New York—The US Food and Drug Administration has confirmed that IQOS, Philip Morris International’s electrically heated tobacco system, is appropriate for the protection of public health and authorized it for sale in the United States.
FDA’s decision follows its comprehensive assessment of PMI’s premarket tobacco product applications 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 pursuant to the 2009 law that empowers FDA to regulate tobacco products, including through oversight of innovative products.
PMFTC Inc., the local affiliate of PMI in the Philippines, said while this certainly is good news, “we continue to evaluate market and regulatory conditions for the introduction of IQOS in the Philippines.”
“Our initial research tells us that 6 out of 10 Filipino smokers are already open to trying better alternatives to smoking. The US FDA authorization, as well as our research, are encouraging indicators for us to work hard to be able to offer IQOS to Filipino consumers,” said PMFTC external affairs and communications director Patrick Muttart.
PMI chief executive officer André Calantzopoulos said the FDA’s decision to authorize IQOS in the US was 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. 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,” he said.
“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.