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So, if I'm understanding this correctly, they're more focused on the semantics of the term "harm reduction" than effectively dealing with the endless number of vape shops popping up all over the country that have an economic incentive to sell illegal products? If so, this is crazy.

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Correct. And mind you, there is strong precedent to embrace harm reduction. They have recognized the continuum of risk in the past and have conceded that, categorically, vapes are lower risk than legacy combustible products. Other countries have reduced total tobacco-related health harm by embracing next-gen products. Yet, in action, the FDA appears very interested in roadblocking progress in the US, and due to poor regulation processes, namely authorization of new products and enforcement, has led to the booming illicit market. The rest of 2024 will be very interesting, as the FDA's had may be forced by the courts, and they will likely reach determinations on the remaining backlog of PMTAs submitted by major manufacturers.

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To add, comprehensive analysis shows that vapes have a higher success rate in helping adult smokers looking to quit actually quit compared to cold turkey or nicotine patches/gum. Non-tobacco flavors, such as the 'youth appealing' ones harped on, are also appealing to adults. If adults choose to smoke, that is their right. If they would like a better, more effective off ramp, it is baffling that the FDA appears ardent in stopping them.

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I too watched most of the hearing. I found most of Califf's answers, especially regarding tobacco to be unsatisfactory and mealy-mouthed. No hint of any advanced thought process or cost-benefit analysis when it comes to the public at large. No remorse over the fact that law-abiding businesses have effectively been crowded out by foreign businesses unconcerned with complying with this country's rules and regulations., which in the end is less safe than it otherwise could be.

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Well said, Doug. Also peculiar, which I didn't touch on in the piece (though should have):

1. For all of the concern surrounding underage usage, there was little mention of increasing penalties to retailers found in non-compliance, nor was there any discussion on the usage of more robust age verification technology at point of sale.

2. None of politicians on the panel who had previously supported the White House's menthol ban brought it up during the hearing. No doubt they were told to keep quiet or they risk losing the support of affected voters during the election.

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On the positive side, many questions and comments from our Representatives (Comer, Fallon, Foxx, Fry) are actually pretty sensible. One key theme seems to have been how the FDA is letting illegal Chinese imports proliferate whilst denying or delaying PMTAs.

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This is true. Some excellent points were made - though, unfortunately, were often conflated with false talking points that distract from the core issues at hand.

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For the benefit of doubt, it could be the reality that FDA lacks legal enforcement resources, as it is not getting much user fees from the vaping industry, while civil money penalties collected from non-compliant retailers was not enough. Still, it occurs to me that Robert Califf is suggesting FDA and CTP shouldn't be held accountable for proliferation of illicit disposable vapes in the U.S. It seems universal among big corporates and government authorities that senior leadership care about job security far more than getting things done.

With more PMTA registry bills getting passed in various states, perhaps state-level legal enforcement agencies may be mobilised to act upon illicit disposable vapes. As the bills start taking effect later this year, I am intrigued to find out how it affects each marketplace. And more importantly, for merchants who anticipate such regulation, how they adapt to it. They still need to make a living one way or another.

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Hi Devin,

My name is Ross Thompson, and I am a former investment banker/hedge fund investor. I now manage my own capital. I am in the process of investing in one or more tobacco companies. I think your analysis of the tobacco industry is the best I have read anywhere! I would love to contact you directly to discuss the industry further. If you are interested in contacting me my email is rossthompson@live.com.au

To provide a little more background; many years ago, I wrote a blog on investing. It is somewhat dated now but it does outline the core principles of my investment methodology. If you are interested in the blog, please see:

https://rthompson5.wordpress.com/category/my-quantitative-valuation-model-2/

Thank you.

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this 'war' long ceased to be non-conflicted ever since multiple levels of american gov are income partners with their corporate frenemies.

worried about cannabis since their is no rec benefit? no problem, use the same solution society accepts for alcohol and nicotine !

Califf is simply saying he wants congress to make the call...such as the hypocrite Nancy Mace that is grilling him.

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