The Belfast Council in Northern Ireland is considering banning anyone under the age of 18 from vaping at its sites and premises around the city.
UUP John Kyle has forwarded a motion to be debated by the full council next week, calling upon Belfast City Council to convene a working group with other stakeholders considering measures to strengthen current legislation and enforcement in relation to vaping, according to Belfast Live.
The motion also calls for a ban on the use of vapes by all under 18’s indoors all council premises.
At the recent meeting of the council’s Standards and Business Committee, Councillor Kyle said: “Part of the purpose of this motion is that people, particularly parents of young people, are unaware of the dangers of vaping. It has become such a common practice with kids at school.
“Part of the purpose is to publicize the issue, make people aware of it, so I propose it is aired at full council before going for consideration to the committee to work it through. It would be beneficial if we as a council give some air space to what is a growing public health problem.”
The vape industry in Malaysia expressed support for a potential exemption of liquid nicotine from control under the Poisons Act 1952 in the government’s bid to tax e-cigarettes.
Associations representing vape and e-cigarette companies claimed that this would enable regulations to be introduced for the vape industry, according to CodeBlue.
“Continuing to subject vape products containing nicotine under the Poisons Act does not help as it is not a suitable framework and does not work for the products,” Adzwan Ab Manas, president of the Malaysia Retail Electronic Cigarette Association (MRECA), said in a statement.
Currently, nicotine – except tobacco that is regulated separately under the Control of Tobacco Product Regulations 2004 under the Food Act 1983 – is classified as a Group C poison under the Poisons Act that can only be dispensed by medical practitioners or pharmacists.
Dewan Perniagaan Vape Malaysia (DPVM) secretary-general Ridhwan Rosli, in a separate statement, claimed that if liquid nicotine is exempted from control under the Poisons Act, vape products can be regulated under “current legislation”.
However, the only current law regulating vape products is the control of liquid nicotine under the Poisons Act which the government may soon eliminate.
It would also get the Attorney General’s Office to report on the extent to which Vermont may legally restrict advertising and regulate labels for the products.
Several states in the Northeast have or are considering flavor bans. Connecticut also introduced a bill that would ban flavored e-cigarettes. New York, New Jersey and Rhode Island have barred the sale of flavored vaping products. Massachusetts banned all flavored tobacco items, including flavored cigars, cigarettes and vaping goods.
Vermont’s ban was originally proposed in early 2020 as a way to prevent youth use, but was sidelined after the Covid-19 pandemic began to impact the country.
Chairman James Comer is conducting the probe of the FDA’s regulation of tobacco and nicotine products through the CTP, stating that the center has failed to effectively define and administer its tobacco and nicotine regulatory programs.
The failure has resulted in industry uncertainty and unsafe products reaching the marketplace, according to a committee press release. In a letter to FDA Commissioner Robert Califf, Comer is requesting documents, communications, and a staff-level briefing related to the CTP’s activities to ensure it is performing its regulatory function as intended.
“The Committee on Oversight and Accountability is conducting oversight of the Food and Drug Administration’s (FDA) regulation of tobacco and nicotine products through its Center for Tobacco Products (CTP). A recent evaluation of CTP by the Reagan-Udall Foundation (RUF) found that CTP has not clearly set out the most basic elements of its tobacco and nicotine regulatory programs. This has resulted in confusion, inefficiency, litigation and suspicions of political interference. CTP has fostered uncertainty in the marketplace and has allowed unsafe and unregulated products to proliferate. Therefore, we seek documents and information regarding CTP’s activities to enable transparency and to ensure the CTP is performing required functions,” wrote Comer.
An evaluation of the CTP by the Reagan-Udall Foundation stated that the CTP is unable to perform its basic functions and ensure that Americans have access to products that have the potential to lower the rate of smoking-related disease and death. Amidst unclear policies, stakeholders have even reported having to guess what the CTP’s regulations might be. Congressional oversight is needed to bring transparency to the CTP’s lack of clear policies that have resulted in market uncertainty, unregulated products and enforcement failures, according to the press release.
“We have deep concerns that CTP’s decisions have been influenced by political concerns rather than scientific evidence,” wrote Comer. “Comments from FDA staff to RUF, which are no longer available on its website, reflect such concerns. For example, one commenter said, ‘[i]n cases where reviews are finished and scientific decisions are made, they are also overruled by political agendas and pushed to change decisions.’ Another stated, ‘scientific disagreement is frowned upon, if not entirely suppressed,’ while a third said leadership was ‘… unsupportive of a reviewer’s fundamental duty to provide an unbiased review using the best available science.’ FDA must clearly identify and publicize what scientific criteria are necessary for a product, to include [electronic nicotine-delivery system (ENDS) products] and smokeless products, to be authorized through the PMTA pathway and—where appropriate—the subsequent [modified-risk tobacco product applications (MRTPs)] pathway.”
