Food and Drug Administration Issues IQOS Modified Risk Approval


The Food and Drug Administration (FDA) has issued a modified risk tobacco product (MRTP) marketing order for the IQOS tobacco heating system, a major step toward Philip Morris International’s stated goal of achieving a “smoke-free world.”

FDA Center for Tobacco Products Director Mitch Zeller said that IQOS, developed by Philip Morris International (PMI) as their next-generation flagship product, has been approved for an exposure modification marketing order. As a result, PMI can market the product in America as a replacement to what the industry calls “traditional combustible tobacco products,” but most people know as “cigarettes.”

“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 Zeller, a regulatory lawyer by trade, in a statement. IQOS is the first and only electronic nicotine delivery system to receive an MRTP approval from the FDA.

PMI’s CEO André Calantzopoulos said that IQOS is “a fundamentally different product than combustible cigarettes and must be regulated differently, as the FDA has recognized.” According to PMI and the FDA, marketers for IQOS can now claim that the system has certain modified characteristics that other smoke-free products can’t.

Read full article here.

Michael McGrady – Inside Sources – July 8, 2020.

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