The marketing campaign teams allege that PMI violated the FDA’s orders by suggesting IQOS provided decrease dangers than cigarettes
Well being campaigners have written to U.S. regulators accusing Philip Morris Worldwide PM.N of misrepresenting previous regulatory choices, looking for to disrupt the launch of its flagship heated tobacco machine IQOS in the USA.
The world’s largest tobacco firm by market worth has spent billions of {dollars} creating the product, which buyers see as key to driving future development. Nevertheless it wants permission from the U.S. Meals and Drug Administration to promote it on the planet’s second largest tobacco market by income.
Six anti-tobacco and well being teams, together with the Marketing campaign for Tobacco-Free Youngsters, the American Academy of Pediatrics and the American Lung Affiliation, wrote to the FDA to oppose IQOS-related functions PMI has submitted to the company.
“PMI has repeatedly made deceptive and misleading statements wrongly suggesting that the FDA has discovered that IQOS reduces the danger of illness,” the letter, dated June 27 and reviewed by Reuters, mentioned.
The marketing campaign teams allege that PMI violated the FDA’s orders by suggesting IQOS provided decrease dangers than cigarettes. Their letter cited 4 examples of such statements in the USA, the Philippines, Mexico and Kazakhstan.
Additionally they mentioned within the letter that upcoming impartial research contradict PMI’s findings about what number of IQOS customers utterly change to the machine from cigarettes.
Shows on the research from the Worldwide Tobacco Management Mission (ITC) at Canada’s College of Waterloo are connected to the letter as displays.
They present the ITC discovered a far decrease charge of IQOS customers had stop smoking in Japan and Korea than estimates from PMI.
These components “straight bear on whether or not PMI ought to be permitted to market IQOS” in the USA, the campaigners’ letter mentioned.
The contents of the letter haven’t been beforehand reported.
IQOS market share throughout key nations
Requested by Reuters to answer the letter, a PMI spokesperson mentioned the corporate was proud to debate the FDA’s conclusions on IQOS.
The spokesperson didn’t handle every instance however mentioned among the language flagged by campaigners was, within the firm’s view, suitable with the FDA’s orders.
“Wherever we focus on our science and our merchandise, we achieve this in accordance with all relevant legal guidelines,” the spokesperson mentioned.
Reuters couldn’t decide whether or not the campaigners’ letter would change the FDA’s method to IQOS. The company mentioned it had obtained the letter and would reply on to the senders. It didn’t remark additional.
Gadgets like IQOS warmth up sticks of floor tobacco with out burning them in an try and keep away from the dangerous chemical compounds launched by way of combustion.
The FDA first authorised PMI to promote an older model of IQOS in 2019. It subsequently authorised the corporate to promote it as providing diminished publicity to dangerous chemical compounds versus cigarettes for people who smoke who utterly change – generally known as an “publicity modification order”.
The FDA can even concern a “danger modification order”, authorising an organization to assert its product reduces the danger of tobacco-related hurt and illness. However that is more durable to show, particularly with out long-term, epidemiological research.
The FDA rejected PMI’s earlier utility to say its older IQOS machine leads to diminished well being dangers, saying there wasn’t ample proof to help this.
PMI utilized in 2023 to resume its current publicity modification orders. Later that 12 months, it additionally utilized to promote and market a more moderen model of the IQOS machine in the identical method. The FDA has but to determine on these functions.
Advertising and marketing the product as having well being advantages in comparison with conventional cigarettes might assist PMI persuade shoppers to modify in addition to afford it tax advantages versus cigarettes in some U.S. states.
SWITCH RATES
The marketing campaign teams additionally cited preliminary information from ITC research in Japan and Korea, saying it contradicted PMI’s findings about what number of IQOS customers utterly change from cigarettes.
The altering U.S. nicotine market (billions)
The research have been introduced at educational conferences however haven’t but been submitted for publication in a journal, ITC researchers informed Reuters. In consequence, examine abstracts have been peer reviewed however the full findings have but to undergo that course of.
Japan is IQOS’ largest market and the introduction of heated tobacco there coincided with an accelerated decline in cigarette gross sales.
PMI estimates greater than seven out of 10 of its registered IQOS prospects globally have stop cigarettes. A 2023 PMI utility to the FDA emphasised that almost all of IQOS customers have been utilizing IQOS completely.
Nevertheless, the ITC’s researchers put the share of all IQOS customers that had stop smoking at simply 15% in Japan and 30% in Korea in 2021.
Customers mostly used IQOS and cigarettes concurrently, generally known as “twin use”, typically resulting in an general enhance in tobacco consumption, the ITC researchers discovered.
PMI pointed to a 2019 Japanese authorities well being survey, the place 75% of respondents who reported utilizing heated tobacco mentioned they didn’t smoke.
Nevertheless, a paper printed this 12 months, led by researchers from Georgetown College, highlighted flaws within the authorities’s survey, together with adjustments to the query format that may result in under-reporting of smoking.
Different surveys have additionally discovered larger charges of twin use than the federal government, it mentioned.
