US FDA approves IQOS marketed with “Reduced Exposure” information

US FDA approves IQOS marketed with “Reduced Exposure” information

By Hafidz Baharom

The IQOS Tobacco Heating system is now the second set of products authorised by the U.S Food and Drug Administration to receive “exposure modification” orders, allowing the marketing of the e-cigarette as containing a reduced level or presenting a reduced exposure to a substance.

While this does not mean that the Philip Morris product is “FDA approved”, the company had requested that both a “risk modification” and an “exposure modification” order.

“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 FDA’s director of the Centre for Tobacco Products, MItch Zeller, J.D.

With the approval from the FDA, the IQOS can now be marketed with the following information:

“AVAILABLE EVIDENCE TO DATE:

– The IQOS system heats tobacco but does not burn it.

– This significantly reduces the production of harmful and potentially harmful chemicals.

– Scientific studies have shown that switching completely from conventional cigarettes to the IQOS system significantly reduces your body’s exposure to harmful or potentially harmful chemicals.”

The approval of IQOS also tasks Philip Morris PRoducts S.A to conduct postmarket surveillance and studies to determine the impact of these orders on consumer perception, behaviour and health, with the FDA granted access to review the accuracy of the predeterminations upon which the orders were based.

This includes a rigorous study on toxicity using computer models to help chart out adverse effects on users, as well as monitoring youth awareness and use of the products.

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