The FDA emphasized that the action allows these tobacco products to be sold in the United States, but does not mean these items are safe or “FDA approved.” “All tobacco products are harmful and addictive and those who do not use tobacco products should not start,” wrote the federal agency. But R.J. Reynolds (RJR) Tobacco Company has now been granted the right to sell three of its Vuse vape products (including tobacco-flavored e-liquid pods) because intensive research and evaluation have suggested they can help smokers cut back on their habit or possibly stop smoking altogether. “The manufacturer’s data demonstrate 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,” said Mitch Zeller, the director of the FDA’s Center for Tobacco Products, in a statement. The products given the okay for sale are the Vuse Solo Power Unit, Vuse Replacement Cartridge Original 4.8 percent G1, and Vuse Replacement Cartridge Original 4.8 percent G2. At the same time it granted this authorization, the FDA also denied 10 RJR applications for flavored products (sold under the same Vuse brand) for failing to demonstrate that these products would be appropriate for the protection of public health. (The health agency said it could not publicly disclose the specific flavored products because of “potential confidential commercial information issues.”) When it comes to this first-ever authorization, Patricia Folan, DNP, director of the Center for Tobacco Control at Northwell Health in Great Neck, New York, voiced concerns. “I believe the distinction between permission to sell and FDA approval will be lost on the American public,” says Folan. “Although the FDA is indicating that these vape products may be beneficial in assisting adult smokers to quit, we know for sure they are detrimental to youth because of their capacity for addiction and damage to the developing brain as well lung injury and respiratory consequences.” In issuing its decision this week, the FDA recognized that youth e-cigarette use continues to be a serious public health concern. A study published at the beginning of October from the FDA and the Centers for Disease Control and Prevention (CDC) estimated that more than two million U.S. middle and high school students reported currently using e-cigarettes in 2021, with more than 8 in 10 of those youth using flavored e-cigarettes. The agency defended its decision by pointing to evidence indicating that young people are less likely to start using tobacco-flavored ENDS products and then switch to higher-risk products, such as regular cigarettes. Data also suggest that most youth and young adults who use ENDS begin with flavors such as fruit, candy, or mint, and not tobacco flavors. In an effort to limit potential youth exposure to tobacco advertising for these products, the FDA has imposed strict marketing restrictions on the company. The Campaign for Tobacco-Free Kids expressed serious reservations about this first-of-its-kind authorization. The organization said in a press release that these products have three times the nicotine concentration legally permitted in Canada, the United Kingdom, and Europe. “Vuse products with this level of nicotine leave our nation’s youth at an undue risk of addiction,” said the Campaign’s president, Matthew L. Myers, in a statement. Folan added that there are already other effective means for adults to quit smoking, and allowing the sale of new products that are high in nicotine content may cause America to lose ground in the fight against nicotine addiction. “Smoking rates among adults and teens have decreased dramatically over the last several years,” says Folan. “Without data to show the safety of these products, do we really want to take a chance on exposing youth to these products and addict a whole new generation to nicotine by selling these products, knowing teens will obtain and use them?” The FDA plans to keep a close eye on the sale of these e-cigarette products and warned that it could suspend or withdraw authorization if it determines the continued marketing of a product is no longer “appropriate for the protection of the public health,” such as if there is a significant increase in use among America’s young people.
