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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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It also affects kidney function, increasing the risk of diabetic kidney disease , which can lead to kidney failure over time

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