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Health authorities should reconsider their position on legalising smoke-free products in Australia following a historic decision by the U.S. Food and Drug Administration (FDA).

The US FDA authorised the marketing of IQOS, Philip Morris International’s (PMI) electrically heated tobacco system, as a modified risk tobacco product (MRTP) yesterday.

In authorising the marketing of IQOS, the FDA confirmed that:

  • The IQOS System heats tobacco but does not burn it;
  • This significantly reduces the production of harmful and potentially harmful chemicals; and
  • Scientific studies have shown that switching completely from conventional cigarettes to the IQOS system reduces your body’s exposure to harmful or potentially harmful chemicals.

The FDA decision stands in stark contrast to the interim decision by the Therapeutic Goods Administration (TGA) to not support making heated tobacco products available to the approximately 3 million adult smokers in Australia.

In its interim decision issued last month, the TGA said heated tobacco products “are not Food and Drug Administration (FDA)-approved, which is a requirement for a tobacco product to be marketed with reduced exposure or risk claims” and there is no “compelling evidence to establish a public health benefit from greater access to nicotine in heated tobacco products”.

However, in issuing its decision this week, the FDA said: “The available scientific evidence demonstrates that the issuance of an exposure modification order for IQOS would be appropriate to promote the public health and 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.”

Philip Morris Australia Managing Director, Tammy Chan, welcomed the FDA’s decision.

“We are excited that this important decision will help guide the choices of adult smokers in the U.S. The best choice for health is to never start smoking or to quit altogether. For those who don’t quit, the best thing they can do is switch to a scientifically substantiated smoke-free product,” Ms Chan said.

“It’s a shame that adult smokers in Australia cannot even attempt to switch to a smoke-free product, as the government continues to deny them that opportunity,” Ms Chan said.

“In other comparable countries, adult smokers are switching to smoke-free products and as a result, are reducing their exposure to harmful chemicals found in cigarettes. In Australia, however, adult smokers who don’t quit can only smoke cigarettes even though we know there are better alternatives that can be made available,” Ms Chan said.

“The science is absolutely clear: the moment you stop burning tobacco, the exposure to harmful chemicals is significantly reduced. So then why are adult smokers in Australia constantly left behind when all around the world, other smokers are giving up cigarettes by switching to less harmful, smoke-free products?” Ms Chan said.

According to government figures, the smoking rate has remained relatively similar since 2014-15. Legalisation and comprehensive science-based regulation of smoke-free products in Australia can have a significant impact on the number of people who smoke, as is the case in other countries, while also guarding against unintended consequences.
Philip Morris Australia will respond to the TGA’s interim decision on heated tobacco products this week.

“I’m hopeful health authorities in Australia, including the TGA, will carefully consider the FDA’s decision and truly embrace the opportunity to promote public health by making smoke-free products available to adult smokers,” Ms Chan said.

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