High denial rates stifling e-cigarette market

23rd Oct 2024

A brief, submitted to the US Supreme Court, argues that the Food and Drug Administration’s (FDA) regulation of e-cigarettes is arbitrary and capricious and has been detrimental to public health.

The amicus curiae brief was submitted by the Taxpayers Protection Alliance (TPA). An amicus curiae brief is a brief written by an individual or a group not directly involved in a case but sufficiently authoritative to provide evidence to help the court make a decision.

The brief argues that despite all the scientific evidence in support of e-cigarettes as viable alternatives to cigarettes, the FDA “is doing everything in its power to undermine the use of e-cigarettes as a smoking-cessation pathway”, It further says that Family Smoking Prevention and Tobacco Control Act (TCA) is vague and delegates excessive power to the FDA.

Martin Cullip, Senior Fellow at the TPA, told Hayppgroup that “FDA inertia is suffocating progress. Its high denial rates for new e-cigarette products stifle market diversity and limits consumer choice, particularly harming adults who smoke and who might benefit from less harmful alternatives.

The TPA is proud to have submitted an amicus curiae brief which urges the Supreme Court to uphold the Fifth Circuit’s decision that the FDA’s approach is deeply flawed. There has been too much indecision and delay. It is beyond time for the FDA to focus on its role of protecting public health by installing a workable regulatory framework for reduced-harm products, rather than its current actions which only serve to confuse the public and needlessly obstruct significant potential health gains.”

The TPA is asking for a regulatory framework that adequately considers the benefits of e-cigarettes and gives regulated parties fair notice of how their products will be evaluated.

The TPA brief was submitted in support of the Wages and White Lion Investments case challenging the FDA’s regulation of e-cigarettes.