The Food and Drug Administration (FDA) on Friday issued six warning letters to manufacturers and retailers for the sale or distribution of unauthorized e-cigarette products promoted at the Total Product Expo industry trade show, a spokesperson for the FDA told CSP.
After observations made by the FDA’s Center for Tobacco Products (CTP) staff attending the trade show, the agency said it conducted investigations and issued the warning letters. Total Product Expo did not immediately respond to a CSP request for comment.
“Regulated industry should be aware that CTP obtains leads that inform investigations from many sources, including trade shows,” said John Verbeten, director of CTP’s office of compliance and enforcement. “We remain committed to identifying and taking action against those breaking the law, including at these events.”
Regulated entities must comply with all applicable requirements under the Federal Food, Drug, and Cosmetic Act. Under these requirements, the sale and distribution of unauthorized tobacco products is illegal, including at industry events such as trade shows or expos.
The FDA also announced the issuance of 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. Raz was identified as a popular brand through routine surveillance, with youth-appealing flavors such as sour mango pineapple and razzle dazzle, the agency said.
The companies receiving these warning letters sold or distributed e-cigarette products that have not been granted marketing authorization from FDA, in violation of the law, the agency said. They have 15 working days to respond with how they will correct the violation and prevent future ones. Failure to do so could result in additional FDA action such as injunctions, seizure or civil money penalties.
The FDA said Friday’s actions are part of the agency’s ongoing efforts to crack down on unauthorized e-cigarettes across the supply chain, including retailers.
The FDA has issued more than 690 warning letters and more than 140 civil money penalty actions to retailers for the sale of unauthorized e-cigarettes. To date, the FDA has authorized 34 e-cigarette products and devices.
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