Author: Staff Writer

  • Proposed EU Vape Tax Needs to be Done Properly

    Proposed EU Vape Tax Needs to be Done Properly

    Unless properly structured, Europe’s tobacco and vapor tax plans may not achieve their public health objectives.

    By Stefanie Rossel

    The European Commission’s (EC) December 2022 proposal for an update to the 2011 EU tobacco excise directive came with a first: In addition to a significant hike in cigarette excise rates, the draft also calls for a bloc-wide vaping levy.

    According to the proposal, the current minimum EU excise tax rate of €1.80 ($1.92) should increase to €3.60 per pack of 20 cigarettes. This would double excise duties in member states with low cigarette taxes (in eastern European countries, a pack of cigarettes can currently sell for under €3) and affect excise duties in countries such as Luxembourg and Austria, where cigarette prices are low relative to income. The EU hopes to generate an additional €9.3 billion in revenue from the tax harmonization, which would be a welcome windfall for pandemic-struck and inflation-struck member states. If enacted, the proposal would also increase taxes on hand-rolled tobacco.

    E-cigarettes with less than 15 mg of nicotine per milliliter of liquid would attract a 20 percent excise duty, and stronger products would be subject to a duty of at least 40 percent. In the EU, nicotine content of e-liquids is limited to 20 mg per milliliter. According to the draft proposal, heated-tobacco products (HTPs) would attract a 55 percent excise duty, or a tax of €91 per 1,000 items sold.

    The proposed legislation would harmonize the fragmented EU vapor market, where each member state taxes vapor and HTP products at its own rates. It is part of a push aimed at accelerating the reduction of smoking rates throughout the EU. As part of the common market’s Beating Cancer Plan, introduced by the EC in February 2021, health officials seek to lower the current EU smoking prevalence of 26 percent to 20 percent by 2025 and achieve a “tobacco-free generation”—that is, a smoking rate of below 5 percent—by 2040.

    The draft was released only weeks after the EC imposed a ban on flavored HTPs to cut the growth in demand among younger consumers. Responses were mixed. While some argued that union-wide taxes are necessary because less harmful products still present risk, tobacco harm reduction advocates warned for unintended consequences.

    Too High, Too Complex

    David Sweanor

    “Simply increasing cigarette taxes is a blunt instrument when trying to reduce the health toll from cigarette smoking,” says David Sweanor, adjunct professor of law at the University of Ottawa in Canada. “It is far more powerful than other standard anti-smoking measures but has limitations and constraints that are often overlooked. Price sensitivity is real, but many people who smoke cigarettes will seek to deal with increased costs through access to contraband, the cross-border trade, simply changing the way they smoke without achieving health improvements, or further diminishing their overall well-being by redirecting expenditures from healthier purchases to the purchase of cigarettes.”

    Taxing low-risk alternatives reduces the incentive to switch from cigarettes and can make illicit cigarettes more competitive, according to Sweanor. In his view, it is akin to making alcoholics who give up drinking by taking up jogging pay a tax on running shoes. “It misses the point of how taxes can be justified due to the relative health impact of certain behaviors,” he says.

    Dustin Dahlmann

    Dustin Dahlmann, president of the Independent European Vape Alliance, believes that EU policy should be guided by scientific evidence. “Science around the world agrees that vaping is significantly less harmful than smoking,” he says. “E-cigarette taxes that are too high [to] prevent socially disadvantaged groups in particular from switching to e-cigarettes. In the first instance, there should not be excise duties for electronic cigarettes, as they are a means for smokers to switch to less harmful alternatives. If further harmonization of excise duties is considered, legislators should take into account the significant differences in risk profile between tobacco cigarettes and electronic cigarettes and apply the excise duties methodology accordingly, i.e., proportionality to the harm reduction benefits brought about by tobacco replacement products.”

