• Deanna Clark-Esposito

FDA Meeting on Battery Concerns & ENDS


Last month the FDA hosted a meeting at its Silver Springs, MD White Oak Campus on Battery Safety Concerns in Electronic Nicotine Device Systems (ENDS). It was the agency’s first workshop on batteries to examine the scope and impact of ENDS with regards to fires and explosions, product design, and the communication of risks associated with e-cigarette batteries to consumers, retailers, and distributors. Significantly, the purpose of the workshop was to get scientific information on batteries only – not advice or consensus on the devices as a whole – and the latter was not once sought throughout the two days of presentations and public questions.


As I’ve written about in other posts, the FDA was mandated to prevent new “tobacco products” (which includes e-cigarettes, e-hookahs and other vape products) that it considers inappropriate for the protection of public health from entering the market. FDA therefore, took the broad actions it did in its “Deeming Rule,” in an effort to reduce incidents of death and disease from several non-tobacco containing products, as well as a handful of products actually containing tobacco.


FDA has yet to have a meeting on the health concerns around nicotine or the other ingredients that make up an e-liquid and likely, never will in relation to the toxicity of combustible, i.e., traditional, cigarettes. Rather, FDA is treating ENDS as a public health concern due to the Lithium-ion batteries used with e-cigarette devices, and has a particular concern with rechargeable batteries due to the rare, but known to occur event, of “thermal runaway” that could lead to a battery explosion.


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FDA

PMTA

lithium-ion

batteries

e-cigarettes

vape pens

safety

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health

tobacco

risks

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