Court allows firm to continue e-cig sales after ‘inadequate’ FDA denial order

The US Court of Appeals for the Fifth Circuit concluded that the Food and Drug Administration (FDA) “inadequately addressed or explained” a premarket tobacco product application (PMTA) that resulted in a marketing denial order (MDO), and decided to temporary allow a company from Texas to keep its flavoured products on the market until it resolves the case.

In a 20-page opinion, the court states that the federal agency did not properly address the marketing plan from Triton Distribution to reduce the products’ appeal to youth – something that was “a critical factor” for the FDA, according to the judges – and the evidence on the potential benefits of flavoured e-cigarettes.

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

David Palacios Rubio

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