Category: Heat-Not-Burn

Reduced-Exposure Claim for IQOS 3
Photo: PMI
The U.S. Food and Drug Administration has issued a modified-risk granted order authorizing Philip Morris Products to market the IQOS 3 system holder and charger with the following reduced-exposure information:
The IQOS system heats tobacco but does not burn it.
This significantly reduces the production of harmful and potentially harmful chemicals.
Scientific studies have shown that switching completely from conventional cigarettes to the IQOS system significantly reduces your body’s exposure to harmful or potentially harmful chemicals.
This reduced-exposure information is the same as the information previously authorized by FDA in July 2020 for an earlier version of the device.
Today’s action follows the FDA’s review of a new modified-risk tobacco product (MRTP) application submitted by the company for the IQOS 3 system holder and charger. This MRTP application primarily cross-referenced the supplemental premarket tobacco product application for this device, which was authorized for legal sale and distribution in the United States in December 2020, as well as the MRTP application for the previous version of the device.
The IQOS 3 device is similar in design to the previous version (with mainly aesthetic changes), uses the same tobacco source, and the company requested to use the same exposure reduction claim as authorized for the previous version of the device. Given these similarities, FDA largely relied on its past evaluations of the IQOS 3 device and previous version of the device in determining that the IQOS 3 device meets the authorization criteria to be marketed as an MRTP.
Headquartered in Switzerland, Philip Morris is currently banned from importing the product into the United States following an adverse ruling in a patent dispute with BAT’s Reynolds American subsidiary.
In an interview with Bloomberg, PMI CEO Jack Olczak said the company plans to manufacture IQOS in the U.S. to get around the import ban.
March 11, 2022
Taat to Develop HNB Product with Shunho

Photo: Taat Global Alternatives
Taat Global Alternatives has signed a letter of intent with a U.S. subsidiary of Shanghai Shunho New Materials Technology Co. to undertake development work for a white-labelled heat-not-burn device as well as heatable sticks containing Taat’s proprietary tobacco-free and nicotine-free Beyond Tobacco material in all three flavors (original, smooth, and menthol).
As heat-not-burn has proven to retain users exceptionally well compared to other tobacco cigarette alternatives, Taat has identified the opportunity to build upon its existing international market share in the tobacco industry by planning an expansion into the heat-not-burn category with a tobacco-free and nicotine-free offering that would be among the first of its kind in the United States.
In addition to procuring heatable Taat sticks made using the company’s Beyond Tobacco material, Shunho’s U.S. subsidiary is to supply a proprietary heat-not-burn device on a “white-label” basis, which is to be commercialized in the United States under the Taat brand name. Uniquely, this device will offer reverse compatibility with heated tobacco sticks offered by the company’s competitors, as well as the Taat original, smooth, and menthol heatable sticks.
Headquartered in Shanghai, Shunho is a renowned tobacco ancillary service company that has worked closely with international tobacco companies. Under Shunho, there is a portfolio of firms that are currently developing next-generation electronic cigarette and vaporizing products. Taat will be the first foreign third-party with whom a Shunho subsidiary has partnered for white-label production of heat-not-burn products. Additionally, distribution services will be provided for the Taat heat-not-burn offerings through various in-house and third-party e-commerce channels in the United States.
“The reason we chose to pursue the heat-not-burn segment is because it is the most ‘sticky’ option out of all commercially available alternatives to cigarettes,” said Taat CEO Setti Coscarella in a statement. “The tobacco industry has invested heavily in cultivating a user base for heat-not-burn to the point that it may even replace major brands of tobacco cigarettes altogether in certain markets.
“We are excited to be leveraging innovative technologies to create a unique nicotine-free and tobacco-free experience using heat-not-burn for consumers who currently use and prefer this method. Because the Taat heat-not-burn device will work with Taat sticks as well as certain competitors’ heatable tobacco sticks, we believe this strategy authentically embodies our values as a company by providing consumers the choice and flexibility they deserve to have.”
February 21, 2022
PMI to Make IQOS in the U.S. After Import Ban

