United States: Millions of non-compliant vaping products remain on sale

Truth Initiative associations[1] and Campaign for Tobacco-free kids[2] (CTFK) are denouncing the Food and Drug Administration’s (FDA) delay in reviewing premarket applications for vaping products that had been set by a federal court for review by September 9, 2021. According to the FDA, all of these reviews cannot be completed until June 2023, allowing a large number of unverified products to be sold and consumed.

The FDA is responsible for ensuring that new tobacco and nicotine products are subject to prior approval to meet certain health standards before they are marketed. If a product does not meet a particular standard, the agency issues an order denying the marketing application. It is therefore illegal to market a new tobacco product, including vaping products, in the United States without this prior FDA marketing approval.

The complex path of e-cigarette marketing applications

E-cigarettes have gained popularity in recent years in the United States but have benefited for years from a vague legal framework that did not allow the FDA to intervene. On August 8, 2016, the FDA's "Deeming Rule" came into effect. Under this rule, all new tobacco and nicotine products, including e-cigarettes, must comply with a series of regulatory requirements such as registration, ingredient listing, health warnings, age restrictions and, most importantly, premarket authorization for any new product first marketed or modified after February 15, 2007.

From that date, the state agency then gave e-cigarette manufacturers a two-year deadline to prepare their premarket applications in order to be allowed to remain on the market. In 2017, the FDA extended the deadline for filing premarket applications to August 2022, but public health organizations filed an appeal in federal court and successfully moved the deadline forward to September 9, 2020. Following the COVID-19 pandemic and at the request of the FDA and vaping manufacturers, a one-year extension was again granted, pushing the deadline back to September 9, 2021.

The court ruling in the health organizations’ proceedings also provided for a one-year period during which products whose applications had been filed on time could remain on the market pending review by the FDA. But in May 2022, the FDA announced in federal court that it would not be able to complete the review of all marketing applications until June 2023, nearly two years after the court’s September 9, 2021 deadline. As a result, many brands that have been on the U.S. market for years are currently still on sale even though they have not – yet – been reviewed by the agency. Manufacturers are thus taking advantage of the FDA’s failures in its prior product review obligations to keep products on the market that should be withdrawn.

Millions of applications submitted to FDA

The FDA has received applications from more than 500 companies for more than 6.5 million tobacco and nicotine products. To date, the FDA has reported that it has denied marketing applications for more than 1 million flavored vaping products. However, the FDA has yet to make decisions on many of the e-cigarette brands that hold the largest market share, such as View of BAT, or which are the most used by young people such as puff bar.

The problem of synthetic nicotine

The FDA is also criticized for its delay in withdrawing from the market e-cigarettes based on synthetic nicotine, particularly puffs. In March 2022, the US Congress adopted a text specifying that synthetic nicotine products should be regulated by the FDA's Center for Tobacco Products in the same way as nicotine products derived from tobacco.

Despite this legislative development, the FDA has failed to meet the deadlines set by Congress to remove these illegal synthetic nicotine puffs from the market.

Delays that allow youth consumption to grow

Public health groups say the delays allow the nicotine industry to continue flooding the market with new products that are popular with young people, helping to keep consumption very high. According to Nielsen data, since the end of 2021, more than 1,000 new nicotine products have been introduced into the retail supply chain.

A new analysis from the Truth Initiative also shows that nearly 2.5 million teens and young adults (ages 15-24) have started using nicotine with e-cigarettes since the FDA missed its September 9, 2021 deadline. This figure includes 1.2 million teens (ages 15-17), more than 500,000 minors (ages 18-20—the majority in the U.S. is 21), and more than 700,000 young adults (ages 21-24).

Truth and CTFK urge the FDA to take immediate action to remove these noncompliant products from the market.

Keywords: FDA, Truth, Campaign for Tobacco-Free Kids, vaping products, ban, marketing application, youth, e-cigarette

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[1] Press release, New Truth Initiative data show 2.5 million youth and young adults started using e-cigarettes since FDA missed the September 9, 2021, court-ordered deadline to remove unreviewed products from the market, Truth Initiative, published September 9, 2022, accessed September 12, 2022

[2] Press release, One Year After Deadline for FDA Action, Flavored E-Cigarettes Remain Widely Available and America's Kids Remain at Risk, Campaign for Tobacco-Free Kids, published September 9, 2022, accessed September 12, 2022