The Australian government has launched secret talks on introducing a strict near-complete ban on vaping in the country but has hidden the new proposals from the public, according to media reports. The rules could force traveler’s to the country to have a doctor’s note for any vape brought to the country.
The Therapeutic Goods Administration – which oversees the approval of prescription drugs and medicines for the government – has revealed the secret plans in an official consultation paper.
It outlines four proposals including a widespread ban on all single-use vapes, fruit-flavored vapes, personal importation of vaping products and all vaping ads. Only therapeutic nicotine vapes on prescription, available through pharmacies, would be allowed under the reforms – and they will only be tobacco or mild mint-flavored.
Prescription vape liquid will also be banned from using any ingredients outside a limited list of medically-approved chemicals under the proposed legislation.
All travelers to Australia will need to bring a prescription for their vape or a letter from their doctor, and be limited in how much vape they can bring into the country. A consultation paper and feedback form is also hidden from public view and is not included in TGA’s list of other past and present consultation papers on its website.
The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) has launched new resources to help applicants navigate the agency’s premarket tobacco product application (PMTA) process.
Specifically, CTP is offering a new webpage with more in-depth information on how to complete the three required PMTA forms to submit and amend pending applications.
Over the last few years, CTP has received more than 26 million PMTAs and made determinations on 99% of those applications.
Based on this experience and communications with applicants, CTP has developed the new online resources, which includes easy-to-access tips to help applicants submit in the future.
“These new online resources are part of CTP’s ongoing efforts to enhance the center’s efficiency, effectiveness, and transparency in response to recommendations from an independent external evaluation led by the Reagan-Udall Foundation,” a release states.
Pastel Cartel, the manufacturer of Esco Bars vaping devices, has submitted a legal complaint to the U.S. Federal District Court in the Western District of Texas.
The dispute is in regards to a U.S. Food and Drug Administration decision to reject over one hundred documents that Pastel Cartel had included in their premarket tobacco product applications (PMTAs), according to court records.
In the lawsuit, Pastel Cartel accuses the FDA of acting negligently and carelessly by issuing refusing to accept (RTA) letters for the company’s PMTAs on technical grounds.
The company is seeking:
A preliminary injunction staying the RTA orders until the case is decided;
A judgment finding the RTAs violate the Administrative Procedure Act (APA) and the U.S. Constitution (the Due Process Clause of the Fifth Amendment);
A final judgment setting aside the RTA orders and remanding the company’s PMTAs back to the FDA for further review.
Earlier this year, Shenzen Innokin Technology Co. Ltd., the producer of Esco Bars products, and Breeze Smoke, LLC who import and distribute Breeze products also received warning letters for manufacturing, distributing, and/or importing unauthorized tobacco products in the United States, according to the FDA.
The Indonesian Parliament recently passed Health Law No. 17 of 2023, which categorizes e-cigarettes as addictive substances, according to 2Firsts.
Teguh Basuki A Wibowo, chairman of the Indonesian Electronic Nicotine Industry Alliance, stated that including e-cigarettes in the legal framework for solid and liquid tobacco products legalizes industry participants and allows smokers to find alternative products.
The law puts Indonesia on equal footing with countries like the Philippines and the U.K., which have similar legislative frameworks for e-cigarettes, he said.
Bangladesh is set to ban vapes and nicotine pouches, according to Filter.
The government has been considering a vape ban since 2019 when the U.S. e-cigarette or vaping product use-associated lung injury outbreak occurred—later determined to be caused by adulterated illicit products.
The health ministry has now drafted an amendment to Bangladesh’s Smoking and Using of Tobacco Products (Control) Act, which has been reviewed by the cabinet and must now be approved by parliament.
If the proposed ban is approved, anyone caught vaping, regardless of nicotine content, will be subject to a fine of BDT5,000 ($46). Sales, production, import, export, storage and transportation of vapes would also be banned, with penalties starting at a higher fine, three months’ incarceration or both. Larger scale activity or repeat offenses would face longer sentences.
The amendment would also ban flavors in tobacco products, increase the fine for smoking in public places and include further penalties for unlicensed tobacco sales.