Photo: Mariakray
Philip Morris International plans to manufacture IQOS in the United States to get its tobacco-heating device back on that country’s store shelves, reports Bloomberg.
The move follows an adverse ruling against the company and its U.S. partner, Altria Group, in a patent dispute with British American Tobacco.
In September 2021, the International Trade Commission (ITC) upheld an initial determination from May 2021 that IQOS infringes on two patents owned by BAT subsidiary Reynolds American Inc. (RAI).
The ITC instituted an import ban and issued a cease-and-desist order, barring Altria Group from importing PMI’s IQOS 2.4, IQOS 3, IQOS 3 Duo products into the U.S. By declining to intervene, the U.S. Trade Representative upheld the ITC finding in November, leaving PMI with the options to produce IQOS domestically or tweak the design.
A design change, however, would require authorization from the U.S. Food and Drug Administration again.
In an interview with Bloomberg, PMI CEO Jacek Olczak, said the company had planned to manufacture IQOS in the U.S. all along. “From the very beginning of us going to the FDA, we had in mind that IQOS would one day not only be sold in the U.S., but manufactured there, if you take into consideration the size of the market and the opportunity for IQOS,” he said. “It’s just happening sooner because of the ITC decision.”

In July 2020, the FDA authorized PMI and Altria to market IQOS with certain modified-exposure claims, giving the company a leg up over its rivals.
PMI has not specified where it will be manufacturing IQOS but said it plans to sell IQOS in the U.S. again in the first half of 2023.
February 11, 2022
Poda Receives Patent for Closed Bottom Pod

Photo: Poda Holdings
Poda Holdings has received a U.S. patent for its closed bottom vaporizer pod. The patent was granted on Dec. 28, 2021.
“Receiving this Notice of Issuance is the culmination of a substantial amount of work by Poda and our intellectual property team,” said Ryan Selby, CEO of Poda, in a statement. “The application for this invention was initially filed on March 17, 2017. After almost five years of dedicated work and substantial financial investments, I am extremely proud to have this valuable patent granted by the U.S. Patent and Trademark Office.
“With the granting of this U.S. patent, Poda will effectively be the only company that can market a closed-ended heat-not-burn cigarette in the United States. We have already received a granted Canadian patent for this invention, and we now look forward to receiving granted patents for this application in the over 60 additional countries where this application has been filed. We believe this patent has incredible applicability in the global heat-not-burn market, and we look forward to marketing our patented products on a global scale.”
January 13, 2022
Iluma Prime Debuts in Switzerland Duty Free

Photo: Taco Tuinstra
Philip Morris International has launched the new IQOS Iluma Prime in Switzerland duty free, according to DFNI Frontier.
The announcement follows the market launch of IQOS Iluma in Japan in 2021.
The IQOS Iluma Prime is PMI’s first tobacco-heating system to introduce induction-heating technology, which utilizes no blade and requires no cleaning.
“Our objective is a world without cigarettes, a world where cigarettes are replaced by smoke-free alternatives that are a better choice than continued smoking,” said PMI CEO Jacek Olczak. “We have launched several generations of our IQOS heated-tobacco system, expanding our portfolio to offer constantly improved, science-backed solutions that take advantage of advancements in technology and address pain points heard from consumers.
“This commitment to continuous innovation plays a significant role in our ambition to deliver a smoke-free future. The launch of IQOS Iluma, our most innovative device yet, gives adult smokers another better choice and represents an important leap forward in our efforts to accelerate the end of smoking.”
“IQOS Iluma is our most innovative offering to date and the new flagship in our portfolio of science-backed, smoke-free products. Its breakthrough induction-heating technology heats tobacco from within, without burning, so there’s no smoke, no ash and, like previous IQOS devices, it emits, on average, 95 percent lower levels of harmful chemicals compared with cigarettes,” said Michele Cattoni, vice president of heated-tobacco platforms at PMI.
“However, unlike our previous tobacco-heating systems, IQOS Iluma has no blade. That means no tobacco residue or cleaning—ever. With this, and other product features, we aim to address consumer pain points that may have hindered some adult smokers from beginning or maintaining their journey away from cigarettes in the past.”
January 6, 2022
Making its Mark

