FDA’s Vape Ban Hits the Right Note: Supreme Court Says “Let It Be”

Last week, the Supreme Court issued a unanimous decision in FDA v. Wages & White Lion Investments, LLC, No. 23-1038 (Apr. 2, 2025) that affirms FDA’s denial of authorization to market flavored vape products. This opinion, which overrules a Fifth Circuit decision that FDA had acted arbitrarily and capriciously in denying premarket tobacco product applications submitted by manufacturers of flavored e-liquids for open-system e-cigarettes, marks the latest development in the ongoing debate and FDA regulation of flavored vape products.

By way of background, when FDA issued its rule in 2016 that deemed e-cigarettes and e-liquids to be tobacco products subject to regulation under the Family Smoking Prevention and Tobacco Control Act of 2009 (TCA), it required manufacturers of these products to obtain marketing authorization by submitting a premarket tobacco product application for their e-cigarette and e-liquid products (you can read more about the so-called “deeming rule” in our prior post here).

Following several years of delayed enforcement, FDA began reviewing a first wave of applications.  To the manufacturers’ chagrin, FDA squarely rejected approximately 1.2 million product applications belonging to 320 applicants—including the respondents—concluding that the manufacturers failed to provide sufficient product-specific scientific evidence to demonstrate enough of a benefit to adult smokers that would overcome the risk posed to youth.  Specifically, FDA cited the lack of “evidence from a randomized controlled trial, longitudinal cohort study, or another reliable and robust method that desert-, candy-, and fruit-flavored products had benefits over an appropriate comparator tobacco-flavored product.”  Id. at 16.

The manufacturers called foul, asserting that they had relied on a number of statements from FDA officials and guidance that suggested such product-specific and comparative scientific evidence would not be necessary.  In a scathing decision, an en banc panel of the Fifth Circuit agreed with the respondents, holding that FDA acted arbitrarily and capriciously and performed a “surprise switch” by “unquestionably chang[ing] its position and then pretend[ing] otherwise.”  (See our prior post on the Fifth Circuit’s decision here).

The Supreme Court overruled the Fifth Circuit, holding that FDA had not acted in an arbitrary and capricious manner.  Noting that respondents challenged the agency’s pattern of seemingly changing requirements and positions, the Court applied its “change-in-position doctrine.”  The doctrine acknowledges that “agencies are free to change their existing policies as long as they provide a reasoned explanation for the change,” “display awareness that they are changing position,” and “consider serious reliance interests.”  Id. at 22.  As a first step, the Court ascertains whether the agency has actually changed an existing policy.

Here, the Court found that FDA had not, in fact, changed an existing policy.  Sorting through a litany of statutory provisions, regulations, guidance documents, and public statements, the Court found that FDA never laid out a clear test on the type of scientific evidence necessary to support the manufacturers’ applications, and that FDA had made no hard-and-fast commitment as to the minimum evidence required for authorization.  The Court held that it was a “fair summary” of FDA’s position that (a) it was not essential for manufacturers to submit evidence based on well-controlled investigations, but (b) if they did not do so, they would have to provide rigorous scientific evidence that the sale of their products would be appropriate for the protection of the public health.  Id. at 28.

In short, FDA had provided “largely noncommittal guidance.”  Id. at 29.  Frustrating as that may be for the manufacturers, FDA’s denial orders did not constitute a change in existing policy.  The Court similarly found that requirements for comparative efficacy studies (comparing the health effects of the manufacturers’ non-tobacco flavored products to those of tobacco-flavored products), and FDA’s general approach of treating “closed” and “open” system flavored e-cigarette products the same, did not constitute a change in policy.

The Court remanded the case to the Fifth Circuit to determine whether FDA had engaged in harmless error when it abandoned a prior requirement that manufacturers submit its marketing plans for their products.

The Court’s decision marks an end to the circuit split caused by the Fifth Circuit’s en banc panel on this specific issue, but we fully expect continued litigation and regulation over this hot topic.  We will continue to monitor these developments as they unfold.