FDA Gathering Information From E-Cigarette Manufacturers
The FDA Center for Tobacco Products has issued letters to e-cigarette manufacturers requesting information regarding the safety of electronic cigarettes.
The letters note that FDA has authority under the Tobacco Control Act to assert jurisdiction over e-cigarettes, and that FDA intends to do so by issuing appropriate regulations.
The letters request information regarding the following issues:
- Customer complaints and “adverse event issues.”
- Reports of “consumer misuse.”
- Descriptions of product labeling.
- Systems in place to review customer complaints and adverse events.
Based on the information requested, it appears that FDA’s letters may have been prompted by a report earlier this year of an e-cigarette exploding in a man’s mouth. Although there is no verified information regarding the incident, news reports suggest that the e-cigarette at issue was a “mod,” whereby some consumers modify the product to obtain a stronger nicotine “hit.” Such “mods” could represent a dangerous change to e-cigarettes by changing the battery in ways that the product was not designed to accommodate.
Based on the foregoing, it appears that FDA may be considering ways to address consumer misuse of e-cigarettes as it drafts regulations covering the industry. The Troutman Sanders Tobacco Team will report back on further developments on this issue.