In 2009, Congress passed the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) and for the first time conferred on FDA regulatory authority over tobacco products. The law, among other critical oversight and regulatory features, established premarket-review requirements for new tobacco products, including through Premarket Tobacco Product Applications (PMTAs). The law also requires FDA to review PMTAs within 180 days of acceptance of an application.
The U.S. FDA established a framework that acknowledges that nicotine can be delivered on a continuum of risk, with combustible products on one end being the most dangerous and lethal, and nicotine replacement therapies such as gums and patches being the least harmful. The framework contemplates that products that deliver nicotine without burning tobacco can pose much lower levels of individual risk than combustible cigarettes.
Juul Labs respects the original intent of the TCA and the framework that acknowledges a continuum of risk for less harmful alternatives to cigarettes for adults who smoke. Through the PMTA process, FDA has the statutory authority and mandate to promote public health by authorizing new, less harmful nicotine and tobacco products to the U.S. market. The statutory standard is “appropriate for the protection of public health,” which relies on a weighing of the potential risks to nonusers of tobacco products (particularly those underage) and the benefits for Americans who smoke. In July 2025, FDA formally authorized the JUUL System for sale in the U.S. after the agency’s scientific review found our products met the statutory standard of being “appropriate for the protection of public health.”
To date, FDA has authorized fewer than 100 smokefree products through the PMTA process with an average review time of over 1500 days. It is critical that Americans who seek alternatives to cigarettes have options that have been scientifically validated and authorized by FDA. The TCA mandated a 180-day review period, and there are policies FDA can put into place to keep its high standards while reducing the review burden on themselves and applicants. These process improvements include leveraging the “least burdensome” principles from the medical device center (CDRH), clear checklists for smokefree product applications, finalizing the Tobacco Product Manufacturing Practices, allowing FDA reviewers to reach out to applicants with questions that can be quickly resolved, as well as templates for industry.
Juul Labs recognizes the important role state and local policymakers can play to combat underage use, particularly with enforcement to prevent the proliferation of illegal and potentially harmful disposable vapor products which now represent ~80% of the US market. The companies manufacturing and distributing these illicit products completely disregard the law, and many use irresponsible marketing and packaging that appeal directly to youth. Data from the CDC’s 2024 National Youth Tobacco Survey shows that these disposables are the top product type used by those underage. Furthermore, they have unknown ingredients and manufacturing practices that could pose serious risks to adults who smoke and are looking for a less harmful alternative. These disposable products threaten the opportunity for adult smokers to maintain access to potentially less harmful alternatives that abide by U.S. rules and regulations.
State and local policymakers must help provide less harmful alternatives for adults who smoke by ensuring that products sold are in accordance with federal regulation. In general, we believe that public policy should reflect the continuum of risk for nicotine delivery, and should encourage adults who smoke to transition toward potentially less harmful noncombustible products, while combating underage use. This belief informs the following positions we hold on public policy questions surrounding vapor products.