FDA Changes Decision on 15 MDOs

Some orders for tobacco products were rescinded or remain under review
Vape pen
Photograph: Shutterstock

SILVER SPRING, Md. — The U.S. Food and Drug Administration issued a marketing denial order (MDO) and then changed its decision for 15 companies that submitted applications through the premarket tobacco product application (PMTA) process, according to the most recent list available on the FDA’s website.

If a new tobacco product submitted through the PMTA process does not meet a particular standard, the FDA will issue an MDO, which makes it illegal to market in the United States. However, according to the list, last updated Feb. 18, some of the MDOs issued have later been rescinded, partially rescinded, stayed or remain under further review from the FDA and, in some cases, appeals courts.

The list details the action for each company but doesn’t list the specific product it applies to or that is under consideration. Companies whose MDOs have been rescinded in some form or remain under review, according to the FDA’s list, include:

  • Avail Vapor LLC: FDA issued a stay
  • My Vape Order Inc.: FDA partially rescinded denial
  • Bidi Vapor: Court issued a stay
  • Diamond Vapor: Court issued a stay
  • Johnny Copper: Court issued a stay
  • Vapor Unlimited: Court issued a stay
  • Pop Vapor Co LLC: FDA partially rescinded denial
  • Al Khalifa Group LLC: FDA issued a stay
  • Gripum LLC: Court issued a stay
  • Fumizer LLC: FDA partially rescinded denial
  • ECS Global: FDA partially rescinded denial
  • Wages & White Lion Investments dba Triton Distribution
  • Vapetasia LLC: Court issued a stay
  • Humble Juice Co., LLC: MDO rescinded denial 
  • TPB International LLC: MDO rescinded denial 

The FDA has also granted marketing orders for PMTAs, but the grants are far fewer than the denials. The agency has said it is about 99% through timely submitted applications, but results from some major players in the vapor space like Juul and Vuse Alto remain in limbo.

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