On-Line Retailers Receive FDA Warning Letter Over Illegal Sale of Disposable E-Cigarettes

FDA has only approved 23 disposable e-cigarettes for the U.S. market, banning those the agency finds too appealing to teen users.

Federal drug regulators have issued warning letters to 14 online sellers of unauthorized vaping products, including Elf Bar and Esco Bar, two of the most popular vape products among teens, as part of ongoing regulatory action the agency has taken against e-cigarettes in recent years.

On May 1, the U.S. Food and Drug Administration (FDA) issued warning letters over the sale of illegal vapes in the U.S. The products were singled out by the agency as being especially appealing to teens in the U.S.

According to the 2023 National Youth Tobacco Survey, 2.1 million teens currently vape. Among those, more than 50% said they commonly use Elf Bar vape products and more than 20% said they often use Esco Bar e-cigarettes. These disposible vape pens account for nearly 1.5 million teen users across the country.

The warning letters also identified other brands that are popular with teens, according to retail sales data and internal FDA data from a survey among teen users.

Teen Vaping Concerns

Recent studies indicate disposable e-cigarettes are linked to higher vape rates among teens in the U.S. Teens and young adults who use them are more likely to keep vaping and vape more frequently.

Research published in 2019 indicated many e-cigarette brands, including the popular JUUL brand, were specifically designed to be as addictive as Marlboro cigarettes, leading a new generation to nicotine addiction.

However, FDA enforcement efforts have had little effect on reducing teen vaping, according to recent data. Teens simply find new devices and flavor combinations when others are banned and ignore the warnings of health side effects including damage to human DNA, increased risk of cardiovascular disease, and a higher likelihood of suffering from major depression previous research has determined.

Disposable E-Cigarette Warning Letters

The warning letters were issued to Elf Bar, Esco Bar, Funky Republic, Hyde, Kang, Cali Bars, Lost Mary, and other e-cigarette retailers. The warning letters cite the vape companies for selling unauthorized disposable e-cigarettes.

The retailers sold or distributed e-cigarette products in the U.S. that were not authorized by the FDA, putting them in violation of the Federal Food, Drug, and Cosmetic Act, the agency indicates.

To date, the FDA has authorized only 23 tobacco-flavored e-cigarette products and devices. These are the only vape products legally marketed and sold in the U.S.

The companies issued warning letters were given 15 working days to respond to the letters and should include the steps they plan to take to address the violations and prevent future violations, the FDA stated.

Failure to quickly address the violations can result in FDA regulatory actions, including injunction, seizure, and/or civil money penalties.