US FDA: IQOS authorization ‘appropriate for promotion of public health’

US FDA: IQOS authorization ‘appropriate for promotion of public health’

MANILA — The recent decision of the US Food and Drug Administration (FDA) authorizing IQOS as a “modified risk tobacco product” acknowledged that the marketing of the product is “appropriate for the promotion of public health,” Philip Morris International Chief Executive Officer André Calantzopoulos said.

Images of different IQOS products

In a global virtual press conference, Calantzopoulos described the US FDA decision as a “historic moment for public health” as the agency noted that the order is expected “to benefit the health of the population.”

Issued on 7 July 2020, the US FDA’s latest decision marks the first time the agency has granted MRTP marketing order for an innovative electronic alternative to cigarettes. The IQOS Tobacco Heating System includes the electronic IQOS device that generates a nicotine-containing aerosol by heating tobacco-filled sticks wrapped in paper (HeatSticks).

“I hope that the FDA decision will end the debate on whether all tobacco products are the same and whether nicotine is the issue. We now know that not all tobacco products are the same and that combustion—not nicotine—is the issue. An enormous public health opportunity will be missed if smoke-free products that are scientifically reviewed are not made available to smokers today, and if appropriate cost commercialization policies and surveillance are not implemented to maximize adoption of smoke-free alternatives by adult smokers and minimize any unintended use by nonsmokers, especially the youth.”

“The latest MRTP authorization issued by the US FDA with the designation ‘appropriate for the promotion of public health’ is certainly a step up,” said Dr. Moira Gilchrist, Vice President, Strategic & Scientific Communications, PMI. “Underpinning all of the US FDA decisions is a science-based approach, something that we certainly want to see happen in many other countries around the world.”

“This decision confirms that IQOS is distinctly different than cigarettes. This information should be communicated to consumers to help guide their choices,” said Dr. Gilchrist. “Now is the time to rapidly shift smokers away from cigarettes. Scientifically substantiated better alternatives like IQOS represent a public health opportunity.”

Potential to phase out cigarettes in 10-15 years

“For many years, tobacco control policies have focused on restrictive marketing and fiscal measures in order to convince smokers to quit and prevent non-smokers from smoking. Although largely appropriate, these measures have reached their limit in many countries…[and] there are still over a billion smokers globally,” Calantzopoulos said.

While restrictive measures on cigarettes obviously must continue, he said, advances in technology have resulted in the development of novel smoke-free nicotine products.

“All of these novel products have one foundational characteristic: they do not burn—there is no combustion—and therefore they produce less harmful substances. These can be IQOS or properly manufactured and regulated vapor products [e-cigarettes or vapes]. Undeniably, these products are better alternatives to cigarettes.”

Calantzopoulos believes that the US FDA has a clear overall policy on tobacco regulation that is anchored on two important pillars: continue imposing restrictions on cigarettes while, at the same time, create a policy environment that makes alternative smoke-free products and information about such products available to smokers so they can make informed decisions.

“Now is the time for governments around the world to adopt a policy that has both pillars, so that over time we can get to a point where other regulatory measures of this nature can be used to phase out cigarettes more quickly,” Calantzopoulos said.

“With the right approach from governments, regulators and public health authorities, as well as incentives for manufacturers to develop scientifically reviewed smoke-free products and make every effort to commercialize them, I believe that we can completely phase out cigarettes in many countries in 10 to 15 years.” (MTVN)

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