    In practice, this would mean a maximum excise duty of €1 per 10 mL or €0.10 per 1 mL of e-liquid, and it should be applied only to e-liquids with nicotine, according to Dahlmann. “The EU draft imposes a combination of an ad valorem and a specific volume base excise that would be an administrative burden for small and medium enterprises and fiscal authorities due to the additional complexity. Giving two options will lead to uncertainty, defeating the purpose of a harmonization of excise rates.”

    Illicit Trade Could Increase

    The question about how the EU’s revised tobacco tax directive would impact the illicit cigarette market is justified. The experience of France provides a cautionary tale. Following a tax increase of almost three times the EC’s minimum level, the illicit market in that country more than doubled, from 13.7 percent in 2017 to 29.4 percent in 2021, leading to an estimated loss of €6.2 billion in tax revenues in 2021, according to a KPMG report. In general, the study found, illicit consumption in the EU increased by 3.9 percent, or 1.3 billion cigarettes, in 2021, which corresponds to a loss of €10.4 billion in taxes.

    How the suggested excise duty increase would impact markets with relatively low income and high smoking levels, such as Greece (42 percent smoking prevalence) and Bulgaria (38 percent), is anybody’s guess. “I have worked globally on illicit trade issues for decades,” says Sweanor. “There is much we can do to limit the trade, but the economics makes [illicit cigarette trade] so lucrative that it is hard to imagine bringing it under control so long as there remains a significant market for cigarettes. Markets meet needs, including illicitly. Cigarettes are extraordinarily inexpensive to make, and taxes and the huge profit margins of Big Tobacco create a business opportunity many people can be expected to see as a money spinner. The real answer is to facilitate disruptive technology that makes cigarettes as undesirable to consumers as unsanitary food or leaded petrol.”

    To achieve the latter, the EC would have to acknowledge the harm reduction and smoking cessation potential of novel tobacco products. In February 2022, the EU Parliament became the world’s first elected chamber to endorse THR when it adopted a resolution on cancer prevention and treatment that notes that e-cigarettes “could allow some smokers to progressively quit smoking.” Dahlmann praised the move as a “landmark declaration” that would help reassure smokers of the benefits of switching to vaping. “All other EU institutions—and in particular the European Commission—should take this on board and ensure that policy follows science, not the other way around,” he said at the time.

    Sweanor is less upbeat. “The taxation of low-risk products reflects an understanding of differential risks. But it fails to come to terms with the full magnitude of the harm from cigarette smoking and the enormous potential to dramatically reduce it. When we are looking at hundreds of thousands of annual deaths, surely it is a public health emergency—and policies should reflect that. Language such as “could allow some smokers…” and policies that limit the relative acceptability of low-risk alternatives indicate that the extent of the public health opportunity is not fully grasped.”

    Differentiated Approach Required

    Whether the EU is prepared to part ways with anti-novel nicotine product sentiment of the World Health Organization Framework Convention on Tobacco Control (FCTC), which the common market has ratified, remains to be seen.

    “The EU is obligated to support tobacco harm reduction as a signatory to the WHO’s FCTC as stipulated in the introduction, article 1 (d) of the treaty,” says Dahlmann. “The FCTC requires the EU to not only allow reduced-risk products but to actively promote them. However, this definition is not actively supported by the WHO. The rule here is much more ‘quit or die.’”

    “The WHO’s FCTC process has followed in the footsteps of narcotics protocols in being hijacked by ideologues who seek an abstinence-only approach on drugs where total abstinence is simply not a viable nor a humane goal,” Sweanor adds. “As with those narcotics protocols, caring governments that follow the Enlightenment principles of science, reason and humanism will either creatively skirt such guidelines or simply ignore them. This is something we are now seeing unfolding globally with cannabis policies.”

    The goal of the new tax directive to create a smoke-free European society, he says, is noble and achievable—and far more quickly than envisioned in that 2040 goal. “But it requires bold rather than tentative steps. Policymakers should act in ways consistent with cigarette smoking being a public health crisis of enormous importance,” says Sweanor. “The best way to tackle this is by use of cross-elasticities, of empowering and facilitating people who smoke cigarettes to make healthier choices. This is accomplished by measures such as the widest possible cost differential between lethal cigarettes and low-risk alternatives. Given the horrendous death and disease tool from cigarettes, this should be a huge priority.”

