PMTA Update: Implications of Recent Decisions and Litigation скачать в хорошем качестве

PMTA Update: Implications of Recent Decisions and Litigation

Dr. Jessica Zdinak, Chief Research Officer, and fellow PANELISTS Clive Bates and Azim Chowdhury (Keller and Heckman LLP). CTP has yet to issue a Marketing Granted Order (MGO) for a flavored e-cigarette and has not issued any MGOs in well over a year, leading to speculation about de facto flavor and new product bans. This session will review CTP’s recent PMTA decisions and litigation challenging its Marketing Denial Orders (MDOs), then address current and future implications for the alternative nicotine product marketplace. TIMESTAMPS: 00:00 FDA extended authority to regulate all nicotine products, created deferred compliance policies, and denied non-tobacco flavored products and synthetic nicotine applications, leading to rigorous review process and denials for PMTA applications due to minor mistakes. 14:12 Many PMTA applications have been denied, leading to litigation and court challenges, with the FDA facing criticism for inconsistency and violation of rulemaking rights. 25:11 The lack of authorized flavors for vaping products has led to a flooded market of illegal and untraceable vape products, raising concerns about consumer safety and the need for rigorous scientific evidence in the PMTA process. 34:20 The FDA's strict requirements for research on flavored tobacco and nicotine products are hindering the US vaping market and leaving it open to Chinese companies. 45:08 The FDA's recent decisions and litigation related to PMTA have financial barriers to entry, a difficult efficacy standard for flavored products, and overlook the potential public health benefits of vaping for adults who quit smoking. 54:00 FDA's assumptions about flavor bans and vaping impact lack evidence, market surveillance is lacking, speaker suggests standards-based approach, FDA's handling of duties frustrating, legal challenges and split court opinions on scientific review requirements. 01:03:26 Companies are struggling to meet FDA requirements for product authorization, and legal efforts to change this may be complicated due to current political inclinations, with the solution likely lying with Congress creating a new framework. 01:08:51 Thank you all for coming, we have a reception downstairs for further conversations.