Photo: Poda Holdings
By addressing the shortcomings of existing products, Poda Holdings is pushing heat-not-burn technology to new levels.
By Marissa Dean
Sales of heat-not-burn (HnB) products have increased dramatically in recent years. In Japan—the world’s largest market for these products—HnB has helped drive down traditional cigarette consumption to unprecedented lows. Due to the absence of combustion, HnB devices release significantly lower levels of harmful toxicants than traditional cigarettes, allowing smokers to move down the risk continuum while continuing to derive the satisfaction they seek from nicotine.
Globally, the HnB market is dominated by large companies, such as Philip Morris International, BAT and Japan Tobacco International, along with regional players, such as KT&G. But smaller companies, too, are eager to make their mark. By addressing what they perceive to be the shortcomings of existing devices, they are slowly but surely claiming their share of this promising category.
Poda Holdings is one such company. The firm was founded in January 2015 with the goal of creating the best HnB product ever made, according to CEO Ryan Selby. “Many adult smokers have been seeking smoke-free products that have the potential to reduce the risks associated with their smoking habit,” he said. “By focusing on their wants and needs, we were able to identify some key components missing from the heat-not-burn industry.”
The company offers an HnB tobacco-free product called Beyond Burn. “Our flagship Beyond Burn Poda Pods contain a unique tobacco-free blend of pelletized tea leaves infused with synthetic nicotine, which have been expertly crafted to mimic the sensorial experience of traditional cigarettes without the smoke, without the smell and without the tobacco,” the company explains on its website. The tea leaves (versus tobacco or other substances) provide a stable, consistent and low-cost substrate that is truly tobacco-free for use in the device, according to Poda.

“The closed-ended design allows an incredibly wide variety of substances to be used in our system—something that open-ended systems simply cannot do.”
Ryan Selby, CEO, Poda Holdings
A New, Clean Technology
Poda’s current technology, which took six years to develop, consists of the Beyond Burn Poda Pods and the Beyond Burn heating device. The device features a single button with three temperature settings. It has a fast-charging battery that is capable of heating a full pack of pods on a single charge, and the company plans on launching additional devices across different price points in the future to allow consumers more choices.
“When we looked at the HnB space, it was clear that innovations were happening all around,” said Selby. “We knew that making a product that replicated the sensorial experience of smoking was only half the battle. Being well-versed in the space, we knew that odor and residue buildup in heating devices was a major user pain-point and one that no one had yet solved. In our research, this was one of the primary challenges users faced—a heating device that started out with excellent performance, only to degrade with use, gathering strong odors and requiring extensive cleaning to keep the device operational. This contamination also left flavor residue in the heating devices, limiting the options for switching different flavors and different types of substances. It was our goal to solve that problem as a primary focus, finding a way to keep all the mess contained within each disposable pod.”
The Beyond Burn Poda Pods are considered “zero-cleaning,” meaning that their pod design keeps any potential mess contained within the pod itself, taking away the need for cleaning or maintenance. This also means there is no residual odor in the heating device and no cross-contamination between pods when they are switched. “What sets us apart really boils down to our patented closed-ended pods,” said Selby. “The closed-ended design … allows an incredibly wide variety of substances to be used in our system—something that open-ended systems simply cannot do. Ground plant matter, pellets, sheets, liquids, etc., are all possible in our pods, where our open-ended competitors would have to come up with solutions for each of these material forms individually.”
“Big Tobacco was coming at the challenges in the space with answers that fit their existing manufacturing methods and techniques, and thus they weren’t thinking very far outside the box,” Selby said. “Poda came at the problem from a totally different angle.”
Pods are currently packaged in the company’s facility in China and are packaged in cartons of 200 pods, with each carton containing 10 packs of 20 pods. The current manufacturing capability is over 400,000 pods per month, but the company is currently scaling up production and plans to produce over 10 million pods per month by the end of 2021. “We’ve raised enough capital to scale up our production capabilities to meet initial launch demand, and we have a comfortable runway to execute our launch plans,” said Selby.

