Tag: pmi

Expert: Heat-not-Burn Products Safer Than Smokes

Credit: PMI
Next generation tobacco products like heat-not-burn (HNB) offer a less risky alternative to combustible cigarettes. Making these products more available to smokers would translate into public health gains, according to Helen Redmond, adjunct professor at New York University-Silver School of Social Work.
Because the tobacco is not burned, the levels of harmful chemicals produced by HNB products are significantly lower compared to combustible cigarette smoke, according to Redmond. She made the statement before the U.S. Food and Drug Administration (FDA) authorized the marketing of IQOS, the tobacco heating system produced by Philip Morris International, as a modified risk tobacco product (MRTP).
It has been known for decades that tar and carcinogens found in tobacco smoke, causes the death and disease associated with smoking and not nicotine. “The use of nicotine is no threat, because nicotine is not the problem. Combustible tobacco is,” Redmond said. “There is a widespread, mistaken notion that nicotine causes cancer and other health problems. That is false. What causes health problems is lighting tobacco on fire. The combustion releases thousands of toxic chemicals.”
The FDA’s MRTP authorization shows that IQOS is a fundamentally different product than combustible cigarettes, and must be regulated differently. The FDA’s decision is consistent with earlier conclusions of other leading regulatory and scientific bodies, including in the United Kingdom, Germany and the Netherlands, which have found that the product emits lower levels of harmful toxicants.
“If HNB products appeal to smokers who, for whatever reason, find that vaping — estimated by Public Health England to be 95 percent safer than smoking — isn’t for them, it’s a huge win for public health,” she added.
She said e-cigarettes and HNB devices proved effective in making smokers switch because they offer the same pleasure, rituals and relaxation associated with smoking. A February 2019 clinical trial by UK’s National Institute for Health Research found that e-cigarette was twice as effective as nicotine replacement treatments such as patches and gum at helping smokers quit.
Redmond cited the case of Japan where nearly a third of smokers have already switched to HNBs. “HNB products have been available in Japan since 2014. The result— cigarette sales in the country have plummeted, outstripping anything abstinence-only messages have achieved” she said.
PMI has conducted extensive research on IQOS, including 18 non-clinical and 10 clinical studies. Based on PMI evidence to date, switching completely to IQOS — while not risk-free — is a better alternative for those who would otherwise continue to smoke.
Another study by Canadian and American researchers looked at how trends in the sale of cigarettes in Japan between 2011 and 2019 correspond to the sales of HTPs that were introduced into the Japanese market in late 2015.
The researchers concluded that the accelerated five-fold decline in cigarette sales in Japan since 2016 was due to the introduction of HTPs.
August 21, 2020
KT&G Exporting Heat-Not-Burn Device to Russia

KT&G started exporting its e-cigarette heating devices to Russia last month in accordance with the company’s agreement with Philip Morris International (PMI). The agreement allows the two parties to collaborate on promoting global marketing campaigns, according to a press release.
During a conference call upon the announcement of its second-quarter results, the company confirmed an analyst question that won12.5 billion ($10.54 million) worth of e-cigarette devices were exported to Russia throughout last month. KT&G signed a pact for strategic collaboration with its rival PMI in January, according to a story in The Kores Times.
“It is true that e-cigarette devices were exported last month. We plan to announce further details on the outcome of the PMI deal in the near future,” the company said during the call. The partnership is calling for KT&G to export its “lil” tobacco heating devices and tobacco sticks worldwide through PMI’s global sales network spanning 180 international markets, without specifying which markets the two companies will focus on.
Some questions have persisted over the progress of the deal so far, as no visible outcome has been achieved over the past six months since the agreement was made. However, as exports have now begun, KT&G’s effort to expand its e-cigarette presence is anticipated to pick up momentum.
The export came after heat-not-burn (HNB) tobacco products’ domestic market penetration rate declined for the second consecutive quarter. The rate stood at 13 percent at the end of last year, but declined to 12.6 percent in the first quarter and 12.4 percent in the second quarter. The company, however, said this does not mean a deadlock in HNB products’ growth, citing the expansion in overseas markets.
