Thinking 'bout THR News & Views
January 21-24, 2025
Fear
All policies have intended positive outcomes. And I’d argue that all policies have unintended consequences.
I’m curious: How many of you have read the proposed VLNC rule? I have not, and I hoped to see summaries giving different perspectives. So, my reactions to the rule are not based on my knowledge of its contents. Instead, they come from research I’ve done and things I’ve read, and they are based mainly on how I feel about VLNCs.
I couldn’t pass up the opportunity to take inspiration for today’s commentary from the Dune movies and a series of books.
Fear is a powerful emotion. It can motivate us to make changes or freeze us from doing so. It can also cloud our thinking and prevent us from considering other perspectives.
Sometimes, being in the nicotine space can feel like wandering aimlessly in a desert. Each step is a painful struggle, and it is hard to see if we’re getting any closer to an oasis. What defines an oasis will depend on our individual opinions of what the conclusion of The Great Nicotine Debate should look like.
In Dune, the Fremen’s eyes turn blue from Melange, a drug often called “spice.” Spice can affect one's length of life, increase awareness, heighten abilities, and be used to make other products. Spice leads to wealth and power. Does any of that remind you of tobacco and nicotine?
Positive
FDA’s intended outcome is to reduce or eliminate the death and disease caused by combustible tobacco.
The press conference, news release, and proposed rule clearly mention switching to non-combustible products, a strong endorsement from the FDA and CTP leadership at the time of the rule announcement.
This will prevent some people who experiment with smoking from becoming addicted to smoking.
Studies show this will help some people stop smoking.
What I fear
This is the first step in the more significant push for a nicotine-free society. Nicotine will spiral further and further into the war on drugs mode. As we watched reactions to the proposed reduced nicotine rule and announcement of marketing orders for ZYN, we saw vast support for the first, but some of those same groups and individuals were dismayed by the second. “Anti-tobacco groups applauded the FDA's proposed nicotine limit but also said the nicotine limit doesn't go far enough.”
Due to misinformation/misperceptions about nicotine, alternative products, and the industry, the intended transition away from smoking won’t happen to the degree hoped. This reaction from Cernovich indicates how rampant this issue is. They said, “Vaping causes popcorn lung. This FDA rule to cut nicotine levels is cigarettes is almost certainly due to bribery from th[e] vape industry.” Another example is this tweet from the National Center for Health Research, which, to me, implies that if vapes and pouches were included, more lives would be saved. It says, “BREAKING NEWS: The FDA announced a proposed rule to limit nicotine levels in tobacco products like cigarettes and cigars. This change could help save lives, but it does not apply to addictive e-cigarettes or nicotine pouches.”
That some people will believe that VLNCs are safer and take up smoking or continue to smoke for enjoyment, thinking they’ve eliminated the harms of smoking.
And to prove I’m stuck on the Slippery Slope bandwagon - What’s next for those on a mission to determine what’s in the best interest of individuals? I’ll spare you a further editorial on that…
I don’t think we can ignore the potential for illicit markets. We only have to look at the wave of disposable vapes hitting the US and the fire bombings in Australia to know that the possibility is real.
Cruel to people who are addicted. This will be countered by those suggesting medication, NRT, or THR. If those three options are the answer, why do so many people still smoke? Is it compassionate to the people we want to help to one day force them to stop using what they are addicted to without having more alternatives to smoking cessation available to them? Options that are legal, accessible, and either free or very affordable.
Resistance to this rule and other messaging from the FDA because some people don’t think the government has the right to try to force them to do something with their bodies that people see as something that should be their choice.
What I hope will happen
The FDA will see that the medically authorized options are insufficient and will not only authorize more products via the CTP but also make a massive effort to better educate the public on the risk continuum.
Changes in the regulatory pathway for reduced-risk products. How hard is this? The liquids contain PG, VG, flavoring, and nicotine. Why is so much expensive research expected for each SKU? Why can’t we do something like the UK and post-market surveillance?
A more balanced view on APPH with an equal focus on youth initiation and adult use of nicotine. That APPH must be clearly defined.