Poda Holdings’ Beyond Burn Poda Pods contain a unique tobacco-free blend of pelletized tea leaves infused with synthetic nicotine, which mimic the sensorial experience of traditional cigarettes without the smoke, without the smell and without the tobacco.
Regulation
The absence of tobacco in Poda’s products offers opportunities that are unavailable to tobacco-containing offerings. “The tobacco space is heavily regulated throughout the world, and new reduced-risk and heat-not-burn products face many of the same regulations as cigarettes as well as additional regulations pertaining to products in the vaporization space,” said Selby. “This overlap creates a complex regulatory landscape that is constantly evolving—each country having their own unique framework. Our first offering—our flagship Beyond Burn Poda Pods—contain no tobacco products whatsoever, so they tend to be outside the scope of existing tobacco regulations. As the landscape changes, our closed-ended pods will allow for exploring a multitude of different substance options for tobacco and beyond—allowing Poda to navigate regulatory hurdles in a way many of our competitors aren’t able to.”
While Poda Pods do not currently contain tobacco, the company has opted to file a premarket tobacco product application (PMTA) in the U.S. The PMTA pathway is a long process, with only a handful of applications approved to date, but it is necessary to market deemed tobacco products in the U.S. According to the Food and Drug Administration, deemed tobacco products consist of “electronic nicotine-delivery systems, which include e-cigarettes, e-cigars, e-hookah, vape pens, personal vaporizers and electronic pipes; pipe tobacco; dissolvables; nicotine gels; waterpipe (hookah); cigars; and future tobacco products.”
“We believe that our Beyond Burn Poda Pods are not subject to the PMTA as they contain lab-synthesized synthetic nicotine, no tobacco ingredients whatsoever and, importantly, cannot be used with any other tobacco products,” said Selby. “However, there are a multitude of potential future opportunities for Poda products to be used with tobacco, and so in order to demonstrate our commitment to total compliance with the PMTA, we have begun the PMTA process in the USA for Poda products containing tobacco and tobacco-derived products.”
Poda products contain synthetic nicotine, which is essentially chemically identical to tobacco-derived nicotine but currently outside of the FDA’s remit. Poda chose to use synthetic nicotine because it allows for more control over what goes into the pods. “Synthetic nicotine offers the same satisfaction as tobacco-derived nicotine without the chance of impurities and harmful substances from the tobacco plant contaminating it during the extraction process,” said Selby.
Beyond Burn Poda Pods are currently available in three different flavors with more expected down the line. The company is planning for other content offerings as well, including coffee/caffeine infused products, nicotine-free blends, real tobacco, cannabis/CBD and medicinal herbs. “We envision a family of devices, all designed to work with our pods, regardless of pod contents.”

