Today, October 7th, 2021, the FDA released 28 warning letters to Electronic Nicotine Delivery System (ENDS) companies for unlawfully continuing to market products that had previously received Marketing Denial Orders (MDO’s). While the FDA has issued warning letters to over 200 ENDS companies over the past year, these are the first warning letters to be issued due to MDO violations.

As stated in the warning letters, “all new tobacco products on the market without the statutorily required premarket authorization are marketed unlawfully and are subject to enforcement action at FDA’s discretion. Products for which no application is pending, including, for example, those with a Marketing Denial Order and those for which no application was submitted, are among [FDA’s] highest enforcement priorities.” Companies that continue to market their products unlawfully could face regulatory action, “including, but not limited to, civil money penalties, seizure, and/or injunction”.

Companies to recieve letters are:

9 South Vapes – Issued 10/7/2021
Illumivaption Inc. d/b/a Nashville Vapor – Issued 10/7/2021
Planet of the Vapes, LLC – Issued 10/7/2021
Custom Vapors LLC – Issued 10/7/2021
Vapor Lab – Issued 10/7/2021
Vapor Lab – Cleburne – Issued 10/7/2021
Pink Spot Vapors, Inc – Issued 10/7/2021
JMJL Global LLC – Issued 10/7/2021
Gothic Vapor LLC – Issued 10/7/2021
Great American Vapes Shreveport – Issued 10/7/2021
Sabor Vapors LLC – Issued 10/7/2021
Sir Vapes-A-Lot LLC – Issued 10/7/2021
Atomic Vapor – Issued 10/7/2021
Dominant Vapor, LLC – Issued 10/7/2021
BAM Group LLC d/b/a VapEscape – Issued 10/7/2021
Sadboy LLC – Issued 10/7/2021
JOCOR Enterprises LLC d/b/a VOLCANO eCigs – Issued 10/7/2021
The Vape-It Store – Issued 10/7/2021
Great American Vapes Bossier City – Issued 10/7/2021
J-Vapor LLC dba North Shore Vapor – Issued 10/7/2021
The Plume Room LLC – Issued 10/7/2021
Hotspot Vapes – Issued 10/7/2021
ATL Vaping Inc. – Issued 10/7/2021
The Vaping Tiger, LLC – Issued 10/7/2021
Perfect Vape LLC – Issued 10/7/2021
Local Legends Distribution LLC – Issued 10/7/2021
Imperial Vapors LLC – Issued 10/7/2021
Liquid Nics LLC – Issued 10/7/2021

To see and the full list of PMTA related warning letters, click here: FDA PMTA WARNING LETTERS LIST