A Major Victory for Businesses, Vapers and Public Health

The Fifth Circuit Court of Appeals has delivered an important victory for American businesses, consumers, and public health by ruling that the Food and Drug Administration (FDA) unlawfully bypassed the safeguards of the Administrative Procedure Act (APA) when it created and applied its comparative efficacy standard to vaping products.

The court decision has judged that a federal agency cannot create a rule behind closed doors, apply it to thousands of businesses, and then deny their products without giving those affected an opportunity to comment.

The case concerned the FDA’s Premarket Tobacco Product Application (PMTA) system, established under the Tobacco Control Act (TCA) of 2009. Under the law, new tobacco products must demonstrate that they are appropriate for protecting public health, an assessment that requires the FDA to consider both the likelihood that non-users will begin using tobacco products and the likelihood that existing users will stop.

Instead, the FDA developed a comparative efficacy approach for non-tobacco flavored vaping products. Because the agency considered these flavors to carry greater youth initiation risks than tobacco flavors, manufacturers were effectively required to demonstrate that their products provided an additional benefit to adult smokers compared with tobacco-flavored products.

The decision found that the FDA had established a substantive rule that bound the agency, applied prospectively to an unlimited number of applicants and amounted to a de facto ban. The agency therefore ignored the APA’s notice-and-comment requirements.

It was a regulatory barrier of extraordinary proportions and the consequences are staggering. The court noted that the FDA had issued marketing denial orders covering more than 1.2 million flavored electronic nicotine delivery system products, while only a tiny number of flavored products had received authorization. The FDA had received applications for more than 6 million products while authorizing only a very small fraction.

The APA exists to prevent federal agencies from making rules without proper public participation. Common sense dictates that businesses need to know what rules they are expected to follow. They must have the opportunity to provide evidence, challenge assumptions, and explain the consequences of regulatory proposals.

Pharmaceutical companies, technology businesses, manufacturers, financial institutions and countless other American enterprises all depend on the principle that government agencies cannot simply invent requirements and impose them without following the law.

The ruling is also important because of what the word “unauthorized” actually means. When consumers hear that a vaping product is unauthorized or illegal, many naturally assume that the FDA has examined the product and determined that it is dangerous. That is incorrect.

An unauthorized product is a product that has not received FDA marketing authorization. That can include products that have never been submitted, products that failed to satisfy the statutory requirements, and products caught up in the complexity and delays of the PMTA system. The FDA makes clear that authorization is legal permission to sell, not an assertion that authorized products are “safe.”

There are safe vaping products sold legally in markets around the world that cannot be legally sold in America because they have been stuck in the FDA’s authorization process. Their unauthorized status in the United States does not mean they are inherently dangerous.

A regulatory system that prevents potentially beneficial alternatives from reaching adult smokers does not just affect manufacturers. It affects millions of Americans who smoke and who might benefit from switching away from combustible cigarettes. A process that makes authorization extraordinarily difficult can restrict the very alternatives that could contribute to smoking cessation.

This broken regulatory system also affects taxpayers who foot the bill for inflated healthcare costs for people that don’t switch from combustible cigarettes to less harmful options.

The consequences are clear. FDA reported more than 187,000 marketing denial orders in 2025, compared with just five marketing granted orders for vaping products that year. That is not a healthy regulatory marketplace. Instead, it shows a system in which the barrier to legal market entry has become unnecessarily high.

The court has now required the FDA to rethink its approach; it is not a demand for weaker regulation. It is a demand for lawful, transparent and rational regulation. This is good news for American businesses, consumers, and public health.

The FDA should now do its job properly and install a regulatory system that recognizes genuinely dangerous products, protects young people, gives legitimate businesses a fair hearing and preserves access to lower-risk alternatives for adults who want to leave cigarettes behind.

The FDA’s regulatory process has poorly served American public health by placing procedural barriers ahead of meaningful consideration of potentially beneficial products. It is good that the court has put that right.

Martin Cullip is an International Fellow at The Taxpayers Protection Alliance’s Consumer Center and is based in South London, UK.