“From a future business standpoint, the overall heat-not-burn (HNB) tobacco market is expected to grow,” the company said. “When the new products are introduced, the market is bound to grow. While there would be some minor impact from governments’ policies and market events, there is no doubt about the growth trajectory.”
August 6, 2020
FDA Grants IQOS Exposure Claim
Photo: PMI
The U.S. Food and Drug Administration (FDA) on July 7 issued exposure modification orders to Philip Morris Products’ (PMP) IQOS heat-not-burn device system (holder and charger) and three Marlboro Heatstick variants.
The FDA previously authorized the marketing of IQOS without modified risk information in April 2019 via the premarket tobacco application pathway.
In its most recent ruling. the FDA determined that IQOS does not currently meet the standard for marketing with reduced-risk claims but can be marketed with a reduced-exposure claim.
Specifically, the FDA is allowing the company to claim:
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.
“Through the modified risk tobacco product application process, the FDA aims to ensure that information directed at consumers about reduced risk or reduced exposure from using a tobacco product is supported by scientific evidence and understandable,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products.
“Data submitted by the company shows that marketing these particular products with the authorized information could help addicted adult smokers transition away from combusted cigarettes and reduce their exposure to harmful chemicals, but only if they completely switch.”
In its announcement, the FDA stressed that is marketing authorization doesn’t mean the reviewed products are safe or “FDA approved.”
The FDA’s marketing order requires PMP to conduct post-market surveillance and studies to determine the impact of these orders on consumer perception, behavior and health, and to enable the FDA to review the accuracy of the determinations upon which the orders were based.
These post-market requirements include a rigorous toxicity study using computer models to help predict potential adverse effects in users. The orders also require the company to monitor youth awareness and use of the products to help ensure that the marketing of the MRTPs does not have unintended consequences for youth use.
“The FDA’s decision is a historic public health milestone,” said Andre Calantzopoulos, CEO of Philip Morris International. “Many of the tens of millions of American men and women who smoke today will quit—but many won’t. Today’s decision makes it possible to inform these adults that switching completely to IQOS is a better choice than continuing to smoke. FDA determined that scientific studies show that switching completely from conventional cigarettes to IQOS reduces exposure to harmful or potentially harmful chemicals.”
“The FDA’s decision provides an important example of how governments and public health organizations can regulate smoke-free alternatives to differentiate them from cigarettes in order to promote the public health.”
“We’re delighted that the FDA authorized IQOS to be marketed as a modified-risk tobacco product,” said Billy Gifford, CEO of Philip Morris USA’s parent company, Altria Group, which will be marketing the product in the U.S. “This authorization gives PM USA an opportunity to communicate additional benefits of switching to IQOS and this decision is an important step for adult smokers.”
In a note to investors, Morgan Stanley described the FDA’s order as a positive development because it provides greater flexibility for IQOS to be marketed as relatively less harmful than cigarettes.
“The inability to make relative lower harm claims is a constraint to broader IQOS adoption in the U.S.,” wrote Morgan Stanley analyst Pamela Kaufman.
“Over time, PM can continue to submit additional information towards a full MRTP approval. The modified exposure designation combined with pending PMTA approval for IQOS 3 should accelerate MO’s [Altria’s] U.S. expansion strategy for IQOS. The FDA’s recognition of IQOS’s benefits relative to cigarettes may also enhance IQOS’ perception with international health agencies, helping its growth prospects,” Kaufman said.
Anti-smoking activists were less enthusiastic. In a joint statement, the Campaign for Tobacco-Free Kids, the American Cancer Society Cancer Action Network, the American Heart Association, the American Lung Association and the Truth Initiative, said the FDA marketing order would put consumers at risk.
