US FDA Authorizes Marketing of PMI’s heated tobacco product as a Modified Risk Tobacco Product

The following is a press release from Philip Morris Trading (Thailand) Limited. The information and opinions within are their own and may not necessarily reflect those of The Pattaya News Company limited.

9 July 2020

US FDA Authorizes Marketing of PMI’s heated tobacco product as a Modified Risk Tobacco Product

BANGKOK, THAILAND. Mr. Gerald Margolis, Managing Director, Philip Morris Trading (Thailand) Limited, an affiliate of PM, reveals that the U.S. Food and Drug Administration (FDA) on July 7th  authorized the marketing of Philip Morris International’s (PMI) electrically heated tobacco system, as a modified risk tobacco product (MRTP). In doing so, the agency found that the product exposure modification order is appropriate to promote the public health which could be more effective way to protect the public health than the prohibition like Thailand.

The decision demonstrates that PMI’s heated tobacco product is a fundamentally different tobacco product and a better choice for adults who would otherwise continue smoking. PMI’s heated tobacco product is the first and only electronic nicotine product to be granted marketing orders through the FDA’s MRTP process.

The FDA authorized the marketing of PMI’s heated tobacco product with the following information:

• PMI’s heated tobacco product 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 PMI’s heated tobacco product reduces your body’s exposure to harmful or potentially harmful chemicals.

The agency concluded that the available scientific evidence demonstrates that PMI’s heated tobacco product is expected to benefit the health of the population as a whole, taking into account both users of tobacco products and persons who do not currently use tobacco products.

The FDA’s decision further builds on the emerging independent international scientific consensus that IQOS is a better choice than continuing to smoke, and follows the FDA’s April 2019 decision authorizing the commercialization of IQOS in the U.S.

The FDA’s decision provides an important example of how governments and public health organizations can regulate smoke-free alternatives to differentiate them from cigarettes in order to protect and promote the public healt

This decision follows a review of the extensive scientific evidence package PMI submitted to the FDA in December 2016 to support its MRTP applications.

Commenting on the FDA’s announcement, André Calantzopoulos, PMI’s Chief Executive Officer, said: “The FDA’s decision is a historic public health milestone. Many of the tens of millions of American men and women who smoke today will quit—but many won’t. Today’s decision makes it possible to inform these adults that switching completely to PMI’s heated tobacco product is a better choice than continuing to smoke. FDA determined that scientific studies show that switching completely from conventional cigarettes to PMI’s heated tobacco product reduces exposure to harmful or potentially harmful chemicals. The product is a fundamentally different product than combustible cigarettes and must be regulated differently, as the FDA has recognized. Now—more than ever—there is an urgent need for a fundamentally different conversation on a cooperative approach to achieve a smoke-free future. The FDA’s decision provides an important example of how governments and public health organizations can regulate smoke-free alternatives to differentiate them from cigarettes in order to promote the public health.”

Mr. Gerald Margolis, added that “while we are extremely excited that this important decision will help guide the choices of adult smokers in the U.S., there are over 10 million Thai smokers who deserve an equal opportunity to accurate information and access to alternative products.   We believe that the decision by the US FDA should inspire the Ministry of Public Health, public health organizations, policy makers and legislators to review the scientific evidence of PMI’s heated tobacco product and regulate smoke-free alternatives to protect the health of Thai smokers and non-smokers for the benefit of the population as a whole”