The Supreme Court has decided not to take on a case that challenged the Food and Drug Administration's authority to regulate vaping products.
Big Time Vapes, a vape shop in Mississippi, filed a lawsuit against the FDA challenging the FDA's authority to regulate vape products under the 2009 Tobacco Control Act. That suit was rejected by the lower courts and landed in the lap of the Supreme Court on appeal.
The lawsuit hinged on whether the FDA should be allowed to regulate the vape market at all. The FDA granted itself that power when it published the so-called "deeming rule" in which the FDA "deemed" vape products to be tobacco products and therefore under FDA regulatory oversight. The Tobacco Control Act originally only applied to cigarettes and smokeless tobacco products so, prior to the deeming rule, vapes were not be considered subject to the Act.
The Big Time Vapes lawsuit argued that the deeming rule improperly gave FDA too much authority and should be thrown out. That's because there is "no guidance as to the circumstances under which the Secretary should regulate additional products" written into the law which meant that the decision to deem vape products as tobacco products fell unconstitutionally to the FDA's "unbridled discretion," according to the lawsuit.
The lawsuit also emphasized that vape products should be part of a harm reduction strategy and that the FDA's regulatory oversight threatened their availability.
"The FDA’s Regulatory Impact Analysis promulgated with the Deeming Rule estimated that the Rule would cause 54% of ENDS delivery system hardware products to exit the market and 50% to 87.5% of e-liquid products to exit the market," Big Time Vapes stated in their suit.
With, by the FDA's own estimate, up to nearly 90% of all e-liquid products predicted to disappear from the market as a result of the deeming rule, a process that is currently underway as vape companies are crushed by the expense and demands of the PMTA process, Big Time Vapes certainly had a point.
However, it's not a point the Supreme Court cares to contemplate. The Supreme Court's decision to pass on the case means the ruling of the lower courts stands and the PMTA process will continue.
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