Tag: regulation

  • Step by Step

    Step by Step

    Credit: Balint Radu

    Embracing tobacco harm reduction involves more than words, and consumers should be involved.

    By George Gay

    Earlier this year, I received a press note headed, “Recommendation: Seven steps for the new Italian government to reduce smoking”—a note that also carried the subsidiary heading, “World Vapers’ Alliance presents seven steps toward harm reduction in Italy as the new government takes office.”

    This was all very well, but there was something odd about the note because the text gave the first step in the strategy as “embrace tobacco harm reduction.” It seemed that the “seven steps toward harm reduction” had been reduced to one, “embrace tobacco harm reduction.”

    This is not meant as a criticism. I’m certain the people at the Alliance know the new Italian government better than I do, and if they decided it was best to keep things simple, if they deemed the government incapable of following a complex, seven-step strategy, who am I to argue? After all, there is no way that I would propose a seven-stage strategy to the U.K. government. Four would be the upper limit:

    1. Choose a new leader.
    2. Try not to crash the economy.
    3. Oh dear, never mind.
    4. At least try to embrace tobacco harm reduction.

    Okay, I lied. I might have a tiny criticism of the press note. One of the people who sat alongside Michael Landl, the Alliance’s director, when the strategy was announced in Rome, was the Italian MEP (Lega party), Gianna Gancia, who said, in reference to the proposed revision of the EU’s Tobacco Products Directive, that it was necessary for the Italian government to insist on some fundamental points concerning legislation on electronic cigarettes.

    “In particular, Italy should maintain a wide range of flavors, which would help the consumer in the transition from traditional to electronic smoking …,” she was quoted as saying in part.

    To my mind, the reference to “electronic smoking” was unhelpful and unnecessary. It will have played into the hands of the vaping industry’s opponents, who will be whispering into the government’s other ear, “see, they’re both smoking; there is no difference.”

    Why, if she wanted to advance the cause of vaping, did she not say, “… which would help the consumer in the transition from smoking to vaping, and in this way, attempt, rightly, to put clear water between smoking and vaping.”

    After all, the need for that division is well understood by the Alliance. The strategy announced in Rome is part of a Europe-wide campaign presented under the slogan #BackVapingBeatSmoking.

    Words matter. It was unfortunate, though understandable in some respects, that vaping devices were first referred to as electronic cigarettes, but we are where we are. There is no need to hand more ammunition to those opposed to vaping and tobacco harm reduction.

    Although I never write headings, I am fascinated by them to the point where I keep pinned to the notice board above my desk one of my all-time favorites, a heading cut from a years-old issue of the London Review of Books, which simply says: “They treat us like shit.”

    You could complain that this heading isn’t a good one because it’s not obvious who “they” and “us” are, but, my goodness, it makes you want to read the piece. In fact, it was about those in power in an authoritarian state, the “they,” and the ordinary citizens of that state, the “us.” The heading has about it an air of whimsy on the point of turning violent. It seems to pour from the lips of the downtrodden, who are finally plotting revolution. Of course, it is lifted by the final scatological note, but, above all, to my way of thinking, it is blessed with brevity.

    The trouble is that, in going for brevity, you need to be careful not to wind up following the path of reductio ad absurdum, which, I’m afraid, is the route this one from opinion.inquirer.net took: “Harm reduction for tobacco?” When I first read this heading, I was excited because I thought that what was on offer was a forward-looking opinion examining ideas about plant consciousness and whether it is morally wrong to tear leaves off living tobacco plants, process and burn them.

    Surely, at the very least, the heading should have read, “Harm reduction for tobacco users?” because that was what the piece was about. Or perhaps not. After all, many of us constantly use the expression “tobacco harm reduction.”

    One final point. Since when has it become OK to put a question mark at the end of a heading introducing an opinion piece? An opinion writer surely provides her opinion; she doesn’t pose questions and ask for the reader’s opinion.

    It’s little wonder that I’m fascinated by headings. Look at this one from theguardian.com: “Australian teenagers are readily accessing illegal vaping products. Here’s how Christina Watts, Becky Freeman and Sam Egger for the Conversation.”