Organizations like the Bangladesh Medical Association support the proposed ban, equating vaping with smoking cigarettes.
“A ban on vaping devices will have disastrous consequences for people trying to quit smoking cigarettes,” said Nafis Farhan, a member of Voice of Vapers Bangladesh. He attributed continued high smoking rates in the country to “limited availability of cessation tools, such as vapes.”
The proposed ban represents “a missed opportunity for harm reduction and a setback for public health,” according to Michael Landl, director of the World Vapers’ Alliance.
The U.S. Food and Drug Administration has posted a new webinar to help online retailers respond to warning letters from regulatory agency’s Center for Tobacco Products (CTP).
The webinar provides an overview of warning letters and outlines the process for responding to a warning letter, such as corrective action taken by the firm to address any violations and its plan for maintaining compliance, according to an FDA release.
In the webinar, you will learn about:
FDA’s internet and publication surveillance of tobacco products
Examples of violations cited in warning letters sent to online tobacco product retailers
Actions to take after receiving a warning letter
Regulators in the United States began cracking down on online retailers selling vaping products that are attractive to youth. The Food and Drug Administration last week issued warning letters to 16 (the agency reported 15, but lists 16) online retailers for selling and/or distributing unauthorized e-cigarette products packaged to look like cartoon characters, school supplies, toys, and drinks.
The U.S. Court of Appeals for the D.C. Circuit yesterday found that the Food & Drug Administration failed to conduct the proper analyses before rejecting some vaping product applications.
This is the second circuit court of appeals to accuse the FDA of a “surprise switcheroo” when reviewing vaping product applications.
Fontem, the company behind the Blu and myBlu vaping brands, argued that the FDA had not conducted the proper analysis prior to rejecting their applications. The D.C. Circuit Court agreed with Fontem in regards to their unflavored products, ruling that the FDA had “neglected to conduct the overall public health review specified by law.”
Judge Rao’s opinion for the court (joined by Judge Walker and Senior Judge Ginsburg), stated that with respect to Fontem’s unflavored products, the FDA also denied Fontem’s applications on the public health ground.
“While the FDA identified multiple ‘deficiencies,’ it failed to analyze the tradeoffs necessary to make a public health finding. Nor did the agency explain how the specific deficiencies relate to its overall conclusion that Fontem failed to demonstrate its unflavored products were appropriate for the protection of public health,” the opinion states. “The agency’s denial therefore failed to comport with the requirements of the Tobacco Control Act.”
In denying Fontem’s unflavored products, the FDA relies solely on the public health ground. The FDA could have promulgated regulations imposing consistent requirements on the composition and manufacturing of tobacco products, according to the order.
“Had the agency done so, Fontem’s failure to meet those standards would be an independent and sufficient ground for denying the applications, regardless of the overall public health consequences of Fontem’s products,” the order states. “But the agency has not exercised its regulatory authority. Because the FDA has chosen to proceed application by application under the public health ground, it must undertake the holistic inquiry required by the statute.”
Instead of making an overall assessment that Fontem had not shown its products were beneficial to the public, the agency identified five highly technical deficiencies, according to the order. But nothing in the denial order explains how the deficiencies relate to the overall public health consequences of Fontem’s unflavored products.
The FDA’s failure to correctly apply the public health inquiry to Fontem’s unflavored products led it to make another serious error, according to the order. In its initial deficiency letter, the FDA requested certain information from Fontem, thereby indicating such information would be sufficient for the agency to approve Fontem’s products.
“Cf. 21 U.S.C. § 387j(c)(3) (providing an application denial “be accompanied by a statement informing the applicant of the measures required to remove such application from deniable form”),” the order states. “But in several instances, the FDA changed its tune in the denial order, reproaching Fontem for failing to provide information the agency had never explicitly sought.
“Shifting the regulatory goalposts without explanation is arbitrary and capricious. By indicating in its deficiency letter that Fontem could resolve issues with its applications by providing specific information, the FDA represented such information would be sufficient to secure approval.”
FDA is extending the proposed rule’s comment period by an additional 30 days to allow people additional time to submit comments. Comments on the proposed rule will now be accepted through Oct. 6, 2023.
