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In this model, providers Ask all patients if they use tobacco, Advise tobacco users to quit through personalized messages, and then Refer tobacco users to appropriate community cessation services (including Quitlines)

Further, on May 20, 2022, the Company received notification of the FDA's filing of its bundled PMTA, which reflected the FDA's determination that the Company's PMTA "is sufficiently complete to enter [the] substantive review phase." The Company does not use synthetic nicotine in its products, and therefore the recent federal legislation subjecting synthetic nicotine products to FDA regulation does not impact any of Black Buffalo's products

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