FDA Approves Marketing of E-Cigarette Products

For the first time, the U.S. Food and Drug Administration (FDA) has authorized the marketing of three e-cigarette products due to their value in helping adults quit smoking traditional combustible cigarettes. However, the FDA made clear this does not mean these electronic nicotine delivery system (ENDS) products—known as "vapes" or "vaping devices"—are "FDA approved" or "safe."

The three R.J. Reynolds (RJR) Vapor Company products granted marketing approval are Vuse Solo closed ENDS device, Vuse Solo Power Unit and Vuse Replacement Cartridge Original 4.8 percent G1, and Vuse Replacement Cartridge Original 4.8 percent G2.

The authorizations, which occurred in October 2021, are an "important step toward ensuring all new tobacco products undergo the FDA's robust, scientific premarket evaluation," said Mitch Zeller, J.D., director of the FDA's Center for Tobacco Products, in a press release.

"The manufacturer's data demonstrates its tobacco-flavored products could benefit addicted adult smokers who switch to these products—either completely or with a significant reduction in cigarette consumption—by reducing their exposure to harmful chemicals," Zeller said. "We must remain vigilant with this authorization, and we will monitor the marketing of the products, including whether the company fails to comply with any regulatory requirements or if credible evidence emerges of significant use by individuals who did not previously use a tobacco product, including youth."

What goes into the FDA's review process?

The FDA authorized the marketing of the three RJR e-cigarette products through its Premarket Tobacco Product Application pathway. When reviewing the premarket tobacco product applications (PMTAs) of e-cigarette products, the FDA assesses the scientific evidence presented to determine whether permitting the marketing of the product would be "appropriate for the protection of the public health." The FDA assesses the risks and benefits to the population as a whole, taking into account the likelihood tobacco users will stop, as well as the likelihood that those who do not use tobacco will start.

The FDA's evaluation includes reviewing a product's components, ingredients, additives, constituents, toxicological profile and health impact. The agency also looks at how the product is manufactured, packaged and labeled. The FDA's analysis also includes the potential negative health effects of dual use of both e-cigarettes and cigarettes, as well as the possibility that e-cigarettes could be a "gateway" product to combustible cigarettes for youth.

According to an FDA spokesperson, the agency continues to work expeditiously on the remaining applications submitted by the September 9, 2020, deadline, which was ordered by the United States District Court for the District of Maryland. Many of the applications are in the final stages of review, and the agency has about 55,000 products pending.

What experts say about the FDA's decision

The FDA's move echoes questions Amanda R. Mathew, Ph.D. has heard from her patients, particularly adults who are cigarette smokers wondering about the harm reduction aspect of switching to e-cigarettes.

"It seemed clear from the FDA that that was why this decision was made—because the data shows that there is some harm reduction to people who switch," said Mathew, an assistant professor in the Department of Preventive Medicine at Rush University in Chicago, Illinois. "E-cigarettes are almost certainly a lower risk product."

'I think the jury is still out on whether people who are using an e-cigarette are also vulnerable to going back to those cigarettes after weeks or months.'

Mathew still encourages her patients to first try the FDA-approved smoking cessation prescription medications Chantix (varenicline tartrate) and Zyban (bupropion hydrochloride). For people who have experienced limited success with those treatments, Mathews thinks they may want to consider a harm reduction approach with vaping.

"I think the jury is still out on whether people who are using an e-cigarette are also vulnerable to going back to those cigarettes after weeks or months," Mathew said, adding that the ultimate goal is to make the switch permanent and not simply back and forth between the two products.

Health risks of vaping

While e-cigarettes are less harmful than combustible cigarettes, they are not without their health risks. People who vape have a higher prevalence of respiratory symptoms, including shortness of breath, cough and wheezing, than people who do not vape, according to Mark A. Yoder, M.D., a pulmonologist and associate professor of medicine at Rush Medical College.

"More scientifically, there's been a lot of studies showing the vapor from the liquid can have effects on cells in the body—actually shortening the survival of some of the cells that line the airways and damaging DNA," Yoder said.

Yoder added that vaping stresses the lungs in a similar way to how ozone and air pollution molecules harm the lungs. Yoder also noted there have been reports of people exposing themselves to heavy metals such as lead and mercury when they vape.

The addictive potential is the biggest risk with vaping, according to Mathew. Depending on the type of device people are using, there are various modifications they can make to the strength of the e-cigarette liquid, the concentration of nicotine, and even the temperature of the device's heating element.

"You can get a lot of exposure to nicotine, potentially more than you could from a regular cigarette," Mathews said. "The addictive potential is very, very high, and that's especially a concern for adolescent users who never maybe would have picked up regular cigarettes and are starting straight with vapes. I think for them that risk certainly outweighs any benefit."