Tobacco control and prevention efforts in the US – Open Access Government

Tobacco control and prevention efforts in the US – Open Access Government

After receiving millions of premarket applications for e-cigarette products last year, the agency has recently issued marketing denials for over one million flavoured ENDS. Many of these denials were because applicants did not provide sufficient evidence that the benefit to adult smokers who used the flavoured products would overcome the public health concern posed by the well- documented and considerable appeal of these products to youth.

E-cigarettes are the most commonly used tobacco product by youth in the U.S. According to recent data from the National Youth Tobacco Survey, over two million U.S. high school and middle school students used e-cigarettes in 2021, of whom more than 85% used flavoured e-cigarettes. Among high school students who currently used e-cigarettes, 43.6% reported use on 20 or more of the past 30 days, and 27.6% reported daily use. Among middle school students who currently used e-cigarettes, 17.2% reported use on 20 or more of the past 30 days and 8.3% daily use. Most e-cigarettes contain nicotine, often at higher levels than other tobacco products, and we know that nicotine is especially harmful to youth, whose brains are still developing. Moreover, nicotine is the same highly addictive chemical in cigarettes that keeps people smoking even when they want to quit.

FDA’s review of applications, nonetheless, is conducted on a case-by-case basis, and any product with sufficient evidence to meet the public health standards in the law will be authorised. For example, R.J. Reynolds Vapor Company recently received marketing authorisation in October 2021 for an ENDS device and tobacco-flavoured e-liquid pods after FDA determined that the manufacturer’s data demonstrated its 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.

As part of this scientific review, FDA considered the risks and benefits to the population as a whole, including users and non-users of tobacco products, and importantly, youth. Available data suggest that most youth and young adults who use ENDS begin with flavours such as fruit, candy or mint, not tobacco flavoured. These data reinforce the FDA’s decision to only authorise the company’s tobacco-flavoured products, while denying the applications for their flavoured products, because these products are less appealing to youth and authorising these products may be beneficial for adult combusted cigarette users who completely switch to ENDS or significantly reduce their cigarette consumption.

FDA is committed to working to transition the current U.S. marketplace to one in which all ENDS products available for sale have demonstrated that marketing of the product is “appropriate for the protection of the public health.”

In an ever-evolving landscape, the premarket review of new tobacco products is essential to protecting public health. The FDA will continue to make application decisions and formulate policies based on the best available science with the goal of reducing the preventable disease and death caused by tobacco use. To learn more about our comprehensive efforts in this area, visit


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