Tag:e-cigarette
The Tobacco Loophole: How FDA Tobacco Regulations Let Underregulated Products Slide
On September 2nd, 2026, U.S.-based tobacco companies Helix Innovations, LLC and NJOY, LLC (collectively, Altria) filed a lawsuit against the FDA to vacate its 2021 Pre-Market Tobacco Applications (PMTA) rule. Specifically, Altria seeks to block the enforcement of pre-market review requirements for pending tobacco products which primarily affect smokeless tobacco products and electronic nicotine delivery systems (ENDS). Under the Tobacco Consumer Act (TCA), the FDA is mandated to approve or deny applications for tobacco products within 180 days. However, Altria argues that the promulgation of the 2021 PMTA rule coupled with the 2016 “Deeming” Rule has caused extensive regulatory backlogs for the FDA, resulting in their numerous violations of the statutory deadline to review tobacco product applications.
Altria’s complaint contends that delays have harmed both domestic business and public health by creating a regulatory gridlock. Under the 2021 PMTA rule, tobacco manufacturers are required to submit substantial evidence reports with distinct materials for each product, including risk investigations, marketing plans, environmental and population impacts, and other uniquely relevant documentation. While U.S. manufacturers seeking to comply face excessive red tape stalling scientifically backed products from reaching the market, foreign-sourced tobacco products have flooded the U.S. market with unregulated alternatives that expressly target American youth. By failing to issue timely decisions, the FDA has inadvertently undermined consumer safety and penalized companies attempting to follow the law.
FDA Issues Warnings Regarding E-Cigarettes
On Wednesday, September 11, 2019, the Trump Administration issued a statement regarding the recent outbreak of illnesses and deaths related to the use of electronic cigarettes (“e-cigarettes”). Soon after, the Food and Drug Administration (“FDA”) quickly followed suit. The Trump Administration’s statement comes after reports of 380 cases of lung illness associated with the use of e-cigarettes in 36 states, in addition to 7 deaths. Both political parties have pressed for flavor bans, age restrictions, and other restrictions on the sale of vaping products. They have urged the FDA to move quickly and decisively to investigate and regulate e-cigarettes. E-cigarettes have been touted by manufacturers as a way to wean people from traditional cigarettes but have recently led to an “epidemic” of youth vaping of nicotine. E-cigarettes are popular among teens due to their availability, advertisements, e-liquid flavors, and the belief that they are safer than cigarettes. The long-term risks of vaping are currently unknown, but a growing numbers of studies show that e-cigarette vapor has severe health risks, including damaging lung tissue and blood vessels.
FDA Warns E-Cigarette Manufacturers: Stop Teen Epidemic or Face Consequences
The rise of electronic cigarettes was initially met with relaxed FDA regulation given optimism that they could help adult smokers curb use of more toxic combustible cigarettes. This optimism was in spite of e-cigarettes’ growing popularity among adolescents and young adults. On September 12, the FDA signaled a pivot from this approach when FDA Commissioner Scott Gottlieb described youth e-cigarette use as having reached epidemic proportions. Gottlieb announced that the FDA had issued more than 1,300 warning letters and fines to retailers caught selling e-cigarette products to minors. It also issued an order to the five major e-cigarette manufacturers (Juul, Vuse, Blu, MarkTen XL, and Logic) to each submit a plan outlining how the company will address youth access and use of their products. Failure to submit a sufficient plan could lead the FDA to revisit its earlier decision on flavored e-cigarette products, which allowed manufacturers a grace period until 2022 to receive FDA approval.