    This, I assume, was written by somebody who believes that it is not only acts that are illegal, a point of view that has made common the hideous phrase “illegal immigrant,” meaning somebody who by their very existence is illegal. This unfortunate person might, in desperation, have committed illegal acts in order to get to what she hopes is a country that will not persecute her, but she is not illegal.

    Is this sort of heading just a mistake? I hope so, because otherwise, it is purposely trying to shift the blame from the teenagers to the perfectly innocent vaping products. It is the teenagers who are committing the illegal acts, possibly in cahoots with sellers acting in an illegal manner.

    I shan’t comment on the second sentence of the heading, which is simply too awful to contemplate.

    I’ll give the headline writer at ctpublic.org her due because it seems she was embarrassed enough to put the phrase, the more lethal product, inside inverted commas: “New Yale study suggests higher e-cigarette taxes could push vapers to smoke ‘the more lethal product.’”I guess she, but not the person responsible for the quote, is aware that there are no degrees of lethal. Something is either lethal or it is not; just as something is unique or it is not, despite the common use of phrases such as “really unique.” But I must say that I would have been more impressed if the heading had been cut after the word “smoke.”

    Otherwise, it would have been less coy to have replaced “the more lethal product” with “combustible cigarettes,” or have we become so sensitive that we can no longer refer publicly to combustible cigarettes?

    When is a sobriety test not a sobriety test? How about, for instance, when the test is being applied to discover whether you are under the influence of alcohol? That would surely be a drunkenness test.

    I started to wonder about this on seeing a Eurekalert news story entitled “Can vaping cause you to fail a sobriety test?” Talking of a sobriety test seems to me to assume that drunkenness is the default setting of the human animal, who has to be tested whenever she displays signs of sobriety: talking coherently, acting rationally and driving in a straight line on a straight road.

    But this is nonsense. I mean, no matter what the gleaming adverts might want to make you believe, you don’t go along to your local hospital or clinic to have a wellness test. You go along to find out whether you are suffering from some disease or other. Even if you go along for an annual checkup, the tests are looking for early signs of disease, not early signs of wellness.

    The idea of a sobriety test seems to smack of a police state in which people are pulled over for acting in what I would describe as a normal way. And for those people concerned with human rights and the fear generated by slippery-slope theories, it could lead to anxieties over whether people could be pulled over for other normal behaviors: breathing, thinking and being happy.

    The heading is also misleading, in my view, because it implies that the fault lies with vaping whereas it lies with the testing, as is almost made clear in the story’s introduction. “While ethanol [alcohol] is often a hidden ingredient in e-liquids, a new study finds vaping won’t trigger a false positive sobriety test—but only if police employ a proper waiting period [between stopping the driver and testing],” the introduction states. It is important to make clear that the “proper” waiting time referred to is in fact the standard time used in a DUI (driving under the influence) roadside stop.

    Note, too, how we’ve gone from the possibility of vaping’s causing a person to fail a sobriety test, according to the heading, to the possibility of its causing a “false positive sobriety test,” according to the introduction. What is this “false positive sobriety test?” To me, this means that the person being tested has gotten away with it when she should have been charged with DUI, but according to the context, a person who is positively sober is in fact drunk.

    A heading on a recent BBC news story asked the question “Should disposable vapes be banned?” Any thoughts anyone? No?

    As is often the case with stories with headings that end in a question mark, no answer was given, though one person, perhaps two, were quoted as saying “yes.” It makes you wonder whether the person who wrote the heading read the story.

    Still, I mustn’t grumble. I think the BBC did well to give the issue of disposable vapes an airing, even if the story provided little more than an opportunity for people to complain about how carelessly discarded, disposable vaping products were littering the U.K. and an opportunity for everybody to blame everybody else for this state of affairs. This debate has not been encouraged nearly enough.

    There is clearly a need to go back to basics and ask whether vaping devices, disposable or otherwise, are a positive. This means honestly addressing the question of whether we should, in trying to reduce the harm caused to smokers by their consuming combustible cigarettes, allow the further degradation of the environment. Yes, vaping devices might help individual smokers avoid the harms they would otherwise have suffered, but should this be at the expense of the environment and, therefore, everybody?

