FDA's PMTA Update Could Spell Trouble for Small Vape Companies

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The FDA has nearly finished reviewing premarket tobacco applications (PMTAs) for mass-market vaping products, as stated in a July 22 progress report to the U.S. District Court for Maryland. The agency reports that only one application remains under review.

With the court-mandated review of products sold in Nielsen-tracked outlets like convenience stores and gas stations nearing completion, the FDA has started issuing a new wave of marketing denial orders (MDOs) to small manufacturers.

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The FDA’s list of marketing denial orders (MDOs), though not comprehensive, reveals that 260 companies received MDOs between August 26 and October 6, 2021. Most of these orders affected dozens, hundreds, or even thousands of individual products. Often, the FDA issued blanket MDOs for all of a company’s flavored products, leaving only tobacco- and menthol-flavored products under review.

After the 2021 PMTA upheaval, the FDA significantly slowed the issuance of MDOs. During this period, the agency focused on reviewing applications mandated by Judge Grimm, defending its decisions in court, and attempting to block unauthorized disposable vapes from China. In 2022, only four MDOs were issued, with just one affecting a small company. In 2023, the FDA issued only 13 MDOs, including nine to independent manufacturers.

However, the agency now seems to have adopted a strategy to address the thousands of products still on the market under pending PMTAs. While only 10 MDOs were issued to small vape companies over 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)