Comer specifically asked the FDA to provide: FDA staff comments to the Reagan-Udall evaluation; all communications with the White House and Department of Health and Human Services (HHS) regarding tobacco or nicotine policy; documents and communications between the FDA and the Centers for Disease Control and Prevention (CDC) regarding CTP policies; documents and communications between the FDA and “public health advocacy groups” regarding CTP policies; all documents that describe the specific analytic process the FDA uses to apply the “appropriate for the protection of public health” standard; and all documents and communications related to the FDA’s enforcement efforts to remove illegally marketed tobacco or nicotine products from retail locations.
The Kansas Senate passed House Bill 2269, 28-11, which will raise the minimum tobacco purchasing age in the state to 21 from 18, reports ksnt.com. The bill now heads to the governor’s desk.
The bill would bring Kansas into compliance with federal law, making it illegal for a retailer to sell tobacco products, including electronic cigarettes and cigarettes, to anyone under the age of 21.
Representative Tom Kessler, a Republican from Wichita who carried the bill, said the state could lose funding from the federal government if the legislation is not enacted. “We do stand to lose a little bit of funding if we don’t conform with federal law,” Kessler said. “We’re going to lose about $1.2 million of funding if we don’t make this transition within the window that the feds allowed us to.”
Representative John Eplee said that some retailers in the state have moved toward federal compliance but others have not, making federal law harder to enforce. “Most vendors have already complied with this, but are not required to, and it makes enforcement ‘herky jerky’ in our state,” Eplee said. “Forty-six other states have already fallen into compliance … we’re just asking Kansas to do the same thing.”
The Ministry of Health of Argentina has banned the importation, distribution, commercialization and advertising of different types of electronic cigarettes and accessories “throughout the national territory,” reports MercoPress.
Health Minister Carla Vizzotti signed a resolution prohibiting heated-tobacco products (HTPs) “based on the risks involved” in using them. The health department stated that many studies have shown HTPs “produce aerosols with nicotine and other chemicals, such as acetaldehyde, acrolein and formaldehyde, [and] are harmful and potentially harmful to health.”
“Evidence suggests that novel products such as HTPs and similar products are particularly attractive to children and adolescents, and their introduction into the market has the potential to lead to tobacco initiation in young and nonsmoking adults, threatening the achievements already made in tobacco control,” the official document stated.
The National Risk Factors Survey 2018 showed that 1.1 percent of the adult Argentinian population used electronic cigarettes while the 2018 Global Youth Tobacco Survey showed that 7 percent of those aged 13 to 15 consumed electronic cigarettes.
A trial against Juul Labs and Altria for youth marketing begins today in the U.S. state of Minnesota. It is the first state to go to trial against the e-cigarette manufacturer and tobacco company.
Jury selection in the trial comes more than three years after Minnesota Attorney General Keith Ellison first filed a lawsuit against Juul Labs, reports CARE11.
“We will prove how Juul and Altria deceived and hooked a generation of Minnesota youth on their products, causing both great harm to the public and great expense to the State to remediate that harm,” said Ellison, in a press release.
Minnesota is the first case to go to trial against Juul since more than a dozen states sued the company beginning in 2019.
“It’s a pretty significant case,” said David Schultz, a law professor at the University of Minnesota. “The case comes down to two or three basic issues. First, it’s about the claim that Juul marketed to minors. Second, it did nothing in terms of trying to prevent minors from accessing their product. And third, it was about the fact that they did not make appropriate disclosures regarding the health and safety risks surrounding the use of vaping and some of these smokeless tobaccos.”
The state believes Juul Labs, enabled by Altria, “engaged in consumer fraud, negligence, and created a public nuisance.”
This isn’t new territory for the state. Minnesota was the first state in the country to successfully sue the tobacco industry and win in the 1990s.
Earlier this year, A U.S. district judge handed Juul Labs preliminary court approval of a $255 million settlement resolving claims by consumers that it deceptively marketed e-cigarettes, as the company seeks to resolve thousands of lawsuits.
