December has already been a busy month for the U.S. Food & Drug Administration in its battle to prevent the unauthorized manufacture and sale of electronic cigarettes and e-liquids.
In just the first five days of the festive month, the FDA has filed CMP (Civil Money Penalty) complaints against numerous retailers and sought a permanent injunction against a vape brand for manufacturing, distributing, and selling unauthorized vape products.
CMPs Filed Against Online Retailers for the First Time
Following similar actions in September and November of this year, the FDA has filed CMPs against 25 retailers for continuing to sell unauthorized vape products.
This action, announced on December 5th, takes the total number of CMPs issued to 67. As with the previous complaints, these are focused heavily on retailers selling brands such as Elf Bar, EB Designs, Flum, and other flavored disposables. The 2023 NYTS (National Youth Tobacco Survey) found that Elf Bar was the brand used most often by middle and high-school students, making it a prime target for the FDA to pursue.
The recipients of these latest CMPs, which could result in penalties of around $20,000 for a single violation, include brick-and-mortar retailers from 14 states and, for the first time, four online retailers. Each retailer has 30 days from receipt of the complaint to pay the penalty, enter into an agreement to settle the complaint, or file an answer in mitigation and request a hearing to decide the outcome.
The issued notices are unlikely to be a surprise to the retailers in question as they are always preceded by warning letters. The FDA has sent out more than 400 warning letters to stores selling unauthorized vape products, as well as 630 letters to manufacturers or distributors of similar products. It is, therefore, highly likely that additional civil penalties will be issued in 2024.
No PMTA, No Right to Manufacture E-liquid, Says FDA
Despite being previously warned over violations of the Federal Food, Drug, and Cosmetic Act’s PMTA requirements, Florida-based Vape Junkie Ejuice has become the 7th company targeted by a permanent injunction ordering it to stop manufacturing, selling, and distributing their vape products. In this case, e-liquids.
Issued by the DOJ (Department of Justice) on behalf of the FDA, the December 4th injunction is another of the tools federal authorities have at their disposal to prevent the distribution of unauthorized vape products. It is action, insists the FDA, that is essential but reserved for vape brands that persistently ignore the laws surrounding PMTAs.
“[The] FDA has been abundantly clear that we will not stand by as bad actors choose to blatantly disregard the law, especially after being duly warned,” said Brian King, Ph.D., M.P.H., director of the FDA’s Center for Tobacco Products (CTP). “This manufacturer continued to break the law, and that behavior has consequences.”
PMTAs, or Pre-Market Tobacco Applications must be approved before the manufacture or distribution of new vape products is allowed. When all vape products were reclassified as tobacco products, this rule was retrospectively applied to include everything from e-liquids to coils and vape tanks already on the market.
Getting PMTA approval has proved to be almost impossible for a huge number of vape products, particularly non-tobacco flavored liquids. According to FDA documentation, in 2022, around 20 PMTAs were approved, all for refillable devices or tobacco-flavored liquids. During that same period, many thousands of applications were denied. In 2023, just three new PMTAs have been approved, all for heated tobacco products.