2022 - Session 3 Seminars

FDA has taken action on millions of e-cigarette PMTAs over the past year.  I will provide any update on those actions and discuss some of the major issues that FDA encountered when evaluating these PMTAs.  I will also look forward to what the future holds for e-cigarette regulation in the United States.

Followed by Open floor Q&A

The preparation of a PMTA that will be sufficient to establish, to FDA’s satisfaction, that the marketing of a product is “appropriate for the protection of public health” requires careful consideration of multiple sources of FDA’s expectations and requirements for such a filing.  These include guidance’s, proposed rules, formal scientific advice, PMTA workshop presentations, and other sources.  I will discuss my perspective on the challenges and opportunities that characterized my participation, on behalf of an applicant, in this important and historic process.

This presentation will look at underlying flaws in the FDA's understanding of key regulatory issues such as youth vaping, e-liquid flavours and tobacco product risks, raising its vulnerability to unintended consequences. We will briefly consider how the agency could better serve the American public and public health.

In this session Marc Slis will describe how his independent vapor industry shop such has evolved and it's unique role within his community.  The session will explore how the regulatory environment has impacted his ability to operate and most importantly his ability to help current smokers move towards becoming smokefree.  The foundation of the services is recognizing that each potential client is a unique individual, determining their specific needs and unique circumstances as they relate to tobacco use and cessation.  Marc Slis was a smoker for 41 years, unable to quit he intimately knew the futility of trying to force a round peg into a square hole.  His method is to individually carve the best fitting hole for each client that walks in to his shop and treat them as a human being throughout the process.  No matter how long it takes. No lies. No Shame, judgement, penalties or exclusion.  There are no rules and no limits, only guidelines suggestions and encouragement.

Kathi Hoke will take us on a short tour down memory lane when there was no FDA Center for Tobacco Regulation yet over decades state and local governments and public health advocacy organizations methodically worked to reduce smoking and tobacco use and the related health harms. In the shadow of intense focus on what the FDA can and should do, what a comprehensive plan looks like, what the PMTA process should accomplish, state and local governments continue to innovate in tobacco regulation. In many areas of the country, adult tobacco use is in the single digits. In other areas, public health agencies are earnestly developing programs, policies, and laws to reduce health inequities cause by the tobacco industry’s targeting of Black communities, LGBTQ populations, and other marginalized people. What are the innovative approaches state and local governments are taking or considering? How does federal law or the CTP support this work and how do they get in the way? Kathi will address how the CTP could enhance its collaborations with state and local government and provide resources to support these laboratories of innovation.

• Has the lack of federal regulation led to a “wild west” for lawmakers and industry?
• “Big Tobacco” v Vape Stores –what are the regulatory implications for both, what significance will this have
• Will there be enough PMTA approved products to meet adult demand?
• Will the PMTA process create a 2-tier product category and a black market?
• Do people working in public health, Research and tobacco control know enough people who smoke?