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Nicopure appeal over FDA deeming regs moves forward; opening briefs filed

Nicopure appeal over FDA deeming regs moves forward; opening briefs filed

The National Law Review is reporting that attorneys for Nicopure Labs and the Right to be Smoke-Free Coalition have filed opening briefs to appeal the July 2017 decision in their lawsuit over the FDA deeming regulations.  Last year, Judge Amy Berman Jackson of the Federal District Court in Washington D.C. the issued a 93-page decision in favor of the FDA.  The plaintiffs (appellants) disagree with Berman’s decision and filed an appeal based on two primary arguments.

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Firstly, the Modified Risk Tobacco Product (MRTP) provision of the Tobacco Control Act (TPA) prohibits vape shop owners and employees from providing their customers information regarding the tobacco harm reduction benefits of vaping.  Retailers are also prohibited from offering free e-liquid samples.  Nicopure Labs and the Right to be Smoke-Free Coalition argue that the new restrictions violate the first amendment right of free speech.

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Secondly, the appellants believe that the Pre-Market Tobacco Application (PMTA) process should not apply to vaping products.  Because the FDA deeming regulations now classify e-cigs as tobacco products, vape retailers are now forced to adhere to the same approval process as Big Tobacco, even though e-liquids are 100% tobacco-free.

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The appellants are not opposed to an application and approval process, but they would like to see one that is specifically designed for the vaping industry.  They consider the current PMTA process to be far too complex, time-consuming, and expensive for the average vape shop owner.  Nicopure Labs and the Right to be Smoke-Free Coalition further argue that the FDA deeming regulations in their current state will essentially wipe out nearly 95 percent of the vaping industry as soon as they go into effect.  

(We will keep you updated as the appeal process continues forward.)

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