In court documents from November 2022, the defendants stated, “Minnesota has reaped billions of dollars from tobacco settlements and taxes over the last decade for the purpose of preventing tobacco use and remedying its harms. Yet even after determining that there was an alleged youth vaping problem among Minnesota youth, time and again the State chose to ignore recommended tobacco prevention funding guidelines and instead used these funds to bankroll unrelated projects—like the Minnesota Vikings football stadium.”
When the U.S. Court of Appeals for the 5th Circuit granted a stay to RJ Reynolds Vapor Co. (RJRV) of the U.S. Food and Drug Administration’s denial of its 150,000-page premarket tobacco product application (PMTA) for its menthol Vuse products, the judges indicated that the court believes RJRV is likely to prevail on the merits when the full review is heard.
Tobacco harm reduction expert Clive Bates, of Counterfactual, said the substantive decision rests on three main arguments, as outlined by the judges granting the stay. The order states:
Specifically, RJRV demonstrates that the FDA failed to reasonably consider the company’s legitimate reliance interests concerning the need for longitudinal studies and marketing plans; failed to consider relevant evidence, inter alia, that youthful users do not like menthol-flavored e-cigarettes; and has created a de facto rule banning all non-tobacco-flavored e-cigarettes without following APA notice and comment requirements.
The three main points argued by the court are outlined below:
FDA changed the decision-making criteria after the application.
1. Legitimate reliance interests
“The FDA did not reasonably consider RJRV’s legitimate reliance interests before changing its position on the types of comparative studies and marketing plans critical to a compliant and complete PMTA.”
Failure to consider Reynolds’ arguments adequately
2. Failure to consider relevant factors
The FDA did not adequately address RJRV’s evidence that substantial health benefits would accrue to adult and youth cigarette smokers alike who switched to menthol Vuse, while popularity among youth would remain low overall. For example, RJRV’s application contained studies that “switching from smoking to use of menthol Vuse Vibe substantially reduces toxicant exposure in a manner similar to smoking abstinence.” RJRV also submitted evidence of low popularity among youth relative to other flavored ENDS.
Bates stated that at least one portion part of the court’s argument looks troubling for Brian King, the newly appointed director of FDA’s Center for Tobacco Products (CTP).
Then in July 2022, a new CTP director appeared on the scene and told OS that “the approach to menthol-flavored ENDS should be the same as for other flavored ENDS, i.e., the products could be found [appropriate for the protection of the public health] only if the evidence showed that the benefits of the menthol-flavored ENDS were greater than tobacco-flavored ENDS, which pose lower risk to youth.” OS then changed its position.
FDA has been implementing a de facto tobacco product standard (a flavor ban) without using the rule-making process, public comment etc.
3. “Tobacco product standard”
RJRV has adduced evidence that the FDA has effectively banned all non-tobacco-flavored e-cigarettes, pursuant to its new and secret heightened evidentiary standard, without affording affected persons any notice or the opportunity for public comment. There is no dispute that the TCA requires the FDA to abide by notice-and-comment rulemaking procedures before establishing a “tobacco product standard.”8 21 U.S.C. § 387g(c)–(d). Similarly, it is clear that a ban on all but tobacco-flavored e-cigarettes would constitute a “tobacco product standard.”
Bates explains that the court justifies its assertion that FDA is imposing a de facto standard with reference to the so-called “fatal flaw memo.” This was an expedited decision-making regime that stipulated that applications for non-tobacco-flavored products must be supported with controlled trials or longitudinal studies showing a quitting or switching advantage over a tobacco flavor. Otherwise, they would be automatically denied.
We conclude that the Fatal Flaw memo’s heightened evidentiary standard “bears all the hallmarks” of a substantive rule. City of Arlington, 668 F.3d at 242. First, the memo is binding on its face by mandating that applications contain “the necessary type of studies.” Second, it has been applied in a way that indicates it is binding; indeed, the subsequent, myriad Denial Orders refer to the same deficiencies identified as “fatal” in the memo. Third, it took away the FDA reviewers’ former discretion to consider individual PMTAs solely on their merits and instead requires a cursory, boxchecking review.
Finally, it affected the rights of literally hundreds of thousands of applicants whose PMTAs were denied. This is not a close call.
Bates stated that the third point the court makes is potentially “very” serious for the FDA and “not a close call,” as the court suggests. “A tobacco product standard under the TCA s.907 means that the burden is on FDA to show that its de facto standard is appropriate for the protection of public health – e.g. considering the impact of closing down all vape shops, likely impact on adults or youth who smoke, unintended consequences, illicit trade etc,” explains Bates. “It shifts the analysis from the individual applicant (PMTA) to the system-wide impact (Product Standard) – and FDA will find this difficult or impossible to meet, in my view.”
