Blog - Tobacco Reporter

UKVIA Seeks Clarity on Advertising Notice

The U.K. Vaping Industry Association (UKVIA) is seeking clarification following the recent Committee of Advertising Practice (CAP) enforcement notice on the prohibition of vaping ads on social media.

The UKVIA is particularly concerned that “factual (nonpromotional) information” should only be made available to those who have “actively and specifically sought it out,” which would limit such content to social media accounts set to “private.”

The industry group is especially worried that this means factual posts, such as repeating evidence-based statistics such as vaping is 95 percent less harmful than smoking, for its annual VApril Vape Awareness Month will now be deemed unlawful.

“Around 40 percent of U.K. smokers wrongly believe that vaping is at least as harmful as, or even more harmful than, cigarettes, which suggests we need more evidence-based vaping facts on social media, not less,” the UKVIA wrote in a statement.

One of the main aims of VApril is to use both paid and organic posts on LinkedIn, X and Facebook to give facts to smokers to help them make informed decisions over how they consume nicotine.

The CAP says that after March 28, it will enforce restrictions under the Tobacco and Related Products Regulations 2016, which prohibit “ads that have the direct or indirect effect of promoting nicotine-containing electronic cigarette products” from being shown in most social media.

The Enforcement Notice says: “Electronic cigarette ads are prohibited in any online media where content is shared to users who have not specifically sought it out.

“This means paid-for display ads in all online space are prohibited, but it also means that regular, non-paid-for posts and content in social media, which might get shared by an algorithm to users, are prohibited too.”

The Advertising Standards Authority will hold a webinar on March 21 where the rules on social media vape ads will be explained.

March 4, 2024

U.S. Trade Commission to Probe ALD and Stiiizy

The U.S. International Trade Commission (ITC) will investigate oil vaporizing devices, components and products manufactured and sold by ALD Group and Stiiizy in response to patent violation complaints filed by Pax Labs.

Pax Lab has asked the ITC to issue a limited exclusion order and a cease and desist order.

In a note on its website, the ITC stressed that is has not yet made any decision on the merits of Pax Lab’s complaint. The ITC’s chief administrative law judge will now assign the case to one of the ITC’s administrative law judges, who will schedule and hold an evidentiary hearing. That judge will make an initial determination as to whether there is a violation of section 337 of the Tariff Act; that initial determination is subject to review by the Commission.

The ITC said it will make a final determination in the investigation at the earliest practicable time. Within 45 days after institution of the investigation, the ITC will set a target date for completing the investigation. ITC remedial orders in section 337 cases are effective when issued and become final 60 days after issuance unless disapproved for policy reasons by the U.S. Trade Representative within that 60-day period.

March 4, 2024

PMI Sued Over Zyn

In the first major legal challenge to oral nicotine pouches, a consumer has sued Philip Morris International over its popular Zyn brand, saying the product is addictive and harmful to young people, reports BNN Bloomberg.

The plaintiff, Bailey Wolters, alleges addiction and dental issues as a result of his Zyn use. The lawsuit says that the pouches deliver more nicotine than cigarettes, and that PMI benefits from “Zynfluencers” who promote the brand on social media.

The suit, which is seeking class-action status, also names as a defendant Swedish Match, which made the pouches before PMI bought it for $16 billion in 2022.

According to the plaintiff, the companies failed to warn consumers about the risk of addiction and other harmful effects like cognitive issues, cardiovascular injuries, gastrointestinal problems and gum disease.

PMI insists its pouches are intended only for existing users of nicotine products.

The case was brought by Schlesinger Law Offices, whose initial lawsuit against Juul Labs investors including Altria Group expanded into thousands of legal actions and led to Altria’s eventual settlement of $235 million.

March 4, 2024

FDA Urged to Follow the Science

The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) should open the marketplace for electronic nicotine delivery systems to products with varied characteristics so that those interested in alternative nicotine products can access them, according to R Street resident senior fellow Jeffrey Smith.

In a recently published analysis, Smith critiques the FDA’s disregard for the current research on ENDS, diving into new data that he says represents a “tectonic-shift in the academic medicine community” regarding the safety of ENDS for smoking cessation.

”As evidence grows for the utility of ENDS and other potentially life-saving alternative products, the CTP continues to limit Americans’ access to these products,” writes Smith.

