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UPDATE: FDA Authorizes 3 Vape Products After Rejecting 323 Other Applications From Vape Companies

October 14, 2021

Author

Pader Moua, MPH
Policy Analyst
501-526-2244
PMoua@achi.net

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UPDATE:

On Tuesday, Oct. 12, the Food and Drug Administration (FDA) announced three vape products by R.J. Reynolds Vapor Company were authorized to stay in the market. This is the first time the FDA has authorized the sale of a vape product. The products include the Vuse Solo Power Unit vape device and two accompanying tobacco-flavored e-liquid pods. Ten orders denying applications for Vuse Solo flavored vape products to stay on the market were also issued by the agency; however, the agency said it is still reviewing an application for Vuse Solo menthol-flavored products.

The FDA stated that based on recent data, approximately 10% of high school students who currently use e-cigarettes reported using Vuse as their usual brand.

Original post (published September 29, 2021):

On Thursday, Sept. 23, the Food and Drug Administration (FDA) announced that since Aug. 26 it had issued 323 orders denying applications by companies seeking to keep their vaping products in the market. These denials affect more than 1,167,000 flavored vape products. The FDA said previously it was denying applications that “lacked sufficient evidence that they [vape products] have a benefit to adult smokers sufficient to overcome the public health threat posed by the well-documented, alarming levels of youth use of such products.”

This comes after a Sept. 9 announcement that the agency would not meet a Sept. 9 deadline to make decisions on applications by vaping companies. All manufacturers of e-cigarettes and related products were required under a court order in 2019 to submit applications for FDA review by Sept. 9, 2020. However, the companies were allowed to keep these products on the market for one year while the FDA reviewed the applications.

Despite the progress reported by the FDA in reviewing and taking action on about 93% of applications, the majority of the denials are for flavored vape products from small and medium-sized companies and do not include large companies like Juul, which has a 40% market share.

The Centers for Disease Control and Prevention reported a decline in high school students who reported current use of e-cigarettes — down from 27.5% in 2019 to 19.6% in 2020. However, an overwhelming majority, 84.7%, of high school students who used e-cigarettes in 2020 reported they use flavored e-cigarettes. The 2020 Arkansas Prevention Needs Assessment Survey found that among Arkansas public school students, the average age of first-time e-cigarette users is 13.5 years. The survey also showed that 3.2% of sixth graders, 9.8% of eighth graders, 16.9% of 10th graders, and 19.8% of 12th graders reported using a vaping product within the last 30 days.

States, including Arkansas, have acted to protect young people from the health hazards of vaping products. Arkansas legislation in 2019 increased the minimum purchasing age for vaping products from 18 to 21, shortly prior to federal legislation that increased the minimum purchasing age to 21 and became effective in January 2020.

Additional steps that states could take to curb youth use of vaping products include:

  • Levying an excise tax on e-cigarettes that is no less than the tax on tobacco products and is based on nicotine amounts.
  • Banning all flavored vaping liquids — including those used in tank-based delivery devices — especially sweet, fruity, or candy-themed flavors.
  • Extending the Arkansas Clean Indoor Air Act, which prohibits smoking in most workplaces and public spaces, to e-cigarettes.
  • Increasing enforcement efforts to ensure retailers are complying with the updated age restrictions for tobacco and e-cigarette product purchases.
  • Prohibiting e-cigarette advertising that targets youth.

For more information about this evolving issue that continues to impact Arkansans, visit our Vaping Updates and Insights page.