In Banning Juul, FDA Fails to Follow the Science

Posted on July 11, 2022 by Edward Longe

Over the past year, the Food and Drug Administration has taken an increasingly aggressive and anti-scientific approach to regulating electronic cigarettes, despite empirical evidence showing they are far safer than traditional combustible products. The agency’s approach became very apparent when it ordered JUUL, a manufacturer of popular electronic cigarettes, to remove their products from the U.S. market on the grounds their application to sell their products “lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that marketing of the products would be appropriate for the protection of the public health.”

Thankfully, the order was later placed on hold by the U.S. Court of Appeals for the D.C. Circuit after the D.C.-based company alleged the FDA had “overlooked more than 6,000 pages of data that the company had submitted to the FDA on the aerosols that users inhale.”

The agency’s attempt to ban JUUL from the U.S. market is another contour of a broader effort to limit consumer access to electronic cigarettes that have included bans on flavored products and slow approval. Unfortunately for American smokers, the FDA’s senseless war on electronic cigarettes will deny them access to a product that has routinely shown to be an effective smoking cessation device and a product that is significantly less dangerous than traditional combustible products.

In taking such a severe line against e-cigarettes, the agency is preventing itself from meeting its mission of protecting public health.

Much of the FDA’s hostility toward electronic cigarettes is rooted in the misleading belief of a youth vaping epidemic. In June 2021, then-Acting Commissioner of the FDA Janet Woodcock testified before the House Committee on Oversight and Reform and outlined the agency’s “comprehensive efforts to regulate ENDS, including our actions to prevent youth access to, and use of, these products” that had reached epidemic levels among America’s youth.

Despite the agency’s belief in the existence of a youth vaping epidemic, academic researchers have found no evidence of such a crisis. By the FDA’s admission, only 13.4% of high school students and 4% of middle school students use electronic cigarettes regularly. While these numbers should concern parents and policymakers alike, they do not point to widespread use among America’s youth.

Perhaps most concerning is the fact that banning electronic cigarettes will deny smokers access to a product that is considerably healthier than combustible products that kill 480,000 Americans each year. Unlike traditional flammable products, electronic cigarettes “don’t contain cancer-causing tar” and hold “lower levels of cancer-causing chemicals such as formaldehyde and toluene, as well as carcinogens such as nitrosamines.”

The lower levels of cancer-causing chemicals in electronic cigarettes led Public Health England, one of the most respected public health agencies in the world, to conclude they were 95% safer than combustible products. Researchers at Georgetown University reached a similar conclusion when they suggested that 6.6 million lives could be saved if smokers made the switch from cigarettes and cigars to electronic cigarettes.

Electronic cigarettes have also been proven to be among the most effective smoking cessation products. Empirical studies routinely show that e-cigarettes are nearly twice as effective as smoking cessation aids than comparable products, with higher quit rates in those who used electronic cigarettes when compared to other therapies.

Given the FDA’s historical hostility to electronic cigarettes, it was no surprise that it sought to remove JUUL’s products from the U.S. market. Unfortunately, such an aggressive regulatory agenda fails to follow the science and is predicated on the faulty assumption that youth vaping is at epidemic levels, a belief that holds as much scientific weight as the easter bunny or loch ness monster. Suppose the agency would follow the science. In that case, they could craft a regulatory environment that allows smokers to access a product that is considerably less harmful than traditional products and has been shown to be effective smoking cessation devices. They might even save a few million lives in the process.