“Though the CTP has received millions of applications for ENDS products, it has only allowed a few to be marketed legally in the United States. Of those that have received marketing clearance, only older closed systems have been approved—with tobacco as the only permitted flavor.”

Arguing that a diverse range of ENDS products available to those who smoke and want to quit is critical to reducing the health burdens associated with smoking, Smith urges the CTP to revise its processes and procedures, and allow more cigarette alternatives on the market. Continued delay by the CTP, he says, will only lead to more unnecessary deaths and disease in the United States.

March 1, 2024

Hong Kong to Push Pack Price Above HKD90

Hong Kong will hike the duty on cigarettes by HKD0.80 ($0.10) per stick, pushing the price of a pack of 20 cigarettes to HKD94, reports The Standard. The duty on other tobacco products will be increased by the same proportion.

Currently, a pack of cigarettes costs HKD78 after a 25.8 percent increase last year.

Finance Minister Paul Chan Mo-po expects the proportion of tobacco duty in the retail price of cigarettes to rise to about 70 percent, gradually approaching the 75 percent level recommended by the World Health Organization.

Chan believes this will provide the public with a greater incentive to quit smoking. He said the government will step up enforcement against illicit cigarette trading and strengthen smoking cessation services, publicity and education.

The Coalition on Tobacco Affairs expressed regret over the government’s decision to increase tobacco taxes without disclosing how last year’s price hike impacted the prevalence of smoking.

The coalition said the prior-year increase had exacerbated illicit cigarette activities with customs seizing a record-high 650 million cigarettes in 2023.

“This indicates how syndicates take advantage of Hong Kong’s high tobacco tax policy to control the sale of illicit cigarettes with the aim to provide funding to other criminal activities,” the coalition said in a statement.

March 1, 2024

Ireland Prepares Vape Tax

The government of Ireland is working to introduce a tax on e-cigarettes in 2025, reports The Irish Times.

Finance Minister Michael McGrath confirmed that his department had started work with the revenue department to announce the tax in the next budget and introduce it next year.

McGrath cited the vaping industry’s “insidious” targeting of e-cigarettes toward young people as justification for the tax.

“There’s no doubt, but it is a deliberate policy,” he was quoted as saying. “In my mind, what is happening when you see all the attractive flavors and names, it’s definitely targeting young people and very successfully.”

While acknowledging that e-cigarettes are helping some smokers quit more harmful combustible cigarettes, McGrath also noted that there are many unknowns about the long-term effects of e-cigarettes.

He said it was important for the Department of Finance’s proposed tax to align with policies of other departments around e-cigarettes and vapes, such as the Department of Health and the Department of Environment.

March 1, 2024

More FDA Warnings

The violations involve products sold under the Elf Bar/EB Design/EB Create, Funky Republic, Lost Mary brands.

The U.S. Food and Drug Administration has warned five more online retailers for selling flavored disposable vaping products.

On Feb. 28, the regulatory agency announced that the warning letters cite the sale of disposable e-cigarette products marketed under popular brand names such as Elf Bar/EB Design/EB Create, Funky Republic, Lost Mary, Hyde, Breeze and Cali Bars, according to a press release.

“Protecting our nation’s youth from the harms of tobacco products is crucial to our center’s public health mission,” said Brian King, director of the FDA’s Center for Tobacco Products in a statement. “We’re committed to continuing to use a data-driven approach to identify and prevent the sale of unauthorized tobacco products and to take compliance and enforcement action when appropriate.”

March 1, 2024

Cuba Festivalgoers Roll Cigars at Factories

Activities during the 2024 Habanos Festival usually only vary slightly. However, this year, attendees were allowed to roll a cigar alongside professional rollers at one of five factories. It marked the first time the festival hosted its master rolling class in the same buildings where Habanos cigars are produced.

Daymi Difurniao Rodríguez, communications and marketing specialist for Habanos, said that the venue change was to allow more attendees to learn firsthand about the “Totally by Hand” production process of a Habano.

“I wanted the press to make their own Habano so they could understand the details and intricacies involved in creating the Habanos, the world’s finest cigars,” she said.

