The e-cigarette market has seen a considerable period of growth over the last few years, as smokers see them as less harmful than traditional cigarettes and legislation on smoking in public places has become more restrictive.
This rapid growth, though, has not come without some serious issues, and recently there have been a number of cases where the batteries in some e-cigarettes have exploded without warning. In order to assess the potential dangers of these products, the US Food and Drug Administration (FDA) has announced that there will be a two day workshop covering the issue, to be held in April.
When e-cigarettes were first launched, manufacturers didn’t require any form of FDA approval, but with the market continuing to increase and numerous instances where they’ve exploded, the FDA had already announced that it would begin to implement regulations for the devices, potentially requiring FDA 510k approval of all devices.
How long does it take to get a FDA 510k approved?
The approval process will be an important step in ensuring the safety of users, as sales figures show no sign of slowing. Between 2015 and 2025, it is estimated that the global market will increase by $50 billion. In the UK alone, they are used by 2.6 million adults. Companies looking to gain FDA approval for these e-cigarettes can use sources such as http://www.fdathirdpartyreview.com/ to fast track submissions.
How e-cigarettes work
E-cigarettes work by heating liquid nicotine, which then becomes a vapour, to be inhaled by the user. They use powerful small lithium-ion batteries, which appear to be the source of the explosions.
From 2015 to early 2016, the FDA looked at 66 cases where e-cigarettes had exploded and the batteries had overheated and then caught fire or blown up. In many instances, these were not serious, but there have been cases where users have been burned or maimed, including facial bones and teeth being shattered, following such explosions. In the year to October 2016, the University of Washington Regional Burn Center saw 22 patients that had received burns or other injuries from e-cigarettes.
The FDA will report on its findings following the workshop, and interested parties are able to submit public comments or attend the public workshop online or in person if they so wish.