FDA Issues Additional 23 PMTA Marketing Denial Orders to ENDS Companies




On August 26th, 2021, the FDA published a press release announcing they had issued marketing denial orders to JD Nova Group LLC, Great American Vapes, and Vapor Salon for their applications for about 55,000 flavored ENDS products. Since that original release, the FDA has quietly released an additional 23 marketing denial orders to:

  • Big Time Vapes
  • SS Vape Brands Inc. Dba Monster Vape Labs
  • J-Vapor LLC dba North Shore Vapor
  • Custom Vapors
  • The Vaping Tiger
  • Gothic Vapor
  • TrendSetters E-liquid LLC
  • SWT Global Supply
  • Diamond Vapor
  • American Vapor Group
  • MV Enterprises
  • Planet of the Vapes
  • CITTG dba Orgnx E Liquids
  • Vapors of Ohio Inc. dba Nostalgic Vapes
  • Buckshot Vapors Inc.
  • Royalty Premium E Juice
  • Imperial Vapors
  • Midwest Vape Supply
  • Dominant Vapor
  • Mountain Vaporz
  • Sir Vapes -A-Lot
  • Loveli Design LLC dba Alice in Vapeland
  • Nicquid

At this time, the specific product names and number of products included in each of these marketing denial orders is not available. Per the FDA Marketing Orders webpage, “FDA understands that the public may be interested in the specific names of the currently marketed products subject to the negative decisions. However, before releasing this information, FDA needs to ensure the Agency is not releasing the applicant’s commercial confidential information. Given the large number of products involved, sharing this information requires additional time and resources. Accordingly, FDA is actively exploring options related to this issue”

For a full list of current PMTA submissions, warning letters, marketing denial orders, and market authorizations – click here.