FDA Gives Green Light for Sale of Certain E-cigarette Products on Market
In a landmark decision reached in October, the FDA announced that they would allow the marketing of certain e-cigarette products in the United States, marking the first authorization of a vapor product.
The decision came after the discovery of data demonstrating that e-cigarettes may be a safer alternative for smokers. This symbolizes a significant development in tobacco products' research and could set a precedent for the future of e-cigarette sales. However, this privilege has only been extended to one company in particular.
Photo Courtesy: Mark Stehle/Associated Press
The permit to sell e-cigarettes was granted to the R.J. Reynolds Vapor Company (RJR), a subsidiary of R.J. Reynolds Tobacco Company, an American tobacco manufacturer. RJR is the second-largest tobacco manufacturer in the country and is known for producing recognizable brand-name cigarettes such as Newport and Lucky Strike. It is one of many tobacco manufacturers pivoting to the e-cigarette market as a way to maximize new growth strategies.
Specifically, the FDA is permitting RJR to sell its Vuse Solo electronic nicotine delivery systems (ENDS) device or the e-cigarette that dispenses vapor. Also included in the authorization are replacement cartridges or nicotine-flavored "pods," containing the actual nicotine substance.
Nicotine is an addictive ingredient in tobacco. When condensed into a liquid form, it can be loaded into pods, or cartridges, then emitted as vapor from the device. The standard Vuse device has a nicotine content of about 4.8%.
Vuse was the top-selling e-cigarette device in the United States until 2017, when Juul surged in popularity. However, the brand continues to be widely used nationwide. One study found that many American teenagers cite Vuse as the brand of their choice, having particular features of e-cigarettes that make them particularly attractive to this demographic.
At the same time, the FDA refused the application for RJR to distribute flavored pods, which might encourage youth usage. Flavors like mango and mint are trendy among a younger demographic and are more conducive to consumption than the authorized Vuse Solo device. The 2021 National Youth Tobacco Survey (NYTS) found that 85% of students used flavored products, compared to only 8% of students using unflavored products. Currently, only the nicotine flavor has been authorized. However, the agency did open the possibility of allowing menthol-flavored products, a common additive to tobacco that is also used frequently in other household items such as mouthwash.
According to the FDA, Vuse products are being authorized because "the agency determined that study participants who used only the authorized products were exposed to fewer harmful and potentially harmful constituents (HPHCs) from aerosols compared to users of combustible cigarettes." In addition, although the products are detrimental to younger individuals, the studies concluded that this risk is outweighed by the potential benefit that Vuse products have for smokers who transition to electronic devices.
In the United States, smoking is the cause of 480,000 deaths per year and can increase the risk of heart disease, stroke, and cancer. However, evidence indicates that liquid nicotine is safer to consume than inhaling tobacco smoke from cigarettes because nicotine alone is not a carcinogen or a substance that has the potential to cause cancer.
The effects of electronic nicotine products like Vuse on youth are being documented more frequently, leading to more extensive research and information. The National Youth Tobacco Survey also found that around 11% of high school students regularly use e-cigarettes, and 10% of those individuals cite Vuse as their preferred brand. However, related studies discovered that youth who use tobacco-flavored electronic products are less prone than users of non-tobacco-flavored products to switch to more harmful non-electronic products, providing support for the FDA's decision.
Unsurprisingly, there has been an intense backlash in response to the basis behind this FDA ruling, most notably from health groups. For example, the American Lung Association condemned the decision for not recognizing the widespread use of ENDS among youth and the related adverse effects. Criticism also came from prominent figures in government, such as Sen. Dick Durbin (D-Il).
Durbin tweeted that: "The FDA is making a grave mistake authorizing Vuse e-cigarettes to flood the market. We've seen this playbook before and we shouldn't pretend we don't know where we're headed. This is a decision that engenders our children."
Meanwhile, other large manufacturers such as Juul are awaiting FDA authorization. Currently, the FDA is reviewing around 6.5 million applications, including ones from Vuse, Juul, and many other smaller companies. Unfortunately, these are probably less likely to succeed unless health professionals can also determine a positive health benefit that justifies the distribution of other brands in the market.
The newfound freedom RJR has to distribute its product does not come without limits. The FDA stipulated that the company is subject to stringent restrictions on what and how they advertise in the media due to the potential effects on youth consumption. In a recent NYTS study of middle and high school students, the top three cigarette brands preferred by youth were also the top three cigarette brands in the U.S. market share.
As the first Vuse devices hit shelves in stores across the country, a close eye will be kept on how the marketing of e-cigarettes affects the consumption of standard, non-electronic cigarettes going forward. This decision may also set a precedent for future authorizations by the FDA, depending on the public health outcomes.