Monday, June 17, 2024

Nicopure Labs Has First PMTAs Accepted Quickly by US FDA


The U.S. Food and Drug Administration has accepted Nicopure Labs first round of premarket tobacco product applications (PMTA). The application will now move into the substantive scientific review phase of the process, according to a press release.

“I am extremely proud of all the hard work and dedication from the Nicopure Team that’s been put forth into our first round of applications. Over the next few days we will be filing additional applications and are very optimistic about Halo’s future,” said Jeffrey Stamler, CEO of Nicopure Labs. “Halo e-liquid flavors have been chosen by millions of vapors around the world as the Tobacco and Menthol e-liquids that vapers prefer.”

The regulatory agency took just three day to accept and file the submissions for Tampa-based Nicopure Labs’ Halo Tribeca Tobacco e-liquid, Halo SubZero Menthol e-liquid and Halo Fusion e-liquid.

“Halo’s 10-year history as a prominent brand, specializing in the tobacco-flavored e-liquid space has positioned the brand well for what is likely to come for the vaping industry. With California and New York becoming tobacco flavor-only markets, it is expected that more states will follow suit and Halo will be well-prepared with their award-winning tobacco flavors,” the release states. “Once accepted for filing, the final phase of the PMTA review process will be the FDA’s comprehensive evaluation of the scientific data supplied in the (PMTA) After all information has been fully evaluated and inspected, the FDA will make their final approval decision.”

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