- Federal regulators have approved three e-cigarette products, the first such items to receive approval in the United States.
- Regulators said the benefits of people using e-cigarettes in an attempt to quit using tobacco outweigh the risk of teens vaping.
- Health experts say there are still significant health dangers associated with vaping e-cigarettes.
Electronic cigarettes have been unregulated but legally sold in the United States for more than a decade.
Now, the Food and Drug Administration (FDA) has for the first time given regulatory approval for a handful of e-cigarette products after banning tens of thousands of others from being marketed.
Last week, FDA officials
“[The] FDA’s orders confirm that the marketing of Vuse Solo products are appropriate for the protection of the public health, underscoring years of scientific study and research dedicated to ensuring that adult nicotine consumers age 21+ have access to innovative and potentially less harmful alternatives to traditional tobacco products,” company officials said in a news release.
In a statement, Anne Marie Hummel, associate executive director for advocacy and government affairs at the American Association for Respiratory Care, called the FDA decision “extremely disappointing given the harmful effect of tobacco use and its relationship to chronic respiratory disease.”
Other medical experts agree.
“Any way you’re getting it, the use of nicotine has a lot of negative effects on the cardiovascular system,” Dr. Sanjivan Singh Kohli, a pulmonary and critical care medicine physician at Providence Mission Hospital in California, told Healthline.
Kohli said that vaping “is not benign in any way,” noting he has cared for numerous people with vaping-related lung condition known as e-cigarette vaping acute lung disease.
Longer term, Kohli added, the vasoconstriction caused by inhaled nicotine can cause damage to the arteries as well as other forms of cardiovascular disease.
“On the one hand, vapes cut out all of the carcinogenic stuff you get from inhaling noxious fumes from tobacco,” Kohli said. “But people are still getting large doses of nicotine. So it’s the best worst choice. The only good option is complete cessation.”
The approved products are the first to be authorized by the FDA through the agency’s new Premarket Tobacco Product Application (PMTA) process.
They include the Vuse Solo electronic nicotine delivery system (ENDS) device and two accompanying tobacco-flavored e-liquid pods.
“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,” 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. We will take action as appropriate, including withdrawing the authorization.”
“The FDA’s authorization of Vuse Solo in tobacco flavor will require continued vigilance on purchasing patterns and youth uptake and utilization,” according to a statement from the
The PMTA requires that manufacturers demonstrate to the FDA that any new tobacco products coming on the market protect public health.
In its review, the agency found that Vuse Solo users were exposed to fewer harmful and potentially harmful constituents (HPHCs) from aerosols than users of combusted cigarettes.
They also reported that the vapor from these products is significantly less toxic than combusted cigarettes, and the health benefit to smokers who switch from combusted cigarettes to e-cigarettes outweigh the risk of youth use of e-cigarettes.
About 10 percent of high school students who currently use e-cigarettes name Vuse as their usual brand, according to the CDC’s most recent
However, the FDA noted that research shows that few teens later switch from e-cigarettes to the more dangerous combustible cigarettes.
“The data also suggest that most youth and young adults who use ENDS begin with flavors such as fruit, candy, or mint, and not tobacco flavors,” according to the FDA.
“These data reinforce the FDA’s decision to authorize the tobacco-flavored products because these products are less appealing to youth and authorizing these products may be beneficial for adult combusted cigarette users who completely switch to ENDS or significantly reduce their cigarette consumption,” the FDA stated.
RJR’s bid for FDA approval of its menthol-flavored Vuse cartridges remains under review.
“The FDA is right to continue to deny authorization for tobacco companies to sell flavored e-cigarettes, which have fueled the nicotine epidemic among youth nationwide and put millions of kids at risk for a lifetime of tobacco use and addiction,” according to the American Heart Association.
“The FDA should follow today’s announcement by also denying RJR’s application for Vuse Solo menthol flavor cartridges. For decades, tobacco companies have aggressively marketed menthol-flavored tobacco products to Black communities, other groups of color, and youth, fueling a scourge of nicotine addiction,” the association said.
The FDA’s decision on Vuse comes after the agency denied marketing approval for 55,000 flavored e-cigarette products from three different applicants: JD Nova Group LLC, Great American Vapes, and Vapor Salon.
The FDA stated in August that these products “lacked sufficient evidence that they have a benefit to adult smokers sufficient to overcome the public health threat posed by the well-documented, alarming levels of youth use of such products.”
All of the denied products were non-tobacco flavored, including varieties such as Apple Crumble, Dr. Cola, and Cinnamon Toast Cereal.