IQOS was approved for sale in the US more than two years after Philip Morris submitted a pre-application for tobacco to the FDA. The PMTA was submitted in March 2017 along with a Risk Change Request (MRTP) to which the Agency has not yet responded.
Although the application was filed by Philip Morris S.A. (a division of Philip Morris International – PMI), IQOS is marketed in the USA by Altria Group, the largest cigarette manufacturer in the country. The Marlboro brand is the most popular American cigarette brand.
The FDA marketing order for IQOS is the first approval of a PMTA for an inhalable nicotine consumer product. (The only previously approved PMTA was for several Swedish Match snus products.) No Vapour manufacturer has yet submitted a PMTA for a traditional steam product.
While news is often confusing, IQOS is a non-flammable tobacco product, not a steam product that uses e-liquid. The IQOS "tobacco heating system" consists of three main parts: a handheld device, a charger and small tobacco-filled sticks (HeatSticks or HEETS) that are heated by the device to a temperature high enough to vaporize the tobacco but too low to cause combustion. The tobacco is not burned like cigarettes and there is no smoke. Heat-not-Burn (HNB) is a heat-sensitive product (HNB) that does not produce smoke.
Scientific studies have shown that IQOS is much safer than smoking and emits less toxins than burnt tobacco; it is widely accepted that IQOS is not as safe as modern steam products that do not contain tobacco; however, HNB devices such as IQOS could provide enormous public health benefits if used by a large number of people who currently smoke cigarettes; and in Japan and South Korea, where IQOS has been available for several years, HNB devices have received awards for enormous losses in cigarette sales.
It is unlikely that IQOS and other HNB products will compete with e-cigarettes for the business of existing Vaper's. The experience and taste of heated tobacco is much closer to smoking than vaporizing, and the retail price of HeatStick refills is likely to reflect the price of cigarettes. As the FDA technically classifies HeatSticks as cigarettes, Altria is subject to taxes and fees for refills similar to those for cigarettes, and it is prohibited to advertise on television or radio.
According to the FDA, this does not mean that tobacco products are safe or approved by the FDA, but despite the FDA's protests, most people are likely to believe that the marketing regulations will be adhered to, issued a confirmation by the health inspectorate and wonder why vaping products are not also approved by the FDA, and the FDA can use the approval as an example of how fair its tobacco inspection system is to manufacturers.
While the FDA's decision may seem encouraging to vapour manufacturers when considering their own PMTAs, the details do not offer much hope; the FDA took four times as long to approve the IQOS application when the Agency's guidelines promised; no vaporizer company can afford to hold its business for two years and wait for FDA approval (which is not guaranteed); of course, no vaporizer company can fall back on cigarette sales if its PMTA is delayed or rejected; PMI and Altria may be encouraging to vapour manufacturers to consider their own PMTAs, but the details do not offer much hope.
In addition to the excessively long wait for FDA action on an application, the high cost of submitting a PMTA would prevent the submission of an effective application for all but a few vaping manufacturers (probably only JUUL and the major tobacco companies). No one could afford the extensive research and analysis PMI collected for its IQOS application. The tobacco company has reportedly spent billions of dollars on its PMTA and MRTP submissions.
It is almost impossible to imagine that this federal agency, whose recently deceased commissioner helped create a moral panic over teenage steam, would at this point find a steam product "suitable for the protection of public health", even for IQOS The FDA's marketing regulation contains restrictions on marketing and advertising, as well as a call for comprehensive monitoring of the postal market to ensure that it does not become popular with teenagers.
"Until the FDA's regulatory system is reformed, no one but the largest tobacco companies will ever get a vaping product through the FDA's pre-approval process," said Gregory Conley, president of the American Vaping Association.
PMI has recently started to use the IQOS name as a brand and use it on its non-smoking products, such as the IQOS Mesh steam cooker (not sold in the US). According to PMI, reduced-risk products accounted for approximately 14 percent of global sales last year. The approval granted yesterday only applies to the IQOS tobacco heating system, which includes the IQOS appliance itself, the Marlboro HeatSticks, the Marlboro Smooth Menthol HeatSticks and the Marlboro Fresh Menthol HeatSticks.
According to Altria, IQOS products are tested in the Atlanta, Georgia area before they are launched nationwide.