The Legal Examiner The Legal Examiner The Legal Examiner search feed instagram google-plus avvo phone envelope checkmark mail-reply spinner error close
Skip to main content
Three different vape pens standing side-by-side

The Food and Drug Administration (FDA) recently released new guidelines meant to help increase the safety of vaping products.

A 2017 report released by the U.S. Fire Administration showed that between January 2009 and December 31, 2016, there were 195 separate incidents of explosion and fire involving e-cigarettes. These included 133 acute injuries, 29 percent of which were considered severe.  About 62 percent of the incidents occurred when the device was either in a pocket or actively in use.

News source ECigOne.com has compiled 316 reports of e-cigarette explosions and notes that e-cigarettes explode during use more than ever before.   The FDA suggests in its new guidelines that manufacturers comply with certain safety standards that are intended to reduce the risk of these types of explosions.

FDA Allows Manufacturers to Make Changes Without Further Review

On August 8, 2016, all e-cigarettes and other electronic nicotine delivery systems (ENDS) or vaping products came under the authority of the FDA to regulate.  The FDA has worked with the U.S. Consumer Product Safety Commission (CPSC) and others to develop a voluntary standard meant to help manufacturers limit potential battery-related risks associated with their products.

The new guidelines are meant to “provide clarity to manufacturers” considering any modifications they may need to make to their products, and outline the FDA’s compliance policy for premarket review requirements for these modifications.

The FDA noted that to comply with these new standards, manufacturers may have to change certain aspects of their products, “which may render their products as new tobacco products.”  The FDA will not require these companies to submit those products for another premarket review, however, as long as the only changes are those made to comply with the new guidelines.

FDA Believes Compliance with the New Guidelines Will Make E-Cigarettes Safer

The FDA notes in its guidelines that between 2009 and 2017, the number of battery-related injuries and damage reports associated with ENDS products increased nearly 100-fold.  These explosions have resulted in serious, disfiguring, and disabling injuries, and between 2015-2017, they may have been responsible for about 678 emergency room visits per year.

The new voluntary industry standard UL 8139 prescribes an approach to “evaluate the safety of the electrical, heating, cell, battery, and charging systems of these products,” the FDA writes.  It also provides guidelines for testing, which should include mechanical stress testing, accidental activation, environmental resilience, and more.

The FDA believes that products in compliance with UL 8139 will have a significantly reduced risk of battery-related explosions.

FDA Will Allow Companies to Modify Nicotine Solution Packs

In a press release related to the new guidelines, the FDA noted that Congress passed the Child Nicotine Poisoning Prevention Act (CNPPA), which requires liquid nicotine containers to have special packaging that makes it difficult for children to open.  Companies that need to modify their products to meet these standards will not have to worry about the FDA enforcing violations of the premarket review requirements.

Comments are closed.

Of Interest