In 2016, the Food & Drug Administration (FDA) deemed electronic cigarettes and other vaping products to be "tobacco" products for the purposes of federal law. This move gave the FDA's Center for Tobacco Products legal authority to regulate vaping products like combustible cigarettes. How the FDA has proceeded to regulate such products since, however, has been something of a mess, suggesting either some degree of administrative incompetence, malice against portions of the industry, if not both.
Last October, the U.S. Court of Appeals for the Fifth Circuit eviscerated the FDA for flouting the basic administrative law requirements of "reasoned decisionmaking" when it denied Triton Distribution's premarket tobacco applications (PMTAs) for a range of vaping products. This is a big deal because vaping companies cannot sell their products if their PMTAs are denied.
In November, the U.S. Court of Appeals for the Sixth Circuit also found fault with the FDA's attention to basic administrative law requirements, this time in the agency's review of PMTAs from Breeze Smoke, another vaping product company. While the Sixth Circuit did not grant Breeze Smoke the relief it wanted, it was critical of the FDA's "formulaic" review of the PMTA materials.