Foster more dialogue among opposing views on this and all use of nicotine
There is more acceptance that some people want to use nicotine, just like they want to ingest caffeine, drink alcohol, or use cannabis.
We won’t forget that from farmers on up the supply chain, many families are dependent on income from the tobacco industry. I hope we work together to find them new ways to generate an income and continue to support their families.
Fear IS a mind-killer. The Litany Against Fear Is Good Psychological Advice. The next step is to learn more about the proposed rule. Talk to each other about what we believe is “good” and “bad” about it, and then make up our minds based on facts, not emotions. Once we’re to that point, it’s important to submit our comments to the FDA by the comment deadline.
Submit a comment: Tobacco Product Standard for Nicotine Yield of Cigarettes and Certain Other Combusted Tobacco Products. The submission deadline is September 15, 2025. Information about the rule is here.
Until next time…
PS: For more thoughts on the future of the nicotine space and the policies we need to examine, please read Clive Bates's Tobacco Endgame.
The weekly PubMed reviews by Clive Bates and Arielle Selya.
An e-mail from Dr. Brian King.
Kathy Crosby for encouraging balance.
Opportunities to use my voice to represent people who don’t have one.
My wonderful friends who are the world’s best support team.
Reviving the Regulatory Flexibility Act. “Now for the current stock of regulations: To reduce the problem, the Regulatory Flexibility Act directs federal agencies to identify and reassess existing rules that have “a significant economic impact upon a substantial number of small entities.”
The legal requirement is simple: Ten years after rules are finalized, agencies have to determine whether they are having such an impact, and must decide whether they should be amended or rescinded.”
Historical and political context for Philip Morris International’s continuing medical education courses on harm reduction: Implications for current product regulation. “Implications for Current FDA Activities. The result is that the FDA has taken the position that if a new product delivers less of some toxicants in “traditional” tobacco products — cigarettes and smokeless tobacco — it is a candidate for a “reduced exposure” claim and the presumption of reduced risk. The problem with this view is that it ignores the fact that that “new” products deliver smoke different toxicants at higher levels than “traditional” products. FDA’s failure to recognize this fact is why their proposal to lower allowed nicotine is limited to cigarettes and other older products and excludes e-cigarettes and other “reduced exposure” products. The same logic forms the foundation for FDA’s recent decision to authorize 20 flavors of Philip Morris’ ZYN smokeless product. (In doing so, FDA claims that youth use is a “low” 1.8% in 2024, while ignoring the fact that this is almost twice the 1.1% youth prevalence in 2022.)
FDA needs to move beyond the narrow thinking about what toxicants are important by updating its list of Harmful and Potentially Harmful Compounds (HPHC) that form the basis for its current decision making. Doing so would lead to a more up-to-date assessment of comparative risks of these products and likely lead to fewer being authorized.”
Jeffrey Weiss. “…In the meantime, we will see whether the Zyn authorizations represent the beginning of a determined effort by FDA to enable a robust non-combustible marketplace prior to finalization of a VLNC rule. We will know that FDA is serious when it starts to issue more marketing granted orders, including for flavored vaping products.”
Global Action to End Smoking. “FREE course alert:…Tobacco & Nicotine: Public Health, Science, Policy, and Law, available online.”
Sharon Cox - The SRNT-Europe Conference Debate is back! Submit your ideas for debate topics.
Jeffrey Weiss. “It would be helpful to Campaign’s own credibility if it would acknowledge its past mistakes and the effect they have had on delaying effective FDA oversight of a functioning non-combustibles marketplace – and consider a return to its original strong support for the integrity of the FDA review process.”
ASH Webinar: Supporting Hidden Populations with Smoking Cessation. “The webinar features analysis of population data to better understand how many people might be missing from our understanding of smoking prevalence. Following this it reviews two projects developed to engage and support homeless people in tobacco harm reduction.”
USA withdrawing from the WHO and it's consequences on vaping and THR | Ep. 73 with Clive Bates. “Joining us is Clive Bates, a renowned expert in public health and harm reduction. Clive has had a remarkable career, including roles as Director of Action on Smoking and Health (UK), working in Prime Minister Blair’s Strategy Unit, and serving the United Nations in Sudan. He now leads Counterfactual, a consultancy focused on pragmatic solutions for sustainability and public health.”
