U.S. court revokes FDA e-cigarette marketing denial order, five companies are allowed to continue selling products

U.S. court revokes FDA e-cigarette marketing denial order, five companies are allowed to continue selling products

The U.S. Court of Appeals supported a lawsuit filed by five e-cigarette manufacturers, asking the FDA to reevaluate the marketing denial order (MDO) and retain their market access. The five manufacturers can now continue to sell their products until the agency conducts a new scientific review of their premarket tobacco product applications (PMTAs), or until the Supreme Court takes action.

 

According to Vaping 360, on July 31, a three-judge panel of the U.S. Court of Appeals for the Fifth Circuit cited its ruling in the Triton Distribution case as a precedent, approved the review request of the five e-cigarette manufacturers, and revoked the FDA's marketing denial order (MDO).

 

The court sent the case back to the FDA for further review.

 

The five manufacturers can now continue to sell their products until the agency conducts a new scientific review of their premarket tobacco product applications (PMTAs), or until the Supreme Court takes action.

 

The five companies are:

 

Cloud House, LLC

Paradigm Distribution

SWT Global Supply, Inc.

Vaporized, Inc.

SV Packaging, LLC

The court stated in its ruling: (1) FDA did not give e-cigarette manufacturers fair notice of the long-term research required for PMTAs; (2) FDA did not acknowledge or adequately explain its change in position; and (3) FDA ignored manufacturers' legitimate and serious reliance on pre-market denial order (MDO) guidance.

 

In January, the Fifth Circuit ruled 10-6 in favor of Triton Distribution (which appears in court documents by its legal name Wages and White Lion Investments) in its appeal of the FDA's market denial order (MDO).

 

Two months later, the FDA asked the Supreme Court to review the Fifth Circuit's ruling, and last month the Supreme Court agreed to hear the FDA's appeal.

 

The case could be decided next spring and could reshape the FDA's e-cigarette product regulatory practices.

 

The Fifth Circuit held that the case decided this week raises the same issues as Triton's case:

 

"The applicants in this case, which produce flavored e-cigarette liquids containing nicotine, spent considerable time and resources preparing their PMTAs in accordance with FDA guidance that stated they were not required to submit long-term clinical studies. Yet, FDA denied their PMTAs using the same jargon as it denied the Wages petitioners and thousands of other e-cigarette manufacturers. Therefore, for reasons fully explained by the full court in Wages, we hold that FDA's conduct in this case was also unlawful because it denied the applicants' PMTAs based on a lack of long-term clinical studies."

 

The five companies filed petitions with the Court in October 2021 challenging MDOs received in August and September of that year, which were part of earlier denials issued a year after the September 2020 PMTA submission deadline. The Court consolidated the five cases and granted all five petitioners stays in November 2021 pending review.

 

In its most recent PMTA review progress report, the FDA said it had issued MDOs for 46,000 e-cigarette products. Dozens of e-cigarette manufacturers have challenged the denial orders in federal court.