FDA War on Disposables Heats Up with 189 New Warning Letters

The FDA announced today it has issued warning letters to 170 stores and 19 online retailers for selling unauthorized Elf Bar and Esco Bar products. The agency said the letters—all dated between June 5-16—came after a “nationwide retailer inspection blitz” conducted over the past several weeks.

Most of the brick-and-mortar stores receiving warnings are convenience stores, gas stations or smoke shops, but some vape shops are named. Many of the stores are owned by or affiliated with major retail and gas station companies. At least two major online vape retailers—Directvapor and MyVaporStore—were among those cited.

The stores were not warned for selling to underage customers, but simply for selling products to adults that haven’t been authorized by the FDA through the premarket tobacco (PMTA) pathway. None were cited for selling the Vuse Alto or JUUL devices, although those too are unauthorized.

The warning letter recipients have 15 business days to dispute the allegations in the letters or explain how they will correct the violations.

The FDA's new war on disposables

The enforcement actions are the latest salvo in the FDA’s increasingly desperate war on disposable vapes. The usually fruit-flavored single-use products have grabbed a huge share of the convenience store/gas station segment of the vaping market since the FDA targeted flavored pod-based vapes for enforcement in early 2020.

Today’s FDA press release quoted Centers for Disease Control and Prevention (CDC) analysis—coincidentally also published today—of recent retail data showing that Elf Bar and Breeze Smoke disposable vapes had joined the top five c-store vape brands as of December 2022, and that disposables as a class had displaced a significant portion of pod-based vaping product sales. (However, Vuse and Juul remain the top two brands.)

The FDA is under growing pressure from members of Congress, tobacco control groups and especially cigarette giant R.J. Reynolds to crack down on sales of disposables and other flavored vape products. The agency has engaged in multiple whack-a-mole enforcement actions over the last several month.

In mid-May, the FDA issued import alerts ordering FDA inspectors to detain shipments of Elf Bar and Esco Bar products. A week later, the agency sent warning letters to the manufacturers of Esco Bar and Breeze disposables, ordering them to remove products from the market. Soon after that, the FDA warned several retailers to stop selling Puff Bar and Hyde disposables.

Can FDA put the vaping toothpaste back in the tube?

Millions of vaping products are sold in the United States, and the vast majority are disposable vapes and bottled e-liquids in flavors other than tobacco and menthol. Even if the FDA manages to eliminate imports and sales of Elf Bar and Esco Bar products, other disposable brands will replace them. The regulatory agency also faces dozens of lawsuits from e-liquid manufacturers challenging marketing denial orders for flavored products.

“To date, the FDA has authorized 23 tobacco-flavored e-cigarette products and devices,” the agency says in its press release. “These are the only e-cigarette products that currently may be lawfully sold in the U.S.”

The eight vape devices authorized by the FDA are ineffective, unpopular products—all made by companies affiliated with major tobacco firms—and are only legally available with tobacco-flavored refills. (One of the devices, the Vuse Ciro, was so unpopular it was discontinued by manufacturer R.J. Reynolds after it was authorized by the FDA to be sold.)

The FDA has not authorized any vaping products in flavors other than tobacco, and has authorized no bottled e-liquids or refillable devices. The two disposable devices authorized by the agency are slightly different versions of the ancient and mostly forgotten NJOY Daily.

The problem the FDA faces is that people like flavored vapes. Cutting off the supply of any particular brand of popular e-cigarette will not significantly reduce demand, and as long as millions of consumers want vaping products that work well and are available in popular flavors, enterprising wholesalers and retailers will continue to supply those products.