    The answer to this question probably depends on how many smokers can be switched to vaping devices and what is the level of environmental damage that will be suffered. And, of course, into that equation will have to be factored the environmental gains that will accrue because smokers who switch will no longer be discarding cigarette butts.

    Other factors will have to cover what percentage of vaping devices are likely to be disposed of properly if widespread recycling systems can be put in place and how efficient will be the recycling processes. It has to be remembered that some things cannot be recycled while others might require huge amounts of energy to recycle them.

    A major factor in my view concerns consumer attitudes. The blame for the abundance of cigarette butts that litter our streets and waterways is often heaped on cigarette manufacturers, and I would say that, despite the huge profits they have made over the years, they have never properly got to grips with this problem. But there is no getting away from the fact that it is consumers who drop butts on the ground. If they had been willing to put their butts in designated bins, it would have been a reasonably easy task to have them collected and recycled into pallets and whatever. But too many consumers have never proved amenable to doing this.

    The BBC story quoted one former vaper as saying that she had had no idea disposable vaping products were recyclable, adding that the messaging on the products could definitely be improved. “If the vape companies ran social media ads letting people know how to dispose of them, it would grab our attention,” she was quoted as saying.

    Now I don’t want to be harsh, but this sounds a bit flaky to me. People shouldn’t think it’s OK to consume an e-cigarette without taking some responsibility for doing so. If you Google “can vapes be recycled,” there is no end of information available. I’m not saying that this information will answer all your questions, but it will answer enough to allow you to dispose of your vaping devices in a way that will cut out much of the environmental damage caused by throwing them on the street.

    We should not let consumers get away with not acting responsibly. Otherwise, more people will be answering the heading’s question in the affirmative.

  • FDA Accepts Bantam Vape Non-Tobacco PMTAs

    FDA Accepts Bantam Vape Non-Tobacco PMTAs

    Bantam Vape received acceptance of its premarket tobacco product application (PMTA) submission from the U.S. Food and Drug Administration for its non-tobacco nicotine e-liquids, according to a press release. Bantam’s application now moves to the next step in the PMTA process—a preliminary scientific review to confirm the application contains all required items to permit a substantive review by the FDA.

    Bantam submitted its application for its non-tobacco nicotine e-liquids to the FDA on May 13, 2022, and is seeking marketing orders from the agency.

    “The receipt of this acceptance letter reflects Bantam’s efforts to provide adult consumers with high-quality, science-based e-liquids while upholding our responsibility to restrict youth access and use of these products,” said Bantam spokesperson Anthony Dillon. “Bantam remains supportive of the need for science-based regulation in the e-liquids industry and is proud of the progress of our various PMTAs. We remain confident in the quality and consistency of our products and the science behind them.”

    Prior to its non-tobacco nicotine-focused submission, Bantam submitted a PMTA to the FDA in September 2020 for its tobacco-derived e-liquids. The application entered scientific review in August 2021, and, to date, remains under FDA review.

    Earlier this year, the -liquid manufacturer received an exemption from the United States Postal Service (USPS) that allows the company to ship its e-liquid products to select vape retailers and distributors throughout the United States.

  • Kuwait Pauses 100% E-Cigarette Customs Duty Tax

    Kuwait Pauses 100% E-Cigarette Customs Duty Tax

    Credit: Zero Photo

    The government has decided to defer the application of a 100 percent customs duty tax on e-cigarettes – including flavored products – until further notice. The tax was supposed to go into effect on Jan. 1, 2023 after being postponed from Sept. 1 of this year, reports Al- Anba daily, as reported by the Arab Times.

    “The Acting Director General of the General Administration of Customs, Suleiman Al-Fahd, according to a local Arabic daily, has issued instructions regarding postponing the application of single-use cartridges containing nicotine and packages of liquids or gels containing nicotine, whether flavored or unflavored, and packages of liquids or gels containing nicotine from the 100 percent customs tax,” the story states.

    Al-Fahd had previously issued customs instructions to postpone the imposition of 100 percent tax on electronic cigarettes and their liquids, whether with or without flavor, for a period of 4 months, specifically, but according to the instructions, it is decided to postpone the tax application on four items until further notice.”

