Assessing E-Cigarette Battery and Device Safety
E-cigarettes are growing in popularity with usage expected to continue at an increasing pace. While e-cigarettes, or electronic nicotine delivery systems (ENDS), offer an alternative to traditional tobacco products, they introduce several new risks to consumers.
The U.S. Food and Drug Administration (FDA) is addressing these risks by requiring ENDS manufacturers to submit a Premarket Tobacco Application (PMTA) for any product marketed after February 15, 2007. The scope of the PMTA includes multiple sources that could impact public health such as factors that result in a change in the likelihood of tobacco product use or cessation.
Addressing this requirement represents a substantial challenge for manufacturers, understandably drawing focus towards concerns related to the use of e-liquids. However, it is also important to recognize that these products introduce new safety risks associated with the delivery device itself, which includes battery safety.
There have been more than 300 reported e-cigarette explosions in the media1. These have occurred in a variety of contexts, including during use, during charging and during transport, with serious bodily harm in some instances and at least one death.
Personal injury from battery failures in consumer devices is not exclusive to ENDS products but it is worth noting that the nature of the relationship between the consumer and the device produces somewhat unique use and interaction scenarios that can affect severity. The desire to minimize the occurrence and severity of battery related injuries has resulted in the inclusion of battery and device safety assessment as part of the PMTA process, where e-cigarette device manufacturers must submit results from battery and device safety testing as described in application guidance2.
ENDS devices and their components – including batteries, atomizers, chargers and software – must be assessed in a systematic manner to understand the overall device safety risk profile during normal use and foreseeable misuse. The information needed to support risk identification and mitigation may be collected by leveraging testing standards, such as those from the International Electrochemical Commission (IEC) and Underwriters Laboratories Inc. (UL). The results may reveal that design changes are needed to decrease the safety risk associated with a specific device.
Battery and device safety assessment is not only an important component in the PMTA narrative regarding appropriateness for the protection of public health (APPH), but it also is important to include early in, and throughout, the product development cycle to help decrease the probability of late-stage design changes that may result in the expense of repeating qualification, testing, or even PMTA submission. Adopting this mindset affords manufacturers an opportunity to develop a more compelling application with improved product design files.
Through a robust battery and device safety assessment, e-cigarette manufacturers can develop insights and implement design mitigations to not only reduce the risk of user injury but also decrease development costs and time to market, greatly enhancing their ability to participate in this growing market.
About the Author
Eric Scribben is a Senior Research Scientist at Battelle.
1. https://ecigone.com/featured/e-cigarette-explosions-comprehensive-list/
2. https://www.fda.gov/media/127853/download
The U.S. Food and Drug Administration (FDA) is addressing these risks by requiring ENDS manufacturers to submit a Premarket Tobacco Application (PMTA) for any product marketed after February 15, 2007. The scope of the PMTA includes multiple sources that could impact public health such as factors that result in a change in the likelihood of tobacco product use or cessation.
Addressing this requirement represents a substantial challenge for manufacturers, understandably drawing focus towards concerns related to the use of e-liquids. However, it is also important to recognize that these products introduce new safety risks associated with the delivery device itself, which includes battery safety.
There have been more than 300 reported e-cigarette explosions in the media1. These have occurred in a variety of contexts, including during use, during charging and during transport, with serious bodily harm in some instances and at least one death.
Personal injury from battery failures in consumer devices is not exclusive to ENDS products but it is worth noting that the nature of the relationship between the consumer and the device produces somewhat unique use and interaction scenarios that can affect severity. The desire to minimize the occurrence and severity of battery related injuries has resulted in the inclusion of battery and device safety assessment as part of the PMTA process, where e-cigarette device manufacturers must submit results from battery and device safety testing as described in application guidance2.
ENDS devices and their components – including batteries, atomizers, chargers and software – must be assessed in a systematic manner to understand the overall device safety risk profile during normal use and foreseeable misuse. The information needed to support risk identification and mitigation may be collected by leveraging testing standards, such as those from the International Electrochemical Commission (IEC) and Underwriters Laboratories Inc. (UL). The results may reveal that design changes are needed to decrease the safety risk associated with a specific device.
Battery and device safety assessment is not only an important component in the PMTA narrative regarding appropriateness for the protection of public health (APPH), but it also is important to include early in, and throughout, the product development cycle to help decrease the probability of late-stage design changes that may result in the expense of repeating qualification, testing, or even PMTA submission. Adopting this mindset affords manufacturers an opportunity to develop a more compelling application with improved product design files.
Through a robust battery and device safety assessment, e-cigarette manufacturers can develop insights and implement design mitigations to not only reduce the risk of user injury but also decrease development costs and time to market, greatly enhancing their ability to participate in this growing market.
About the Author
Eric Scribben is a Senior Research Scientist at Battelle.
1. https://ecigone.com/featured/e-cigarette-explosions-comprehensive-list/
2. https://www.fda.gov/media/127853/download
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