‘MDO Rescission Not Necessarily a Precedent’

Even as consumer activists, vapor manufacturers and tobacco harm reduction advocates have taken heart from the U.S. Food and Drug Administration’s decision to rescind the marketing denial order (MDO) it had issued to Turning Point Brands (TPB), it is unclear whether that move sets a precedent, writes Alex Norcia in Filter.

The problem, according to Norcia, is that TPB’s premarket tobacco product application is not publicly available, so that other manufacturers are left to guess how the company managed to get the agency to backtrack.

At least 27 manufacturers and distributors, including Avail Vapor, Triton Distribution, Gripum LLC and My Vape Order (MVO), have filed petitions asking federal circuit courts to review their MDOs. MVO and Gripum has had their motions to stay the MDO granted by courts. Avail is rumored to have had its MDO rescinded. 

In his article, Norcia details the travails of MVO, which on Oct. 20 petitioned a federal court of appeals for “an emergency motion for a stay pending a review and for expedited consideration” on the company’s vapor products that have been removed from the market.

Lawyers for MVO revealed that their client had shared studies and data with TPB and other companies, essentially arguing that the company did not receive the same treatment as TPB, even though the applications contain some of the same information.