Tracking the FDA's PMTA Enforcement Letters

CHICAGO — Companies that did not submit a premarket tobacco product application (PMTA) for deemed new tobacco products on the market may soon receive a warning letter from the U.S. Food and Drug Administration (FDA).

The agency is cracking down on electronic nicotine delivery systems (ENDS) firms that did not apply for premarket authorization by the Sept. 9, 2020, deadline.

Since the start of 2021, the agency has issued four rounds of warning letters to more than 40 firms illegally selling products.

When it sends a letter, the FDA asks the recipient to respond within 15 working days detailing how the recipient intends to address the agency’s concerns. Failure to do so could result in a civil money penalty complaint, seizure or injunction, the FDA said.

The FDA is prioritizing the enforcement of ENDS products and will make enforcement decisions on a case-by-case basis, the FDA’s Center for Tobacco Products (CTP) Director Mitch Zeller said. It intends to prioritize enforcement based on the likelihood of youth use or initiation to make the most efficient use of resources.

There are some exceptions. Currently, the FDA is prohibited to enforce the premarket authorization requirement for premium cigars until after the agency considers developing a streamlined substantial equivalence process specifically for those products.

Premarket review for deemed new tobacco products on the market after Aug. 8, 2016, were required to be submitted by the Sept. 9 deadline, according to a court order. Companies that submitted applications by the deadline are generally allowed to continue selling those products for up to a year, pending a negative action taken by the FDA on the application.

The FDA keeps a running list of warning letters on its website.

It also recently created new webpages for retailers to track the status of exemption from substantial equivalence requests (EX REQ), substantial equivalence (SE) reports and PMTAs, which will be update as the process to go through the applications for millions of products submitted is ongoing.

Click through to see which firms the FDA warned so far.

This list will be updated periodically when the FDA issues more related warning letters to tobacco companies selling products without premarket authorization.

On Jan. 15, the FDA sent warning letters to 10 firms that manufacture and operate websites selling e-liquids.

The companies that received letters are Little House Vapes LLC; Castle Rock Vapor LLC; Dropsmoke Inc.; Perfection Vapes Inc.; CLS Trading LLC doing business as Vape Dudes HQ; Session Supply Co.; Coastal E-Liquid Laboratory/GC Vapors LLC; Dr. Crimmy LLC dba Dr. Crimmy’s V-Liquid; CMM Capital LLC dba ETX Vape; and E-Cig Barn LLC, according to the administration.

Collectively, they have listed more than 100,000 products with the FDA.

On Jan. 29, the FDA sent warning letters to nine manufacturers that sell unauthorized ENDS.

Manufacturers that received warning letters were The Mad Alchemist LLC, Austin Vapor, BloVape, Bombay Vapor LLC, Chief Vapor, American Legends E-Liquid LLLP, Average Joes Juice LLC, Cloud Chasers Apothecary LLC and Carolina Vapor Mill LLC, doing business as Carolina Vapor Mill.

Collectively the companies have a total of more than 100,000 products with the FDA.

On Feb. 12, the FDA issued warning letters to 11 firms that manufacture and sell unauthorized e-liquids.

The firms that received warning letters are Jojo's Smokeless World Inc. doing business as Mod Shield; Sugar Vapor Company; DC Vapor Inc.; Take Off Corp; The Vapor Spot LLC; Premium Vapor Technologies LLC; Vaping Xtreme LLC; Vapes Gone Wild Juice LLC; Vapeoholic LLC; Vaporescence LLC doing business as Vape King USA; and Elemental Vapor Bar LLC.

Collectively the companies listed a combined total of more than 150,000 products with the FDA.

On Feb. 26, the FDA issued warning letters to 18 firms that manufacture and sell unauthorized e-liquids.

Firms that received warning letters were Square Vape Labs Inc.; The Vapor Emporium LLC; Tally Ho Vapor Tonic LLC; The Vape Corner Inc.; Dripco. LLC doing business as Dripco Vape Co.; VaporIce Inc; Vapor Maven E-Juice LLC; Vapor City Plus LLC; Vapor Invasion LLC; Vaporatory LLC; Chuckin’ Clouds Vape Shop Inc.; Black Dog Reserve LLC; California Vaping Co. Inc.; The Chubby Baker LLC; Smooth Vapes Inc.; Bulldog Vapor LLC; Adore eLiquid; and E-Cig Outlet LLC.

While the letters cited specific products as examples, collectively the companies have a total of more than 234,000 products with the FDA, the agency said. 

On March 12, the FDA issued warning letters to 13 firms that manufacture and sell unauthorized e-liquids.

The companies receiving warning letters were: VapinUSA-WI LLC doing business as VapinUSA; Vapor Springs LLC; Vapor Cigs LLC; Vegas Vapor Emporium LLC; Vape 911; The Philosopher's Stone LLC; The Clean Vape; Tooters Vape Shop; Cloudchasor LLC; Boardwalk Elixir LLC; Dieselbycg-Hometown Vape Lounge; Blue Lab Vapors LLC; and Revolution Vapor LLC.

Collectively, the companies have listed more than 75,000 products with the FDA, the agency said.

In April, the FDA issued 24 warning letters to firms that manufacture and sell unauthorized e-liquids. Each of the warning letters cited specific tobacco products that lack premarket authorization, but collectively these firms have listed a combined total of more than 154,000 products with the FDA.

Since January, the FDA has issued 103 warning letters to firms selling or distributing more than 904,000 unauthorized electronic nicotine delivery systems (ENDS) that did not submit PMTAs by the Sept. 9 deadline.

A full list of warning letters and companies that received them can be found at on the FDA’s website.  

The FDA issued 19 warning letters in May to firms that manufacture and sell unauthorized e-liquids. The FDA advised these companies that selling products that lack premarket authorization is illegal and prevents the products from being sold or distributed in the United States.

These companies did not submit a premarket tobacco product application (PMTA) by the Sept. 9, 2020, deadline. The firms warned in May have a combined total of more than 378,000 tobacco products listed with the FDA.

Since January, the FDA has issued 122 similar warning letters. A full list can be found on the FDA’s website.

The FDA issued nine warning letters in June to firms that manufacture and sell unauthorized e-liquids. Because the products do not have premarket authorization, it is illegal to sell or distribute them in the United States. Collectively, the firms have listed a total of nearly 200,000 products with the FDA.

So far this year, the FDA issued a total of 131 warning letters to firms illegally selling or distributing unauthorized ENDS products, the agency said.