The proposed TPMP rule would place new requirements for tobacco product manufacturers regarding the manufacture, design, packing and storage of their products.
These proposed requirements would help protect public health by, among other things, minimizing or preventing contamination and limiting additional risks by ensuring product consistency.
Suriname has banned the sale of all vaping products. The small South American country has been named among eight countries that are adopting measures in line with the World Health Organization’s (WHO) Framework Convention on Tobacco Control (FCTC) to protect the health of their populations from novel tobacco products.
The Republic of Suriname, a country in northern South America, borders the Atlantic Ocean in the north, French Guiana in the east, Guyana in the west, and Brazil in the south.
The WHO said Friday that with the recent ban on the use and marketing of electronic cigarettes in Venezuela, currently, 21 countries in the Americas regulate electronic nicotine delivery systems (ENDS), such as e-cigarettes and vapes.
“The resolution that regulates new and emerging nicotine and tobacco products in Venezuela is an important step forward for the country and for the region,” said Anselm Hennis, director of Non-Communicable Diseases Mental Health at the Pan American Health Organization (PAHO/WHO).
“We hope that this measure motivates other countries to take action on these products, which are addictive, harmful and aggressively advertised towards the youngest,” he added.
The eight new countries to join the initiative are Argentina, Brazil, Mexico, Nicaragua, Panama, Suriname, Uruguay and Venezuela and PAHO said these countries prohibit their sale altogether, and the other 13 countries have partially or totally adopted one or more regulatory measures.
The PAHO report states that 14 countries in the Americas, including the Caribbean, lack any regulation of vaping products.
When it comes to advertising, vaping and alcohol have separate standards of regulation.
By George Gay
Here are a couple of newspaper quotes worth comparing:
“Marked with a label showing a cartoonish red beast [my emphasis] in shorts and high socks wielding some glasses, Chin Chin has become the wine of now, the Casillero del Diablo of Gen Z, relatively affordable, instantly recognizable, and it looks good on Instagram.”
“One of the recommendations was closing the loophole on free samples, but others included considering banning the online sale of vapes, banning cartoon characters [my emphasis] or images appealing to young people from vaping products ….”
The first quote is from a piece in the U.K. edition of The Guardian newspaper of May 8, “Chin Chin! The party drink putting fizz into summer”;the second is from a piece in The Guardian of May 31, “New laws for vaping mooted to deter sale [sic] to children.” The May 8 story was promotional; the May 31 story was denunciatory.
Yes, hypocrisy is alive and well. Apparently, according to The Guardian, cartoon characters on vaping products, never known to have killed anybody in the U.K. as far as I am aware, are beyond the pale, but a cartoon character on alcohol, the biggest risk factor for death, ill health and disability among people 15–49 years of age in the U.K., is just tickety-boo.
The Guardian has seemed lately to take every opportunity to issue dire warnings about unproven risks related to vaping, a habit that is helping many people to quit smoking, while it treats alcohol as a product worth promoting and drunkenness as just a bit of fun. On May 4, it ran a story under the headline “Solved: Why bubbles in champagne follow a straight line, unlike people who drink it.”
While I would admit there is something comical about a person staggering down the pavement under the influence of alcohol, seeing him step into the path of an oncoming vehicle is less so. And according to a National Institutes of Health study, “The most numerous group of road accident fatalities among pedestrians are men, with a particular emphasis on men under the influence of alcohol.”
It seems to me that The Guardian, a newspaper I have read daily for 40 years and that I generally admire, is lending its voice to the forces of those trying to ban vaping and generally undermine tobacco harm reduction in the U.K., something I find puzzling since the paper takes what I would describe as a generally liberal attitude to the use of recreational drugs.
Indeed, as I have indicated, it promotes alcohol. The Chin Chin story, cartoon character and all, took up about three-quarters of a right-hand page. The paper runs adverts for alcohol, and each week, it devotes a page of its half-page-format Feast magazine to the promotion of alcohol. On June 17, it included in its Saturday edition a 36-page supplement on Food and Drink, which probably should have read “Drink and Food,” partly because most of the front page was taken up with a picture of “this season’s hottest cocktail.”