    The list of the four items includes – the flavored single-use nicotine cartridges; unflavored disposable nicotine cartridges; liquid or gel packs containing flavored nicotine and liquid or gel containers containing unflavored nicotine.

    The instructions come in addition to other Customs Instructions No. 19 of 2022 issued in Feb. 2022 regarding the application of what was introduced in the Main Clause 2404 of Chapter 24 of the unified customs tariff system for the GCC countries by subjecting cartridges containing single-use nicotine flavored, unflavored and packages of liquids or gels containing flavored or unflavored nicotine for a 100 percent customs duty.

  • California’s Flavored Tobacco Ban Begins Today

    California’s Flavored Tobacco Ban Begins Today

    Credit: 4kClips

    California’s controversial ban on flavored tobacco begins today. A week ago, the U.S. Supreme Court blocked R.J. Reynolds Tobacco Company’s contention that the new state law conflicted with federal law.

    Flavored tobacco products such as e-cigarettes, menthol cigarettes, flavored cigars and more can no longer be sold in stores.

    “If they wanted to ban flavored tobacco or regulate it, I feel they should have selected certain stores to be authorized to retail it. It’s saved so many lives, helped so many people get off cigarettes,” said Carlo Sharmoug, owner of Ziggy’s Smoke Shop at the corner of West Lane and Alpine Avenue in Stockton, speaking with ABC10.

    Sharmoug says in his 14 years in business, his store has never once sold tobacco to a minor.

    Freitas says California’s tobacco rates among teens at one point began to decline until e-cigarettes appeared.

    “They started being sold in flavors like grape and cherry and gummy bear. And all of a sudden, we saw our youth tobacco rates increasing again,” said Freitas.

    Smoke shops like Ziggy’s say California will lose out on millions in tax revenue and believes product will be sold on the black market. However, Frietas disagrees, saying the savings in medical treatment in California alone will be huge.

  • OSC Sends Letter to Biden for FDA’s ‘Public Failure’

    OSC Sends Letter to Biden for FDA’s ‘Public Failure’

    Credit: Tada Images

    The U.S. Food and Drug Administration’s (FDA) Center for Tobacco Products (CTP) had relaxed its standards of review for certain tobacco products and stifled attempts by its scientists to raise concerns, according to an investigation conducted by the U.S. Office of Special Counsel (OSC). The OSC sent a letter to the President and Congress outlining the findings.

    The investigation began after a leading CTP toxicologist-turned-whistleblower disclosed to OSC that a 2019 memorandum issued to CTP’s scientists revised the process for evaluating potentially harmful ingredients in substantial equivalence applications used for certain tobacco products. According to the whistleblower, the memo directed scientists to stop using objective, quantitative data to evaluate applications and to instead use an approach which was more akin to “eyeballing it,” resulting in unclear review standards and less reliable decisions, according to the CTP.

    The whistleblower also alleged that flaws in CTP’s internal scientific dispute resolution process effectively prevented the whistleblower and several other concerned scientists from raising these issues within the agency. “This internal dispute process is intended to safeguard the integrity of CTP’s scientific evaluations, including consideration of certain tobacco products to ensure those authorized for market meet the applicable health and safety standards,” CTP stated.   

    OSC referred the whistleblower’s allegations for investigation. In response, the FDA convened an independent panel of scientific experts to evaluate allegations concerning the allegedly flawed tobacco application review process. The panel largely agreed with the whistleblower’s concerns, finding that the process lacked “quantifiable standards or criteria.” The expert panel made six recommendations, including a new process for resolving scientific discrepancies, which the agency largely adopted.

    In response, the whistleblower acknowledged CTP’s progress in giving scientists discretion to consider quantitative data in reviewing potentially harmful chemical compounds in substantial equivalence applications for new tobacco products. CTP also revamped its scientific dispute procedures and created a mandatory training program for all CTP staff involved in scientific decision-making. While supportive of these steps, the whistleblower stated that FDA scientists will still need courage to challenge a system that “discourages dissenting voices.”

