NICOPURE LABS ANNOUNCES ADVANCEMENT OF PMTA FROM ACCEPTANCE REVIEW TO FINAL STAGE SUBSTANTIVE REVIEW


Tampa, FLA, Sept. 09, 2020 (GLOBE NEWSWIRE) -- Nicopure proudly announces that their recently filed Pre-Market Tobacco Applications (PMTA) for Halo Tribeca E-liquid, Halo SubZero E-liquid, and Halo Fusion E-liquid has rapidly advanced from submission to Substantive Scientific Review phase.

Just days after receiving notice that Nicopure’s PMTAs had been advanced from Acceptance Review to Filing Review, Nicopure was informed by the FDA that the applications are now under Substantive Scientific Review. According to a timeline provided by the FDA, this phase of the review process will be the final one prior to the FDA’s approval decision. 

Halo’s 10-year history as the prominent tobacco and menthol brand has defined the tobacco and menthol e-liquid space, as well as lead the way with Best by Dating, Lot Codes, and complete Cleanroom environment - well before the FDA PMTA regulation was announced. 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.

“Our entire team has been working tirelessly for over four years to ensure we provided the safest, most consistent, quality product batch after batch and provide the FDA with the necessary testing and documentation to demonstrate the Product’s position within Public Health.”, said Jeffrey Stamler, CEO and Co-Founder Nicopure Labs LLC.  

“Since founding Halo over 10 years ago with my business partners, I’ve made it my personal mission to provide the absolute purest e-liquid product possible. As an ex-smoker, I understand the need to be around for my children and this drove me every day. Halo. Here Today, Tomorrow, & For Years to Come.”, Jason Del Giudice, CTO and Co-Founder Nicopure Labs LLC.

 

About Nicopure Labs

A subsidiary of Pure Laboratories operating since 2009, Tampa-based Nicopure Labs, LLC is an industry leading e-liquid manufacturer that produces its award-winning e-liquids in the USA. Nicopure Labs has a best-in-class 110,000-sq. ft. manufacturing and distribution facility in Gainesville, Florida with a 10,000-sq. ft. ISO 7 cleanroom.

For more information about Nicopure Labs, visit nicopure.com. For additional information regarding their premium American-made e-liquids and innovative line of vaporizer devices, please visit halocigs.com.

 

About Pure Laboratories


Operating since 2009, Gainesville-based Pure Laboratories LLC, also known as Pure Labs, is an industry leading manufacturer that produces award-winning products in the USA.  Pure Labs has a state-of-the-art 110,000-sq. ft. manufacturing and distribution facility in Gainesville, Florida with a 10,000-sq. ft. ISO 7 cleanroom, as well as Headquarters based in Tampa, Florida.

For more information about Pure Labs, visit purelabs.com. For additional information regarding their premium American-made e-liquids, CBD products and innovative line of vaporizer devices, please visit halocigs.com. For media inquiries, please email press@purelabs.com.

 

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Image Sourced From  https://www.fda.gov/tobacco-products/market-and-distribute-tobacco-product/premarket-tobacco-product-applications#3

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