Thinking 'bout THR News & Views
November 22-25, 2024
Miscalculations…
In a must-read piece by Clive Bates, he said, “FDA also grossly underestimated the number of applications it would receive. It has had 26 million PMTA applications for vaping products, but its RIA [Regulatory Impact Analysis] estimate was for up to 4,050 e-liquids and 747 ENDS devices.”
Have you ever wondered why that number was so far off? Or has anyone wondered why the FDA didn’t expect more PMTAs after vape businesses went through the steps before needing to file a PMTA? All businesses had to register with the Center for Tobacco Products (CTP), submit their labels, and submit ingredient listings for each product.
Why wasn’t that a clue as to what would happen by the deadline to submit PMTAs? Why wasn’t that an indicator of what would happen when products made with synthetic nicotine came under the regulatory authority of the FDA?
Who filed all those PMTAs? And why did they file them?
There’s a story that hasn’t been told. It is the story of the “Poor Man’s PMTA.” It will take a few weeks to get it written up, but I’ll let you know when the group compiling the information has it ready.
No matter what you call them; “Big Tobacco” or “Legacy Tobacco Companies,” it is not their story. This is the story of good old-fashioned, roll up your sleeves, help your neighbor, American grit kind of story.
A classic David and Goliath. And David is still swinging while holding their breath to see what happens on December 2nd.
Until next time….
PS: I’m working on a piece about nicotine pouches. What data is out there about them? Risk, use, PMTA status, media reactions, survey results, etc. Send me the goods, please!
Ernesto Fragoso (please read the thread) - “after nearly 7 years, i've made the difficult decision to close new start vapor company. wanted to share what happened & some thoughts on this journey”
American Vapor Manufacturers - “Breaking news. The Supreme Court has just put out notice that oral argument in FDA v. Triton will be delivered for the government by Curtis Gannon, Deputy Solicitor General.” (Thread)
Jeffrey Willett - “With major change often comes unexpected opportunities. I believe this is the case for tobacco control in the United States and outline four opportunities that seem aligned with the new administration's emphasis on chronic disease prevention and efficient government regulation…”
Jeffrey Weiss - “When it comes to FDA’s tobacco and nicotine policy, the most critical person has been the Director of the Center for Tobacco Products. This is a role that historically has been a civil service rather than political position - and thus immune from changes in administration. Mitch Zeller, for example, served from 2013 to 2022. There is strong reason to believe that this is poised to change...”
Jonathan Foulds - “If you have something negative to say about #ECIGS , you don't even have to publish your study in a peer-reviewed journal to make the headlines on CNN.”
Not Invented Here #4 - Smoking. “You would think that anti-smoking campaigners would be delighted to find something that gets millions of people to stop smoking and offers an alternative to those who otherwise would have started. But you would be wrong. Although some ‘public health’ professionals have embraced reduced-risk products, the response from the global tobacco control movement has been suspicious and hostile from the start.”
Canada-wide vape flavour ban: a community discussion. "“There are over 1.9 million adult Canadian vapers, and we want regulations that ensure the safety, efficiency and availability of vaping supplies... We’re not against regulations. We welcome it... but banning flavours is the wrong way to go.”
Cigarette Alternatives - “Several consumer products can act as safer alternatives to deadly cigarettes, but they are not being promoted effectively. In fact, more and more political action is making them less pleasant, more expensive, and more difficult to obtain. Health Canada needs to radically rethink its attitudes to safer nicotine products such as vape, heat-not-burn, snus and nicotine pouches. Millions of lives are at stake.”
More Studies Confirm That Vaping is Significantly Safer Than Smoking for Respiratory Health. “Ultimately, all experts agree that evaluating the relationship between vaping and respiratory health, must be done in the context of the role of vaping as a harm reduction tool for smokers, seeking to quit or reduce risks. For these individuals, switching to vaping is a scientifically supported strategy to mitigate the damage caused by combustible tobacco.”
Will Indonesia, a Key Tobacco Control Outlier, Keep Vaping Legal? “Indonesia’s government ultimately opted for regulation instead. But this has not stopped groups like the Southeast Asia Tobacco Control Alliance (SEATCA), a nonprofit funded by Bloomberg Philanthropies, from amplifying calls for prohibition and false claims that vapes are as harmful as cigarettes. Both SEACTA and another Bloomberg grantee, the Campaign for Tobacco-Free Kids, have helped cast doubt on media and public support for vaping in Indonesia.”
Vapes to be used in community pharmacy smoking cessation pilot. “Community pharmacies in Medway, Kent, are taking part in a smoking cessation pilot, using e-cigarettes as a quit aid, Community Pharmacy England (CPE) has announced. Seven pharmacies are providing the locally commissioned service, in which smoking cessation advisers will provide patients with a voucher for a starter kit and up to a four-week supply of vape liquid.”
OPINION: The Case for Vaping. “Broad generalizations about safety lead to broad regulation, broad regulation leads to wide loopholes, and these cycles of misinformation lead to you having no idea if vaping — or the particular vape you’re using — is safe. No, I don’t think that every 12-year-old in the Tri-State needs an Elf Bar, but it would be great if everyone who currently smokes cigarettes had an easy, safer alternative. However, thanks to the demonization of vapes, many think they don’t.”
Vaping ban issue to be discussed with Health Ministry, says Nga. “On Nov 19, Health Minister Datuk Seri Dzulkefly Ahmad said the government will continue to regulate vaping through the Control of Smoking Products for Public Health Act that came into force on Oct 1. He added that the government has no plans to ban vaping at the national level. However, he said the decision is ultimately up to the respective state governments. On Monday (Nov 18), it was reported that the Pahang Sultan suggested that the use of electronic cigarettes or vapes be completely banned.” (Malaysia)
Michael Siegel - The Rest of the Story - “After the start of the COVID-19 pandemic, I took an almost complete break from blogging about tobacco policy to concentrate on some other public health topics. Now that more than 4 years have passed, I decided to take a look at the websites of some of the major national health organizations to see whether they have started to accurately communicate the facts about vaping and smoking.”
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.
I believe that everyone deserves a seat at the table. If you’re interested in nicotine with a focus on THR, this newsletter is for you.
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