Ironically, in a different section of the same paper, a book reviewer described how Drug Science, an organization set up by neuropsychopharmacologist professor David Nutt, had, in the past, published a table showing the relative risks of different drugs in which alcohol was rated by far the most dangerous.
It’s not that The Guardian doesn’t think about the ethics of what it does. In its June 16 edition, it announced a global ban on gambling advertising, arguing it was “unethical to take money from services that can lead to ‘addiction and financial ruin.’” The announcement, in my opinion, was nuanced and demonstrated that the paper’s position was not judgmental toward those who wanted to bet occasionally.
But vaping is not given a similarly fair hearing. The significant volume of negative vaping stories the paper carries and the way the stories are presented indicates to me a lack of objectivity over this issue. Here is one example taken from a story on June 6, “Disposable vapes should be banned to protect children, U.K. pediatricians say.” In this piece, the paper references Action on Smoking and Health (ASH) just once: “Action on Smoking and Health data also shows that experimental use of e-cigarettes among 11-to-17-year-olds is up 50 percent on [that of] last year.”
Credit: Beam Suntory
This quote is taken from the 2023 ASH-commissioned YouGov survey published online in May, “Experimental child vaping up significantly since 2022 but not current vaping.”1 It is based on the second bullet point of four that open the document, but the significant thing is that the story makes no reference to the first bullet point: “No significant change between 2022 and 2023 in the proportion of 11[-year-olds to] 17-year-olds currently vaping or smoking.”
There is no reference either to the statement made further down in the document: “However, fears that vaping is leading a whole generation to be addicted to nicotine are not justified by the evidence to date.”
What is happening here? I suspect that for some reason, The Guardian has picked up on the moral panic centered on “children” and “kids” that was whipped up in the U.S. and that proved successful in throwing doubt on whether it was appropriate to use vaping as a tool to quit smoking and decided to run with it.
I say this because what is striking is that there seems to be little interest at The Guardian in respect of the issue of tobacco smoking among young people, an activity that should be much higher up the agenda of concern. Why is this? Could it be that, as in the U.S., the vaping-and-children issue has risen to the top because it is the “children” of the financially better off who are vaping?
Let me be clear. I do not have a shred of evidence to support this speculation, but I think it is worth asking questions along these lines. Could it be that the offspring of financially impoverished people who tend not to have a public voice are still smoking tobacco while those of financially more secure parents who tend to be pushier have moved on to vaping?
If I am correct, nobody needs to be surprised because such a divide would be in line with what has become the natural order in the U.K., where the large and growing number of young people from disadvantaged backgrounds are to be found at the back of the queues when it comes to food, basic hygiene products, good health outcomes, clothing, education, recreational opportunities, employment prospects … well, you name it.
But, circling back to the question of alcohol, I don’t want to be unfair because The Guardian does occasionally run a negative piece on drinking. On May 24, for instance, it carried this story: “Government’s failures on alcohol have led to health crisis, say MPs.” Below are the first two paragraphs of that story, which was by Andrew Gregory, health editor:
“The government’s failure to tackle alcohol harm in England has caused a public health crisis affecting millions of people, according to a damning report by the public accounts committee published today,” the story stated.
“Problem drinking is fueling violent crime and costing the NHS [National Health Service] and wider society [GBP]25 billion a year, with deaths almost doubling in two decades, the report says. Ministers are accused of slashing funding for support services by hundreds of millions of pounds while breaking promises of action and ditching policies aimed at resolving the crisis.”
Two questions arise, I think. Why, when it is clearly aware of this stuff, does The Guardian promote alcohol and drinking and, indirectly, violent crime? And can The Guardian be surprised with what has been happening when the U.K. Parliament operates out of subsidized bars with attached debating chambers?
Another reason why I believe The Guardian’s coverage amounts to a campaign against vaping is that its stories drag in a lot of issues in support of its take on underage vaping that, while important, need to be addressed separately. The stories embrace such issues as illicit products, illegal sales and the environment, but no attempt is made to get to the root of these issues.
For instance, I would have thought it would have been worthwhile asking why the U.K. is seemingly awash with noncompliant vaping products. I would have thought it would have been worthwhile asking why retailers can apparently sell vaping products to underaged customers with near impunity. And I would have thought it would have been worthwhile asking whether underage people are the victims, the villains or both in respect of the environmental harms being caused by carelessly discarded vaping devices, especially “single-use” devices.