The torcedor (cigar roller) who taught the El Laguito class was Ana Isel Mederos Cano, main quality specialist at El Laguito. She is also a nominee for the Habano Woman of the Year award in the production category for the XXIV Habano Festival currently taking place in Havana.

She has been at El Laguito for 25 years, 11 of them as a roller and the past 14 in her current position.

“I love that I have been given this opportunity to teach the art of cigar rolling to the representatives of media from around the world,” she told Tobacco Reporter.

The venue change was a welcome addition, according to several festival attendees. A seasoned festival media participant, Nicholas Syris of LH Cigars and several cigar podcasts, who also rolled at El Laguito, said the personal attention from the professional rollers helped festival goers learn the challenging art of rolling cigars better than in a large conference room setting.

“It was really good. It was a nice addition to the festival,” he said. “I would say many more people rolled a smokable cigar than previous editions of the festival.”

Visitors had the opportunity to visit La Corona, Partagás, H. Upmann and Carlos Baliño. El Laguito was for media only.

La Corona has about 750 employees, 300 of which are dedicated rollers. The rollers produce brands such as Hoyo de Monterrey, Montecristo, Cuaba, Diplomaticos and San Cristobal de la Habana.

At the H. Upmann Factory, H. Upmann, Montecristo, and Romeo y Julieta, and sometimes several sizes of Cohiba are produced. Partagas is one of Havana’s iconic factories and Carlos Baliño is the former El Rey del Mundo factory.

Tobacco Reporter was only permitted to attend El Laguito, the legendary home where many of Habanos’ premier marcas are produced.

Festival roller trainees were given a wooden board to roll, a “chaveta” tobacco leaf cutting blade, some vegetable glue, and an apron. Several factory rollers made rounds around the room helping festival attendees roll their cigars.

“I love this new idea,” said Brooks Whittington with Halfwheel, a major industry cigar information website. “While the rolling competition has always been a favorite part of the festival for me, getting to roll the cigars at the actual factory we were visiting took the experience to the next level.”

Many other attendees said they hope the tradition continues. The 2024 Habanos Festival is being held in Havana from Feb. 26 – March 1.

March 1, 2024

Green Pact

Filtrona partners with Greenbutts to expand its range of sustainable filter offerings.

By Stefanie Rossel

Discarded cigarette butts are a major source of plastic pollution. Of the more than 5 trillion cigarettes produced globally per year, an estimated 4.5 trillion end up in the environment, with 40 percent making their way into our oceans and waterways. Smokers often are unaware that the products will not decompose. While most of a cigarette’s components disintegrate quickly when disposed of, the filter will not. Around 98 percent of cigarette filters consist of cellulose acetate (CA), a polymer that is very slow to degrade in the environment. Depending on the environmental conditions, a CA cigarette filter can take up to 14 years to degrade.

While littering is illegal in many jurisdictions, the potential penalties, which can include fines, cleanup, community service or imprisonment, are insufficient to deter many consumers.

By banning single-use plastics, such as disposable plastic cutlery, fast food packaging or cups, from July 2021, the European Union became a forerunner in the fight against marine litter and plastic pollution with its Single-Use Plastics Directive (SUPD). While the legislation does not prohibit CA cigarette filters, it has established extended producer responsibility schemes (EPR) requiring tobacco companies to tackle the single-use plastic pollution generated by the filters they put on the market.

Although a February 2023 report by Rethink Plastic Alliance and other NGOs noted significant delays in implementation, the SUPD definitely helped trigger a rethink within the tobacco industry on the sustainability of its products. Experts believe that environmentally friendly filter solutions will be the next big thing in the industry, and they may be right.

In February 2022, the United Nations Environment Programme partnered with the Secretariat of the World Health Organization Framework Convention on Tobacco Control to raise awareness and drive action on the environmental and human health impacts of microplastics in cigarette filters, which it designated as a form of single-use plastic. One month later, the U.N. Environmental Assembly adopted a resolution to draft a legally binding U.N. treaty on plastic pollution, which addresses the full life cycle of plastic, from production to product design to waste management. Public health organizations around the world argue that the Intergovernmental Negotiating Committee for the plastics treaty, the fourth session of which will be held this April, must consider a ban or strict regulation of all single-use plastics as a necessary measure to reduce pollution.

