For State, Local, Territorial, and Tribal Health Departments

What is New

Recent CDC laboratory testing of bronchoalveolar lavage (BAL) fluid samples (or samples of fluid collected from the lungs) from 29 patients with EVALI submitted to CDC from 10 states found vitamin E acetate in all of the BAL fluid samples.  Vitamin E acetate is used as an additive in the production of e-cigarette, or vaping, products. This is the first time that we have detected a potential chemical of concern in biologic samples from patients with these lung injuries.

CDC continues to recommend that people should not use e-cigarette, or vaping, products that contain THC, particularly from informal sources like friends, or family, or in-person or online dealers. We will continue to provide updates as more data become available.

Public Health Reporting
  • Healthcare professionals are advised to report cases of lung injury of unclear etiology and a history of e-cigarette, or vaping, product use within the past three months to state, tribal, local, and territorial (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 eocevent101@cdc.gov
  • STLT health departments that need data collection tools, reporting guidelines, and case investigation forms should email CDC at eocevent101@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.
Laboratory Testing by CDC
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. FDA is analyzing e-liquids for the presence of a broad range of chemicals. When sufficient liquid product is available, CDC will conduct aerosol emissions testing of the e-cigarette, or vaping, product. The graphic below outlines the process for states to submit product samples to FDA and CDC for testing.

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.

This graphic outlines how states can submit product samples for testing at CDC and FDA for the lung injury response. 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 link it with a CDC case ID. 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 can request to submit product to either CDC or FDA. Product(s) must be linked to a confirmed or probable case and have a CDC case ID. 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, points of contact will review sample submissions using agreed upon criteria (e.g., volume of sample). These points of contact will then work with the state on next steps. From here, the graphic points to two different boxes, depending on how the sample is triaged. The top box shows the situation in which the product sample contains sufficient volume and CDC will conduct aerosol testing on it. 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.

States can request to submit product to either CDC or FDA. Product(s) must be linked to a confirmed or probable case and have a CDC case ID.

  • For information about collection and submission of e-cigarette, or 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 vaping, products, including e-liquids, associated with confirmed or probable cases for possible aerosol emissions testing by CDC, contact IncidentResponse@cdc.gov.
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. Guidelines for specimen submission are available on the Healthcare Provider page of CDC’s Lung Injury response website: www.cdc.gov/lunginjury.
  • 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])

Resources for State and Local Health Departments

Fact Sheet for Evaluating and Caring For Patients with Suspected EVALI pdf icon[PDF – 119 KB]
(also available in Spanish pdf icon[PDF – 82 KB])
The purpose of this fact sheet is to provide a brief summary of  the Update: Interim Guidance for Health Care Providers Evaluating and Caring for Patients with Suspected E-cigarette, or Vaping, Product Use Associated Lung Injury — United States, October 2019.

Lung Injury Associated with E-cigarette Use or Vaping National Case Form pdf icon[PDF – 264 KB]
(also available in Spanish pdf icon[PDF – 304 KB])
The purpose of this document is to provide guidance for local and state health departments to report any probable or confirmed patient case of EVALI and transmit data to CDC using the Data Collection and Integration for Public Health (DCIPHER) platform, or by contacting CDC at eocevent101@cdc.gov.

International Classification of Diseases, Tenth Edition, Clinical Modification (ICD-10-CM)-Supplement pdf icon[PDF – 160 KB]
The purpose of this document is to provide official diagnosis coding guidance for healthcare encounters related to the 2019 health care encounters and deaths related to e-cigarette, or vaping, product use associated lung injury (EVALI). This guidance is consistent with current clinical knowledge about disorders related to use of e-cigarette, or vaping, products.

Update: Interim Guidance for Health Care Providers Evaluating and Caring for Patients with Suspected E-cigarette, or Vaping, Product Use Associated Lung Injury — United States, October 2019
This guidance document provides recommendations for health care providers regarding e-cigarette, or vaping, product use associated lung injury (EVALI). This document provides interim guidance for 1) initial clinical evaluation; 2) suggested criteria for hospital admission and treatment; 3) patient follow-up; 4) special considerations for high risk groups; and 5) clinical and public health recommendations.

Laboratory Clinical Sample Collection, Storage, and Submission Guidance for Lung Injury Associated with E-Cigarettes, or Vaping pdf icon[PDF – 198 KB]
(also available in Spanish pdf icon[PDF – 98 KB])
The purpose of this document is to provide general sample collection, storage, and shipping guidance for healthcare providers and public health laboratory personnel involved in the care of patients who meet, or are highly suspected of meeting, the case definition for lung injury related to the use of e-cigarette, or vaping, products. For information on the submission of non-tissue samples, please contact IncidentResponse@cdc.gov.

Specimen Submission Guidance for Pathologic Evaluation of Tissue Specimens from Cases of Lung Injury Associated with E-Cigarette, or Vaping Product Use pdf icon[PDF – 142 KB]
This guidance document will assist health departments, healthcare providers, medical examiners or coroners, and pathologists with submission of tissue specimens that could be collected from cases of EVALI.

FDA Resources

FDA Sample Collection Criteria and Information for Vaping Related Incidentsexternal icon

Publications

Morbidity and Mortality Weekly Report (MMWR)

New England Journal of Medicine

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.