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Philip Morris aims to acquire ‘risk modification’ nod from FDA

Calls for separate regulations for heated cigarettes citing FDA’s recognition of ‘modified exposure’

Managing Director at Philip Morris Korea Paik Young-jay (Philip Morris Korea)
Managing Director at Philip Morris Korea Paik Young-jay (Philip Morris Korea)
Philip Morris Korea on Wednesday called on the government to introduce separate regulations for heat-not-burn cigarettes, as it touted the latest authorization by the US Food and Drug Administration of its Iqos brand.

The FDA decided in July to authorize the marketing of the company’s electronically heated tobacco system as a type of modified risk tobacco product in an industry first. There are two types of MRTP orders the FDA may issue: a “risk modification” order or an “exposure modification” order. Iqos has been acknowledged for “exposure modification” and it now aims to receive the “risk modification” by providing additional information required by the FDA going forward.

“If adult smokers are given incorrect information and policy to help them switch (to electronic cigarettes) doesn’t exist, they will continue to smoke regular cigarettes, which is the most harmful (choice),” said Paik Young-jay, managing director at PMK during a livestreamed press conference.

The company refreshed calls on the Korean government to follow in the footsteps of the US and set policies based on scientific evidence.

The comments come as the government has proposed multiple bills in recent months to toughen regulations on heated cigarettes, including a tax increase and requiring health warning labels.

PMK, meanwhile, noted that the FDA itself doesn’t “approve” of tobacco products in general and that Iqos is also not risk-free.

By Yim Hyun-su (