Giving C-store Operators the Lowdown on the FDA Crackdown

NATIONAL REPORT — The government is taking aim at the illegal e-cigarette business. Since early this year, a nationwide blitz has been underway by the U.S. Food and Drug Administration (FDA) to crack down on the illegal sale of popular disposable e-cigarettes.

"The FDA has initiated a higher level of enforcement on the manufacturer, wholesaler and retailer levels by increasing the number of inspections, including inspections of retail stores," Thomas Briant, retired executive director of the National Association of Tobacco Outlets (NATO), told Convenience Store News. "These retail inspections have focused on whether unauthorized flavored electronic cigarette/ vapor products are being sold in stores."

The Warnings

In May, the FDA issued warning letters to 30 retailers, including one distributor, for illegally selling unauthorized tobacco products, which included various types of Puff and Hyde brand disposable e-cigarettes, including Puff Bar.

The agency maintains that it is dedicated to protecting the nation's youth from tobacco products. According to the "2022 National Youth Tobacco Survey," about 20 percent of youth e-cigarette users reported using Puff Bar or Hyde brand products. They were the most popular and third-most popular brands with youth, respectively, in 2022.

[Read more: FDA Continues Crackdown on Sales of Illegal Vapor Products]

"We're committed to holding all players in the supply chain — not just manufacturers but also retailers and distributors — accountable to the law," stated FDA Commissioner Robert M. Califf.

"Retailers and distributors play a key role in keeping unauthorized tobacco products off the shelves and if they fail to do so, we're committed to taking appropriate action," added Brian King, director of the FDA's Center for Tobacco Products.

In June, the FDA issued more warning letters to 189 retailers for selling unauthorized tobacco products, specifically Elf Bar and Esco Bars products. Both brands are disposable e-cigarettes that come in flavors like bubblegum and cotton candy that have youth appeal.

Once again, King sent out a very pointed message. "All players in the supply chain — including retailers — have a role in keeping illegal e-cigarettes off the shelves," he said at the time. "This latest blitz should be a wake-up call for retailers of Elf Bar and Esco Bars products nationwide. If they're waiting for a personal invitation to comply with the law, they might just get it in the form of a warning letter or other action from the FDA."

To be clear, Elf Bar and Esco Bars products, as well as Puff Bar and Hyde brand products, do not have the required marketing authorization from the FDA. To date, the FDA has authorized 23 tobacco flavored e-cigarette products and devices (see page 56 for approved items). These are the only products in the category that may be lawfully sold in the United States currently.

In another recent action, the FDA issued import alerts for all products under both the Elf Bar and Esco Bars brands. An import alert places these tobacco products on what is known as the "red list," which makes them subject to detention without physical examination upon importation through a port of entry into the U.S.

On the distribution side, the FDA in late July issued warning letters to three distributors — ABS Distribution Inc., EC Supply Inc. and Easy Wholesale LLC — for selling and/or distributing multiple unauthorized e-cigarette products, including Elf Bar, EB Design, Esco Bars and Puff Max items.

The Aftermath

"Warning letters are generally the first step once an inspection reveals a violation of the law," explained Ann Simoneau, director of the Office of Compliance and Enforcement within the FDA's Center for Tobacco Products. "We will monitor to ensure these violations are corrected and if they are not, the recipient is at risk of further actions such as civil money penalties, seizures and injunctions."

NATO's Briant confirmed that if a retailer is inspected and found to be selling unauthorized products, the agency generally issues a warning letter first, which the retailer has 15 days to respond to in writing, explaining how it will become compliant with the law.

"If the retailer does not come into compliance, then the FDA can conduct additional inspections of the store and issue civil money penalties — fines — that increase significantly for each additional violation," Briant said. "The FDA also has the authority to seize unauthorized products, as well as potentially seek criminal prosecution."

According to Simoneau, a majority of warning letter recipients voluntarily take corrective action. However, within the past year, the FDA did issue its first injunctions and civil money penalties against e-cigarette manufacturers.

"It is the agency's intent to make these actions a routine component of its enforcement portfolio moving forward," she said. "For example, since January 2023, the agency has issued 15 civil money penalties against manufacturers for the illegal sale of e-cigarettes."

While this and harsher penalties haven't happened at the retailer level yet, that doesn't mean they're not coming. Retailers currently selling unlawfully marketed e-cigarette products face a greater risk of more enforcement action on a second inspection, according to Bryan Haynes, a partner specializing in tobacco/nicotine with the national law firm Troutman Pepper.

He calls these legal issues "fairly black and white," and encourages retailers that have and have not received warning letters to be prudent and stop selling unlawful products.

"I would return them to the manufacturer or distributor," he advised. "Continuing sales even in an effort to liquidate inventory would be risky."

Haynes would like to see tobacco retailers get onboard only with suppliers that are FDA authorized or have a premarket tobacco application (PMTA) pending with the agency.

"The biggest thing for retailers is due diligence," he said. "Ask for documentation that a PMTA was submitted ... how it was received and accepted for filing and ultimately, for review. Those are verifications that suppliers should be able to provide to retailers that they want to do business with."

The Future

The FDA in 2020 issued a guidance document calling for the removal of cartridge or pod-based flavored electronic cigarettes (except tobacco and menthol flavors) from the marketplace. But the document did not call for the removal of flavored disposable e-cigarettes, Briant noted.

Since then, underage individuals have continued to use flavored disposable vaping products, including products for which the manufacturer may not have submitted a PMTA, which is required by law for a tobacco product to be authorized for sale in the U.S.

The aim of the FDA today is to continually refine its response time and enforcement. Recently, the FDA and the National Institutes of Health awarded funding for a new Center for Rapid Surveillance of Tobacco.

"The FDA is committed to keeping a finger on the pulse of the rapidly evolving e-cigarette landscape, including through a variety of scientific assets equipped to quickly identify products with high youth appeal," King explained. "We will continue to use this data-driven approach across the entire supply chain."