FDA Issues Warnings Regarding E-Cigarettes

Michael Manganelli

Associate Editor

Loyola University Chicago School of Law, JD 2021


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.

The current state of the e-cigarette

Alongside the government’s top health officials, President Trump acknowledged that a vaping problem exists, stating, “[w]e can’t allow people to get sick. And we can’t have our kids be so affected.” The Trump Administration further stated that Juul Labs, the manufacturer of the most popular form of e-cigarette, has been targeting its products at minors. In response to this accusation, Juul has denied that it has aimed its products at minors.

On June 22, 2009, President Obama signed the Family Smoking Prevention and Tobacco Control Act (the FSPTCA) into law. The FSPTCA granted the FDA authority to regulate the manufacturing, marketing, and distribution of cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco products to protect the public health and to reduce use by minors. The FDA currently requires retailers to provide an ingredient list, report of the harmful or potentially harmful constituents, and a tobacco health document submission.

In 2016, the FSPTCA was amended to extend to all products that meet the statutory definition of tobacco products, which covers e-cigarettes. Under this extension, not only are e-cigarettes retailers required to post the ingredients, harmful constituents, and submit a tobacco health document to the FDA, but they also must obtain pre-market authorization for each new tobacco product they prepare for sale of distribution to customers. The FDA uses the premarket application to determine the product’s impact on public health.

Given the recent outbreak of vaping related illnesses and deaths, the FDA and the Department of Health and Human Services took a hard stance against the growing popularity of vaping among teens. On September 9, 2019, the FDA took action against Juul, sending a warning letter accusing the company of violating the FSPTCA and other federal regulations by promoting its vaping products as a healthier option than cigarettes.

The future of the e-cigarette

Recognizing the dangers of their products, conservative organizations and the vaping industry proposed requiring retailers to curb access to vaping devises, pods, and other paraphernalia by placing these objects in age restricted areas, which are off-limits to minors. However, this suggestion was quickly rejected due to being impractical and having significant legal hurdles. The Vapor Technology Association (VTA), a major trade group, issued a statement calling the proposed ban “misguided.” The VTA further stated that “[m]ore than two million Americans have died from cigarette smoking-related illnesses over the last five years.” When e-cigarettes first came on the market, they were seen as a “safer” alternative to traditional cigarettes. While some cigarette smokers have used vaping to quit smoking, these products have also hooked many of the new generation on nicotine. In a study of more than 800 people who said they were using e-cigarettes to help them quit traditional smoking, only nine percent reported having quit when asked a year later.

A House oversight panel has asked Dr. Robert Redfield, the director of the Center of Disease Control, to appear on September 24 to testify about the outbreak of vaping-related lung illnesses. During this process, the FDA has been collecting and analyzing samples submitted by a number of states for the presence of a broad range of chemicals, including nicotine, THC, cutting agents/diluents and other additives, pesticides, opioids, poisons, heavy metals, and toxins.

While the studies continue, health officials remain unsure whether flavored e-cigarettes are involved in the emerging illnesses and deaths. In the meantime, officials urge people to stop using e-cigarettes as the “recent deaths across the country, combined with hundreds of reported lung injury cases continue to intensify.”