The FDA issued a first-of-its-kind authorization of the sale of an e-cigarette device and its associated tobacco-flavored cartridges in the US. It argued that the benefits for cigarette smokers aiming to ditch the habit outweigh the risks of youth appeal. The agency also denied approval of a handful of flavored cartridges produced by the same brand. The move could represent a new direction for tobacco regulation in the US.
The US Food and Drug Administration (FDA) yesterday announced it will authorize the sale of an e-cigarette in the United States – representing the agency’s first such approval. No other e-cigarette products have previously been authorized by the FDA.
Specifically, the organization approved the sale of the Vuse Solo closed electronic nicotine delivery system (ENDS) devices, as well as associated tobacco-flavored cartridges, including the Vuse Solo Power Unit, Vuse Replacement Cartridge Original 4.8% G1, and Vuse Replacement Cartridge Original 4.8% G2. The products are produced by Winston-Salem, North Carolina-based tobacco giant Reynolds American Inc.
In its announcement of the decision, the FDA suggested that while e-cigarette products have known risks – especially in regard to their appeal to young people, a concern that has landed other e-cigarette and vaping companies like Juul in hot water – the benefits of some such products for smokers outweigh the dangers. The agency asserts that Vuse’s e-cigarette in particular may help wean cigarette smokers off the deadly products.
“Today’s authorizations are an important step toward ensuring all new tobacco products undergo the FDA’s robust, scientific premarket evaluation,” said Mitch Zeller, JD, director of the agency’s Center for Tobacco Products, in a statement released by the FDA. “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.”
Further, the FDA asserted that “the authorized products’ aerosols are significantly less toxic than combusted cigarettes based on available data,” per its statement. The organization also expressed it had “determined that the potential benefit to smokers who switch completely or significantly reduce their cigarette use, would outweigh the risk to youth.”
Dr Robert Jackler, MD, a professor at Stanford University School of Medicine who has studied the rise of e-cigarette use among youth, believes that the FDA’s decision is reasonable. Jackler – who served as an expert on retainer for the North Carolina Attorney General’s office during the landmark case earlier this year in which Juul agreed to pay the state $40m over allegations that it marketed to underage consumers – understands that brands such as Vuse pose dangers to teens. He also believes that tobacco and e-cigarette regulations require a degree of compromise. “Authorizing e-cigarette brands offered exclusively in unsweetened tobacco flavor is a reasonable regulatory approach, which seeks [to] balance youth protection while maintaining an alternative for adult smokers who seek to quit smoking cigarettes,” he tells The Drum.
Flavors fall out of favor
A major problem with youth getting hooked on tobacco has to do with kid-friendly flavored cartridges, per Jackler. Indeed, pressure from interest groups and lawmakers led Juul – by and large the most popular e-cigarette brand among young people – to cease sales of products infused with flavors other than menthol. Jackler says that since most adolescents don’t prefer tobacco flavor, youth Vuse users, who number about 140,000 in the US, are likely using the company’s menthol cartridges.
The FDA denied R.J. Reynolds’ request for approval for its Vuse brand flavored ENDS products. It also indicated that any flavored Vuse products currently available on the market must be removed immediately or risk enforcement. The FDA is still reviewing the company’s menthol-flavored products for authorization.
Jackler advises that the FDA should prohibit menthol-flavored e-cigarette products, claiming such products are a “potent attractant to non-smoking youth.” He also stresses that sales and use of Vuse’s tobacco-flavored products should be closely monitored by regulators — and that if such products remain popular among youth, the FDA’s authorization should be reconsidered or revoked. And to further mitigate youth appeal, Jackler says, the definition of “tobacco flavor” should be specified so as to not include sweeteners “lest e-cigarette companies add chocolate, honey, mint etc. to products labeled ‘tobacco’ to enhance their youth appeal.”
As it stands, Vuse is the second most popular e-cigarette brand among US high schoolers, used by nearly 11% of the country’s 1.27 million high school students, per data from the recently-released 2021 National Youth Tobacco Survey.
It’s important to note that Vuse’s 57.4 mg/ml nicotine concentration contains nearly three times the nicotine levels as the 20mg/ml limit imposed by the European Union, the UK, Israel and other nations. So, while the FDA believes Vuse products could help transition cigarette smokers toward better health outcomes, Vuse’s products are, all things considered, still more dangerous than many e-cigarettes around the world. “When used by non-smoking youth, this super-high concentration is potently addictive,” Jackler points out.
The impact on the e-cig industry and advertising
In the wake of the FDA’s announcement, other tobacco and e-cigarette companies are already weighing in on the decision. British American Tobacco, whose products account for the largest share of net sales of tobacco in the US, today released a statement saying it is “pleased” with the decision. The company went on to say that it is “committed to reducing the health impact of its business through a multi-category approach,” and that the FDA’s marketing orders concerning Vuse products “are a significant regulatory accomplishment.”
Other tobacco and e-cigarette companies including Imperial Brands and Japan Tobacco International – which in 2015 acquired American e-cigarette company Logic – declined a request for comment. Imperial Brands and Japan Tobacco International, along with many other companies, have filed Premarket Tobacco Product Applications with the FDA, seeking authorization for their own tobacco and e-cigarette products.
How Tuesday’s decision will impact tobacco and e-cigarette marketing remains to be seen. As it stands, regulations concerning marketing and advertising in the industry are complex. A 1970 decision by Congress barred tobacco advertising on radio, TV and what were then referred to as “mass media” channels. In the late 90s, however, the tobacco Master Settlement Agreement introduced new restrictions that limited billboard advertising, celebrity brand endorsements and the use of cartoon characters. While tobacco marketing has been largely restricted in the US, it’s still rife online and at the point-of-sale in convenience stores and gas stations. Plus, federal oversight of social media marketing of these products remains limited. FDA authorizations of tobacco and e-cigarette products could reignite discussions of tobacco and e-cigarette marketing and advertising among lawmakers.