FDA Continues Crackdown on Unauthorized E-Cigarettes
WASHINGTON, D.C. — In September, the U.S. Food and Drug Administration (FDA) made several moves against tobacco manufacturers and retailers for the sale of unauthorized tobacco products, including issuing civil money penalties (CMP) against several for their failure to comply with earlier warnings.
The agency initially issued six warning letters to manufacturers and retailers for the sale or distribution of unauthorized e-cigarette products promoted at an industry trade show. The letters were issued after an FDA investigation was launched in the wake of personal observations made by Center for Tobacco Products (CTP) staff attending the show.
"Regulated industry should be aware that CTP obtains leads that inform investigations from many sources, including trade shows," said John Verbeten, director of the CTP's office of compliance and enforcement. "We remain committed to identifying and taking action against those breaking the law, including at these events."
The FDA additionally issued warning letters to five online retailers for selling unauthorized e-cigarette products popular with youth, including products marketed under the brand names Breeze, Mr. Fog and Raz. Results from the recently released 2024 National Youth Tobacco Survey found that Breeze and Mr. Fog were among the top five most commonly used brands among youth who use e-cigarettes.
The companies receiving these warning letters sold or distributed e-cigarette products that have not been granted FDA marketing authorization in violation of the Federal Food, Drug and Cosmetic Act. Warning letter recipients are given 15 working days to respond with the steps they will take to address the violations cited in the warning letter and to prevent future violations.
Failure to promptly address the violations can result in additional FDA actions such as an injunction, seizure and/or civil money penalties. In the case of two brick-and-mortar retailers and nine online retailers, follow-up inspections revealed that the retailers had failed to correct their violations even after given time to comply with previous letters. Accordingly, the agency is now seeking a CMP of $20,678 from each retailer.
Throughout the last year, the agency has conducted inspections of retailers to identify those selling unauthorized e-cigarettes — including in August, July, June, May, March and February. To date, FDA has filed civil money penalty complaints against 70 manufacturers and 160 retailers for distribution and/or sale of unauthorized tobacco products.
The newly issued penalties are similar in scope to previously sought fines.