Category: Heat-Not-Burn

FDA Grants Reduced-Exposure Claim to PMI’s 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 Bypass Import Ban by Manufacturing IQOS in U.S.

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’s Patent Approved for Innovative 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
Imperial to Test its Heated Tobacco 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 per cent 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
Imperial Launches Tobacco-Heating Products in Czechia

Photo: Imperial Brands
Imperial Brands has launched its heated-tobacco products in the Czech Republic.
The launch is the first of two planned European pilot trials for the company’s Pulze device and iD heat sticks.
Imperial is investing in heated-tobacco opportunities in a focused number of markets in Europe as part of its new strategy to build a targeted and sustainable next-generation product (NGP) business.
The Czech pilot is the first step in Imperial’s approach of entering markets where the category is already established and where the business is able to leverage an existing strong route to market.
“Heated-tobacco offers significant growth opportunities in Europe where, in many territories, it is the biggest NGP category and the fastest growing,” said Joerg Biebernick, Imperial Brands’ president of the European region, in a statement. “Detailed market testing will allow us to quickly expand our consumer insights and inform the potential to launch validated heated-tobacco products in further European markets.”
Heated-tobacco currently accounts for around 10 percent of the total nicotine sector in the Czech Republic, with further strong growth anticipated.
The Pulze device heats rather than burns iD heat sticks to provide nicotine and tobacco aromas containing fewer and substantially lower levels of the harmful chemicals found in 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 heat sticks are being made available in five flavors: Rich Bronze with rich tobacco flavor and triple flow filter technology, Balanced Blue, Mint Polar Green, Mint Ice and Capsule Polar.
September 1, 2021
PMI Launches ‘Cleaner’ Bladeless IQOS in Japan

Photo: Kuznietsov Dmitriy
Philip Morris International has launched IQOS Iluma, the brand’s first tobacco-heating system based on induction-heating technology, in Japan.
The device’s Smartcore induction system heats the tobacco from within the new Terea Smartcore Stick. These newly designed sticks are to be used only with IQOS Iluma, which features an auto-start function that detects when the Terea stick is inserted and automatically turns on the device.
According to PMI, the bladeless IQOS devices offer a cleaner way to heat tobacco from the core without burning it. They also provide a more consistent experience and leave no tobacco residue, eliminating the need to clean the device. Additionally, the devices generate no combustion and no smoke. PMI says its market research indicates that IQOS Iluma provides a more pleasurable experience compared to previous IQOS generations.
“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, in a statement.
“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.”
IQOS Iluma is available in two versions—IQOS Iluma Prime and IQOS Iluma. Both devices use new induction-heating technology but offer different designs. IQOS Iluma Prime and IQOS Iluma are available in Japan for pre-order on IQOS.com beginning Aug. 17, 2021, and for purchase at IQOS stores on Aug. 18, 2021.
As of June 30, 2021, PMI’s smoke-free products are available in 67 markets. The company has stated its ambition to be present in 100 markets with its smoke-free products by 2025. There are more than 20 million users of the IQOS tobacco-heating system globally, and PMI estimates that more than 73 percent (approximately 14.7 million) of these men and women have switched completely to IQOS and stopped smoking with the balance in various stages of switching. PMI’s ambition is that by 2025, at least 40 million PMI cigarette smokers who would otherwise continue to smoke will have switched to smoke-free products. Furthermore, the company’s ambition is that more than half of its net revenues will come from smoke-free products by 2025.
August 17, 2021
Heating Products Exempted from Mexico ENDS Ban

Photo: niyazz
Mexico’s Supreme Court has ruled that heated tobacco products (HTP) will be exempted from a February 2020 presidential decree that bans importation of electronic nicotine delivery systems (ENDS), reports Filter.
Prior to the on July 16 ruling, manufacturers were able to import and sell HTPs legally using a loophole in the law called “habeas corpus trials.” But the loophole prevented the development of a fully regulated, legal market. The new presidential decree reverses that and allows for increased sales of these devices.
Vapor products that use e-liquids continue to be banned by the Mexican government. According to Roberto Sussman, a researcher at the National University of Mexico and president of Pro-Vapeo Mexico, the vapor market in Mexico has been functioning since 2009 as part of the huge informal economy, which employs more than 50 percent of the workforce and it is illegal but not criminal.

