E-cigarettes have been on the market for over a decade with little regulation. Despite evidence they are harmful to human health, the FDA has recently authorized the first three vaping products for sale in the U.S: the Vuse Solo Power Unit and two tobacco-flavored replacement cartridges. 

In 2016, the FDA was granted authority over all tobacco products, giving the agency permission to restrict sales to youth, prohibit flavors and take other actions to protect public health. As part of its oversight, the FDA required all tobacco products that entered the market or underwent formula changes as of February 2007 to apply for authorization by September 2020. Authorization would be granted if the tobacco company could prove their product is “appropriate for the protection of public health” – in other words, convince the FDA the benefits in helping adult smokers quit outweigh the risks of hooking young people.

LHSFNA Management
Co-Chairman
Noel C. Borck

Vuse’s products are the first of thousands of tobacco products to receive authorization, and experts have mixed feelings about it. Some see the authorization as a helpful harm reduction technique and a step in the right direction, whereas others argue the risks e-cigarettes pose far outweigh any possible benefits.

“While health experts were split on the decision to approve these tobacco products, one area they all agree is that nicotine is harmful to your health,” says LHSFNA Management Co-Chairman Noel C. Borck. “The best choice you can make for your health is to avoid tobacco products in any form, and if you don’t already smoke or vape, don’t start.”

A Case for E-Cigarette Authorization

E-cigarette advocates tout vaping devices as safer cigarette alternatives that may even help people quit nicotine for good. E-cigarettes contain fewer toxic chemicals and carcinogens and are likely far less harmful than traditional cigarettes. Studies have also shown that vaping is up to two times more effective than nicotine gum and patches at helping smokers quit cigarettes.

Vaughan Rees, director of Harvard’s Center for Global Tobacco Control, stands by the FDA’s decision, explaining that the products’ primary purpose is to reduce risk for adult smokers, not eliminate it entirely. 

“Smoking is still responsible for almost half a million American deaths each year,” he said. “So far we have lacked properly regulated devices that lower exposure to tobacco smoke toxicants, meet the needs of adult smokers and hold low appeal for youth, but e-cigarettes hold great promise in that respect.” 

A Case Against E-Cigarettes

There’s evidence that suggests vapes are safer than cigarettes, but are they actually safe? Just last year, the Centers for Disease Control and Prevention (CDC) reported over 2,800 cases of vaping-associated lung injury (EVALI) and confirmed that at least 68 people with EVALI died from using e-cigarettes. Experts say vapes are dangerous, cause respiratory issues and pose a serious threat to young people.

One big issue, physician Sanjivan Singh Kohli explains, is that nicotine is bad any way you receive it. In addition to respiratory symptoms like coughing, chest pain and shortness of breath, nicotine also causes blood vessels to constrict, which can damage arteries and cause cardiovascular disease.

More importantly, vaping among high schoolers has skyrocketed in the last decade. In 2020, 20 percent of high school students reported using e-cigarettes, which is concerning not only because nicotine can negatively impact developing brains, but also because 90 percent of adult smokers report starting smoking before age 18. 

So What Now?

Thousands of products, including the highly popular JUUL vapes, still await the FDA’s decision and can be legally sold in the meantime. If the FDA finds a product’s ingredients, toxicological profile, manufacturing, packaging and marketing plans unsatisfactory, it will issue a marketing denial order (MDO), which requires the product to be removed from shelves. 

But even FDA approvals aren’t necessarily final. Companies that receive the stamp of approval are required to continually report sales data, research study results, marketing campaign plans and other relevant information to the agency to maintain their status. 

“We must remain vigilant with this authorization and we will monitor the marketing of the products,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products. “We will take action as appropriate, including withdrawing the authorization.”

At the end of the day, the agency must strike a balance between the sometimes conflicting goals of preventing kids from vaping and providing adults with science-based tools to quit smoking. Vaping might be able to play a role in the country’s efforts to reduce tobacco-related disease and death, especially alongside methods like tobacco taxes, marketing restrictions and anti-smoking public awareness campaigns. 

[Hannah Sabitoni]