Thinking Outside the Industry
To better reflect its broad, multisector ambitions, Poda recently announced a new planned corporate structure featuring six subsidiaries—Poda (Tobacco), Poda (Alternatives), Poda (Therapeutics), Poda (THC), Poda (CBD) and Poda (Research and Development). Poda has also filed intellectual property patents (already granted in Canada) for its proprietary technology, brought on new board members and created new positions. Former Juul Canada president, Michael Nederhoff, joined the global advisory board and is consultant to Poda’s management team and the company’s board, assisting with the company’s global expansion. Nicholas Kadysh, former Juul head of corporate affairs, recently joined Poda’s global advisory board as well.
Poda is also thinking beyond consumer goods, entering the medical device market and appointing the company’s first chief medical officer, Jagdeep Gupta. “I am very pleased to have received approval from the board to enter the medical device market and to create the position of chief medical officer for Poda,” wrote Selby in a press release. “In addition to providing exceptional reduced-risk products designed for current adult smokers, Poda is also committed to providing effective smoking cessation products designed to help adult smokers quit smoking.”
“Quitting smoking can be difficult, and the addition of Dr. Gupta as chief medical officer will help Poda to develop medically approved products and treatment strategies designed to provide adult smokers with the tools they need to successfully quit smoking. In addition, there are numerous opportunities for Poda to utilize our intellectual property and related technologies to potentially facilitate the delivery of many different therapeutic molecules by inhalation.”
Gupta later announced that he began clinical trials for Poda’s smoking cessation products. “I have already initiated the process of setting up the first clinical trials related to the efficacy of Poda’s products as smoking cessation tools,” Gupta wrote in a release. “I am currently in the process of setting up a pilot study, which will give us a solid platform for developing strong and effective clinical trials. These clinical trials will be designed to result in the publication of Level 1 evidence in respected medical journals globally if the data provides evidence. The pilot studies will also be designed to establish a scientific basis for the efficacy of Poda’s products as smoking cessation tools and additionally may provide Poda with access to research grants and other funds that can be used for additional studies, clinical trials and validation research.”
In addition to expanding into the medical device industry, Poda signed a supply agreement with Greenbutts, a biodegradable filter manufacturer. “This supply agreement will provide the company with access to 100 percent biodegradable filters for use in our Beyond Burn Poda Pods,” according to Selby. “The inclusion of Greenbutts’ biodegradable filters into our already biodegradable and compostable Poda Pods allows Poda the ability to offer a completely biodegradable and truly compostable heat-not-burn product, something that has never been done in the heat-not-burn tobacco market.”
Gamechanger
Poda has accomplished a lot in the past six years and is now poised to be a potential gamechanger in the heat-not-burn market. A mess-free, zero-cleaning biodegradable product that could reach beyond tobacco and nicotine products seems like it would be a very attractive product for consumers—and it would seem others agree; Poda recently received an order for 500,000 Beyond Burn Poda Pods and 2,000 Beyond Burn Heating Devices, expected to be used during the initial launch in the European market later this year.
Time will tell how this technology impacts the market. Selby, for his part, is confident Poda could change the face of HnB. “I believe that Poda really is the solution the HnB space has been waiting for,” he said.

Marissa Dean joined Tobacco Reporter in the summer of 2018 as a copy editor.Since that time, she has taken on additional responsibilities, including feature writing.Her skills span the publishing industry from layout and design to copy editing to content creation.

January 1, 2022
Lil Now Available in 20 Countries

Photo: KT&G
KT&G has launched its heat-not-burn product Lil in more than 20 markets within two years after signing a supply agreement with Philip Morris International for overseas sales of Lil in early 2020, the South Korean company announced on its website
Last year, KT&G and PMI launched Lil Solid 1.0 in Russia and Ukraine, and Lil Hybrid 2.0 in Japan. This year, the two companies expanded into other markets including Kazakhstan, Serbia and Armenia, with Lil Solid 2.0 as the flagship product. This August, an announcement was made that Lil was launched in a total 10 markets globally, Albania being the latest market at the time.
KT&G added additional markets in the fourth quarter this year. In November, Lil debuted in Guatemala, the first market in Central America, and the company expanded into the Asian market further, launching Lil in Malaysia after Japan. Additionally in the same month, Lil Solid 2.0 and its dedicated stick Fiit were launched in Italy.
Lil Solid 2.0 is a second-generation model of KT&G’s heat-not-burn products. It boasts improved battery performance and induction heating technology, and it comes in two colors, “stone grey” and “cosmic blue” outside Korea.
The dedicated sticks come in a total of eight variants including Fiit Regular and Fiit Crisp, and a new variant, Fiit Alpine, has been launched in the fourth quarter this year. Two to five variants have been launched in each country‒tailored towards consumer taste preference.
“Lil was able to quickly expand internationally thanks to Lil’s innovative technology in addition to PMI’s commercial resources and infrastructure,” said Wang Seop Lim, chief of KT&G’s next-generation products division. “We will continue to provide high quality products to consumers outside Korea through strategic collaboration with PMI going forward.”
December 20, 2021
Poda Delivers 500,000 Pods