American Vapor Manufacturers. “An new installment of Shaping Vaping -- Forecast for 2025 and beyond. Featuring the perspicacious Joe Gitchell and our own Jim McCarthy.”
Guess who's back, back again? Lindsey back, tell a friend. Lindsey chats with fellow advocates about all things vaping. FDA, policy, etc.
Ep: 9 - It's Time To Embrace Harm Reduction With Dr Colin Mendelson. “This episode features Dr. Mendelsohn discussing vaping’s role in harm reduction, societal misconceptions, the stigma smokers face, and the impact of Australia’s restrictive vaping policies. A must-listen on the realities of tobacco harm reduction.”
Sarah Jackson. An informative thread about a study looking at dual-use.
Arielle Selya. A thread about a study on biomarkers of exposure.
Being me means I have a big heart. I take in most information on an emotional level, and sometimes, it is tough for me to regulate my emotions. I can feel strong emotions even about people I don’t know.
It is painful for me to watch the news and see the many ways people suffer. It is hard to see misinformation on the news and know it will only result in more suffering. The news can make me cry.
I try to pay attention to the misinformation and misperceptions in the nicotine space because lives depend on us correcting it. Today is one of the days where I must stay away from this topic because of how it affects my mental health. Even typing this makes me think of all the people who will die from smoking, and the tears have begun to flow.
Community Notes. “Starting today, you can add a source when you request a Community Note. This makes it easier for note writers to understand what context might be helpful on a post, so it can accelerate the process of a note appearing. Initially you can add another X post as a source. We know people sometimes see a reply or quote with useful added context, and then request a note. This makes it easy to send that info to prospective note writers.”
The Making of Community Notes. “A third (and final?) comment on the Community Notes system recently picked up by Meta, following a great article about the original team which designed it.” (Part One and Part Two)
“Setting the record straight” About WHO Misinformation. “That would be all very well if the WHO had not been caught by X’s Community Notes system lying the big one on at least sixteen different occasions about vaping.”
Update - Tweet(s) now displaying a community note:
Wael Awad. “Finally, published…”
World Health Organization (WHO) Western Pacific. “Have you been thinking about trying vapes or e-cigarettes? Think again!…”
Smoking cessation trend: U.S survey reveals modified risk products among the most popular methods to quit. “To better understand the scope and significance of the data collected, the CoEHAR team reports here the summary of the results of the study conducted by dr. Floe Foxon, Pinney Associates, expert in tobacco harm reduction policies.”
Skepticism Over FDA Bid to Mandate Very Low-Nicotine Cigarettes. “Abrams, a professor of social and behavioral sciences at the NYU College of Global Public Health, has found the misconception that reducing nicotine reduces the risk of harms like cancer to be widespread. A 2018 study he co-authored, “Public misperception that very low nicotine cigarettes are less carcinogenic,” showed that almost half of people who smoke held that belief.”
Ditching, Depression, and Doing the Right Thing. “I was grateful to see the Truth Initiative move the needle closer to the middle ground. That is progress and an improvement over the campaigns they have released in the past few years. I hope we see more of that kind of communication from the Truth Initiative in the future. They showed leadership that can help society make real strides in improving public health.”
Public submission from the Considerate Pouchers to the Finnish Government. “The Finnish Government has introduced a draft amendment to the Tobacco Act that includes strict regulations for nicotine pouches. The proposal seeks to ban most flavors, impose stringent limits on nicotine concentrations, mandate plain packaging with health warnings, and introduce new restrictions on their sale and use. The Considerate Pouchers group is actively engaging in the consultation process, offering evidence-based arguments to oppose these measures.”
One in 20 adults in England both smoke and vape. “Lead author Dr Sarah Jackson (UCL Institute of Epidemiology & Health Care) said: “Dual use of vapes and cigarettes is often a transitional state as people seek to quit smoking or reduce their smoking. Therefore, it is not necessarily bad for people’s health over the long term, if it helps people move away from smoking.