Taking everything into account, the court weighs up its decision to grant the stay against four criteria, as Bates outlined:
Our judgment is “guided by sound legal principles” that “have been distilled into consideration of four factors: (1) whether the stay applicant has made a strong showing that he is likely to succeed on the merits; (2) whether the applicant will be irreparably injured absent a stay; (3) whether issuance of the stay will substantially injure the other parties interested in the proceeding; and (4) where the public interest lies.”
Bates stated that the first of these four criteria reflects the courts’ view on the merits discussed in the three above-stated substantive arguments. In the fourth: (4) where the public interest lies, the court gives significant weight to the “highest public importance that federal agencies follow the law” and states:
In sum, “there is generally no public interest in the perpetuation of unlawful agency action,” Texas v. Biden, 10 F.4th at 560. And there is no evidence that “Congress’s policy choice” included an exemption from mandatory federal administrative procedures.
No date has been set for the court to complete its full review.
Tobacco harm reduction initiatives should also cover e-waste management, say experts.
Contributed
E-waste is an emerging unintended environmental consequence of the revolution in electronic nicotine-delivery systems, threatening to undermine a technological innovation in public health. This conversation examines the intersection of regulatory policy, consumer behavior and the vaping products’ industry and hopes to map a sustainable path for the future.
In the discussion below, John Dunne from the U.K. Vaping Industry Association (UKVIA) brings in the vaping industry perspective, Pieter Vorster brings expert views on global tobacco and nicotine industry transformation, and Sudhanshu Patwardhan (Sud), a nicotine expert and health-tech entrepreneur, proposes a broader definition and scope of tobacco harm reduction (THR).
Sudhanshu Patwardhan
Patwardhan: We know that in the U.K. and the European Union, where they are regulated, vapes, or e-cigarettes, are classed as waste electrical and electronic equipment (WEEE). Ideally, consumers in these countries should dispose of vapes at a household recycling center or at the shop where they bought the device. Manufacturers are also required to make recycling options available. Many consumers, however, are unaware that single-use vapes can or should be recycled. Incorrect disposal of these items can potentially release plastic, electronic and hazardous chemical waste into the environment and represent a fire hazard. How big is this issue currently? Does the industry have numbers contrasting sales to recycling?
Dunne: In the U.K., around 459 million e-cigarettes of all kinds are purchased each year, of which 168 million, or 37 percent, are single-use vapes. Approximately 43 percent of all vapes purchased are recycled, although this number is likely much lower for single-use (“disposable”) products:
Twenty-three percent of e-cigarettes are recycled in-store when consumers buy a new one.
Twenty percent are recycled at a local authority recycling center.
On the face of it, the 43 percent recycled figure for e-cigarettes compares favorably with the 31.2 percent of waste electrical and electronic equipment in the U.K. that was recycled or reused in the U.K. in 2021. However, vaping products’ relatively short lifespan means more waste is generated.
Patwardhan: Good to get that broader electronic products-based perspective and the product use life cycle nuance with regards to e-cigarettes. Obviously, there is a still a gap between current practices by consumers versus what would make e-cigarettes environmentally sustainable in the long run. Pieter, do you think there are any good examples of industry players showing some leadership in this?
Vorster: All three tobacco companies that sell single-use vaping products in the U.K.—BAT (Vuse Bar), Imperial (Blu bar) and PMI (VEEBA), for example—advise consumers not to put them in household waste and offer free returns services on their websites. This information is displayed on the webpages where these items are sold. Consumers who don’t buy these products online need to read the package insert. They are advised that the product should not be placed in household waste but collected separately for recovery and recycling. The package insert also directs users to the manufacturer’s website for details of its recycling program. Whether consumers ever read these inserts is open to debate!
Independent U.K. brands are not far behind either; Riot Bar and Blo Bar have also introduced comprehensive recycling schemes. Blo also offers consumers one free Blo Bar for every 10 disposable vapes of any brand sent to them for recycling. Most online retailers in the U.K. offer disposal and recycling advice, and VPZ, the U.K.’s largest vaping retailer, has announced that it is introducing a comprehensive return and recycling program in its stores before the end of March.
