FDA Cracks Down on Illegal Sales of Disposable E-Cigarettes

WASHINGTON, D.C. — The Food and Drug Administration (FDA) issued warning letters to 30 retailers, including one distributor, for illegally selling unauthorized tobacco products. 

All of the cited products were various types of Puff and Hyde brand disposable e-cigarettes, which are two of the most commonly reported brands used by youth e-cigarette users, according to last year's "National Youth Tobacco Survey." Among those users, about 20 percent reported using Puff Bar or Hyde brand products in 2022. 

"Protecting our nation's youth from tobacco products — including disposable e-cigarettes — is a top priority for the FDA," said FDA Commissioner Robert M. Califf. "We're committed to holding all players in the supply chain — not just manufacturers but also retailers and distributors — accountable to the law."

The warning letters came amidst a nationwide blitz to crack down on the sale of unauthorized e-cigarettes that are popular with youth, which included investigations of hundreds of retailers and distributors across the country. 

When e-cigarettes lack a marketing authorization order from the FDA, selling or distributing them to consumers in the U.S. is prohibited under the Federal Food, Drug and Cosmetic Act. The FDA generally sends warning letters the first time an inspection or investigation reveals a violation of the law, and recipients are given 15 working days to respond with the steps they'll take to correct the violation, as well as how they'll prevent future violations. A majority of recipients of warning letters voluntarily correct the stated violation. However, failure to promptly address the issue can result in additional FDA actions such as an injunction, seizure and/or civil money penalties. 

The latest FDA actions are happening concurrently with c-store industry stakeholders calling for better regulation of illegal tobacco product sales. In February, RAI Services Co. sent a petition to the agency, requesting the closing of a loophole which allowed illegal disposable e-cigarettes to flourish. In April, New York state convenience stores urged government action at the state level to crack down on tobacco smuggling.

To date, the FDA has filed civil money penalty complaints against 10 e-cigarette manufacturers, while in October 2022, the first complaints for permanent injunctions were filed against six manufacturers.