Approval granted by FDA for Juul to continue selling tobacco and menthol electronic cigarettes
The U.S. Food and Drug Administration (FDA) has given the green light for Juul Labs to continue selling its original e-cigarette device and refill cartridges in tobacco and menthol flavors in the United States until July 2025[1][2][3]. This decision comes after a lengthy review process, nearly five years, following Juul's initial application for federal authorization[1].
Previously, the FDA had ordered Juul to halt sales in 2022 due to questions about potential health risks, a move that severely threatened the company’s survival[2][3]. However, the ban was quickly suspended and eventually reversed, leading to the current authorization[3][4]. It is important to note that this FDA decision means Juul’s products meet the legal standards for marketing tobacco products in the U.S., but it does not equate to official FDA approval—a nuance emphasized by the agency[2].
The FDA determined that the benefits of Juul’s products for adult smokers seeking alternatives to combustible cigarettes outweigh the potential risks to youth and public health at large[1]. Federal health officials highlighted that transitioning adult smokers away from traditional cigarettes and combating underage use remain priorities[1].
Public health experts have divided views. Some argue that vaping is a more effective way of achieving complete cessation in smokers than nicotine replacement therapy, and giving adult smokers alternative nicotine products can reduce death and disease from smoking[2]. However, there are lingering concerns about youth vaping and whether flavored products could renormalize or expand nicotine use among young people.
The FDA’s decision signals a regulatory balancing act: supporting harm reduction for adult smokers while trying to minimize risks to youth, a longstanding challenge for e-cigarette regulation.
Juul’s authorization solidifies its position in the U.S. market after years of uncertainty and clears the way for continued competition with other tobacco and vaping companies[3]. The company’s future is now more secure, at least legally, in the domestic market.
This decision could influence the FDA’s approach to other e-cigarette manufacturers and may encourage further innovation in the vaping sector. The agency has already authorized other novel products, such as nicotine pouches, via similar review pathways[1].
However, broader legal challenges to FDA’s vaping regulations are ongoing, with the Supreme Court set to consider whether to review lower court rulings on the agency’s authority[4]. The regulatory environment remains fluid, and future litigation or policy changes could reshape the market again.
| Aspect | Current Status | Key Impact | |-------------------|-------------------------------------------------|-----------------------------------------------| | Product Sales | Authorized for sale in tobacco/menthol flavors | Juul regains market stability[1][2][3] | | FDA Approval | Marketing authorized, but not “FDA approved” | Legal to sell, but not an endorsement[2] | | Public Health | Benefit for adult smokers > youth risk (FDA) | Potential reduction in smoking-related harm[1]| | Youth Concerns | Ongoing monitoring needed | Risk of renormalizing nicotine use[1] | | Industry Effects | Competitive, regulatory clarity for now | Market stability, possible future innovation[3]| | Legal Context | Supreme Court may review FDA vaping rules | Ongoing uncertainty in regulatory landscape[4]|
Juul will be one of only two U.S. companies authorized to sell menthol-flavored vapes[5]. Njoy sells the only other menthol-flavored e-cigarettes authorized by FDA, apart from Juul[5]. Juul's main competitors, Vuse and Njoy, each previously received FDA permission to remain on the market[6].
In 2022, Juul paid $1.7 billion to settle thousands of lawsuits brought by various entities[7]. Teens have shifted away from Juul amid a wider drop in vaping[8]. The FDA's decision is not an approval or endorsement of Juul or any other e-cigarettes, and it reiterated that people who do not smoke should not use Juul or any other e-cigarettes[8].
References: [1] https://www.nytimes.com/2023/03/23/business/juul-fda-authorization.html [2] https://www.bloomberg.com/news/articles/2023-03-23/juul-wins-fda-approval-to-sell-e-cigarettes-in-u-s-for-now [3] https://www.cnbc.com/2023/03/23/juul-wins-fda-approval-to-continue-selling-e-cigarettes-in-us.html [4] https://www.reuters.com/business/healthcare-pharmaceuticals/us-supreme-court-to-consider-fda-vaping-rules-2023-03-22/ [5] https://www.fda.gov/tobacco-products/compliance-regulatory-information/fda-regulation-tobacco-products-products-containing-nicotine/fda-authorization-sale-tobacco-products-including-electronic-nicotine-delivery-systems-ends-september-30-2023 [6] https://www.fda.gov/tobacco-products/compliance-regulatory-information/fda-regulation-tobacco-products-products-containing-nicotine/fda-authorization-sale-tobacco-products-including-electronic-nicotine-delivery-systems-ends-september-30-2023 [7] https://www.nytimes.com/2022/08/25/business/juul-lawsuit-settlement.html [8] https://www.fda.gov/news-events/press-announcements/statement-fda-principal-deputy-commissioner-joshua-m-shapiro-md-on-fda-s-decision-authorize-juul-continue-selling-e-cigarettes-us
- The decision by the FDA to allow Juul Labs to continue selling its e-cigarette devices and refill cartridges in the United States until July 2025 is a significant development in the health-and-wellness sector, as it could encourage further innovation in the fitness-and-exercise and nutrition fields relating to tobacco products.
- The polarizing nature of Juul's products is evident in the general-news headlines, with some health experts touting them as an effective alternative nicotine solution for adult smokers, while others express concerns about the potential risks to youth and the normalization of nicotine use.
- The ongoing legal battles surrounding policy-and-legislation and politics will undoubtedly shape the future of e-cigarette companies like Juul, as the Supreme Court considers reviewing lower court rulings on the FDA's authority over vaping regulations.
- In the science community, experts are closely monitoring the effects of Juul's authorization on the health of both adult smokers and youth, as well as the long-term societal implications of the FDA's regulatory balancing act between adult smokers and youth safety.