“With today’s action, the FDA has created a real danger that kids and adults will falsely believe IQOS has been proven to present a lower health risk and that kids will be exposed to marketing that portrays IQOS, a highly addictive tobacco product, as an appealing, cool alternative to cigarettes, in much the same way as e-cigarettes,” the anti-tobacco groups wrote in their statement.
IQOS is the first tobacco product to receive exposure modification orders and the second to be authorized as a modified risk tobacco product. In October 2019, the FDA authorized Swedish Match U.S. division’s amended MRTP applications for eight varieties of General Snus, giving the company the right to market the product as a less harmful alternative to cigarettes.
July 8, 2020
PMI Files Counterclaims Against RJR for Patent Breach

Philip Morris International (PMI) filed counterclaims against R.J. Reynolds (RJR) for patent infringement in the federal court action that RJR commenced against PMI and Altria, PMI’s IQOS distributor in the US, on April 9, 2020 in the Eastern District of Virginia.
PMI also filed a partial motion to dismiss RJR’s claims against it. PMI believes that RJR’s infringement action is without merit, and that RJR’s own electronic nicotine delivery system (ENDS) products infringe multiple patents owned by PMI and Altria. PMI is bringing counterclaims to “recover the considerable damages” caused by RJR’s infringements, according to the filing.
“RJR appears to have brought this action in the hopes of stopping [PMI’s] innovative IQOS heated tobacco system, which has a proven track record in switching smokers away from combustible cigarettes, from disrupting its core business in combustible cigarettes and overtaking its secondary line of e-vapor products,” the filing states. “Having failed to develop a competing offering in the heated tobacco space, RJR apparently now seeks to block that space in its entirety by bringing this meritless litigation. But in its haste to do so, RJR has overlooked the fact that its own line of e-vapor products (which are far less effective in switching smokers away from combustible cigarettes than IQOS) infringe multiple patents owned by [PMI].”
The counterclaim alleges that RJR was concerned by the commercial threat posed by IQOS, and RJR is now attempting to stop IQOS with this case. “But in its haste to stop IQOS, RJR committed two fatal errors. First, it asserted meritless patent claims,” the filing states. “Second, it overlooked the fact that its own e-vapor products infringe multiple patents owned by [PMI] and co-defendants Altria Client Services and Philip Morris USA, Inc. [PMI] thus responds to RJR’s Complaint and brings counterclaims to recover the considerable damages flowing from RJR’s infringement.”
June 30, 2020
PMI Gets ‘Brexit-Proof’ Patent Protection for IQOS

Credit: iQOS
Last week, a London judge granted Philip Morris International (PMI) an injunction prohibiting a Chinese competitor from putting an alleged “knock-off” of its smokeless tobacco-delivery device on the market in the U.K. because of European design protections.
As part of his ruling, High Court Judge Anthony Mann granted the tobacco giant’s request for default judgment in the case since defendants Shenzhen Shunbao Technology Co. Ltd. had not participated in the proceedings. He also granted Philip Morris’ request to extend the intellectual property protections the company currently has for its product under a European Union registered community design so it will remain in effect in the U.K. after Britain leaves the bloc, according to information on law360.com.
“I have satisfied myself that all of the relief included in the order, including the references to various Brexit matters, are forms of relief for which the claimants would be entitled, had they fully proved everything that they had pleaded in their particulars of claim,” Judge Mann said at the conclusion of a video conference hearing.
The smoking device dispute wafts back to November 2018 when Phillip Morris first sued Shenzhen for infringement of its registered design. The product design is for a “smoke-free alternative to cigarettes,” according to Philip Morris, which markets the device under the trademark name IQOS, according to law360. The tobacco-delivery system includes tobacco “sticks and a rechargeable holder that heats up, the registered design relating specifically to that device.”
Phillip Morris filed its claim in the U.K. shortly after discovering the rival company had created a “cheap knock-off” smokeless product called AMO, that was already being marketed in China, according to its written arguments to the court.
