Statement from Acting FDA Commissioner Ned Sharpless, M.D., and CDC Director Robert R. Redfield, M.D., on federal and state collaboration to investigate respiratory illnesses reported after use of e-cigarette products

SILVER SPRING, Md., Aug. 30, 2019 /PRNewswire/ -- Both the U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention are working tirelessly to investigate the distressing incidents of severe respiratory disease associated with use of e-cigarette products. We were deeply saddened last week to learn of the death of an adult in Illinois who had been hospitalized with a severe respiratory illness following the use of an e-cigarette product. We are working closely with state and local health officials to investigate these incidents as quickly as possible, and we are committed to taking appropriate actions as a clearer picture of the facts emerges.

We've also made it a top priority to communicate with the public about our efforts. Today, we are providing several updates about efforts between FDA, CDC and state health officials to investigate these incidents that have impacted both youth and adults across the country. First, we are updating the number of potential cases of respiratory illnesses reported after use of e-cigarette products. Additionally, we are sharing more details about the work CDC and FDA are undertaking as part of the investigation, including its current status. We are also providing the public and our health partners across the country with information to help mitigate the risk of additional incidents and what health officials and clinicians can do to help us gather as much data as possible to better understand these illness and potential causes.

As of Aug. 27, 2019, 215 possible cases have been reported from 25 states, and additional reports of pulmonary illness are under investigation. States are completing their own investigations and verifications of cases based on CDC's recently released standardized case definition. While some cases in each of the states are similar and appear to be linked to e-cigarette product use, more information is needed to determine what is causing the respiratory illnesses. In many cases, patients reported a gradual start of symptoms, including breathing difficulty, shortness of breath, and/or chest pain before hospitalization. Some cases reported mild to moderate gastrointestinal illness including vomiting and diarrhea, or other symptoms such as fevers or fatigue. In many cases, patients have also acknowledged recent use of tetrahydrocannabinol (THC)-containing e-cigarette products while speaking to healthcare personnel, or in follow-up interviews by health department staff.

Even though cases appear similar, it is not clear if these cases have a common cause or if they are different diseases with similar presentations, which is why our ongoing investigation is critical. CDC and the FDA are providing consultation to state health departments and working closely with them to gather information on any products or substances used. For example, our agencies are working to standardize information collection at the state level to help build a more comprehensive picture of these incidents. This includes investigating the brand and types of e-cigarette products, whether any of them are products that would fall within the FDA's regulatory authority, as well as where they were obtained.

CDC is helping involved states investigate whether the illnesses may be linked to specific devices, ingredients or contaminants in the devices, or substances associated with e-cigarette product use, with the FDA's assistance. Current assistance to states includes deploying CDC staff to Illinois and Wisconsin to assist their state health departments with the respective state investigations; releasing a Clinician Outreach and Communication Activity (COCA) Clinical Action Alert describing this investigation and asking providers to report possible cases to their state health departments; developing and distributing to involved states a standardized case definition, medical chart abstraction form, and case interview questionnaire with input from states  who are running investigations; reviewing and providing feedback on data collection and health messaging tools for states; and facilitating information sharing between states with possible cases.

In addition to daily meetings between our federal agencies, as well as frequent communication with state health officials, the FDA has been and will continue to provide laboratory assistance. The FDA has received about 80 samples and continues to receive requests from states to send more samples for the FDA to analyze. The samples represent a variety of different types of products and substances – a number of which contained incomplete information about the product. The FDA is analyzing those samples for their contents, whether they contain nicotine, substances, such as THC or other cannabinoids, or other chemicals and ingredients. The results of that testing will be shared with the respective states to aid in their investigations and will help inform the federal response.

More information is needed to better understand whether there's a relationship between any specific products or substances and the reported illnesses. At this time, there does not appear to be one product involved in all of the cases, although THC and cannabinoids use has been reported in many cases. At this time, the specific substances within the e-cigarette products that cause illness are not known and could involve a variety of substances. We continue to gather information about the names of the products used, where they were purchased, and how the products were used. That information is critical to help determine whether patterns emerge on which we can take additional action. While we continue to gather more information about these incidents and any specific products or substances involved, we also believe it's important to provide the public with useful information to help protect themselves and their loved ones, as well as continue to notify health care professionals about the illnesses, what to watch for, and how to collect and report information on these cases. As part of that commitment, CDC today issued a Health Alert Network (HAN) Health Advisory. The advisory includes the recommendation that while this investigation is ongoing, if you are concerned about these specific health risks, consider refraining from the use of e-cigarette products.

Anyone who does use e-cigarette products should not buy these products off the street (e.g., e-cigarette products with THC or other cannabinoids) and should not modify e-cigarette products or add any substances to these products that are not intended by the manufacturer. Regardless of the ongoing investigation, e-cigarette products should not be used by youth, young adults, pregnant women, and adults who do not currently use tobacco products. If you use e-cigarette products, monitor yourself for symptoms (e.g., cough, shortness of breaths, chest pain) and promptly seek medical attention if you have concerns about your health. CDC and the FDA will continue to advise and alert the public as more information becomes available. Adult smokers who are attempting to quit should use evidence-based treatments, including counseling and FDA-approved medications. If you need help quitting tobacco products, including e-cigarettes, contact your doctor. If you are concerned about harmful effects from e-cigarette products, call your local poison control center at: 1-800-222-1222. We also continue to encourage the public to submit detailed reports of any unexpected tobacco- or e-cigarette-related health or product issues to the FDA via the online Safety Reporting Portal.

As this investigation continues, our agencies remain committed to working as quickly as possible, in collaboration with our state and local public health partners and the clinical community, to find out as much as we can about these cases and potential causes and communicating with the public about these efforts to protect and promote the public health. Our ongoing oversight and educational efforts related to e-cigarettes is critical to our public health mission and, especially, to protecting youth from the dangers of nicotine addiction and tobacco-related disease and death.

For more information:
Safety Reporting Portal for Tobacco Products

Severe Pulmonary Disease Associated with Using E-Cigarette Products

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

CDC works 24/7 protecting America's health, safety and security. Whether disease start at home or abroad, are curable or preventable, chronic or acute, or from human activity or deliberate attack, CDC responds to America's most pressing health threats. CDC is headquartered in Atlanta and has experts located throughout the United States and the world.

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SOURCE U.S. Food and Drug Administration

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