Vaping goes to the Supreme Court
This piece is in response to breaking news. It has been updated. Please contact pr@rstreet.org to speak with the scholar.
This past week, the Supreme Court held oral arguments in the Food and Drug Administration (FDA) v. Wages and White Lion Investments, L.L.C. case. The main question in the case is how much authority the FDA has over which nicotine vapes can come to the market.
Wages and White Lion argued that decisions made by the FDA’s Center for Tobacco Products (CTP) related to their marketing denial were arbitrary and capricious, whereas the CTP claims the company’s market-entry application did not provide enough evidence to meet the “appropriate for the protection of public health” standard. This case is the culmination of many years of challenges back and forth between the FDA and the tobacco industry.
The FDA CTP has been in place for nearly 15 years. During that time, the only genuinely measurable outcome––a reduction in tobacco-related death and disease––that provides evidence of effectiveness and protection of public health suggests the CTP had little to no impact on public health. What they have done is institute rules and processes that have led to thousands of small businesses shutting their doors, introduce barriers to the marketplace that have stifled innovation, and place procedures into the regulatory pathway that have placed unnecessary burdens on manufacturers, which block access for consumers to access products they desire.
Most importantly, the CTP created an environment that has allowed an explosion of illicit products that are not vetted in any manner before American consumer use. With nearly $8 billion spent, through industry fees without the same level of congressional oversight as individual taxes, many in Congress have asked how and where these funds have been spent when so little progress has been made.
Given this record, it is not surprising that all who interact with the CTP are calling for reform. In the fall of 2022, the Reagan-Udall Foundation—an independent organization established by Congress to advance the mission of the FDA—evaluated the CTP and identified several key areas for improvement. Released in December 2022, the report outlined 15 things the CTP must improve to effectively implement the regulatory goal of the organization’s mission: the protection of public health.
Since then, the primary changes (beyond CTP leadership asking for a budget increase so they could more effectively perform their responsibilities) have focused on improving external concerns. These include illicit trade, public awareness, and activities not directly related to the premarket tobacco product application (PMTA) process. But little has changed to resolve any of the outcomes described above.
Two recent events have provided hope that the environment in which the CTP operates will force significant change.
The first occurred during the summer of 2024. The Supreme Court published a decision limiting the ability of regulatory agencies to “interpret” the laws they administer. The overruling of the Chevron doctrine allows judges to determine if the regulatory agency’s oversight (often driven by its interpretation of a law) should be questioned. The first test of this new judicial environment took place with this week’s oral arguments.
If the court sides with Wages and White Lion, the call will be to clarify the Tobacco Control Act in a manner that will require more specificity to the law, which should give manufacturers a clearer pathway to market their products. The justices’ opinions won’t be known until late spring; however, questions asked from the judge’s dais were directed toward clarification on the FDA process and how that process impacted the petitioner’s ability to successfully complete their application and have it reviewed fairly.
The second is the recent results of the general election in the United States. The incoming Trump administration has clearly signaled that a primary target for reform is downsizing the administrative state. Though not clearly fleshed out, the initial indication is that all regulatory agencies will be up for evaluation. From the establishment of the Department of Government Efficiency to the announcement of Trump’s nominees to his cabinet, the president-elect is signaling that regulatory agencies’ effectiveness and necessity will be scrutinized and the status quo aggressively challenged.
What actually changes due to this new focus on the administrative state is unknown, and to attempt to prognosticate what the future of any regulatory agency will be at this time would be a fool’s errand. However, given the attention and grievances directed toward the CTP, it is safe to assume that the organization is a target and that their era of full autonomy might be coming to an end.
Regardless, there is a need for appropriate regulation of the tobacco and nicotine marketplace. The challenge is what “right-sized” oversight is, both protecting the consumer and allowing for consumer choice within the marketplace. The current PMTA process is both burdensome and unclear for any manufacturer who attempts to navigate it. Although millions of products have been reviewed over the last four years, only a handful have received approval (marketing orders) from the CTP, and many still sit in limbo. The lack of clarity, communication, and progress in reviewing these products was a key concern outlined in the Reagan-Udall report. It should be the CTP’s primary focus for improvement.
The coming months will certainly be uncomfortable. The hope is that, through decisions made by the executive, legislative, and judicial branches, appropriate changes to the regulation of tobacco and nicotine products will be instituted and accelerated. The nicotine product marketplace is currently overwhelmed by products without any regulatory oversight, which puts consumers at risk. Effective and appropriate regulation is key in order to develop a tobacco and nicotine product marketplace that provides options for consumers, includes a wide variety of reduced-risk products, and promotes innovation for the introduction of even lower-risk products to reach the hands of consumers who choose to use them.