FDA authorizes Philip Morris’s IQOS products
The U.S. Food and Drug Administration (FDA) authorizes Philip Morris International (PMI)’s IQOS Tobacco Heating System, as a modified risk tobacco product (MRTP).
PMI can market its IQOS products as reducing consumers’ exposure to harmful chemicals found in cigarettes, FDA said.
“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,” Mitch Zeller, director of the FDA’s Center for Tobacco Products, said in a statement.
The IQOS products heat tobacco but does not burn it, which is seen as less harmful than smoking conventional cigarettes. Last April, the FDA authorized IQOS for sale in the U.S.
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. But the agency stopped short of allowing IQOS to be marketed as “reducing health risks associated with cigarette smoking”, saying evidence did not support the claims Philip Morris proposed.
The FDA stressed the decision does not mean IQOS products are safe, rather they can be a less harmful alternative for people who completely switch from cigarettes.
As of March 31, 2020, PMI estimates that approximately 10.6 million adult smokers around the world have already stopped smoking and switched to IQOS.
André Calantzopoulos, PMI’s Chief Executive Officer, said in a statement the FDA’s decision shows that IQOS is “a fundamentally different tobacco product and a better choice for adults who would otherwise continue smoking.”
“We believe that this decision can help to further accelerate the transition of U.S. adults away from cigarettes. We, along with our licensee Altria, are committed to guarding against unintended use and fully support FDA’s focus on protecting youth.”
Altria Group, which sells Marlboro products in the U.S., is marketing IQOS in the country through an agreement with PMI, which sells Marlboro products in other countries.
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.
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