Cliff Douglas’s Statement on FDA’s Authorization of the Marketing of Four E-Cigarette Products

June 21, 2024 

The FDA’s decision to authorize the marketing of four menthol-flavored electronic cigarette products is a most welcome step forward that promises to save lives. The FDA is to be commended for focusing on the need to help people move away from lethal combustible cigarettes by making alternative evidence-based options available to support individuals on their journeys to quitting smoking.

Stating that their decision was made following “extensive scientific review,” the FDA reinforces the clear scientific understanding that reduced-risk nicotine products, like these e-cigarette products from NJOY, can reduce the risks faced by people who smoke.

However, while noting the authorized products can provide a benefit to adults who completely switch away from combustible cigarettes, the FDA begins its announcement by stressing that these menthol-flavored products are not safe and that all tobacco products are harmful and potentially addictive. While true, the agency chooses again – in a challenging information environment – to present confusing information and guidance regarding relative risk and the fact that nicotine itself does not cause the illnesses and death resulting from smoking, which is critical information but goes unmentioned.

On balance, however, the FDA’s announcement is very good news. Since 80% of the world’s more than 1.3 billion smokers live outside of the U.S. in low- and middle-income countries, my hope is other public health authorities around the world will follow the FDA’s lead, look at the science, and give people who smoke far greater options to stop smoking. All effective, non-combustible nicotine-containing products – including medicinal gum, patches and lozenges, and non-medicinal consumer products such as e-cigarettes – should be made available under carefully regulated conditions to accelerate the end of the smoking epidemic.  

Half of people who smoke long-term are killed prematurely as a result. The status quo is unacceptable. Global health authorities must give robust and more effective support to adults in their cessation journeys.