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September 28, 2023
3 min to read

FDA Seeks $19,000 Fines for Repeat Elf Bar Sales Violators

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Jim McDonald

The FDA has announced it will seek fines from 22 retail stores for selling unauthorized vaping products after previously receiving warning letters for the same offense. The agency also announced 168 new warning letters issued to brick-and-mortar stores caught selling unauthorized disposable vapes during retail inspections.

The agency is seeking the largest civil money penalties (CMPs) allowed by law for a single violation. The Food, Drug, & Cosmetic Act (of which the Tobacco Control Act is a part) provides for a maximum CMP of $19,192 for a single violation relating to tobacco products.

“The FDA has been abundantly clear that we are committed to using the full scope of our authorities, as appropriate, to hold those who break the law accountable,” FDA Center for Tobacco Products Director Brian King said in a press release. “These retailers were duly warned of what could happen if they failed to correct their violations. They chose inaction and will now face the consequences.”

Businesses charged with violations punishable by CMPs can pay the full amount immediately, reach a settlement agreement with the FDA, ask for an extension to answer the complaint, or answer with a request for a hearing. They have 30 days to respond or risk a default order imposing the full penalty.

Or... you could regulate vaping and avoid all this "enforcment authority" theater.

— GrimmGreen (@GrimmGreen) September 28, 2023

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.

Almost all of today’s FDA actions addressed disposable vape sales at convenience stores and gas stations. None of the stores facing CMPs are dedicated vape shops, and just a handful of the stores receiving warning letters appear to be vape shops. None of the violations appear to involve sales to underage buyers.

In February, the FDA sought civil money penalties against four small vape businesses, charging they continued to sell products after receiving warning letters for selling unauthorized products in 2021 or 2022. Two of the companies were also manufacturers of products that had received marketing denial orders (MDOs).

In October 2022, the FDA and Department of Justice sought injunctions against six tiny vape companies the agency said didn’t respond to warning letters or refused to stop doing business after acknowledging warnings. The companies were accused of selling vape products for which they had not applied for marketing authorization.

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Jim McDonald

Vaping since: 12 years

Favorite products:

Favorite flavors: RY4-style tobaccos, fruits

Expertise in: Political and legal challenges, tobacco control haters, moral panics

Jim McDonald

Smokers created vaping without help from the tobacco industry or anti-smoking crusaders, and I believe vapers have the right to continue innovating to help themselves. My goal is to provide clear, honest information about the challenges vaping faces from lawmakers, regulators, and brokers of disinformation. I’m a member of the CASAA board, but my opinions aren’t necessarily CASAA’s, and vice versa. You can find me on Twitter @whycherrywhy

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