    “E-cigarettes need to remain accessible and affordable to smokers from all socioeconomic backgrounds who wish to quit smoking,” says Dahlmann. “E-cigarettes offer smokers an alternative that is 95 percent less harmful than smoking. Switching from tobacco to vapor has positive individual, social and economic implications and should be encouraged, not penalized by the tax system. If taxes make vaping more expensive than smoking, many smokers will lose an incentive to switch to the much less harmful alternative. We therefore would see no chance of achieving the EU’s ambitious goals.”

    Before it is enshrined in law, the proposal will have to be agreed on by all EU member states. BAT already noted that this is merely the beginning of a long legislative process. “I assume there will be amendments, but we do not yet know their likely nature,” says Sweanor. “The proposal could be changed to help facilitate a rapid public health breakthrough as people abandon lethal cigarettes in huge numbers. Or it could be amended to make that a pipe dream.”

    This article first appeared in Vapor Voice‘s sister publication Tobacco Reporter.

  • Hong Kong Begins Ban on CBD, Same Penalty as Heroin

    Hong Kong Begins Ban on CBD, Same Penalty as Heroin

    Credit: Proxima Studio

    Once legal in the city, Hong Kong began enforcing its ban on CBD, labeling it as a “dangerous drug” and imposing harsh penalties for its possession on Wednesday. The move is forcing fledging businesses to shut down or revamp.

    THC, the psychoactive ingredient of marijuana has long been illegal in Hong Kong.

    CBD was once legal in the city, and cafes and shops selling CBD-infused products were popular among young people, according to AP.

    But all that has changed with the prohibition, which took effect Wednesday but had been announced by the government last year. CBD-related businesses have closed down while others have struggled to remodel their businesses. Consumers dumped what they saw as a cure for their ailments into special collection boxes set up around the city.

    The new rule reflects a zero-tolerance policy toward dangerous drugs in Hong Kong, a semi-autonomous southern Chinese business hub, as well as in mainland China, where CBD was banned in 2022.

    In contrast. the U.S. Food and Drug Administration recently concluded that a new regulatory pathway for cannabidiol (CBD) is needed. The regulatory agency states it will seek guidance from the U.S. Congress. The new rules would need to balance individuals’ desire for access to CBD products with the regulatory oversight needed to manage risks.

  • CTP to Release Reagan-Udall Response in February

    CTP to Release Reagan-Udall Response in February

    The Head of the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) said in a perspective released today that the Center recently received the findings from the Reagan-Udall Foundation’s independent evaluation of its program and is in the process of closely reviewing the feedback. In February, the Center will provide an update on its planned actions in response to the evaluation.

    When the Reagan-Udall Foundation submitted its recommendations to Robert Califf, commissioner of the FDA, in December, the report concluded that vaping industry stakeholders observed a lack of “consistent implementation” of what the industry understood to be the policies of the CTP, particularly with respect to tobacco harm reduction and the requirements needed to navigate the PMTA process.

    CTP Director Brian King also announced the Center has accepted for review more than 8,600 marketing applications for synthetic products. In a recently released perspective, King said the center received more than 1 million premarket tobacco product applications (PMTAs) from 200 companies by May 14, 2022.

    “FDA has also issued refuse-to-accept (RTA) letters for more than 925,000 products in applications submitted by May 14 that do not meet the criteria for acceptance,” King wrote. “The RTA letters state that it is illegal to sell or distribute the product in the U.S. marketplace without a premarket authorization.”

    Brian King / Credit: FDA

    He also stated that in 2022, CTP participated in 52 meetings with stakeholders – averaging one per week – including 25 meetings since King became director. King also stated that starting when the FDA was given the authority by Congress to regulate non-tobacco nicotine products in April 2022, the CTP has issued more than 75 warning letters to manufacturers through Jan. 20, 2023, including manufacturers of brands popular among youth, such as Puff Bar.

