On October 16th, according to foreign news reports, Wages and White Lion Investments, the parent company of American e-cigarette company Triton Distribution, has been approved to suspend its marketing denial order (MDO) received from the U.S. Food and Drug Administration.

The panel of judges of the U.S. Court of Appeals for the Fifth Circuit issued an order on October 15. The order also approved a motion to expedite the appeal and an emergency ruling.

The approved motion means that the company can continue to sell its electronic nicotine delivery system (ENDS) products until the court makes a ruling on the company’s appeal against the FDA’s decision to reject its pre-market tobacco product application (PMTA).

After the FDA vetoed the company's PMTA, Triton Distribution filed a reservation motion, in which Triton stated that due to the FDA's actions, it has been irreparably damaged. If the reservation motion is not approved, its business will face imminent closure.

"The black rule of administrative law prevents agencies from retroactively changing legal requirements and doing so without considering reliance interests. The FDA failed to meet these requirements when it needed to support flavored electronic nicotine delivery nearly a year later. When the evidence required for the pre-market tobacco product application for the marketing order of the system product has been changed, the application for failure to meet these requirements is due.” The motion pointed out. "The FDA also ignored the relevant evidence found in Petitioner Wages and White Lion Investments, LLCd/b/a Triton Distributions PMTA and issued a Triton a marketing denial order."

At least six companies have filed lawsuits, questioning the agency's decision to let these companies remove their products from the market.

Last week, the FDA revoked the MDO issued to Turning Point Brands (TPB). While the FDA re-examined the company's pre-market tobacco product application (PMTA), the company will be allowed to continue to sell its e-cigarette products.

The US Food and Drug Administration admitted that it made a mistake in TPB's PMTA review, and TPB actually submitted the studies that the agency decided to require during the PMTA process, but for many years it has stated that these studies are not needed. "After further review of the administrative records, the FDA found that the relevant information had not been adequately evaluated." The FDA wrote in a letter to TPB. "Specifically, your application does include a randomized controlled trial comparing tobacco-flavored ENDS with flavored ENDS, as well as evaluating current smokers, current ENDS users, former tobacco users, and never users. It needs further review."

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