    “The public depends on the FDA to vigorously implement and enforce our nation’s health and safety laws, especially when new tobacco products are being brought to market,” said Special Counsel Henry J. Kerner. “I am deeply troubled that FDA’s own scientific dispute process failed our whistleblower and fellow concerned scientists, and as a result failed the public. I commend the whistleblower for persevering in the face of these unnecessary obstacles. I also thank the FDA for taking the allegations seriously by convening an independent expert panel, and for taking positive steps to repair its review process.”

  • Nothing to See: Reagan-Udall Submits CTP Review

    Nothing to See: Reagan-Udall Submits CTP Review

    Credit: Postmodern Studio

    The Reagan-Udall Foundation today submitted its recommendations to Robert Califf , commissioner of the U.S. Food and Drug Administration. The findings are what many in the industry are calling “meaningless” and “less than compelling.”

    The report concludes that vaping industry stakeholders observed a lack of “consistent implementation” of what the industry understood to be the policies of the Center for Tobacco Products (CTP), particularly with respect to tobacco harm reduction and the requirements needed to navigate the premarket tobacco product application (PMTA) process.

    The “Operational Evaluation of FDA’s Tobacco Program” was facilitated at Califf’s request. The announcement came as Califf attempted to push past several controversies that dominated his second stint running the agency, including his issuing of a marketing denial order (MDO) to e-cigarette maker Juul Labs and later having to rescind that order.

    The report did highlight several wide-ranging problems that the report states hinder its ability to regulate the industry and reduce tobacco-related disease and death. The report stated that the CTP should make “process improvements and identify and address the policy and scientific questions” that underpin its regulatory framework. The review concluded that CTP’s implementation of its program also has been affected by “changes in leadership and administrations.” In its first 13 years, CTP has operated under seven different commissioners in three different administrations, and recently hired a third CTP director, Brian King.

    “From the stakeholders’ perspective, policy shifts with broad impact on the industry occurred without notice. The Center has faced significant challenges in clearing its policies through the career and political infrastructure. It took years to establish requirements and standards governing application reviews, frustrating industry and creating problems for the Center itself when it received deficient applications,” the report states. “Issues in application reviews resulted in litigation necessitating re-review of some applications. The current environment reflects an unintended shift from what was structured by law as a pre-market authorization framework to the reality of a post-market regulatory environment, which is much more difficult to deal with given that there are few incentives for industry to come into compliance and many incentives for industry to delay the process.”

    The evaluation and resulting recommendations focused on four program areas: regulations and guidance, application review, compliance and enforcement, and communication with the public and other stakeholders, according to the review. The review and recommendations are meant to assist the agency in making changes to better carry out its regulatory responsibilities; to strengthen its relationships with stakeholders

    The report identified several fundamental issues that the center needs to address and it states that the report offers “cross-cutting as well as program-specific recommendations to help CTP operate more effectively,” according to the authors of the review.

    The key points from the report can be summarized as follows:

    • The panel observes that CTP has been forced to operate primarily in a reactive mode, moving
      from one challenge to the next, mainly provoked by the outside forces. The Center should transition to becoming a more proactive and strategic program. With more substantial engagement with stakeholders and the public, CTP should take the time now to think strategically about where it is today and where it needs to go in the next several years.
    • Although CTP has a critical mission to protect the public health from tobacco-related disease and death and is regulating products that have no inherent benefit and huge societal costs, it is a government regulatory program with a duty to run efficiently, fairly, and transparently. This responsibility to function as an effective product regulator should be captured in the Center’s mission, vision, and goals and carried out to the best of the Center’s ability.
    • The panel recognizes that to improve the effectiveness of its application review, the Center should make process improvements and identify and address the policy and scientific questions that underpin its regulatory framework.
    • CTP needs to work with other entities on strategies to clear the market of illegal tobacco products more rapidly and provide more transparency to the public on its efforts to do so. This work is challenging but essential as CTP adopts a more strategic approach. While there is much the Center can do on its own, the panel notes that enforcement of the premarket requirements in the tobacco laws, particularly to help prevent youth use of tobacco products, requires the involvement and support of agencies other than FDA. The authors encourage the agency to elevate this issue and pursue a more comprehensive approach that leverages the resources of other agencies with a declared role in tobacco control.

