FDA Issues Warning to Manufacturers of Unauthorized Breeze and Esco Bar Disposable Products

The makers of the Breeze and Esco Bar disposable vapes received warning letters from the FDA Center for Tobacco Products (CTP) today directing them to take the goods off the market. The businesses have 15 business days to refute any accusations made in the letters or provide more information.

An FDA "red list" of shippers whose Esco Bar shipments can be held at ports of entry without inspection was expanded to include six Chinese exporters of Esco Bar products, including maker Innokin, last week. Shipments of Elf Bars were also mentioned in the import alert.

Enforcement Actions For New Disposable Vapes

These seem to be a part of the latest round of enforcement measures that CTP Director Brian King has been teasing in talks and speeches. Legislators, organizations opposed to tobacco use, and the tobacco corporation R.J. Reynolds are putting pressure on the FDA to take action against flavored disposable vaporizers, which have become more and more common over the past two years.

In a news release , King stated, "We will continue to use the full scope of tools in our regulatory toolbox to ensure that those who make, distribute, or sell illegal e-cigarette products are held accountable." Businesses that get warning letters from the FDA have 15 days to reply with a plan for handling the infraction.

We may potentially wait for a firm to face a variety of enforcement proceedings if they fail to appropriately remedy the infringement.

The FDA hasn't approved the products listed in the warning letters for sale in the United States, as noted correctly by Breeze Smoke, LLC and Shenzhen Innokin Technology Co., Ltd. However, thousands of other products that are still on the market and have premarket tobacco applications (PMTAs) pending before the agency have also not received the FDA's approval.

Pending PMTAs And Discretion In Enforcement

Based on the FDA's enforcement discretion, all unlicensed products—including these and those produced by mass-market vape manufacturers like JUUL and Vuse Alto—are available on the market. It is evident that the agency has chosen to target the items that R.J. Reynolds has asked the agency to target rather than his highly successful product, the Vuse Alto.

The FDA may no longer take into account pending PMTAs when determining which corporations to take legal action against, as indicated by the recent FDA actions.

Esco Bar is thought to have pending PMTAs that were filed during the limited period in 2022 when the FDA took applications for e-cigarettes with synthetic nicotine. (In contrast to the first round of PMTA submissions, when the FDA made available a list of items filed under the program, the FDA never made available a list of PMTAs submitted for products classified as "non-tobacco nicotine" (NTN) .)

After Breeze Smoke was issued marketing denial orders (MDOs) for many products in 2021, the company promptly petitioned the Sixth Circuit Court of Appeals for a reconsideration. The corporation requested the Supreme Court to grant a stay until the circuit court completes its review after being denied one pending appeal.

Two weeks before the scheduled oral arguments, Breeze Smoke voluntarily withdrew its petition for review from the Sixth Circuit when the Supreme Court declined to grant a stay.

The FDA warning letter from today did not mention any of the MDOs that Breeze Smoke has previously contested in court. It's unclear if Breeze Smoke's current product offerings have any pending PMTAs with the FDA.

Previously This Month: More MDOs For E-liquids

Disconnected from its enforcement proceedings against disposable vape pens, the FDA issued MDOs for over 6,500 e-liquid items from ten manufacturers on May 12. The organization listed eight of the businesses:

• Imperial Vapors LLC
• Savage Enterprises
• Big Time Vapes
• SWT Global Supply Inc.
• Great Lakes Vapor
• DNA Enterprise LLC (Mech Sauce)
• Absolute Vapor Inc.
• ECBlend LLC

The organization awarded 250 MDOs for e-liquid goods made by Mothers Milk WTA on May 18.