FDA's PMTA Progress Report May Mean Bad News for Small Vape Companies

The FDA has almost completed its review of premarket tobacco applications (PMTAs) for mass-market vaping products, according to a July 22 progress report to the U.S. District Court for Maryland. The agency says it has just one application left to review.

As the FDA completes its court-mandated review of products sold in Nelson-tracked outlets like convenience stores and gas stations, it has also begun to issue a new wave of marketing denial orders (MDOs) to small manufacturers.

FDAs new progress report may be its last

The new progress report is the most recent in a series of reports mandated by the district court as part of its decision that forced the FDA to move the PMTA submission deadline forward. The lawsuit—and the motion to mandate FDA progress reports—was filed by several anti-vaping activist groups, including the American Academy of Pediatrics and the Campaign for Tobacco-Free Kids.

In April 2022, District Court Judge Paul Grimm (since retired) ordered the FDA to report its progress reviewing applications for all vaping products “sold under the brand names Juul, Vuse, NJoy, Logic, Blu, Smok, Suorin or Puff Bar,” and any other product with two percent or more market share as measured by market research firm Nielson.

In its first progress report, issued in May 2022, the FDA promised the court it would complete 100 percent of PMTA reviews that met the court’s standard by June 30, 2023. The agency only missed by a year—an impressive feat for bureaucrats that routinely miss deadlines by far greater periods of time.

Since the last progress report was filed in October 2023, the FDA has denied applications for the Suorin Air refillable pod vape and the blu PLUS+ rechargeable cigalike line, and also rejected the myblu menthol refill pod and four flavors of blu disposables. Last month, the agency granted marketing permission to four menthol-flavored NJOY products, and last week it authorized the Vuse Alto and some tobacco-flavored Alto pods.

Juul is still waiting for an answer

The FDA says in its new progress report that it has made decisions on 185 of 186 “covered applications.” The manufacturers of those products have either received an MDO or FDA authorization (a marketing granted order, or MGO). None remain under review, although the report doesn’t seem to count do-over reviews mandated in successful PMTA appeals.

Although the FDA doesn't name the 186th company that meets Judge Grimm’s criteria and remains under FDA review, it is clearly Juul Labs. The FDA issued an MDO to Juul in 2022, but within days stayed its own denial order and agreed to further review the application. Last month, the FDA rescinded the denial order, returning Juul’s products to full scientific review.

The agency says the only reason the lone pending PMTA review has not been completed is “due to a recent, major amendment submitted by the applicant, which will require significant scientific review.” The FDA will not commit to a timeline for completing the review—or even acknowledge it belongs to Juul—because such disclosure “would be inequitable—for FDA, for the applicant, and for the public.”

The report includes an FDA motion asking the court to terminate further reporting requirements, since any future reports would involve sharing progress on a single application.

New MDOs for small manufacturers

Early this year, the FDA again began issuing new MDOs to small manufacturers, after spending the last two years focused mostly on PMTAs from mass-market manufacturers, defending its earlier MDOs in court, and enforcing against disposable vape retailers and distributors. It appears the agency may now have begun taking action on the pending PMTAs for the tobacco- and menthol-flavored products it punted on in 2021.

In August 2021, just under a year after the PMTA submission deadline, the FDA began issuing MDOs to vape manufacturers, mostly for products in flavors other than tobacco and menthol. Before the year was out the agency had denied applications that covered tens of thousands of products. 

In its new progress report to the court, the agency brags that it has issued “over 18 million refuse-to-accept decisions, over 67,000 refuse-to-file decisions, and approximately 46,000 marketing denial orders.” Most of those 46,000 MDOs were for bottled e-liquid made by small- to medium-sized manufacturers—including many tiny businesses with no retail footprint outside their own cities. 

The agency devised the so-called “fatal flaw” review system that allowed it to reject applications for large numbers of flavored products based on standards not described until after companies had already submitted applications. Fifth Circuit Court Judge Andrew Oldham later called the FDA’s actions a “surprise switcheroo.” 

The process allowed the agency to wipe out large swaths of the independent industry without doing the individual scientific reviews mandated for each PMTA by the Tobacco Control Act. 

The FDA’s published list of MDOs (which does not include all denials issued) shows that 260 companies received MDOs between Aug. 26 and Oct. 6, 2021. Most of those denial orders included dozens, hundreds, or thousands of individual products. In many cases, the FDA issued cookie-cutter MDOs for all of a company’s flavored products, but left its tobacco- and menthol-flavored products under review. 

Following the 2021 PMTA bloodbath, the agency turned the MDO spigot to a drip while it spent its energy reviewing applications mandated by Judge Grimm, defending itself in court, and attempting to block the flow of unauthorized disposable vapes from China. In 2022, only four MDOs were issued—and just one to a small company. In 2023, the FDA issued only 13 MDOs, including nine to indie manufacturers.

But the agency may have finally settled on a strategy to address the thousands of products that remain on the market as part of pending PMTAs. While just 10 MDOs were issued to small vape companies during the previous two years, the FDA has issued MDOs to 52 small manufacturers in just the first half of 2024:

• Absolute Vapor Lounge LLC
• Apollo Future Technology Inc
• Bidi Vapor LLC
• BLB7 LLB (The Vape Mall)
• Bogart Enterprises LLC
• Breeze Smoke LLC
• Cool Breeze Vapor LLC
• Cosmic Fog Vapors Operating Company
• Custom Vapor Blends LLC
• Dominant Vapor
• DR Distributors LLC
• ECig Charleston
• eCig Source
• Fuma International
• GRIPUM LLC
• Gundo Distro
• Innevape LLC
• J-Vapor LLC (North Shore Vapor)
• JMJL Global Inc
• JT Wood Investments LLC (Vape It)
• Jvapes LLC
• KJJ Enterprises LLC
• LDP Designs LLC
• Lotus Vaping Technologies LLC
• Mister E-Liquid LLC
• MJ Asset Holdings LLC
• MMWTA, Motherﾒs Milk WTA
• Mom and Pop Vapor Shop
• Mountain Vaporz, LLC
• Newhere Inc (Madhatter Juice)
• NicQuid LLC
• Osment Enterprises LLC (The Vapor Apothecary)
• OVapes Ejuice LLC
• Parallel Direct LLC (The Magic Mist)
• Performance Plus Marketing Inc.
• Planet of the Vapes, LLC
• Quad City Vapers Club LLC
• South Coast Vapor Company
• Southwest Smokeless
• SSY Ejuice Inc.
• Stark Vapor LLC
• Synergy Mixing Labs LLC
• Tasty Haze LLC
• That 1 Vape
• Tiger Vapes LLC
• Vapejoose, Inc
• Vapor Plus Ok
• Vapors of Ohio Inc. (Nostalgic Vapes)
• Vertigo Vapor inc.
• VPR Collection
• VR Labs LLC
• Warlock Vapes LLC (Zuluvape)