Tag:tobacco
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.
A Case for Regulating Facebook
Recently, whistleblower Frances Haugen testified before a Senate subcommittee that Facebook has been deliberately putting its own profits before users’ safety. As Facebook’s former product manager for civic misinformation, Haugen calls for federal regulation of social media platforms and asserts that Facebook will not solve what she calls a “crisis” of deliberately ignoring users’ wellbeing for the sake of its own profits without Congress’s help. She points to tobacco, automobiles, and opioids, stating that when it became clear that those products were harming people, the government took action.
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 Declares War on Flavored E-Cigarette
In July 2017, the Food and Drug Administration revealed a new policy that sought to reduce the deaths and diseases caused by smoking which takes nearly 500,000 lives annually in the United States. In early September 2018, the FDA followed up on its mission by unveiling a plan to address the e-cigarette epidemic. E-cigarettes, and in particularly, a brand of flavored e-cigarettes called “JUULs,” have taken the teenage and adolescent market by storm. While the FDA is primarily concerned with reducing the overall number of smoking-related casualties, it notes a particular concern for a vulnerable young demographic and the effects of nicotine intake on a developing brain.
Impaired and On the Clock: Developing Policies and Procedures to Cope with Impairment in the Workplace
Brittany Tomkies Executive Editor Loyola University Chicago School of Law, JD 2017 Drug and substance abuse has become an epidemic in the United States over the past 15 years, reaching an alarming 9.4% of Americans ages 12 and older in 2013. The human and economic costs of substance abuse are astonishing – some estimate …
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