But even I found that such issues took a back seat when, on June 14, The Guardian’s coverage of vaping took an even worse turn. On that day, the “children”-and-vaping issue was relegated to a double-page spread in G2, which styles itself as the Life and Arts section of the paper. That’s a bit of a push. Most serious reviews seem to be presented in the news section of the main paper.
G2 is more about entertainment. There’s the television guide, some often light-hearted columns and a regular turnaround of pieces on how to sleep better, how to improve your sex life, how to eat more-nutritional food, how to understand your companion animal … oh yes, and, of course, there are the interviews with celebrities who have active agents and a book, film or album coming out and that always start with Joe Bloggs talking to Eoj Sgolb about … (insert three words from the list of drugs, loss, love, sex, drink, rehab …).
OK, I’m sure you know the sort of stuff. Harmless, perhaps, but G2 is not the sort of vehicle, I would have thought, for a discussion of vapes, whose primary purpose is to help shift smokers from their highly risky habit with its high cost to society in general and, especially, to the under-pressure NHS. But then, perhaps I am being unfair because The Guardian, which has otherwise undertaken some serious and important journalism, alone and in conjunction with other outlets, possibly doesn’t believe the vaping issue is serious. Certainly, in relegating it to the G2, it seems to have shown its hand; it believes the “children”-and-vaping issue is entertainment.
The first two-thirds of the opening page of the G2 splash was taken up with a close-up picture of somebody wearing a hoodie and holding a vape, a picture the art department had done its best to make look sinister. In fact, the picture tends to support the idea that we are dealing with a middle-class issue.
The hoodie is neat and clean, and underneath it (to indicate we are looking at a young person) you can see a smart shirt and what looks like a school tie, part of a uniform many financially impoverished people could not afford. The top button of the shirt is done up and the tie neatly secured. The fingers shown holding the vape are definitely not tattooed with H A T E.
In fact, in this guise, vaping has been relegated not only to entertainment but to something resembling a poorly scripted soap opera. The June 14 story was headed “Mum, I can’t go any longer —I really need a vape.” This plaintiff cry was apparently issued from the lips of 16-year-old Josh, who was taking exams, and the reaction of his mum, Hannah, was apparently to break the law and buy him a vape—only this once, she was quoted as saying, rather implausibly. There was no discussion in the story as to whether Hannah would have bought other drugs if Josh had said he needed amphetamines, cocaine or heroin.
Credit: Millstream Brewing Co.
Notwithstanding Hannah’s seeming lack of judgment, she is given a platform on which to expound her assumed expertise on addiction and relative addiction, whatever that might be. At one point, Hannah tells us Josh is “massively” addicted while later, she says he is more addicted than she thought, which presumably takes him into massively addicted-plus territory.
In fact, the June 14 soap was the second episode of the story that had started with what I would describe as a shamefully bad piece The Guardian ran in its main section on March 18—unbelievably on page 5. In the earlier piece, we were told about 14-year-old Liam, who, according to his mother, Sarah, was “completely addicted to vaping,” which raises the question of whether it is possible to be incompletely addicted. Sarah’s reaction? Apparently, to break the law and feed her son’s habit.
The soap’s two episodes are closely similar in format, with drawers full of vapes and seemingly naive, inadequate, middle-class parents blaming others for their offspring’s behavior. They admit to the apparent illegal purchase of vapes for their underage offspring, presumably their nearest and dearest, but complain about retailers, unrelated to the young people, selling them vapes.
And all the while these parents eschew any responsibility for their own actions or those of their offspring, preferring to present themselves as victims. I’m sure they would be shocked to learn that one of the main risk factors of drug-taking among young people is a lack of parental supervision while others are genes and alcohol “misuse” by parents.
But who are these victimizers? Having read columns of this stuff, I’m still not clear who these parents and The Guardian believe are to blame for the current situation as they see it. There is little attempt to get to the bottom of these issues, which seem to me to stem simply from acute and chronic government-imposed austerity measures that, predictably, have led to a failure of policing.