No representative of Shenzhen was present at Monday’s hearing. “It is a straightforward case where the defendant has simply refused to engage with the proceedings,” Philip Morris told the court in its filing. Monday marked the second hearing Philip Morris had over its bid for a final injunction. A different judge determined in February that the tobacco company could serve Shenzhen and several individual company representatives by email.
Philip Morris lawyer James Abrahams said his client was unable to deliver documents related to the proceedings to one individual, a Cherry Zhou, as the email sent was “kicked back” and she later informed Philip Morris’ Chinese legal representatives that she had left Shenzhen.
The injunction granted by Judge Mann on Monday prohibits the Chinese competitor from marketing its infringing product. The order would also allow Philip Morris to pursue any profits Shenzhen made with its device in the U.K., although its written argument notes that “it does not currently appear proportionate to pursue an inquiry for damages or an account of profit.” The written filing also notes that a registered community design is seen as an EU right, so it currently only has effect in the U.K. pursuant to the Brexit Withdrawal Agreement. That will end in the U.K., “as things stand, at the end of the transitional period at the end of this year,” the filing says.
And while a provision of the withdrawal agreement currently provides that at the end of the transition period, holders of registered designs “will enjoy an equivalent U.K. registered design,” Philip Morris asked for — and the court granted — permission to come back to the court if there are any unexpected changes to that as Brexit unfolds.
“We do not know for certain how the law will change at the end of the transition period and the parties ought to be able to apply to the court to deal with such changes,” Philip Morris stated. In a written statement, Philip Morris’ counsel at Bird & Bird LLP emphasized that the injunction will continue to protect the design after Brexit.
“The order granted suggests that the courts are ready and willing to grant Brexit-proof orders where needed,” the law firm said. “This will be a relief to litigants seeking as much certainty as possible with regard to the post-transition period arrangements.”
Philip Morris is on the other end of infringement litigation over its IQOS system in the U.S. R.J.
Reynolds Tobacco Co. is calling on the U.S. International Trade Commission to probe Philip Morris’ tobacco vaping product imports, claiming the tobacco heating system infringes patents covering R.J. Reynolds’ vaporizers.
May 18, 2020
Green Light
The arrival of IQOS in the U.S. market raises some questions and eyebrows.
By Maria Verven
After a two-year wait, Philip Morris International (PMI) has received the go-ahead from the U.S. Food and Drug Administration (FDA) to sell its IQOS heat-not-burn (HnB) tobacco product in the U.S. Reportedly, an estimated 7.3 million consumers worldwide have already switched from combustible cigarettes to the IQOS.
The whole idea is that when tobacco is heated and not burned as in traditional cigarettes, the level of harmful chemicals is much lower. Because the IQOS uses tobacco, PMI claims it’s “a closer experience to smoking cigarettes than other alternatives such as e-cigarettes.”
What exactly is this new product? How does it work? And what possible effect will it have on the U.S. vapor market?
What’s an IQOS and how does it work?
The IQOS (pronounced EYE-kose) works by heating tobacco-filled sticks called HeatSticks just enough to release nicotine-containing vapor (up to 350 degrees C or 662 degrees F) but without creating combustion, fire, ash or smoke.
The IQOS comes in two different versions: One contains three parts—HeatSticks, the IQOS holder and a charger, and the other combines the holder and charger, enabling the user to use it multiple times before having to recharge the battery. Both work the same way: You insert a HeatStick into the IQOS, push a button to turn on the electronically controlled heater and then draw on the end of the HeatStick, which releases an aerosol and the taste of tobacco.
When you’re done, the HeatStick goes in the trash while the IQOS goes back into the charger. The integrated version lasts for 10 consecutive uses before it needs to be recharged.
What’s a HeatStick?
HeatSticks, or HEETS, contain tobacco “plugs” made from tobacco leaves that have been ground and reconstituted into tobacco sheets. Called “cast-leaf,” these sheets are crimped and made into tobacco plugs. They’re specifically designed to be heated, not burned as in traditional cigarettes. Regular cigarettes don’t work in the IQOS.
How much does the IQOS cost?