    “We have also issued over 585 warning letters to retailers for the sale of non-tobacco nicotine products to underage purchasers as of December 2022. In October 2022, the U.S. Department of Justice (DOJ), on behalf of the FDA,” filed complaints for permanent injunctions in federal district courts against six e-cigarette manufacturers that failed to submit PMTAs and continued to sell products,” wrote King.

    In a court filing last week, the FDA stated it will take until possibly December 31, 2023, before it completes the PMTA review process for some of the most popular vapes on the market.

    Much like an earlier op-ed this year, King does not address memos recently submitted to the U.S. Court of Appeals for the Third Circuit that show King reversed a recommended marketing approval of Logic Technology’s menthol vaping products, ignoring the advice of FDA scientists, according to Logic’s lawyers. 

    King also failed to address the conclusion of a recent investigation conducted by the  U.S. Office of Special Counsel that found the CTP had relaxed its standards of review for certain tobacco products and stifled attempts by its scientists to raise concerns.

  • German Industry Group Blasts Call for Vaping Ban

    German Industry Group Blasts Call for Vaping Ban

    Jan Muecke
    (Photo: German Association of the Tobacco Industry and Novel Products)

    Recent calls to ban e-cigarettes lack a scientific basis, according to the German Association of the Tobacco Industry and Novel Products (BVTE).

    In a recent interview with Deutsche Presse-Agentur, Manne Lucha, minister of social affairs, health and integration for Baden-Württemberg, said that e-cigarettes should be treated the same as combustible cigarettes and that flavored vapor products should be banned.

    “It is a scientific consensus that the intake of harmful substances when vaping e-cigarettes is much lower than when smoking tobacco. With his ‘post-factual’ statements, the minister is causing consumer uncertainty with counterproductive consequences for health policy,” said BVTE CEO Jan Muecke in a statement.

    Muecke cited a 2020 statement by the German Cancer Research Center, which acknowledged that a complete switch from smoking to vaping reduces the consumer’s exposure to harmful substances. He also quoted Public Health England’s finding that e-cigarettes are at least 95 percent less harmful than smoking.

    According to the BVTE, e-cigarettes are the most frequently used smoking-cessation tool in Germany, ahead of less effective methods such as medical nicotine replacement products. The wide choice of flavored liquids, meanwhile, is a significant factor for adult smokers to switch to vaping, the organization wrote.

    “Instead of fueling fears with false claims and misguided demands for bans, e-cigarettes should finally be promoted in Germany as an opportunity to minimize risks for smokers,” Muecke said.

  • Judge Lowers Royalty Payments in Vuse Alto Suit

    Judge Lowers Royalty Payments in Vuse Alto Suit

    Photo: RJRVC

    A U.S. federal judge in North Carolina lowered the rate of ongoing royalties R.J. Reynolds Vapor Co. will have to pay to Altria Client Services in an intellectual property dispute involving RJR’s Vuse Alto e-cigarette, reports Law360.

    In September 2022, the U.S. District Court for the Middle District of North Carolina awarded Altria Client Services more than $95 million after finding that Reynolds Vapor Co.’s Vuse Alto e-vapor product infringed three Altria patents.

    In his Jan. 27 opinion, U.S. District Judge N. Carlton Tilley Jr. ruled that continuing royalties on Vuse Alto are justified but not at double the rate decided by the jury.

    The opinion lowers Altria’s requested rate for ongoing royalties from 10.5 percent to 5.25 percent, which Reynolds will have to pay quarterly until the last of Altria’s patents expire on April 22, 2035.

    “Altria has not shown that the pod patents’ contribution to the Alto’s performance since May 2019 justifies increasing the jury’s royalty rate of 5.25 percent,” Judge Tilley wrote.

    Earlier this month, Judge Tilley denied Reynolds a new trial in the Vuse Alto dispute.

