A ‘groundbreaking’ ruling as appeal court orders US FDA to reconsider PMTA denial

In a big win for the vaping industry, a federal appellate court has ordered the US Food and Drug Administration (FDA) to reconsider its denial of premarket tobacco product applications (PMTAs) for six companies.

The 2-1 opinion by the US Court of Appeals for the 11th Circuit says the FDA erred when it issued marketing denial orders (MDOs) to Bidi Vapor, Diamond Vapor, Johnny Copper, Vapor Unlimited, Union Street Brands and Pop Vapor without considering the companies’ plans to prevent children from accessing their products.

Judges William Pryor and Andrew Brasher agreed that the MDOs were “arbitrary and capricious” and sent the PMTAs back to the FDA for further review. Lawyers for Bidi hailed the remand as “groundbreaking” and indicated the company might have a better chance of success in the next review.

Read full article
I'm already a subscriber
Author default picture


This article was written by one of ECigIntelligence’s international correspondents. We currently employ more than 40 reporters around the world to cover individual vaping markets. For a full list, please see our Who We Are page.

Our Key Benefits

The global e-cigarette market is in an opaque regulatory environment that requires professionals to be on top of industry developments to make informed decisions and optimise their strategy.

ECigIntelligence provides organisations with leading market and regulatory data analysis to anticipate and understand market developments globally and the impact of regulatory changes to the business.

  • Stay informed of any legal and market change in the sector that impacts your organisation
  • Maximise resources by getting market and legal data analysis daily in one place
  • Make smart decisions by understanding how the regulatory and market landscape evolves
  • Anticipate risks in your decisions by monitoring regulatory changes that impact your organization