The Supreme Court’s recent decision not to hear a case involving the Food and Drug Administration’s (FDA) authority over flavored electronic cigarettes has significant implications for the vaping industry. This ruling, which affects companies like Avail Vapor, revolves around the FDA’s power to deny approvals for flavored e-cigarettes, aiming to safeguard public health, particularly among the younger generation. The case has a broader context within the vaping industry, which has rapidly evolved into an $8.2 billion market in less than a decade. This article delves into the details of the case, the reasons behind the FDA’s decisions, and the potential consequences for the vaping industry.
The FDA’s Authority and Its Impact on the Vaping Industry
In 2016, the FDA extended its regulatory reach to e-cigarettes, categorizing them as traditional tobacco products. This decision meant that companies had until September 2020 to submit applications for the approval of their vape products, even if those products were already on the market. According to the FDA, nearly seven million applications were submitted by the deadline, but more than one million of them were rejected. The case in question relates to the FDA’s 2021 decision to reject all of Avail Vapor’s applications for its fruit- and dessert-flavored e-cigarettes.
Why Did the FDA Reject the E-Cigarette Applications?
The FDA’s rejection of Avail Vapor’s applications was based on the lack of long-term studies demonstrating that sweet-flavored vapes were more effective at helping adult smokers quit compared to tobacco-flavored e-cigarettes. The FDA asserts that these studies are essential to prove that the benefits of flavored e-cigarettes for adults outweigh the risks to youth. The agency argues that children, teens, and young adults are more attracted to e-cigarettes that mimic the taste of sweet treats. Avail’s applications included studies on the safety and usability of their products but did not make comparisons to tobacco-flavored vapes. Avail had also outlined marketing measures, such as age verification for online sales, designed to prevent underage use of flavored e-cigarettes. Avail argued that the FDA never communicated the need for long-term studies comparing their products with tobacco-flavored vapes during the five-year application period.
Implications for the Vaping Industry
The 4th Circuit Judge, J. Harvie Wilkinson, emphasized that focusing on procedural objections, as Avail Vapor did, neglects the broader goal of the FDA to prevent another generation from becoming addicted to nicotine and tobacco products. Wilkinson clarified that the FDA didn’t reject the applications solely because of the absence of specific long-term studies but rather because Avail didn’t provide robust, product-specific evidence to evaluate the benefits of their e-cigarette products for adults.
The fallout of this case has already had consequences for Avail Vapor, which exited the retail business after the FDA rejected its applications. It’s important to note that Avail Vapor isn’t the only company challenging the FDA’s application rejections. Juul Labs also faced an unfavorable outcome when the FDA banned its vaping products. Despite efforts to overturn this ban, the agency determined that Juul’s products still pose a risk to public health.
While the FDA has authorized some tobacco-flavored e-cigarette products and devices, the market has seen a surge in popularity for unapproved brands, many of which are illegal and appeal to teenagers. Between January 2020 and December 2022, e-cigarette unit sales rose by nearly 47%, indicating the persistent allure of these products.
Takeaway
The Supreme Court’s decision not to hear the case challenging the FDA’s authority over flavored e-cigarettes underscores the agency’s commitment to public health. It’s a reminder that the FDA’s regulations aim to strike a balance between helping adult smokers quit and preventing youth addiction. The implications of this decision ripple through the vaping industry, and companies must navigate the regulatory landscape to ensure the safety and effectiveness of their products.