    Reynolds Vapor Co. has requested a new trial, stating that “Altria’s improper injection of inflammatory evidence regarding patent infringement allegations against Reynolds in other cases denied Reynolds a fair trial.”

  • FDA Says PMTA Reviews to Take Until End of Year

    FDA Says PMTA Reviews to Take Until End of Year

    Credit: F Armstrong Photo

    In a court filing this week, the U.S. Food and Drug Administration stated it will take until possibly December 31, 2023, before it completes a premarket tobacco product application (PMTA) review process for some of the most popular vapes on the market.

    Upon being informed of the delay, Senator Dick Durbin of Illinois began demanding the FDA act immediately in removing e-cigarettes and vaping products from store shelves saying the agency has ignored a court order requiring them to take action by September 2021.

    “On Tuesday, in a stunning filing to the federal judge, the Food and Drug Administration disclosed that it will take another six-month delay in fulfilling the public health duty announced by the court years ago. That the Food and Drug Administration will not finish reviewing applications for the most popular e-cigarettes until the end of 2023, is another outrageous delay,” said Durbin. “How can this federal agency knowingly, willingly ignore this court order to protect America’s children?”

    Durbin, who has repeatedly urged FDA to complete the premarket review of e-cigarettes, called on FDA to use its authority to swiftly remove any and all unreviewed vaping products from store shelves for the safety of American consumers.

    “While the FDA has dithered, dallied and delayed, more than one million of America’s kids have started vaping,” Durbin stated this week calling on the agency to obey the court order. “Not next year. Not next month. Immediately. Today,” Durbin stated in a release.

  • County in Oregon Suing to Undue Flavored Vape Ban

    County in Oregon Suing to Undue Flavored Vape Ban

    Multnomah County in the U.S. state of Oregon in December passed a law banning the sale of flavored tobacco products. Opponents of the ordinance filed a lawsuit in county circuit court Jan. 26, seeking to block the ban.

    The plaintiffs, 21+ Tobacco and Vapor Retail Association of Oregon and a smoke shop called Division Vapor, argue that state law “specifically authorizes the licensed sale of tobacco products and inhalant delivery systems statewide” and that Multnomah County lacks the authority to ban the sale of flavored products used for vaping and in hookahs, according to Willamette Week.

    The ban is scheduled to go into effect in January 2024.

    “Plaintiff Division Vapor requires that anyone entering its store be at least 21 years old and has signs posted at the entrance stating this requirement,” the lawsuit says. “Division Vapor vigorously enforces its restrictions prohibiting entry of underaged individuals.”

    The lawsuit follows an earlier effort by tobacco sellers in Washington County to overturn a ban passed by the board of commissioners there. In that case, a Washington County circuit judge ruled the county didn’t have the authority to issue such a ban. Multnomah County officials say that ruling has no bearing on their ban.

    Lawmakers in Oregon recently introduced a new bill that would end the sale of flavored vaping and other tobacco products across the state.

  • Hardware Must Adapt to E-Liquids After Flavor Bans

    Hardware Must Adapt to E-Liquids After Flavor Bans

    Concept Photo of Huachengda Precision cotton products (Credit: Huachengda Precision)

    Flavor bans are challenging e-liquid and hardware manufacturers to produce adaptive products.

    By Ellesmere Zhu, 2Firsts

    Since China’s e-cigarette control measures took effect on Oct. 1, 2022, consumers can legally purchase only tobacco-flavored vapes in that country. Meanwhile, on the other side of the globe, several U.S. states and cities have banned flavored e-cigarettes. The European Union passed a ban on flavored heated-tobacco products recently, perhaps signaling what may come for flavored e-cigarettes. The once wide range of flavored electronic nicotine-delivery system (ENDS) products is now rapidly narrowing.

    Many industry insiders believe the move to ban flavors could expand globally, pushing tobacco flavors into the mainstream market. The current wave of tobacco flavors are testing the tolerances of both e-liquids and the hardware (vaporizers). Manufacturers are now challenged with producing a flavor that customers are willing to purchase and enjoy in markets where any flavor other than tobacco is outlawed.