Image: Poda Holdings
Poda Holdings has delivered 500,000 Beyond Burn Poda Pods.
The customer is expected to now begin preparations for launching the products into the Asian and European marketplaces.
“This delivery marks the beginning of large-scale sales of Poda’s products,” said Ryan Selby, Poda’s CEO, in a statement. “Our pilot production facility continues to produce nearly 400,000 Poda Pods per month, and this production will be used to support continued sales growth to strategic customers in markets around the world.
“Our goal is to continue priming key markets so that we will be able to sell the entirety of our anticipated 10 million monthly production capacity as soon as the production facility is brought online. I look forward to an exciting 2022 as we, through our strategic subsidiaries, continue to grow our production capacities and sales volumes and expand our operations into markets around the globe.”
October 6, 2021
Tobacco-Heating Market Slumps After Tax Hike

Photo: Юрий Дьяконов
The market for heated-tobacco products in Ukraine has stopped growing in the wake of a significant tax hike at the start of 2021, reports the Interfax-Ukraine News Agency. According to Philip Morris International’s local director, Kostas Salvaras, sales will likely decline in 2021.
PMI estimates the market grew by 80 percent in 2020. On Jan. 1, 2021, Ukraine increased the excise tax on heated-tobacco products by 320 percent, causing retail prices to jump and sales to slacken. According to PMI data, retail prices on tobacco sticks have increased by an average of UAH13 ($0.49).
According to PMI, the state budget receipts from the sale of heated-tobacco products in the fourth quarter of 2021 will decrease by 60 percent to 70 percent compared to the same period in 2020. The company intends to reduce the purchase of excise duty stamps for heated-tobacco products by nearly 67 percent in the quarter.
Meanwhile, PMI has already observed an increase in heated-tobacco products smuggled from neighboring countries where prices are lower.
Salvaras estimates that illicit sales now account for 15.9 percent of the Ukrainian tobacco market compared with 2.3 percent in 2017. Given the current level of illegal trade, the state will receive less than UAH13.2 billion in tax receipts in 2021, he said.
PMI has urged the Ukrainian parliament to reconsider plans to further raise excise taxes and delay the next jump in prices for heated-tobacco products.
“This is a necessary step that will allow consumers and businesses to ‘digest’ the 320 percent increase and adapt to new conditions,” said Salvaras. “It will also stimulate the attraction of additional investments in this area, which is important both for the country’s economy and for public health—after all, the authorities should be interested in motivating smokers to look for a less harmful alternative to cigarettes.”
September 29, 2021
Imperial to Test Heating Product in Greece

Photo: Imperial Brands
Imperial Brands has stepped up market testing of its heated-tobacco products through a national rollout in Greece.
Insights from Greek consumers on the Pulze device and iD heat sticks will help inform the potential for further launches in a focused number of European markets. Earlier this month, Imperial Brands launched a pilot trial for its tobacco-heating products in the Czech Republic.
Building a targeted and sustainable next-generation product (NGP) business is a key part of Imperial’s new strategy and its commitment to make a meaningful contribution to harm reduction.
According to the company, heated-tobacco is an established NGP category in a number of European territories, including where Imperial already has a strong route to market for its traditional tobacco products.
“Heated-tobacco continues to gain traction among adult smokers in Greece, and we see significant growth opportunities for our promising products in this category,” said Imperial Brands’ chief consumer officer, Anindya Dasgupta, in a statement.
“The valuable consumer insights we gain from the pilot initiatives in Greece and the Czech Republic will inform the scale and pace of further market rollouts.”
Heated-tobacco currently accounts for more than 10 percent of the total tobacco sector in Greece, with further strong growth anticipated.
The Pulze device heats but doesn’t burn iD heat sticks to provide nicotine and tobacco aromas containing fewer and substantially lower levels of the harmful chemicals found in combustible cigarette smoke.
Unlike other heated-tobacco products, the Pulze device does not require a charging case, offering up to 20 consecutive uses. It is available in copper and silver colors.
ID tobacco consumables are being made available in Greece in four flavors: Rich Bronze, Balanced Blue, Capsule Polar and Ice.
September 20, 2021