By: Olivia Bravo

On April 2, 2025, the Supreme Court issued a ruling that reaffirmed the Food and Drug Administration’s authority to regulate flavored e-cigarettes, denying a challenge brought by vape manufacturers. This decision is a significant landmark for administrative law and public health advocates. Why was this decision so controversial? And what does it tell us about how courts balance corporate interests with public well-being?

Background

The Food and Drug Administration (FDA) is the administrative agency responsible for overseeing the introduction of new food and drug products into interstate commerce. Before approving new products to be marketed to the general public, the FDA requires manufacturers to submit premarket applications with  “robust” scientific data for review, demonstrating that their products are “appropriate for the protection of public health.” The FDA has the specific authority to regulate the manufacture, distribution, and marketing of tobacco products under the 2009 Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). In 2016, the Tobacco Control Act was amended under the Obama Administration to include e-cigarettes as products subject to agency review. 

Like many federal agencies, the FDA must act in accordance with the Administrative Procedure Act of 1946 (APA), which defines the limits of its regulatory authority and outlines the procedures it must follow when creating or enforcing rules. The APA, mandates transparency, consistency, and fairness in agency actions. That legal framework became central to the industry’s challenge. (See APA, 5 U.S.C. § 553). 

The Legal Challenge: FDA v. Wages and White Lion Investments, LLC

In the precursor Fifth Circuit case FDA v. Wages and White Lion Investments, LLC, plaintiffs White Lion and other manufacturers of e-cigarettes submitted to the FDA applications to market their flavored tobacco products – but were rejected for lacking long-term studies demonstrating health benefits and marketing plans that met regulatory standards. 

The companies pushed back hard, arguing that the FDA had applied inconsistent and opaque standards, effectively moving the goalposts without notice. They claimed that flavored vapes were unfairly singled out and that the FDA’s review process was arbitrary, violating the APA. They contended that this created an uneven playing field, treating flavored e-cigarettes more harshly than other tobacco products and leaving applicants to guess at the “robust standards” they needed to meet. The Fifth Circuit ultimately agreed, holding that the FDA acted outside the scope of its authority. The case was then appealed to the Supreme Court, which granted cert.

FDA Denial and Industry Pushback

What is the crux of the matter? Why did the FDA  deny the companies’ applications to sell their e-cigarettes? 

E-cigarettes and vapes are only two of the many electronic delivery system (ENDS) products that use an “e-liquid” nicotine derived from tobacco (as well as flavorings) as an aerosol that is inhaled. In this case, White Lion’s rejected products included flavors like Killer Kustard Blueberry, Rainbow Road, and Pineapple Express, sold in brightly colored packaging resembling candy or cartoons. The FDA argued that this targeted marketing posed a significant risk to youth. In the last decade, the United States has seen an explosive rise in adolescents’ vaping and the renormalization of smoking, especially among high schoolers. In 2024, 1.63 million middle and high school students used e-cigarettes. Recent statistics show that flavor is one of the most important factors adolescents consider when trying e-cigarettes for the first time. 

The vaping industry continues to frame flavored e-cigarettes as a public health innovation—a tool for adult users seeking an alternative to traditional cigarettes. Companies like Triton and Vapetasia claim their flavored vapes provide a public good by helping adult smokers quit cigarettes, with flavors making it more likely that adult smokers will transition away from combustible tobacco. However, the FDA found that e-cigarettes pose a “known and substantial” risk to youth, and concluded that the risks of bringing a new product to market outweighed any potential benefit. 

Supreme Court Review: Reversing the Fifth Circuit

Earlier this month, in the unanimous Supreme Court decision, Justice Alito agreed with the FDA that the flavored e-cigarettes and vapes proved a danger to the health of young people, writing “the kaleidoscope of flavor options adds to the allure of e-cigarettes and has thus contributed to the booming demand for such products among young Americans.” The Court found that the FDA’s actions did not violate the APA and were consistent with its regulatory responsibilities. 

The Supreme Court and the Fifth Circuit’s decisions differed based on their standards of procedural adherence. While the Fifth Circuit applied a stringent standard, arguing that the FDA acted arbitrarily and capriciously by shifting its standards, the Supreme Court deferred to the FDA’s expertise when no formal policy changes were in place, arguing that their decisions were not outside the scope of their authority. This divergence highlights the broader tension between judicial oversight of agency action and deference to agency expertise in complex regulatory matters, especially those that will have long-term effects on public health.

