Fda renews Iqos and Heets status as modified risk tobacco products
Approvals for two Iqos devices and three Heets variants have been renewed in the US. For the FDA the measure is appropriate for the promotion of public health. Philip Morris International: decision based on scientific evidence
The US Food and Drug Administration (FDA) has renewed marketing orders already granted for two versions of the Iqos device and three variants of Heets tobacco sticks as Modified Risk Tobacco Products (Mrtp).
The renewal allows Philip Morris International (Pmi) to continue to disseminate exposure reduction information to US adults aged 21 years or older who use traditional tobacco products, such as cigarettes.
According to the FDA, the renewal of Mrtp authorisations for Iqos and Heets is appropriate to promote public health and should produce benefits for the population as a whole, considering both users of tobacco products and non-users.
"As the only company to have successfully obtained and maintained Mrtp clearances for heated tobacco products in the US, we are confident that our science-based alternatives can help adult smokers quit cigarettes," said Stacey Kennedy, CEO of Pmi Us. "This FDA decision reflects both the rigorous scientific rationale supporting Iqos and our continued commitment to responsibly offer combustion-free alternatives to adult consumers."
In the ruling, the FDA reiterated that the available scientific evidence, even in the absence of long-term epidemiological studies, shows that a measurable and substantial reduction in morbidity or mortality among individual users of tobacco products is reasonably likely.