    “Overall, the panel is confident that many of the concerns raised in this report can be addressed by CTP’s
    talented and dedicated staff, with the support of FDA leadership,” the report states.

    Numerous comments from purported staffers of the FDA for the Reagan Udall assessment claimed the regulatory agency is in a state of disarray and being influenced by outside forces, not scientific research. One comment stated that reviewers of premarket tobacco product applications (PMTAs) in the CTP Office of Science (OS) lack the autonomy to exercise “best scientific practices” in their reviews of PMTAs. The report fails to address these issues.

    The panel was comprised of former federal public health leaders, regulatory strategists, and process improvement specialists. Lauren Silvis, served as chair of the group, which included Jane Axelrad, Keith Flanagan, Charlene Frizzera, and Alberto Gutierrez.

    “The panel provided recommendations to help the Agency’s tobacco program strengthen its operations as it works to reduce the harm associated with tobacco use,” said Lauren Silvis. “The Center for Tobacco Products has made significant progress in establishing a regulatory program for tobacco products and our recommendations are intended to help the Center develop additional tools for achieving its public health objectives.”

    Through multiple listening sessions, interviews, and an online portal, the group received and carefully reviewed input from a range of stakeholders, including FDA staff and the public, according to the report. The author’s claim the report offers “cross-cutting and program-specific recommendations” for the FDA to consider, “focusing on regulations and guidance, application review, compliance and enforcement, and communication with the public and other stakeholders.”

    The report did not address tobacco policy issues, which are outside the scope of the evaluation, according to a Reagan-Udall Foundation.

    One industry stakeholder, who asked not to be named for fear of retribution from the FDA for its brands under PMTA review by the agency, said the report’s findings were “a joke” and “completely ignorant of the real problems at the CTP.”

    Califf said Monday he will review the recommendations with the aim of outlining the agency’s next steps by February.

    Earlier this month, Reagan-Udall delivered its food report that was commissioned at the same time as the tobacco report. The food response suggests the agency’s leadership be restructured to improve its response to emergencies, including the recent shortage of baby formula

    Reagan-Udall was created by Congress to help further FDA’s mission. The non-profit receives funding from both the FDA and the industries it regulates, including drugmakers.

    The report can be found at reaganudall.org.

  • Ohio Governor Expected to Veto ‘No Flavor Bans’ Bill

    Ohio Governor Expected to Veto ‘No Flavor Bans’ Bill

    Credit: Andy Dean

    It doesn’t look good. Ohio Gov. Mike DeWine appears primed to veto a bill just passed by the state legislature that would prohibit cities like Columbus from regulating vaping and other tobacco products.

    DeWine told ABC 6 On Your Side he supports the Columbus ordinance passed Monday banning the sale of flavored vaping and other tobacco products.

    “Making a decision not to have flavored cigarettes is a logical decision that will save many, many lives and will save taxpayers a lot of money,” the governor said. “Smoking costs the citizens of Ohio hundreds and hundreds of millions of dollars every single year.”

    The day after the Columbus tobacco ban passed, Republicans who control the legislature added a proposal to an unrelated bill mandating that only the state can regulate tobacco products in Ohio. The bill would wipe out attempts by local governments such as Columbus to rein in the use of tobacco products.

  • Ohio Senate Passes Ban on Cities Enacting Flavor Bans

    Ohio Senate Passes Ban on Cities Enacting Flavor Bans

    Credit: Lucitanija

    The Columbus City Council in the U.S. state of Ohio voted unanimously in favor of banning the sale of flavored tobacco and vaping products within city limits on Monday, Dec. 12. Then on Wednesday, the Ohio Senate approved a bill that would make what the Columbus City Council did illegal.

    The Ohio Senate passed H.B. 513 by a vote of 23-8. It includes an amendment that will prohibit local governments in Ohio from enacting any laws regarding tobacco or vaping products that are stricter than state law, a mechanism known as preemption, according to Halfwheel.

    Because of this amendment, the bill now heads back to the Ohio House of Representatives, where it must be approved before heading to the desk of Gov. Mike DeWine. Reports indicate the House vote is expected this week.

