Today, the advisory panel to the Food and Drug Administration voted 5-to-4 to reject a claim from Philip Morris International Inc. that “Switching completely to IQOS presents less risk of harm than continuing to smoke cigarettes.” Phillip Morris claims that using their IQOS device, which heats tobacco rather than burn it, could reduce the risk of tobacco related health issues compared to cigarettes.
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“The advisory panel to the U.S. Food and Drug Administration did smokers and public health a disservice by mostly rejecting Phillip Morris’ claim that their IQOS product should be allowed to be marketed as a reduced risk tobacco product. The advisory panel concluded this even though they overwhelmingly agreed that the IQOS product does significantly reduce exposure to harmful and potentially harmful chemicals.
“How many more smokers will have to die on the FDA’s watch until they catch up to the rest of the world when it comes to supporting harm reduction technologies? The rest of the world is far ahead of the United States in terms of supporting policies that help smokers quit or at a minimum move to less harmful alternatives such as heat-not-burn products, e-cigarettes, and snus.
“Hopefully, the FDA will look at the evidence from around the world that shows that encouraging and allowing companies to honestly market their less harmful products is good for public health. If they do, the FDA would allow IQOS to be marketed as a reduced risk tobacco product.”
“Tobacco Products Scientific Advisory Committee members seemed to be looking for 100% absolute certainty from each study – and each member wanted to use their own preferred word choices in the claims. That wasn’t TPSAC’s mandate. The FDA would be wise to thank TPSAC for their contribution, and then swiftly move forward with its comprehensive nicotine agenda by approving the IQOS MRTP.
“The totality of evidence clearly supports these modified risks claims. Public health ultimately benefits when consumers are empowered to make informed choices based on the best currently available evidence.
“By failing to even acknowledge that “Switching completely to IQOS presents less risk of harm than continuing to smoke cigarettes.” TPSAC rendered its advice to the FDA completely unreliable.
“If the FDA is to be taken seriously about its comprehensive nicotine strategy, it will rely on its own science, rather than that of this misguided advisory committee.”
“The Tobacco Products Scientific Advisory Committee’s negative recommendations were not unexpected, but nonetheless are still disappointing. Over the last several years, it has become clear that TPSAC is a political body with members who are more than willing to overlook facts in favor of ideology and preconceived notions. If anything was revealed by this hearing, it is that the entire Modified Risk Tobacco Products process was designed to end in failure. We are hopeful that FDA Commissioner Dr. Scott Gottlieb will come down in favor of innovation and consumer choice by rejecting TPSAC’s nonsensical conclusions.”