US allows sale of new tobacco device

MANILA, Philippines — In a development that will affect the regulation and sale of electronic cigarettes or e-cigarettes globally, the US Food and Drug Administration (FDA) has authorized the sale of Philip Morris International (PMI)’s IQOS in the US.

In authorizing the sale of IQOS, the USFDA confirmed that the multinational tobacco giant’s electrically heated tobacco system is appropriate for the protection of public health. 

The FDA’s decision follows its comprehensive assessment of PMI’s premarket tobacco product applications (PMTAs) filed with the agency in 2017.

Unlike cigarettes, the IQOS system heats – but does not burn – tobacco. It is the first electrically heated tobacco product to qualify for sale in the US through the 2009 law that empowers the FDA to regulate tobacco products, including the oversight of innovative products.

Meanwhile, PMFTC Inc., the local affiliate of PMI in the Philippines, said it continues to evaluate market and regulatory conditions for the introduction of IQOS. 

“Our initial research tells us that six out of 10 Filipino smokers are already open to trying better alternatives to smoking. The USFDA authorization as well as our research are encouraging indicators for us to work hard to be able to offer IQOS to Filipino consumers,” said Patrick Muttart, PMFTC external affairs and communications director. 

“The FDA’s decision to authorize IQOS in the US is an important step forward for the approximately 40 million American men and women who smoke.

Some will quit. Most won’t and for them, IQOS offers a smoke-free alternative to continued smoking,” André Calantzopoulos, PMI’s chief executive officer, said.

“In just two years, 7.3 million people around the world have abandoned cigarettes and switched completely to IQOS. Today’s decision by FDA makes this opportunity available to American adult smokers. All of us at PMI are determined to replace cigarettes with smoke-free alternatives that combine sophisticated technology and intensive scientific validation.

FDA’s announcement is a historic milestone,” he added.

“The order sets out clear commercialization guidelines, including marketing requirements, that maximize the opportunity for adults to switch from cigarettes, while minimizing unintended use.