It was an embarrassment for President Andrés Manuel López Obrador, who has expressed opposition to foreign NGOs and agents meddling with Mexican government regulations.
Roberto Sussman, president, Po-Vapeo Mexico
More than 1.2 million Mexicans—1 percent of the adult population—use vapor products somewhat regularly, according to a survey by the Global State of Tobacco Harm Reduction.
According to Filter, a fatal blow to the HTP ban came when it was leaked that the draft of the decree was written by a lawyer working for the Campaign for Tobacco-Free Kids.
“It was an embarrassment for President Andrés Manuel López Obrador, who has expressed opposition to foreign NGOs and agents meddling with Mexican government regulations,” said Roberto Sussman.
It’s not the first time Mexico’s Supreme Court intervened in the country’s drug policy. On June 28, it stepped in to legalize marijuana, after lawmakers had failed to finalize the legislation the court demanded three years earlier.
July 23, 2021
Japan Tobacco Launching Ploom X in August

Photo: JT/JTI
Japan Tobacco is launching Ploom X, its next-generation heated-tobacco device, on Aug. 17, 2021. Ploom X will gradually be made available across Japan, including in convenience stores and select tobacco retail stores. Ploom X will also be available for pre-launch sale at the CLUB JT online shop from July 26, 2021.
The device was jointly developed by JT in Japan and JTI, the group’s international subsidiary, headquartered in Switzerland.
“Ploom X is the first global device developed by JT and JTI, bringing together all our resources to offer the best user experience of our time,” said Daniel Torras, senior vice president of reduced-risk products, in a statement.
“We are delighted to be able to offer this new innovative product to adult consumers in Japan, the world’s leading heated-tobacco market and where product standards and quality are of the highest importance. Listening to consumers globally, we have created a proposition that is aligned with today’s lifestyles and choices. This includes a more authentic tobacco taste, new connectivity possibilities and several options to personalize the device to everyday needs.”

Ploom X is the first global device developed by JT and JTI, bringing together all our resources to offer the best user experience of our time.
Daniel Torras, senior vice president of reduced-risk products, JTI
The new device adopts the aesthetic and innovative “Nastro” design with a more intuitive user experience, with no buttons on its surface. In addition to allowing users to precisely control heating temperature, Ploom X is equipped with a new heating technology, Heatflow, which focuses on airflow.
Ploom X is also equipped with Bluetooth functionalities that connect with users’ smartphones, enables consumers to see the battery status, lock the device and much more.
Along with the device, improved heated-tobacco sticks are being rolled out. The regular tobacco stick flavor is blended with lamina, the most aromatic part of the tobacco leaf. There is a range of 12 different heated-tobacco sticks.
July 15, 2021
Lil Moves into Southeastern Europe and Central Asia

Lil Solid 2.0 with Armenian health warnings
(Phot: KT&G)
KT&G’s Lil Solid 2.0 device and its Fiit heated-tobacco stick continues its global expansion with new launches in Central Asia and Southeastern Europe.
As part of a collaboration agreement between KT&G and Philip Morris International, Lil Solid 2.0 has been introduced into four Eurasian countries during the second quarter of 2021.
The device and its consumables debuted in Armenia on June 14. The products were also commercialized in Serbia and Kyrgyzstan on June 3 and 7, respectively. Lil Solid 2.0 and Fiit were previously introduced in Kazakhstan on May 13.
Lil Solid 2.0 is a second-generation model of KT&G’s heat-not-burn product with enhanced performance and design to improve consumer satisfaction. The product was first launched nationally in Korea in January this year. According to KT&G, it gained significant traction with its upgraded battery efficiency and induction heating technology.
The Lil Solid 2.0 device is available in two colors, Stone Grey and Cosmic Blue, in its new markets. The sticks come in seven types, including Fiit Regular, Fiit Viola And Fiit Crisp. Three or four types are sold in each country depending on the market situation.
Following the recent commercialization of Lil Solid 2.0 in four new markets, the Lil brand now is present in seven markets outside of South Korea. Previously, varieties of the brand were introduced in Russia, Ukraine and Japan.
“As Lil Solid 1.0 and Lil Hybrid 2.0 have been well received in their respective markets, we look forward for encouraging performance from Lil Solid 2.0 as well,” said Wang Seop Lim, chief of KT&G’s next-generation products business division, in a statement. “We will continue to provide broader choices to consumers outside Korea in the second half of this year through collaboration with PMI.”
June 16, 2021