ENDS Litigation Update - October 2023

Scientists and regulatory professionals in the nicotine and tobacco space have been well-aware of the litigation environment in the industry for many years. Since September 2021 when FDA CTP began issuing marketing denial orders (MDOs) for many ENDS Premarket Tobacco Applications (PMTAs) a new litigation environment emerged. CTP's full list of MDOs here as of October 2023. (~278 manufacturers have received MDOs)

Over 40 ENDS manufacturers have filed appeals to their MDOs. These appeals are being litigated across the U.S. and are in various stages of review. In light of the current regulatory environment, it makes sense to build a regulatory strategy with a MDO as a possible outcome in addition to the considerations for a marketing granted order (MGO).

MGO considerations - Postmarket surveillance activities. This will be informed by the MGO letter as well as what was provided in the PMTA.

• Adverse-event tracking for the product

• Literature surveillance for relevant science

• Marketing and labeling plans

• Sales data reporting

• Underage use prevention plans

MDO considerations - Litigation support activities

• Compilation of technical project lead (TPL) memos for other PMTAs

• Writing of advocacy positions

• FOIA requests for reviewer memos at CTP