FDA Launches Criminal Probe as Vaping-Related Illnesses Top 500

Megan Brooks

September 19, 2019

In an update on the vaping crisis, federal health officials said today that, as of September 17, the number of confirmed and probable cases of lung injury associated with e-cigarettes and vaping products has climbed to 530 in 38 states and one territory, prompting the FDA to launch a criminal investigation into the possible causes.

"Sadly," seven patients from six states have died as a result of their illness and "we do expect others," Anne Schuchat, MD, principal deputy director, US Centers for Disease Control and Prevention (CDC), told reporters in a telebriefing. 

She said the CDC will update case counts every Thursday going forward.

Earlier this week, the CDC activated its emergency operations center to help coordinate the investigation into the growing number of cases of severe lung illnesses linked to e-cigarette use.

The exact cause of vaping-related lung illness remains elusive. This investigation is "dynamic and complex and I wish we had more answers," Schuchat said. "States are classifying cases and reporting them to CDC on a regular basis."

She emphasized that "no consistent e-cigarette or vaping product, substance, additive, or brand has been identified in all cases; nor has any one product or substance been conclusively linked to lung injury." Many patients reported using multiple types of products, some containing tetrahydrocannabinol (THC), THC plus nicotine, or nicotine only.

Based on available data, Schuchat said three quarters of the cases are males, two thirds are in people 18-34 years of age, 16% are younger than 18 years of age, and 17% are age 35 years or older. In all, more than half of the cases are under 25 years of age.

Patients typically have reported cough, shortness of breath, and/or chest pain, gastrointestinal symptoms (nausea, vomiting, or diarrhea) as well as fatigue and fever.

The CDC continues to recommend that people consider not using e-cigarette products while investigations are ongoing.

FDA's Law Enforcement Arm Involved

Mitch Zeller, director, Center for Tobacco Products at the FDA, said agency scientists are now analyzing 150 vaping product samples for a broad range of chemicals, including nicotine, THC, and other cannabinoids, as well as cutting agents, diluents, additives, pesticides, opioids, poisons, and toxins.

Zeller also said FDA has activated an incident management group, which will serve as the agency's focal point for emergency management and will coordinate information gathering and sharing within the agency and between the FDA, CDC, and states.

He also announced today that FDA's Office of Criminal Investigation (OCI), the agency's law enforcement arm, began "parallel" investigative efforts shortly after the vaping-related illnesses surfaced.

"OCI has special investigative skills and the focus of their work is to identify what is making people sick as well as a focus on the supply chain. OCI is not pursuing any prosecutions associated with personal use of any controlled substances in these cases," Zeller said.

The CDC and FDA urge the public to report unexpected health problems or product issues related to tobacco or e-cigarettes to the FDA using the online Safety Reporting Portal.

Last week, the CDC published an interim case definition for confirmed and probable severe pulmonary disease associated with e-cigarette use.

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