IQOS kits retail starting at $116 (IQOS 2.4 kits are available on Amazon) and up to $300 for the IQOS 3. One carton (10 individual packs of 20 HeatSticks), available in Marlboro, Marlboro Smooth Menthol and Marlboro Fresh Menthol, costs around $90.
Where will it be marketed?
IQOS has been sold in cities all over the world, including in Canada, Europe, Japan and Russia. Now that PMI has secured FDA approval, PMI’s parent company, Altria, will open a brick-and-mortar store as well as mobile stores in Atlanta, Georgia, USA. Shortly thereafter, they will begin selling IQOS all across the U.S., starting in about 500 retail stores, including Circle K, Murphy USA, QuikTrip, RaceTrac and Speedway.
“Japan has had IQOS and similar products longer than any other major market, and in a mere three years, Japan’s cigarette sales fell by a third,” says David Sweanor, chair of the advisory board for the Centre for Health Law, Policy and Ethics at the University of Ottawa. Sweanor has worked on public health policy for tobacco since 1983.
“Scandinavian countries, the U.K. and other places are all clearly showing the ability to replace combustibles. We have never seen such a dramatic decline in smoking,” Sweanor said, predicting that the market will respond with an increasing array of ever-better alternatives to cigarettes, just as risk-reduction innovations have transformed a vast range of other goods and services.
Are there other heat-not-burn products on the market?
Big tobacco companies—which realized as early as the 1950s that cigarettes were potentially lethal—have been trying for decades to develop technology that eliminates the combustion of tobacco since that’s when carcinogens are created.
The idea to create an HnB tobacco product has been unsuccessfully tested in the market at least since 1988 when R.J. Reynolds Tobacco Co. (RJR) came out with Premier. Thus far, these products have not been able to gain market traction, even after constant redesigning and rebranding.
For example, Premier was later redesigned and rebranded as Eclipse, which was sold for only four years, from 2003 to 2007. After that product failed to catch on, RJR came out with Revo, which was just a redesigned version of Eclipse. After that product flopped, it was pulled off the shelves in 2015.
PMI came out with its first HnB product called Accord in 1998, but it too failed to gain traction and was pulled from shelves around 2006. Marketed as a “cleaner” tobacco product, PMI claimed that Accord reduced exposure to the harmful compounds normally released by burning tobacco.
Critics contend that the IQOS is nothing new. The IQOS is a variation on the Accord “without consistent improvements in exposure to aerosol toxic compounds,” says Stanton A. Glantz, director for the Center for Tobacco Research Control and Education at the University of California in San Francisco, California, USA.
“In contrast to PMI’s past claims for Accord, PMI now claims in its MRTP [modified-risk tobacco product] application that IQOS reduces health risk,” Glantz wrote. “This shift in stance is likely not the result of any toxicological difference between Accord and IQOS but rather a change in the social and regulatory landscape permitting these claims.”
Are youth using the IQOS?
In response to a much discussed “epidemic” of teen vaping (see “FDA in Transition,” Vapor Voice, Issue 2, 2019), the FDA has cracked down on e-cigarette sales and marketing. In response to a lawsuit by the American Academy of Pediatrics and other health groups, a federal district judge recently ordered the FDA to speed up the timeline for reviewing the thousands of vapor products now on the market.
Nevertheless, the FDA and PMI both claim that the IQOS won’t be as popular among teenagers as e-cigarettes since it doesn’t come in sweet or fruity flavors. Plus, the price is much higher, especially compared to Juul pods, which have become the most popular vapor product on the market. However, the FDA will still require IQOS advertisements be targeted at adults and will prohibit television and radio advertising.
“Given the rapid pace of innovation in the tobacco products space, we are emphatic that youth should not use any tobacco- or nicotine-containing product,” said PMI’s CEO, Andre Calantzopoulos. “Youth should not become nicotine users. PMI takes that responsibility seriously. In our IQOS stores, we refuse to offer these products to people who have never smoked or those who have quit smoking. We are also clear that these products are not risk-free or a safe alternative to cigarettes.”
