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Turning Point Brands (TPB) is challenging in court the Marketing Denial Order (MDO) issued by the US Food and Drug Administration (FDA) to its premarket tobacco product applications (PMTAs) as it considers the decision “arbitrary”.
The Kentucky-based company, owner of various e-liquid brands in the US, filed a more than 200-page emergency petition with the US Court of Appeals for the Sixth Circuit asking the court to immediately halt the FDA’s decision pending review of the full request.
The vaping manufacturer and distributor warned that it will lose $5m in annual revenue and $3m in annual profits if the FDA’s decision is allowed to stand by the judge. “This is a quintessential case for staying unlawful administrative action pending judicial review,” reads the petition.
It also highlights that “the North Star of administrative law is that agencies cannot induce regulated parties to rely on agency representations about regulatory requirements, then penalize them using unannounced, after-the-fact criteria,” the petition states. “But that is precisely what FDA did here,” it concludes.
The petition refers to the FDA’s earlier instruction that marketing authorisation didn’t require long-term studies but instead needed alternatives such as scientific-literature reviews and consumer-perception studies.
“FDA believes applicants have some flexibility in the types of scientific information they can submit in order to provide sufficient health risk information,” reads the FDA’s guidelines published in September 2019.
TPB is defended in the case by Washington-based law firm Williams & Connolly LLP.
‘Bait-and-switch’
The company claimed it “took FDA at its word” and spent two years and $12m on an 81,000-page application, only to receive what the petition describes as a “terse” denial order that requires it “to immediately withdraw 490 products from the market”.
In the MDO from 14th September, the FDA claimed that TBP failed in conducting “a randomized controlled trial and/or longitudinal cohort study” to show its specially flavoured products help adult smokers to quit.
According to the petition filed in the US Court of Appeals, those were the same exact studies the FDA previously said weren’t necessary, and the ones it rejected as unreliable are the ones it previously encouraged.
The petition calls that a “bait-and-switch” and says its forbidden under the 1946 Administrative Procedure Act (APA) governing the process by which federal agencies develop and issue regulations.
As the company awaits the court ruling, it’s already taking steps to comply with the FDA denial, including “dismantling components of its business and pulling thousands of products from shelves nationwide”.
Earlier this week, the FDA sent the first warning letters to 20 companies for “unlawfully continuing to market” vaping products that are subject to an MDO.
What This Means: This is the first major legal battle over the FDA’s decision to reject millions of PMTAs.
According to the petition, the FDA “has indicated its opposition” to the claim but is not objecting to expedited consideration. The court notified the federal agency on 4th October that it has until 12th October to respond, with an optional reply from TPB due on 14th October.
– Meghann Cuniff ECigIntelligence US legal correspondent