Joining Forces

To meet the growing demand for biodegradable filters, Singapore-based specialty filter manufacturer Filtrona in October 2023 announced a partnership with Greenbutts of California. Greenbutts has developed a patented substrate and filters that are made of all-natural, food-grade fibers, such as abaca fiber, cotton flock and industrial hemp as well as a starch-based binder, which debuted on the market in 2019. The product is sold in bulk or as ready-made rods of filters and filter tips.

“Filtrona’s collaboration with Greenbutts strengthens our support for our customers in helping them shift away from CA to more sustainable materials,” says Filtrona CEO Robert Pye. “As a major supplier to this industry, we are committed to help companies move into more sustainable solutions while ensuring they get the supply. Filtrona will continue to invest in our equipment and technology as we continue our research in alternative materials. Together with our partners and suppliers, we are ready to help our customers make the transition to plastic-free filter solutions. We have expanded our portfolio by adding Greenbutts filters to our ECO Range portfolio, thus providing a wider array of tailor-made solutions to address specific customer requirements in certain territories/markets.”

According to Pye, Filtrona alone can currently not meet the volumes required for sustainable filter conversion. “Filtrona currently works with various suppliers to select the most appropriate materials to create sustainable filter solutions that meet the unique requirements of our customers. We are constantly scouting the market for new, innovative materials. To give our customers wider options, we will offer Greenbutts filters that can be customized according to various product specifications.”

Under the joint development agreement, Filtrona will lease a machine from Greenbutts to produce biodegradable filters using proprietary technology. The company aimed to have the machine at its site in Greensboro, North Carolina, USA, by the end of February and begin production shortly thereafter.

The U.S. has been chosen as a location because the state of New York recently reintroduced the Tobacco Product Waste Reduction Act to the State Senate. The act would prohibit the sale of cigarettes using single-use filters as well as ban the sale of single-use electronic cigarettes. “With New York having proposed a law that would ban the sale of single-use filtered cigarettes and single-use e-cigarettes, we believe North America will eventually follow the EU in implementing the SUPD and EPR in the future,” Pye says. “We want to be ahead of the curve while expanding our capabilities to make our ECO Range available globally.”

Significant Market Potential

For the time being, biodegradable filters remain more expensive than CA varieties, but this may change as output increases. “Globally, consumers and regulators are pushing for more environmentally sustainable solutions and biodegradable products,” says Pye.

“Consumers are increasingly seeking sustainable products while tobacco companies want to be compliant to regulations by reducing the use of single-use plastics and be the first to market sustainable, plastic-free products. But having said that, pricing is still an important factor and will be affected by the scale of production. As the production of biodegradable products grows, we expect prices to become more competitive.”

Beyond the U.S. and Europe, Pye sees potential for environmentally friendly filter solutions in Indonesia, where Filtrona is already supporting the kretek cigarette market with its ECO Range of filter solutions. He also anticipates increasing demand for sustainable filters for heated-tobacco products (HTPs). “We offer a range of patented sustainable HTP filter solutions that has a carbon footprint that is four times lower when compared with a similar offering made with CA, in line with our commitment to develop more renewable, degradable and sustainable products,” says Pye. “We see it as a logical next step for the HTP category to evolve as the market continues to grow rapidly. Filtrona is also at the forefront of revolutionizing the botanicals sector with our sustainable and compliant ECO Range.”

Stefanie Rossel is Tobacco Reporter’s editorial contributor. An experienced trade journalist, she combines sharp reporting skills with in-depth knowledge of the tobacco and vapor industries. Prior to joining Tobacco Reporter, Stefanie was editor-in-chief at Tobacco Journal International, where she worked for a decade. Fluent in English, German and French, Stefanie covers tobacco news around the world. She is based in Germany.

March 1, 2024

System Overload

The broken U.S. new tobacco product application process revealed by the numbers

By Steven McDonald

“How long will it take?” is a question often raised by project managers and executives alike. Typically, a reasonable estimate can be generated, but when it comes to predicting the time it will take for a review of a tobacco product application with the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP), any time estimate is met with skepticism.

The CTP provides performance metrics for new tobacco product applications, which were evaluated for this article to determine if the time an application meanders through the regulatory pathways could be deduced. The backlog of applications brings into question the agency’s capabilities of managing its processes and ability to conduct timely reviews. Unfortunately, the backlog distorts the CTP’s internal process data for reviews and obfuscates the time estimation for a submission. In addition, significant gaps in the data do not allow for robust deductions.