    Reproducing the taste of traditional tobacco in an e-cigarette is no easy matter. It is one of the major hurdles that many enterprises are working on currently. The key to emulating the flavor and taste of traditional tobacco is the vaporizer (coil), a core component of any e-cigarette product. If a vaporizer manufacturer wants to tackle the flavor challenge, it must focus on hardware and software strength.

    Technical Troubles

    In the face of the global trend of enforcing tobacco-only flavors, e-cigarette manufacturers are having a difficult time making the transition. Most manufacturers rely on diluted tobacco flavors to help customers who have traditionally preferred fruit flavors through the transition, which results in the homogenization of tobacco-flavored vapes. This has many manufacturers trying to determine what features are necessary for a true tobacco flavor. Complicating the issue, no country regulates which combination of flavors make up a tobacco flavor nor how a tobacco flavor should taste.

    A representative from Shenzhen Huachengda Precision Industry Co., a global vaping manufacturer specializing in R&D, says that any juice aiming to achieve a global presence must have several characteristics. High recognition, rich fragrance and superior taste are the key to building memorable experiences for customers while dry burning, burnt core, condensation and exploding juice (spitback) are issues to avoid.

    Ceramic wick surface under electron microscope

    The vaporizer, meanwhile, should have a stable structure, which can be achieved by proper assembly and material selection. An unstable liquid absorption rate causes dry burning and burnt cores while unstable heating leads to inconsistency of taste.  

    Currently, the two most popular vaporizer materials on the market are ceramic wick and cotton wick. The current ceramic wick is hard in texture and easy to assemble, but due to technical limitations, its fine and small-size pore textures result in unstable liquid discharge as the juices with a higher viscosity (such as tobacco flavors) cannot flow through smoothly, according to Chen Ping, CEO and chief engineer for Huachengda.

    Cottonwick surface under electron microscope

    In comparison, the cotton wick is fully permeable and has a larger pore size, which allows the juice to pass smoothly (see Figure 2). However, for all cotton wicks offered on the market today, there is a risk of the wicking being burnt if the temperature on the device is set too high.

    “There is a great difference between the characteristics of tobacco-flavored and fruit-flavored e-liquids. If we apply the vaporizer designed for fruit flavor to tobacco flavor, the taste performance and performance of the core is completely different, really an unsatisfactory reproduction of the tobacco flavor,” says Chen. “Taking into consideration the different features between tobacco-flavored and fruit-flavored juice, Huachengda has come up with optimized tobacco flavor through its vaporizers. Ideally, different flavors of juice require different vaporizers, just like one key can only open one lock.”

    The Next Generation

    After the instability issues are resolved, manufacturers like Huachengda must still find the proper hardware to truly unleash the authentic tobacco flavor in e-liquids. To this end, Chen says his company has invested heavily in R&D. The vaporizer’s structure, materials, formulations and heating element must all be optimized, he explains.  

    For example, the previous generation of vaporizers were heated by wires, causing overheating, scorching and even burning. However, the heating element comprising a mesh coil can heat the core evenly, thus producing a richer vapor. It has a solid structure that is not easy to burn off, and the flavor can still be maintained at the initial level of quality over long periods of use, according to Chen.

    Looking forward on the path of innovation, Huachengda has been developing its new “fiber wick” for which the company applied for a patent in 2021. The manufacturing process of the fiber core is to break the fiber into a pulp and then “stick it together” with a binder to ensure the consistency of the material while improving uniformity, stability and vaporization, according to the company.

    However, there is still room for improvement in this technology. When mixed with e-liquid, the fiber wick will absorb the juice and expand gradually. This affects the liquid absorption speed. More performance and material testing are needed before the technology can be applied on a mass scale. As for now, Huachengda has COTTONX, a larger coil that is suitable for disposable e-cigarettes, and its still-in-development fiber wick, a smaller, more compact coil suitable for pod system ENDS products.

