0910-0500 Summary of CTP Exploding Cigarettes survey

0910-0500

FDA’s Rapid Response Survey

Summary of Survey Conducted

FDA’s Center for Tobacco Products needed to use the FDA Rapid Response Generic Survey to send letters to each state’s Department of Health to discuss an issue of possible exploding electronic cigarettes and its effect on public health. It was entitled “FDA’s Center for Tobacco Products State Department of Health Electronic Cigarette Adverse Event Survey”.

What was the problem to be investigated? In February, 2012, FDA learned that certain malfunctions of electronic cigarettes (i.e., reported explosions of electronic cigarettes by e-cigarette users) have occurred which may impact public health. FDA sent this survey letter through the generic collection of 0910-0500 (the Rapid Response Surveys) to each state’s Department of Health asking for information regarding adverse events involving electronic cigarettes. We chose this generic collection so the information could be collected extremely fast, as this was perceived to require additional information to determine if FDA intervention was required.

The method used to obtain the convenience sample. FDA sent a letter of inquiry to each state’s Departments of Health regarding possible adverse events with electronic cigarettes. The letter thanked each state for its continued relationship with FDA, and asked the state whether it had information regarding adverse events involving electronic cigarettes. The expected responses were voluntary and FDA explained that it used the information to help determine whether any action by the agency would be appropriate. This information was collected through the use of a general letter so as not to impose significant burden on the states, to promote the sharing of information between the states and FDA, and to help FDA in its oversight of public health and safety.

Burden imposed. FDA allowed each state 5 working days to gather and submit this information to FDA, and the burden for collecting this information was estimated to take each state’s Department of Health approximately 16 hours. This estimate was based on FDA’s expertise and the knowledge that most health departments have an electronic reporting system that categorizes the information by incident type, date, and description of incident. The total burden for this collection of information was estimated to take 800 hours (50 states x 16 hours).