Conclusion

The Supreme Court’s decision affirms the FDA’s authority to prioritize public health and interstate commerce. In terms of implications for the vaping industry, it is clear the court has drawn the line in the sand between commercial interest and public health priorities, and set a standard for the prioritization of the youth impact over the harm to adult cigarette smokers. While this Court might have previously made different decisions concerning federal agency regulation, it is clear that the targeted health risk to youth was enough of a concern to find in favor of the FDA, whereas in another case, the Court might have gone the other direction.  

Overall, the controversy in this case was a big wake-up call for the FDA and all regulatory agencies that set guidelines for growing and advancing industries. While it might have been easier to set standards for cigarettes when the harmful effects of lung cancer were widely known, the technological and marketing advances of e-cigarettes and other alternative tobacco products have made it difficult for the FDA to keep up with both the pace of innovation and the health implications. Why leave the question of clear regulatory standards and guidelines up for interpretation? Change requirements to keep pace with the advancing world and give notice of those changes in line with transparency.  

#E-cigarettes #FDA #Regulatoryauthority #WJLTA

By: Miranda Glisson

            Recently, I’ve developed a growing interest in car racing – particularly open-wheel, sports car, and touring car disciplines. As a result, I entered the world of Forza video games, including Forza Horizon and Forza Motorsport. While I practiced my driving skills in a not-too-fancy simulator playing Forza Motorsport, I wondered about the challenges Forza and other video games must face with licensing trademarked subject matter like cars after the AM General LLC v. Activision Blizzard, Inc. decision. 

IP Licensing in Video Games

Video games represent the pinnacle of interactive intellectual property, often requiring developers and producers to secure numerous licenses for a single game. Video game licensing refers to an agreement between a video game producer and an external company granting the producer permission to use the company’s intellectual property in their game. Game producers may employ licenses to use copyrighted and trademarked works in their games.

            Video game producers and external companies negotiate and agree upon each license.  Each license can have differing stipulations depending on how an external company wants their copyrighted or trademarked logo/work used within the game, ensuring the user’s perception of the external company’s work aligns with that company’s desire in how they are perceived.

Video game developers may want to obtain permission to use a third party’s trademark in their game to bring their creative vision to life. Incorporating trademarks from other companies can enhance realism, enable parody, or support commentary. However, obtaining the permission to use a trademark in a video game varies in difficulty, and the licenses can boast specific terms and conditions regarding use, scope, duration, quality control, and fees.

AM General LLC v. Activision Blizzard, Inc.

Trademark licenses may not be required when video game developers use the trademarked subject matter artistically or expressively. When one’s trademark is used in an artistic or expressive way by another, courts have narrowly interpreted the Lanham Act (the primary federal statute governing trademark law in the United States) to avoid suppressing protected speech under the First Amendment. In AM General LLC v. Activision Blizzard, Inc., AM General brought a trademark infringement claim against Activision Blizzard for using Humvees in their game, Call of Duty, without obtaining permission. The court determined the inclusion of Humvees in the game was intended to enhance realism, deeming their use as an expressive form of creativity. As a result, Activision Blizzard was within its rights to incorporate real-world subjects for artistic purposes and thus did not infringe upon AM General’s trademark.

AM General LLC v. Activision Blizzard, Inc. had significant impacts on video game licensing by establishing that real-world objects that are depicted in video games enhance artistic realism are protected under the First Amendment. As a result, video game developers do not need to obtain a license from trademark holders if the use is to enhance artistic realism. However, it is unclear how far the holding of AM General LLC v. Activision Blizzard, Inc. reaches. A major factor in the AM General LLC v. Activision Blizzard, Inc. decision was that consumer confusion was unlikely between the plaintiff’s Humvees and the defendant’s game, as there was no evidence of significant market overlap or direct competition. Accordingly, it would be expected that if there was market or consumer overlap between one party’s work and the other’s trademark, there would not be protected use of that mark, and therefore, a license would be required.

            I, as a very novice video game player, enjoy video games’ depictions of realism as it enhances immersion. As video games incorporate brands and products into their games to enhance realism, developers are required to navigate when trademark licensing agreements are required or not. Decisions like AM General LLC v. Activision Blizzard, Inc. show that trademarks can be used if they are for artistic or expressive purposes, if there is little likelihood of consumer confusion. However, this boundary is uncertain and likely creates difficulty for video game developers as, ultimately, video games are a mix of art, collaboration, and commerce, creating difficult intellectual property challenges.

#videogames #artisticrealism #trademarks