Following is an overview of the steps for the different regulatory pathways, the collection and evaluation of the CTP’s (performance) metrics and reporting data, and the ramifications thereof for future submissions. Readers should be aware that the CTP’s past performance may not be an indicator of future results.

Application Process and Performance Metrics

In 2009, Congress passed the Family Smoking Prevention and Tobacco Control Act, which gave the FDA broad authority to regulate the manufacturing, distribution and marketing of tobacco products. This includes decisions on whether new tobacco products can be marketed and evaluation of new tobacco product applications.

New tobacco products can be submitted for review through three pathways: substantial equivalence (SE), exempt from SE (EX), or premarket tobacco product application (PMTA). A fourth submission type, modified-risk tobacco product application, is not a pathway for new tobacco products but a pathway to obtain permission to make advertising “claims” specific to a particular product.

Historically, the applications accepted through the SE and EX pathways have been for cigarettes, smokeless tobacco and roll-your-own products. In August 2016, the FDA’s tobacco authority was extended to all “deemed” tobacco products, including electronic nicotine-delivery systems (ENDS), cigars, hookah and pipe tobaccos. In addition, in 2022, Congress passed a law clarifying the FDA’s authority to regulate tobacco products containing nicotine from any source (nontobacco-derived nicotine (NTN)). The vast majority of applications in the PMTA pathway have been for ENDS. Both the deeming rule and the NTN law led to a crushing number of new product applications submitted to the FDA in 2020 and 2022, respectively.

The CTP posts the estimated number of submissions that are currently at each step on a somewhat regular basis and then publishes the totals for the fiscal year. Unfortunately, the level of detail provided and the frequency for the updates has not been consistent. However, by making use of the currently available information (through fiscal year 2023), annual values for the process steps can be estimated. The data and information, primarily gathered from the Tobacco Product Applications: Metrics and Reporting webpage was collected and compiled for SE, EX and PMTA submissions. For new tobacco product applications, the procedures for the SE and EX pathways are identical, and the PMTA pathway includes an additional step: acceptance review, filing review (PMTA only), scientific cycle reviews and determination.

The enormous number of submissions from fiscal years 2020 and 2022 is working its way through the system, evident from the data, but the backlog indicates that the review process may have overwhelmed the CTP’s capabilities and distorts the internal process data.

Substantial Equivalence

The data for SE is provided in Table 1 for the calendar years 2013–2016 and the federal fiscal years (October to September) hence. It is assumed that these values for SE, in particular, marketing orders, Not Substantially Equivalent (NSE) Orders and Withdrawn, include the provisional SE report applications. Briefly, a “provisional tobacco product” is one that was introduced between Feb. 15, 2007, and March 22, 2011, and for which a provisional SE report had been submitted on or before March 23, 2011. The final three rows, Estimated Administrative (Admin) Backlog, Estimated Office of Science (OS) Backlog and Estimated Total Backlog, are calculated values derived from the data provided. Since there may be additional (unreported) applications, these estimates should be considered conservative.

Table 1: Annual Data for Substantial Equivalence

The metrics are divided into the different phases of the regulatory process: administrative review of the submissions (Accepted, Refuse-to-Accept, Total Received), determinations (Marketing Orders, NSE Orders, Withdrawns) and the calculated values (Total Final Actions, Estimated Admin Backlog, Estimated OS Backlog, Estimated Total Backlog).

The calculated values for Total Final Actions are annual determinations: the sum of RTA, SE, NSE and Withdrawn. The remainder of the calculated values (Backlogs) should be considered estimates as the data missing from prior years may impact the accuracy of the results.

The Estimated Administrative Backlog is a cumulative value, the difference between those applications received and those processed (Accepted or Refused). For example, the Estimated Administrative Backlog for fiscal year 2021 includes the values from fiscal years 2020 and 2021. The Estimated OS Backlog is calculated similarly, beginning in fiscal year 2020, as the difference between those applications accepted to be reviewed and those with determinations (SE, NSE or Withdrawn).

