Philip Morris International can market its IQOS products as reducing consumers’ exposure to harmful chemicals found in cigarettes, the U.S. Food and Drug Administration said Tuesday.
IQOS heats tobacco rather than burning it, a process seen as less harmful than smoking conventional cigarettes. The FDA last year allowed IQOS, which is an electronic device that uses a tobacco plug, to be sold in the U.S. while it reviewed Philip Morris’s modified-risk product application.
IQOS is popular also in the Western Balkan countries including Albania.
The FDA on Tuesday said that available evidence shows IQOS’s production of harmful and potentially harmful chemicals is lower than that of regular cigarettes. The agency cited scientific studies showing that switching completely to the IQOS system from cigarettes significantly reduces exposure to such chemicals.
“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,” a statement reads.
Philip Morris Chief Executive Officer Andre Calantzopoulos hailed the FDA’s decision and said it shows “that IQOS is a fundamentally different tobacco product and a better choice for adults who would otherwise continue smoking.”
The decision concludes a nearly four-year long process for Philip Morris. The company submitted its modified-risk application to the FDA in December 2016 before making its case in 2018 to an FDA advisory panel, which suggested allowing the reduced exposure claim but not reduced-risk claims.
Philip Morris is required to study how the label influences consumers and to monitor youth awareness and use of IQOS products. The marketing order lasts for four years, after which Philip Morris will need to request renewal from the FDA.