds (e.g., cannabidiol) with the intent of inhaling the aerosol.

** Does not include positive results from postmortem microbiologic testing thought to represent normal viral or bacterial colonization of nasopharynx, or postmortem bacterial overgrowth of lung tissues or blood.

*** Recommended microbiology: Nasopharyngeal and/or lung swab testing for influenza, lung swab testing for respiratory viruses, postmortem cultures of lung tissue and blood. Interpretation of postmortem cultures may be complicated because of bacterial overgrowth resulting from tissue breakdown.  Medical examiners and other forensic pathologists should contact their local or state health department for assistance if such testing is not readily available at their agency.  Fixed autopsy tissue specimens can also be sent to the Infectious Diseases Pathology Branch at CDC for histopathologic evaluation, and infectious disease testing, including immunohistochemistry and molecular testing, as indicated (https://www.cdc.gov/tobacco/basic_information/e-cigarettes/severe-lung-disease/healthcare-providers/pdfs/specimen-submission-req.pdf pdf icon[PDF – 142 KB])

If you have questions about CDC’s investigation into the lung injuries associated with use of e-cigarette, or vaping, products, contact CDC-INFO or call 1-800-232-4636.