Patwardhan: It sounds like manufacturers are, in theory, offering the recycling option to consumers. Do we know if consumers know that these options exist? Perhaps there is an education piece that needs to be carried out by key actors in the supply chain, including manufacturers, as well as by the broader regulatory agencies? Do the regulators need to intervene, or does the industry need to act? Or both, and others?
John Dunne
Dunne: Recycling vapes is not straightforward and needs collaboration between adult vapers, retailers, manufacturers, regulators and companies in the waste management sector, which are involved in the current Producer Compliance Schemes under the WEEE regulations. We are liaising with DEFRA [U.K. Department for Environment Food and Rural Affairs] and the Office for Product Safety and Standards and calling upon our members and the wider industry to innovate products that are easier to recycle.
Patwardhan: Talking about multi-stakeholder initiatives, we are on the cusp of another VApril, an annual British feature in April to showcase vaping as a means to stop smoking. As we have seen with a series of successive publications from U.K. health and related authorities and charities—e.g., the 2016 Royal College of Physicians’ Nicotine Without Smoke report—e-cigarettes/vapes are a potential force for good by helping smokers quit smoking. The THR creds of e-cigarettes in the context of current adult smokers are not in doubt. However, this emerging narrative on environmental harms from disposable vapes presents a unique challenge to those in public health and policy, does it not, Pieter?
Pieter Vorster
Vorster: Indeed, Sud. To date, opponents of tobacco harm reduction have often relied on questionable science that is unlikely to withstand rigorous evaluation, as evidenced by numerous retractions in recent years. On the other hand, the science underlying the potential environmental and health risks posed by the inappropriate disposal of reduced-risk products isn’t subject to the same constraints. Furthermore, the emotional appeal for the “environmental harms” narrative from these products has a much broader and vocal activist constituency—thus threatening to undermine the public health arguments of THR. In short, it represents a potentially potent weaponizable tool for those opposed to THR.
Patwardhan: I can see that the recent developments in Scotland, where an environmental activist highlighted the problem of vape littering, and separately, the decision of a large British supermarket chain to stop selling disposable vapes, signal a change in public perception and attitudes toward the product. It is as if an argument is being built in this narrative about disposables being harmful to the environment and are a lost cause as such, as well as the anecdotal observation that disposables are used by a much younger cohort, possibly those underage as well as those who have never smoked cigarettes before. If true, surely that is one issue to address through stronger regulations, especially with regards to preventing youth access and mandatory recycling requirements and refund schemes, right?
Dunne: Preventing the sale of vaping products to minors is one of the industry’s most fundamental challenges, and our members are united behind this goal. We have recently updated our “Preventing Underage Sales Guide” to give retailers all the information they need so they don’t inadvertently sell to someone under 18. However, we need the support of the government, regulators and enforcement authorities to ensure that unscrupulous retailers who knowingly sell to young people face the full force of the law. We believe that there is a need for increased fines for rogue traders, licensing of vape retailers and a national test purchase scheme. In fact, the UKVIA’s Youth Access Prevention Task Force will propose so to regulators this month. Regarding e-waste, the industry also recognizes its environmental responsibilities, and we are working with regulators, waste management experts, product manufacturers and retailers to find a workable solution.
Patwardhan: This is a most fascinating discussion where we find innovative 21st century nicotine products that have huge positive public health potential getting caught into an orthogonal field of great import in global public policy: sustainability and environment. In concert, responsible behavior by industry and retailers, better regulation and enforcement—and not prohibition—and consumer adoption of e-waste management solutions may well be the answer. In fact, we can go one step further and challenge all stakeholders—industry, regulators, public health and consumers—to embrace proactive e-waste management as another opportunity to reduce harms from a transforming tobacco and nicotine products’ landscape whilst maximizing the societal benefits from this shift in consumer behaviors.
A new webpage was published by the U.S. Food and Drug Administration of all the tobacco products-related citizen petitions received by the agency’s Center for Tobacco Products (CTP).
A citizen petition is a way for the FDA to give individuals, regulated industry representatives, or consumer groups to petition the agency to issue, amend, revoke a regulation, or take other administrative action. The requirements for a citizen petition are set out in the Code of Federal Regulations.
As part of CTP’s stated commitment to increase transparency, the webpage was developed to provide the public with more easily accessible and user-friendly information about tobacco product-related citizen petitions submitted to FDA and the center’s responses.
This webpage was one of the immediate actions toward transparency outlined by CTP Director Brian King in CTP’s Response to the Reagan-Udall Foundation’s report.
