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… Read more »
Archives: Seminars
State and Local Governments: The Original Tobacco “Regulators” are Still in the Game
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… Read more »
The Vape Shop Experience
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… Read more »
Why is FDA tobacco regulation such a mess?
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.
An Applicants Perspective -PMTA
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… Read more »
EXTENDED SESSION: FDA – Regulatory Update
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… Read more »
Lunch
Panel Discussion & Q&A: Health Communication and Kids
Are we getting the right information to the right kids in the right way? Has the focus on nicotine over the harms of combustibles made accurate health communication harder Does current health communication reflect the real world and lived experiences of kids Does THR compliment or contradict the 3 pillars of the CDC tobacco control… Read more »
A Child and Adolescent Psychiatrist’s Perspective
Dr. Gray will offer insights based on clinical practice and research focused on understanding and addressing adolescent substance use. Amid a critical developmental window, adolescents are particularly prone to substance initiation and progression to problematic use. Clinical messaging to minimize substance-related harms in this age group presents several challenges. Overly simplistic messaging may be perceived… Read more »
Tobacco Harm Reduction: Sorting Truth
We live in a saturated information environment (infosphere) that has both positive and negative consequences for parsing facts from fiction. This is also true for scientific endeavors, including so-called tobacco regulatory science and tobacco harm reduction science. Unfortunately, the tobacco science infosphere distorts and obscures scientific realities, and it is not clear that conventional scientific… Read more »
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