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“FDA marketing authorization of Vuse signals a new era, and the need for urgent regulatory action on all tobacco products to protect youth and smokers alike.”

Statement from José Luis Castro, President and CEO, Vital Strategies, on FDA’s approval of British American Tobacco’s e-cigarette product

Oct. 13, 2021 (New York) – We are disappointed by the U.S. Food and Drug Administration’s decision to authorize the marketing of an e-cigarette product from R.J. Reynolds, a subsidiary of British American Tobacco. By greenlighting Vuse e-cigarettes – the first-ever electronic nicotine delivery system authorized by the FDA – in an environment where tobacco and nicotine products are underregulated and a well-funded and unscrupulous industry takes advantage of every loophole, the FDA decision potentially endangers youth and the public health benefit to smokers remains questionable. Moreover, with little indication of what data has guided this decision, the FDA needs to provide much greater transparency.

This decision signals a new era for tobacco and nicotine products in the United States—one that necessitates urgent and comprehensive new regulations for all tobacco products on marketing, product formulation and sales. These regulations would protect youth and nonsmokers, and support smokers in quitting or transitioning toward quitting.

The FDA should act now on its 2017 plan to reduce combustible cigarettes to non-addictive levels, a move that would save millions of lives by encouraging smokers to quit or fully transition, as would enacting much higher prices on combustible cigarettes around the country. We need strong independent surveillance and monitoring systems to capture the use and marketing of novel products, particularly the impact e-cigarettes may play in backsliding or harmful dual use.

With 2.06 million youths estimated to be current e-cigarette users in 2021, e-cigarettes remain a significant threat for a new generation of users. Vuse ranks among the most popular products. FDA should continue to deny authorization for all menthol and other flavored tobacco products,  which appeal to youth and promote initiation.

We must also address high nicotine content and chemical additives on these almost completely unregulated products—Vuse 5 % nicotine content is 2.5  times the legal limit of that allowed in the Canada and the United Kingdom. While evidence of long-term health impact of e-cigarettes is already scant, skyrocketing rates of nicotine in these products as they evolve is particularly worrisome, as is recent research by Johns Hopkins that found more than 2,000 chemicals in Vuse and other e-cigarettes.

Lastly, e-cigarettes are popular with smokers partly because decades of inadequate government support for quitting. Governments should fully support robust cessation interventions like distributing  Nicotine Replacement Therapies (NRTs) such as gum or patches, free counseling, media campaigns and quit lines, which have all been woefully underfunded. Now is the time to double down on proven tobacco control interventions.

In the wake of the FDA’s decision, the tobacco industry’s marketing machine is undoubtedly acting with unprecedented speed to acquire new customers – smokers or not. FDA—and Congress—must act with equal urgency to protect public health.

About José Luis Castro

José Luis Castro is the President and CEO of Vital Strategies, where he has led a rapid expansion of Vital Strategies’ portfolio, working with governments to tackle the world’s leading killers, primarily in low- and middle-income countries. The organization now reaches into 73 countries and has touched the lives of more than 2 billion people.

About Vital Strategies 

Vital Strategies is a global health organization that believes every person should be protected by a strong public health system. Our programs reach into 73 countries and help prevent death and illness from noncommunicable disease, reduce harm caused by environmental factors, and support cities as engines for public health. To find out more, please visit or Twitter @VitalStrat.  

Media Contact 

Christina Honeysett, Vital Strategies:; +1-914-424-3356 

Ally Davis, Vital Strategies:; +1-516-205-4203