Washington, D.C. – The U.S. Supreme Court today heard oral arguments in FDA v. Wages and White Lion Investments, LLC, a pivotal case concerning the Food and Drug Administration’s rejection of applications to market flavored nicotine vaping devices.

This is a landmark case for regulatory accountability related to public health and consumer choice.

At issue is whether the FDA acted arbitrarily and capriciously when denying numerous premarket tobacco product applications (PMTA), as alleged by the manufacturers and affirmed by the U.S. Court of Appeals for the 5th Circuit, which accused the FDA of a “regulatory switcheroo”. 

Elizabeth Hicks, US Affairs Analyst of the Consumer Choice Center, observed today’s arguments and weighed in on the consequences of the case for consumers,

“This case underscores the need for fairness and transparency in regulatory processes. The FDA’s blanket denials have placed enormous hurdles on firms providing harm-reduction alternatives, potentially decimating an industry that millions of adult consumers rely on to transition away from smoking traditional cigarettes.”

Advocates of prohibition on flavored e-liquids, including groups like the American Medical Association, have characterized these products as targeting youth rather than adult consumers. Arguments in front of SCOTUS focused on whether the FDA had been transparent and consistent in why product applications were denied and what was lacking in the marketing plans of the applicants.

Associate Justice Clarence Thomas observed that the FDA guidance was indeed “a moving target” that shifted throughout the process, while Associate Justice Neil Gorsuch lamented that applicants where not granted conditions for jury trials in administrative cases, as the Court outlined in SEC v. Jarkesy.

Hicks continued, “The FDA’s rejection of Triton and Vapetasia’s applications demonstrates a failure to balance or even understand public health priorities and opportunities provided by less harmful nicotine products. While we all agree on the need to keep these products out of the hands of young people, denying adult smokers access to safer alternatives like flavored vaping devices could have dire consequences for harm-reduction efforts. Regulatory decisions should be evidence-based, not rooted in unachievable or shifting standards that are unreasonable to provide.”

The Consumer Choice Center calls on policymakers and regulators to prioritize consumer access to safer alternatives and ensure regulatory clarity around nicotine products. 

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The Consumer Choice Center is an independent, nonpartisan consumer advocacy group championing the benefits of freedom of choice, innovation, and abundance in everyday life for consumers in over 100 countries. We closely monitor regulatory trends in Washington, Brussels, Ottawa, Brasilia, London, and Geneva.

Find out more at www.consumerchoicecenter.org