Following warning letters concerning the sale of disposable vapes that have not been given marketing authorization, the FDA announced that more than 20 brick-and-mortar stores have been issued with complaints for Civil Money Penalties (CMPs) of the maximum allowed under federal law.
These fines, of $20,678 per retailer, have been issued because follow-up inspections revealed that these 21 stores had continued to sell the popular Esco Bar disposable vapes despite the earlier warnings and even though it is illegal to sell vape products that haven’t been granted the right to be marketed following submission of a PMTA.
Following the issuing of the penalties, Brian King, Ph.D., M.P.H., director of the FDA’s Center for Tobacco Products, said:
“These retailers were duly warned of what could happen if they continued selling these unauthorized e-cigarettes. They should have acted responsibly to correct the violations, but they chose not to do so and now must face the consequences of that decision. FDA won’t sit back and tolerate inaction to comply with the law.”
Esco Bar, a disposable vape brand created by Texas-based company Pastel Cartel, quickly became highly popular with young vapers. According to the results of the 2023 National Youth Tobacco Survey, Esco Bars were the second most commonly used vape among middle and high school students. As such, they were always going to be a key focus in the FDA’s crackdown on unauthorized tobacco/nicotine products.
In that light, this round of CMPs being issued to retailers selling Esco Bars is unsurprising. It follows multiple similar fines handed to stores selling the even more popular Elf Bar disposable at the end of 2023. Over 45 retailers were warned or handed twenty thousand dollar fines in that previous flurry of enforcement action.
Once a retailer receives a CMP, of which only one per retailer is currently allowed to be issued, they can choose to pay it outright, enter into a settlement agreement if there are mitigating factors, request extra time to answer the complaint, or answer the complaint and request a hearing to decide the outcome. Each retailer has 30 days to take one of these actions before defaulting, at which point the full penalty amount will be imposed.
As of the end of January 2024, the FDA is reported to have issued 440 warning letters to brick-and-mortar and online retailers who continued to sell unauthorized tobacco products (including vapes,) and has followed up with 88 CMPs so far. CMPs have also been issued to 48 e-cigarette manufacturers who continued to make unauthorized products and, alongside the Department of Justice, the agency has sought injunctions against a further seven manufacturers.