“In our study, we found a shift in the behaviour of dual users away from more frequent smoking to more frequent vaping. This may be good news, as dual users can reduce the harm they are exposed to by vaping more and smoking less.
“However, it is important that people quit smoking completely to get the full health benefits.”
What’s in ZYN, the FDA-Authorized Nicotine Pouch? Is It Harmful? “Scientific American spoke further with Ahluwalia and Hrywna about how nicotine pouches work, what scientists know about their effectiveness as a tobacco alternative and what their potential health concerns are.”
Vapes prohibition in Mexico: the full story. “Mexico is the only country in this world where the prohibition of vapes and all Electronic Nicotine Delivery Systems (ENDS) is enshrined (since December 2024) as an article in the constitution.”
More news: Vapers Digest January 22
Tobacco on the way to becoming ‘popular’ in the UK? “This trivialization of smoking is also developing through influencers and social networks, for example an Instagram account exclusively dedicated to broadcasting celebrities smoking, and followed by tens of thousands of people. Given the prescriptive potential of the culture and entertainment industry, such a return can be particularly dangerous, especially for younger generations. This return to glorifying representations of smoking is linked to the considerable decline in public funding for media campaigns to combat smoking. Indeed, between 2008/2009 and 2020/2021, this funding decreased by 95%, from 27.6 to 1.56 million euros.”
Three former FDA officials: Here’s what Trump and his nominees need to know. “But as they and the rest of the incoming team develop plans, we hope that they keep in mind certain key features of the agency that define it. These principles have created what is universally regarded as the leading science-based consumer protection agency in the world.
We have all served in senior positions at the FDA, and we believe we speak for current and former FDA employees in advocating for maintaining the defining features that make the FDA uniquely capable of and respected for protecting Americans from unsafe products.”
FDA Halts Plans to Ban Menthol Cigarettes, Flavored Cigars. “The fight(s) over the menthol cigarettes and flavored cigars bans is not over. Not only could the FDA revive the proposals at any time, the agency has been sued in a federal court in California over its inaction regarding menthol. One of the plaintiffs in that case was the plaintiff in a different lawsuit that likely was the catalyst for the proposals’ announcements in 2021. That litigation remains ongoing, the Department of Justice—which represents FDA in legal matters—has asked to have the case dismissed.” (See withdrawn notice here.)
Menthol vapes and forum shopping, FDA tobacco control comes before justices. “Although the dispute may seem like a technical one, the FDA contends that the stakes are high. If the lower court’s decision allowing RJR Vapor’s case to go forward stands, the FDA says, other manufacturers will also try to get around the restrictions that federal law imposes on where such challenges can be filed. More broadly, the FDA cautions, the 5th Circuit’s ruling could open the door to efforts by other plaintiffs to file their challenges to federal agency actions in courts that they believe will be friendly to them. That kind of forum-shopping, the FDA suggests, is “harmful to the Judiciary.”
Justices Unmoved By Fifth Circuit Forum Shopping Concern. “The statute at the heart of arguments on Tuesday limits where tobacco companies can challenge Food and Drug Administration denial of an application to sell their products. The US Court of Appeals for the Fifth Circuit is the only circuit to side with manufacturers doing so, leading to what Justice Department attorney Vivek Suri called “quite remarkable” forum shopping.”
Supreme Court likely to let vape company’s FDA challenge proceed. “During 72 minutes of oral arguments, almost all of the justices peppered Vivek Suri, the assistant to the U.S. solicitor general representing the FDA, with a barrage of questions. Ryan Watson, who argued on behalf of R.J. Reynolds Vapor Company and a group of retailers based in Texas and Mississippi, primarily fielded questions from just two justices, Justices Sonia Sotomayor and Ketanji Brown Jackson – a promising sign for his clients.”
Notes:
I create these newsletters as a personal project. They are not affiliated with any current or past employers or groups I do volunteer work with. I receive no financial compensation for my efforts to create these newsletters.
My blog, Skip's Corner, has an X/Twitter account. My personal accounts are on BlueSky, LinkedIn, and X (Twitter).