Of note is the over 7,000 applications received by the CTP in 2020, which was likely due to the court-ordered submission deadline for newly deemed products such as cigars, pipe tobacco and waterpipe tobacco. Yet at the end of fiscal year 2021, the backlog of applications (neither accepted nor refused to accept) is less than 500. That number has since swelled to over 1,000, including over 100 submissions in fiscal year 2023 that remained unopened. In fact, during the October 2023 stakeholder engagement meeting, the CTP admitted that none of the SE reports submitted after Sept. 8, 2020, have undergone even an acceptance review.

The thousands of applications from the Estimated OS Backlog and Estimated Total Backlog is staggering. This is in stark contrast to the few hundred Total Final Actions, interrupted only by a spike of Refuse-to-Accept determinations in fiscal year 2021.

Using the historical CTP data and calculated estimates, projections for the CTP’s future throughput can be made. For example, it will take more than six years for the backlog of applications to work through the system with a 20 percent increase in staff and an insignificant number of future SE report submissions. In addition, if one considers a “first in, first out” application process, the time delay for a marketing order for any new SE report applications will be significant.

Exempt from SE

The annual data for Exempt from SE is provided in Table 2. The table structure and calculations are the same as Table 1. Similar to SE applications, the calculated Backlog values should be considered estimates as the data missing from prior years may impact the accuracy of the results.

Table 2: Annual Data for Exempt from Substantial Equivalence (EX)

The Estimated Administrative Backlog for fiscal year 2023 is less than 100 (during the October 2023 stakeholder engagement meeting, the CTP asserted that the EX backlog had been cleared). The Estimated OS Backlog and Total Backlog has been consistently over 1,000. This is in stark contrast to the few hundred Found Exempt Orders averaged annually.

Calculated similarly as that of the SE report throughput (a 20 percent increase in staff and an insignificant number of future Exempt submissions), it will take 16 months for these applications to work through the system if the same rate for reviews is maintained. As with the SE applications, the large number from the Total Backlog suggests that the time delay for marketing orders for any new EX applications will be more than a year (but significantly less than an SE submission) if one considers a “first in, first out” application process.

Premarket Tobacco Product Application

The annual data for PMTAs is provided in Table 3. Again, the final three rows are estimates, calculated values derived from the data provided, and since there may be additional (unreported) applications, these estimates should be considered conservative.

Table 3: Annual Data for Premarket Tobacco Product Application

The metrics provided by the CTP are divided into the different phases of the regulatory process: administrative, filing and determination. A staggering number of applications were received in the fiscal year 2020 through 2022 time frame, and to date, nearly 25 million applications have been rejected without substantive review. The calculated values in the table are generated similarly as for the SE and EX tables.

As the CTP has stated on several occasions (most recently on Jan. 22, 2024, in the press release announcing the marketing denial order (MDO) for flavored Blu e-cigarette products), the “FDA has received applications for more than 26 million deemed products and has made determinations on 99 percent of these applications.” The Estimated Admin Backlog at the end of fiscal year 2023 is over 60,000, and the Estimated OS Backlog is over 300,000. It is difficult to estimate the time for these applications to receive substantive review; however, if one considers the Marketing Granted Order (MGO) and MDO values from fiscal year 2022 as a guideline, values can be determined.

Based on these estimated values, a modest 20 percent increase in staff, and a limited number of future PMTA submissions, it will take more than 16 years for the applications under scientific review (Estimated OS Backlog) to receive a determination. If one considers the Estimated Total Backlog of applications calculated with the same parameters, it will take nearly 30 years for all the currently submitted applications to receive a determination.

Finally, the substantive review of the PMTAs for specific “covered applications” (brand names of Juul, Vuse, Njoy, Logic, Blu, Smok, Suorin or Puff Bar, and those that have a 2 percent or more sales volume as determined by Nielsen) is under a Maryland Federal District Court order (Am. Acad. of Pediatrics v. FDA (AAP), 379 F.Supp.3d 461, 492 (D. Md. 2019)). The original court-imposed deadline to complete the reviews was Sept. 9, 2021, which the agency was unable to meet. Based on the most recent (Jan. 24, 2024) status report filed with the district court, the CTP will take action on 100 percent of these applications by June 2024. This date has been pushed back on several occasions, indicating that even the CTP cannot predict how long it will take.

Steven McDonald is principal scientist, scientific engagement, at ITG Brands.

March 1, 2024