FDA Authorizes First E-Cigarette Products

Advertising Restictions, E-Cigarettes, FDA, Flavors (including Menthol), Product Availability, Youth

On October 12th, the US Food and Drug Administration (FDA) announced that it has given marketing authorization to R.J. Reynolds Vapor Company’s e-cigarette product Vuse Solo, a closed-system device, and the tobacco-flavored e-liquid cartridges that accompany it. This is the first e-cigarette product that the agency has authorized through their premarket review process.

On the same day, the agency announced that it has issued marketing denial orders to 10 other flavored Vuse Solo products. While we don’t know the specific flavors of the products that were issued denials (the FDA is not currently releasing that information), we do know that one of them was not menthol – the FDA says they are still evaluating the application for the menthol-flavored Vuse Solo product.

The marketing denial orders for the 10 flavored products represent a positive step for protecting youth. While some concern for youth use of e-cigarettes in tobacco flavor remains, we know that youth are much more likely to initiate with a non-tobacco flavored product. While this year’s National Youth Tobacco Survey found that nearly 85% of youth who use e-cigarettes use flavored other than tobacco, Vuse was also the second most popular brand among youth. The FDA hopes that “authorizing these [tobacco-flavored] products may be beneficial for adult combusted cigarette users who completely switch to ENDS or significantly reduce their cigarette consumption.”

However, there remain concerns with this authorization. Namely,

  • Nicotine concentration. The nicotine concentration of the authorized e-liquid pods is 4.8%, which, as noted by the Campaign for Tobacco Free Kids, is three times the concentration that is allowed Canada, the UK, and Europe. This high nicotine concentration may lead to greater dependency among users.
  • Lack of action on menthol. It is apparent that the FDA thinks menthol flavored e-cigarettes deserve special consideration. However, we know that youth will use whatever flavor remains on the market. Data has shown that after popular e-cigarette brand Juul stopped selling their mint-flavored pods, leaving only their menthol and tobacco flavors on the market, sales of their menthol flavored soared.
  • Weak marketing restrictions. Although the FDA has placed some marketing restrictions on Vuse Solo products, many avenues that reach youth audiences remain open. As summarized by Eric Lindblom here, the marketing restrictions that the FDA has placed on Vuse Solo still allow promotion by social media influencers and celebrities, sponsorships, and advertising on TV and radio programs for which youth are no more that 15% of the audience.

The FDA does still reserve the right to withdraw marketing authorization if they see the products as no longer appropriate for protection of the public health. Monitoring of both use and marketing of these products will be critical going forward.

The agency has yet to announce any action Juul, NJOY, or other key brands. In addition, data from the 2021 National Youth Tobacco Survey shows that Puff Bar is now the most popular e-cigarette brand among youth. While the FDA already ordered Puff Bar off the market for lack of premarket authorization, the company has reportedly switched to using synthetic nicotine, which likely does not fall under the FDA’s current regulatory purview, as their definition of tobacco product only includes those with nicotine that is made or derived from tobacco. 

Look for additional updates from the FDA’s premarket review process on their Tobacco Product Applications: Metrics & Reporting page, and find any affirmative marketing authorizations posted here. In the meantime, state and local action to protect youth and public health by regulating these products and prohibiting the sale of menthol and other flavored tobacco products remains critical.


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