New research from Truth Initiative finds that the overwhelming majority – more than 86 percent – of e-cigarettes on the market are illegal products.

The Food and Drug Administration (FDA) has granted marketing orders for only 34 products from the NJOY, VUSE, and Logic brands, including four menthol products from NJOY, and had made it clear that these are the only e-cigarette products that currently may be lawfully sold in the U.S.

Researchers examined U.S. retail sales data and determined that the 34 e-cigarette products authorized for marketing by the FDA comprise only 13.7% of the e-cigarette market, while illegal e-cigarette products that lack marketing authorization constitute the vast majority (86.3%) of the market.

While the FDA has been methodical in reviewing product applications, removing illegal products from the market has been slow. This analysis highlights the need for further efforts to prevent products from entering the market without a marketing-granted order and remove the illegal products circulating the U.S. market today.

This chart shows the market share of e-cigarette products by FDA marketing status. The orange line represents the market share over time of the 34 products that have received marketing authorization from the FDA as of July 2024. This market share is expressed as a percentage of the total market. The analysis compares the market share of legally marketed products to those currently sold in the U.S. without FDA marketing authorization. However, the FDA’s first marketing authorization for an e-cigarette product was not issued on October 12, 2021.

Researchers used NielsenIQ Retail Scanner Sales data to estimate e-cigarette sales. These data are presented in aggregated four-week periods and include sales dollars from various sources, such as participating independent stores, chain and gas station convenience stores, food, drug, and mass merchandise retailers, discount and dollar stores, and military commissaries. Several of the products that were granted marketing orders by the FDA were in the market before they received authorization. Therefore, our analysis covered the four weeks ending on October 12, 2013, through the four-week period ending March 16, 2024. This approach takes a retrospective view, presenting market share as a percentage of the total market, as if these products had always been sold under an FDA marketing order, including the 11 products approved after March 2024.

Action is needed to combat illegal e-cigarette sales

The premarket review process provides the FDA with an objective and systematic method to evaluate whether an e-cigarette product benefits public health and can be legally marketed in the United States.

The FDA has denied permission to market many non-tobacco and non-menthol flavored e-cigarette products, however many of those denials are currently under judicial or supervisory review. Additionally, many e-cigarette products on the market have not submitted premarket review applications at all. In recent years, the FDA has increased enforcement efforts around e-cigarette manufacturers and retailers for continuing to sell youth-appealing e-cigarettes. These actions include issuing warning letters, civil money penalties, injunctions, and joint operations with other federal officials to seize imports of unauthorized e-cigarette products.

With 1.63 million middle and high school students reporting e-cigarette use in 2024, actions to address unauthorized e-cigarette sales come at a crucial time. These products pose a significant threat to public health, especially for young people: nicotine addiction is harmful to developing brains and high rates of daily and frequent use could put young users at risk for nicotine addiction.

Truth Initiative applauds action taken to address sales of illegal e-cigarettes and urges all retailers to act swiftly and in compliance with the law to remove these products from the shelves and ensure a safer future for young people.