US FDA Approves IQOS as a "Modified Risk Tobacco Product"

IQOS White

[Asia Economy Reporter Choi Saeng-hye] Philip Morris International (PMI) announced on the 9th that the U.S. FDA has granted marketing authorization for its heated tobacco product, IQOS, as a "Modified Risk Tobacco Product."

The FDA cited the reduction of human exposure to harmful substances from IQOS as a reason, stating that it could help improve public health.

As a result, IQOS became the first and only electronic tobacco product to receive marketing authorization as a modified risk tobacco product from the U.S. FDA.

PMI stated that going forward in IQOS marketing, it can use information such as ▲ the IQOS system heats tobacco without burning it ▲ heating tobacco without burning significantly reduces the generation of harmful substances ▲ scientific studies show that smokers who completely switch from conventional cigarettes to the IQOS system experience a significant reduction in human exposure to harmful substances.

PMI said, "This FDA decision aligns with the consensus of international independent scientific organizations that 'IQOS is a better alternative product than conventional cigarette smoking' and is an extension of last year's decision to authorize IQOS sales in the U.S." It added, "In particular, the FDA's decision can serve as a good example for governments and public health agencies worldwide on how to regulate smoke-free alternative products differently to improve public health."

There are two types of modified risk tobacco product authorizations: 'exposure reduction' and 'risk reduction.' PMI received authorization for exposure reduction this time. PMI plans to actively cooperate with the FDA regarding additional information requested for IQOS's risk reduction authorization in the future.

Andr? Calantzopoulos, PMI Chairman, said, "The FDA's decision will be a significant milestone in public health history," and added, "With the FDA's decision, we can now tell adult smokers that 'completely switching to IQOS is a better choice than using conventional cigarettes.'" He emphasized, "Since IQOS is fundamentally different from conventional cigarettes that are burned and smoked, regulations on it should also be differentiated, as the FDA has done."

This content was produced with the assistance of AI translation services.