Manufacturers and designers of tobacco vaping devices must meet US FDA requirements to sell in the U.S. The deadline for filing the Premarket Tobacco Application (PTMA) was May 12, but due to business and travel restrictions caused by COVID-19, the FDA requested an extension. A federal judge granted that and now companies have until Sept. 9, 2020, to file applications.
Applicants applying by the Sept. 9 deadline can take advantage of the 2019 FDA guideline “Compliance Policy for Limited Modifications to Certain Marketed Tobacco Products.” In this announcement, the FDA gave guidance that devices modified solely to meet UL 8139 battery safety compliance tests would not trigger more stringent compliance testing for modifications to electronic nicotine delivery devices (ENDS) devices that went into effect in 2016. That enables companies to use UL 8139 safety certification in their PTMA application. Devices that do not meet the PTMA compliance rules may not be sold in the U.S. and companies can face stiff penalties.
UL experts recommend seeking a preliminary review or product certification soon to allow for time in the 120-day extension window, to address any compliance challenges that may arise.
UL has taken steps to ensure the safety of our employees and clients so that we can remain open to help you meet safety, performance, interoperability and market access needs – while complying with federal and state government orders.
UL understands regulatory certification changes are rapidly occurring as offices in various countries close or operate with limited hours due to COVID-19. To address this, UL is providing a complimentary webpage resource that lists top changes occurring in key markets. UL is also offering remote witness testing to accommodate for global travel restrictions.
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