FDA Warns Makers of "Unauthorized" Breeze and Esco Bar Disposables

Today the FDA Center for Tobacco Products (CTP) issued warning letters to the manufacturers of Breeze and Esco Bar disposable vapes, ordering them to remove the products from the market. The companies have 15 business days to dispute allegations in the letters or otherwise respond.

Last week, six Chinese exporters of Esco Bar products—including manufacturer Innokin—were added to an FDA “red list” of shippers whose Esco Bar shipments can be detained at ports of entry without inspection. Elf Bar shipments were also included in that import alert.

New disposable vape enforcement actions

Both actions appear part of a new wave of enforcement actions promised by CTP Director Brian King during recent speeches and discussions. The FDA is under pressure from lawmakers, tobacco control groups, and tobacco company R.J. Reynolds to crack down on flavored disposable vapes that have grown in popularity over the last two years.

“We will continue to use the full scope of tools in our regulatory toolbox to make sure that those who make, distribute, or sell illegal e-cigarette products are held accountable,” King said in a press release. “Firms receiving a warning letter have 15 days to respond to FDA outlining how they will address the violation. If a firm doesn’t adequately address the violation, we have a bevy of enforcement actions at our disposal that potentially await them.”

The warning letters to Breeze Smoke, LLC and Shenzhen Innokin Technology Co., Ltd., correctly note that the products listed in the letters haven’t been authorized for U.S. sales by the FDA—but neither have thousands of other products that remain on the market with premarket tobacco applications (PMTAs) pending before the agency.

Pending PMTAs and enforcement discretion

All unauthorized products exist on the market based on the FDA’s enforcement discretion, including these products and products made by mass-market vape manufacturers like the JUUL and Vuse Alto. The agency has clearly decided to enforce against the products R.J. Reynolds has lobbied the agency to target, and not the very popular product made by R.J. Reynolds (the Vuse Alto).

The new FDA actions could signal that the agency will no longer consider pending PMTAs when deciding which companies to enforce against.

Esco Bar is believed to have pending PMTAs submitted during the brief window in 2022 when the agency accepted applications for synthetic nicotine-based vape products. (Unlike during the first round of PMTA submissions, when the FDA published a list of PMTA-submitted products, the agency never issued a public list of PMTAs submitted for what it calls “non-tobacco nicotine” (NTN) products.)

Breeze Smoke received marketing denial orders (MDOs) for several products in 2021, and immediately filed a petition for review in the Sixth Circuit Court of Appeals. Denied a stay pending appeal, the company asked the Supreme Court to issue a stay pending a full review by the circuit court. When the Supreme Court refused to issue a stay, Breeze Smoke voluntarily withdrew its Sixth Circuit petition for review two weeks before scheduled oral arguments.

Neither Breeze product referenced in today’s FDA warning letter was among the MDOs Breeze Smoke previously challenged in court. It is unknown if the products Breeze Smoke currently sells have PMTAs pending with the FDA.

Earlier this month: more MDO’s for e-liquids