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FDA: Premarket Approval (PMA) Required for Existing Vape Flavored Products

Last Updated January 25, 2019

March 13, 2019: The FDA announced premarket approval requirements for all flavored e-cigarette products, with a deadline to file by August 8, 2021. This new deadline is one year earlier than previously proposed.  No flavored tobacco products will be allowed on the market if they have not submitted applications to the FDA after this date. The FDA has stated they believe this will cause some flavored tobacco products to no longer be on the market.

What Vapes need Premarket Approval?

Any electronic nicotine delivery device that contains flavors will need premarket approval by August 2021.  This would include products like JUUL with flavored pods, as well as e-juice products used with vape mod or vape box product. Menthol and mint flavors are exempted and can continue to be sold.

Vape Batteries and Explosions

The focus of today’s FDA announcement was focused on flavored tobacco, both electronic devices and other flavored products such as flavored cigars.  The FDA may issue more updates regarding regulation of batteries such as 18650 batteries, which paired with vape box or vape mod devices have resulted in fires, explosions, injury, and even death.

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Vape Lawyer:

Contact the lawyers at Levin Simes Abrams if you have any questions regarding vape injuries. Our attorneys specialize in representing clients injured by e-cig, vape or mod devices, including vape battery explosions. Reach us at 1-415-426-3000, [email protected], or through this website form or chat.