FDA Pursues $19,000 Penalties for Repeat Offenders Selling Elf Bar

The FDA has declared that, having already issued warning letters for the same infraction, it will pursue sanctions against 22 retail establishments for selling illicit vaping devices. During retail inspections, the agency also revealed that 168 additional warning letters had been sent to physical establishments that were found to be selling illegal disposable vapes.

The agency is requesting the maximum legal amounts of civil money penalties (CMPs) for a single infraction. A single infraction pertaining to tobacco products may result in a maximum CMP of $19,192 under the Food, Drug, & Cosmetic Act, of which the Tobacco Control Act is a component.

Director of the FDA Center for Tobacco Products Brian King stated in a news statement, "The FDA has made it very clear that we are committed to using the full scope of our authorities, as appropriate, to hold those who break the law accountable." "These merchants received a proper warning about the consequences of not correcting their infractions. They will now pay the price for their decision to remain silent.

Companies facing CMP-penalties breaches have four options: pay the full amount due right now, work with the FDA to achieve a settlement, request a hearing, or request an extension to respond to the complaint. They have 30 days to reply, after which the whole penalty will be imposed by a default order.

All of the stores fined today stand accused of selling Elf Bar or EBDESIGN products—one of the most popular disposable vape brands. All 168 warning letters issued today also went to retail stores accused of selling Elf Bar products.

Elf Bar (and its alternate brand EBDESIGN ) has been a major enforcement target in the FDA’s whack-a-mole war on disposables. In May, the agency ordered import inspectors to detain Chinese Elf Bar shipments. Several actions against Elf Bar retailers and distributors have followed.

The FDA took action against the sale of disposable vapes in convenience stores and petrol stations almost exclusively today. Only a few of the stores receiving warning letters seem to be vape shops, and none of the stores facing CMPs are devoted vape shops. It doesn't seem like any of the infractions include selling to minors.

The FDA filed a civil money penalty request in February against four small vape companies, alleging that they sold goods while being warned not to sell unapproved items in 2021 or 2022. Additionally, two of the businesses manufactured goods that were subject to marketing denial orders (MDOs).

The FDA and Department of Justice filed a request for an injunction against six small e-cigarette companies in October 2022. The government said that the companies had either ignored warning letters or had failed to cease operations after being made aware of them. The businesses were charged with promoting e-cigarette products without a marketing permission application.