    If approved, the state law will effectively void the law passed by the Columbus City Council on Monday. The Columbus city law is set to take effect on Jan. 1, 2024.

    Preemption clauses have been a successful tool in blocking bans on the sales of flavored vaping and other tobacco products. To the east of Ohio, the City of Philadelphia lost a federal lawsuit that overturned its flavored tobacco ban due to Pennsylvania’s preemption clause.

  • New Report Finds FDA Fails in Enforcing MDOs

    New Report Finds FDA Fails in Enforcing MDOs

    Photo: Postmodern Studio

    The U.S. Food and Drug Administration has failed to follow through after issuing warning letters to online tobacco products and vapor product sellers, according to a report by the Health and Human Services Office of the Inspector General (OIG).

    Between 2010 and 2020, the FDA issued warning letters to 899 online retailers but “took no enforcement actions,” according to the report.

    The FDA enforcement schedule, as of March 2022, calls for the following actions: first violation—warning letter; second violation within a 12-month period—fine of up to $320; third violation within a 24-month period—fine of up to $638; fourth violation within a 24-month period—fine of up to $2,559; fifth violation within a 36-month period—fine of up to $6,398; sixth violation within a 48-month period—fine of up to $12,794; and five or more repeated violations within 36 months—no-tobacco-sale order of 30 calendar days or six months or permanent.

    The OIG report criticizes the FDA’s lack of transparency, which it says makes it hard to track the FDA’s performance. The report suggests that the FDA collaborate with the Bureau of Alcohol, Tobacco, Firearms and Explosives on oversight of online tobacco retailers; complete its rulemaking on non-face-to-face sales of tobacco products as required by the Tobacco Control Act; collect data to support process and outcome measures for its oversight of online tobacco retailers; and publish information and performance data on its oversight of online tobacco retailers.

    In a response, the FDA did not dispute a lack of enforcement actions and agreed with the first and fourth suggestions, stating it is in the process of making those changes. The organization was noncommittal regarding the other two suggestions.

    The OIG report is separate from the Reagan-Udall Foundation review of the FDA’s Center for Tobacco Products.

  • New Zealand Passes Combustible Tobacco Endgame

    New Zealand Passes Combustible Tobacco Endgame

    Credit: ViDi Studio

    The New Zealand Parliament today adopted the Smokefree Environments and Regulated Products (Smoked Tobacco) Amendment Bill, which is expected to phase out combustible tobacco product use in the country.

    “Today, history was made for public health and for the generations of families who have lost loved ones to the preventable diseases caused by ordinary tobacco use,” said Action on Smoking and Health (ASH) Executive Director Laurent Huber. “New Zealand has single-handedly changed the course of what is possible in tobacco regulations and we stand ready to help other jurisdictions follow their groundbreaking lead.”

    The concept, called “Smoke-Free Generation” (SFG), can also be characterized as a sales ban with a grandfather clause for existing adults who smoke, according to a press release.

    New Zealand will be only the third government to pass such a law, following Balanga City in the Philippines – which has been unable to implement the law due to litigation – and Brookline, Massachusetts, which implemented a similar law (tobacco-free generation) in January 2021 and successfully defended an industry lawsuit in October 2022.

    Unlike New Zealand, Balanga City and Brookline banned sales to anyone born this century, and included all tobacco products (including e-cigarettes and snus), rather than a focus on combustibles.

    “It’s important to stress that the Smoke-Free Generation law applies only to sales of combustible tobacco,” stressed Huber from ASH, which has endorsed SFG for years. “The law does not outlaw individual purchase, possession or use – or the act of smoking. The problem here is the tobacco industry, not their victims.”

    The second leg of the law is a drastic reduction in the number of retailers – researchers estimate that the final reduction may be as much as 95 percent. Finally, the new law includes reducing nicotine content in cigarettes to below-addictive levels, according to the release.

    Hong Kong Health Minister Lo Chung-mau confirmed that banning tobacco sales for future generations will be on the table as a tool to further reduce youth smoking, according to the South China Morning Post. The Malaysian government is also pushing forward a bill that seeks to ban vaping and smoking for those born from 2007, after making amendments following resistance from some lawmakers.