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Home » FDA authorises new system

FDA authorises new system

NT BureauBy NT BureauJuly 17, 2020No Comments
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Chennai: The US Food and Drug Administration has authorised the marketing of Philip Morris Products S.A’s ‘IQOS Tobacco Heating System’ as modified risk tobacco products (MRTPs).

This marks the second set of products ever to be authorised as MRTPs and the first tobacco products to receive ‘exposure modification’ orders, which permits the marketing of a product as containing a reduced level of or presenting a reduced exposure to a substance or as being free of a substance when the issuance of the order is expected to benefit the health of the population, said a press note

Importantly, the authorisation for these products requires the company to conduct postmarket surveillance and studies to determine whether the MRTP orders continues to be appropriate, including assessing the potential for increased use among youth.

“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, J D, director of the FDA’s Center for Tobacco Products.

 

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