    “Improving the user experience has always been the focus of the entire industry,” says Chen, adding that a good example is how cotton dividers on the edge of coils were designed to prevent leakage; however, consumers complain of waste because it would absorb some of the liquids. The need to limit wasted e-liquid has spurred further innovation.

    The development of the vaporizers differs from that of the microchip, clarifies Chen. “For chips, from 10 nm [nanometers] to 5 nm to 2 nm, the smaller the better,” he says. “But for vaporizers, the development direction is still to be explored. We need to develop and customize the products according to specific laws and regulations and user needs in a decentralized manner. This means that only manufacturers with a large pool of technology reserves and strong R&D can go far in this industry.”

    Exterior view of Huachengda, a global professional vaporizer manufacturing base
  • Juul2 Wins UK Retailer’s Product of the Year Award

    Juul2 Wins UK Retailer’s Product of the Year Award

    Taking Retail’s Product of the Year 2023 for the Vaping and Heated Tobacco Products category has been awarded to Juul Labs’ new Juul2 system following an independent nationwide survey of 8,000 adult consumers.

    Juul2 was launched in April 2022 following a successful pilot launch on the brand’s website, according to Talking Retail. The rechargeable pod-based system was updated from previous versions with new technologies and features, which the brand said includes the capability to combat potentially harmful and compatible pods.

    “We are extremely proud that our commitment to product quality and innovation has been recognized by the voters who awarded Juul2 this accolade,” said Efe Abebe-Heywood, senior director of communications and brand at Juul Labs UK. “Our new Juul2 system has marked a step change in vapor technology, providing adult smokers with a product that more closely resembles the consistency and experience of combustible cigarettes to support them on their switching journey.

    “Smoking remains the leading cause of preventable death and disease in the UK, and we remain committed to our mission at Juul Labs to transition even more adult smokers from cigarettes, while combating underage use.”

    The award also coincides with the launch of a new Juul2 Blackcurrant Tobacco variant – a classic tobacco flavor with ripe blackcurrant notes, which further extends the Juul2 portfolio in the UK.

    The new Blackcurrant Tobacco Juul pods launched on the brand’s website in January and will be rolled out across all major retailers nationally from early February.

    In the U.S., Juul2 is under review by the U.S. Food and Drug Administration.

  • FDA Authorizes Three New Heated Tobacco Products

    FDA Authorizes Three New Heated Tobacco Products

    The U.S. Food and Drug Administration today authorized the marketing of three new tobacco-flavored heated tobacco products included in Philip Morris Products S.A.’s supplemental premarket tobacco product applications (PMTAs).

    The products receiving marketing granted orders are Marlboro Sienna HeatSticks, Marlboro Bronze HeatSticks, and Marlboro Amber HeatSticks. 

    The three HeatSticks products are “heated tobacco products” (HTPs) used with the IQOS device.

    Based on FDA’s review of the supplemental PMTAs, the agency determined that the marketing of these products should be authorized because, among other things, the net population-level benefits to adult smokers outweigh the risks to youth. 

    In 2019, FDA authorized the marketing of IQOS and several other Marlboro HeatSticks products through the PMTA pathway. Philip Morris pursued marketing authorization for these new Marlboro HeatSticks by submitting supplemental PMTAs for modified versions and line extensions of the tobacco-flavored product for which the company had previously received a marketing granted order.

    A supplemental PMTA can be submitted in situations where an applicant is seeking authorization for a new tobacco product that is a modified version of a tobacco product for which they have already received a marketing granted order.  

    “Following FDA’s rigorous scientific evaluation of the applications, the agency determined that Marlboro Sienna HeatSticks, Marlboro Bronze HeatSticks, and Marlboro Amber HeatSticks are comparable to the previously authorized tobacco-flavored product,” according to FDA. “Like the previously authorized products, FDA has placed stringent marketing restrictions on the new products in an effort to prevent youth access and exposure.”