“There is a balance that must be struck,” he continued. “Public policy needs to recognize the role that new smoke-free tobacco and other nicotine-containing products can play in helping move adult smokers away from cigarettes. Achieving this balance is absolutely necessary to realizing a true public health breakthrough and requires close coordination with the regulatory agencies.”
Calantzopoulos said that real-world data from countries where IQOS is currently being sold shows that it is reaching the correct audience—current adult smokers. For example, in Japan, the largest IQOS market thus far, 98 percent of IQOS users were tobacco users before switching. Globally, the average IQOS user is between the ages of 30 and 49.
Is the IQOS safer than combustible cigarettes? Where does it fit on the risk continuum?
Although PMI claims that using IQOS exclusively will significantly reduce harm from smoking traditional cigarettes, the FDA is still reviewing PMI’s modified-risk tobacco product application that would allow it to market IQOS as being safer than cigarettes.
PMI’s website touts the following clinical finding: “Smokers switching to Platform 1 (i.e., IQOS) were exposed to lower levels of harmful chemicals compared to those who continued smoking. We measured biological markers in the blood and urine and found that levels of exposure to harmful and potentially harmful constituents (HPHC) were comparable to the levels of those who quit smoking for the duration of the study.”
The FDA corroborates PMI’s claim that levels of cancer-causing chemicals are lower in IQOS’ aerosol than in cigarette smoke. In the news release announcing its approval of the premarket tobacco product application for IQOS, the FDA states, “Through the FDA’s scientific evaluation of the company’s applications, peer reviewed published literature and other sources, the agency found that the aerosol produced by the IQOS tobacco-heating system contains fewer toxic chemicals than cigarette smoke, and many of the toxins identified are present at lower levels than in cigarette smoke. For example, the carbon monoxide exposure from IQOS aerosol is comparable to environmental exposure, and levels of acrolein and formaldehyde are 89 percent to 95 percent and 66 percent to 91 percent lower than from combustible cigarettes, respectively.”
Overall, HnB products have been the source of much study. A systematic literature review of 31 publications on HnB products, secondhand emissions and human exposure published in September 2018 in Tobacco Control found that compared with cigarettes, HnB products reduced levels of HPHC by at least 62 percent and particulate matter by at least 75 percent.
However, it also found that while “HnB use suppressed urges to smoke, participants rated HnB [products] less satisfying than cigarettes. In addition (and in comparison to e-cigarettes), HnB products exposed users and bystanders to toxicants, although at substantially lower levels than cigarettes.”
Not surprisingly, public health groups aren’t any more enthusiastic about HnB products than they are about vapor products, as they remain entrenched in an abstinence-only stance. American Lung Association CEO Harold Wimmer in a statement said that his organization is “deeply concerned about the health impacts of this new product.”
Advocates of the vapor market are also unimpressed.
“If e-cigarettes and vaping products did not exist, then IQOS would be a valuable addition to the market,” said Michael Siegel, professor at the Department of Community Health Sciences at the Boston University School of Public Health. “However, since we already have a thriving market of vaping products—which do not contain any tobacco and are orders of magnitude safer than cigarettes—I don’t see how a heat-not-burn tobacco product really advances the smoking cessation product market.
“There are much safer alternative nicotine-delivering products. While IQOS is somewhat safer than smoking, it is still far more hazardous than vaping products. On the risk continuum, with e-cigarettes at the low end and cigarettes at the high end, IQOS would probably be up towards cigarettes, though not as high but still way above the risk of e-cigarettes.
“To the extent that IQOS diverts attention away from e-cigarettes, it could have negative public health effects. Our focus should be on those vaping products,” Siegel said. “The best scenario would be if IQOS attracts smokers who want to quit but were not able to quit using e-cigarettes or any other strategies.”

Maria Verven
Maria Verven is a 35-year PR veteran and owner of Verve PR, a marketing firm focused on the vapor industry.
June 25, 2019