FDA scrutinized for lack of studies showing how e-cigarettes may reduce smoking-related deaths

Tobacco remains the No. 1 cause of preventable death in the US

While the Food and Drug Administration (FDA) has come under fire for not taking fast action against e-cigarettes, it has also received scrutiny for not prioritizing research to show how vaping products may reduce smoking-related deaths.

About 2,290 cases of e-cigarette use related to a vaping illness caused by products containing illicit THC and vitamin E  have been reported to the CDC as of Nov. 20 in what many are calling a vaping epidemic. So far in 2019, 47 deaths have been confirmed as of Nov. 20, data from the Centers for Disease Control and Prevention (CDC) shows.

Tobacco, however, remains the No. 1 leading cause of preventable death in the U.S., killing nearly 480,000 people annually, according to the anti-tobacco campaign Tobacco-Free Kids.

“Reducing tobacco-related disease and death remains a top priority across the FDA," the FDA told FOX Business in a statement.  "We need to better understand whether novel forms of nicotine delivery can meet the requirements to be marketed as drugs to help smokers quit combustible tobacco, such as nicotine replacement therapy, or potentially as less harmful tobacco products."


Person vaping in February 2014. (AP Photo/Frank Franklin II, File)

"For that reason, it’s critical we continue to build our broader knowledge base about the public health impacts of products like e-cigarettes that could ultimately be evaluated under either regulatory pathway. The FDA has supported and encouraged work in this area and will continue to do so by using all available mechanisms to spur research and development."

The administration continued to say that it believes there may be confusion among those "in the research community about what ... regulatory requirements need to be satisfied in order to study these outcomes," adding, "Researchers can and are studying what impact e-cigarettes may have on currently addicted adult smokers, and many of these projects may not require interaction with the FDA at this time.

Tobacco-Free Kids President Matthew L. Myers told The Wall Street Journal on Monday that the FDA has taken the wrong approach to combatting the vaping epidemic.

"The FDA hasn't approached this with a focus on the half-million people a year who die from smoking," he said. "The FDA hasn't done any of the things it does to fast-track other drugs."

In a September letter to e-cigarette maker Juul, the FDA's Center for Tobacco Products criticized Juul for claiming that its products were safer than tobacco cigarettes and said the company marketed its products as "modified risk tobacco products without an appropriate FDA order in effect."

A man exhales while smoking an e-cigarette in Portland, Maine. (AP Photo/Robert F. Bukaty, File)

"Referring to your [vaping] products as '99% safer' than cigarettes, 'much safer' than cigarettes, 'totally safe,' and 'a safer alternative than smoking cigarettes' is particularly concerning,"  the letter said, citing a presentation by Juul given at a high school in which the company claimed its products were "totally safe."

"Our concern is amplified by the epidemic rate of increase in youth use of [vaping] products, including Juul's products, and evidence that [vaping] products contribute to youth use of, and addiction to, nicotine, to which youth are especially vulnerable," the letter continued.

But experts argue that despite the FDA's concerns about youth vaping and the various studies showing how vaping-related illnesses have led to nearly 50 deaths in the U.S. this year, they believe the administration needs to address the benefits of vaping versus smoking.

"It's essential that we figure out whether e-cigarettes can help people quit smoking," Kurt Ribisl, chair of the Health Behavior department at the University of North Carolina School of Global Public Health, told the Journal.

A study headed by Peter Hajek of Queen Mary University in London and published in the New England Journal of Medicine looked at 886 smokers who tried patches, gum and vaping in an effort to stay off cigarettes. Of those who switched to vaping, 18 percent were able to stay off cigarettes versus nearly 10 percent of those who used patches or gum, the study found.