Philip Morris International has entered the Food and Drug Administration regulatory gauntlet to have its electronically heated cigarette reviewed as a potential reduced-risk product.
The Switzerland-based manufacturer confirmed Tuesday its submission of a modified-risk tobacco product application for its iQOS technology with the FDA’s Center for Tobacco Products.
The technology is in use with the Marlboro HeatStick device in Italy, Japan and Switzerland.
The company expects the FDA will need at least 60 days “to complete an administrative review to determine whether to accept the application for substantive review” as a modified-risk product.
Analysts have projected that the cost of a FDA regulatory review would be several million dollars for each application. An application is expected to be required for each flavoring and nicotine content level.
By comparison, the FDA estimates the average cost of an application at $466,563 each.
Complicating the review process is the pending transition from the Obama administration, which has supported tighter regulations on tobacco products, to the Trump administration, which is likely to favor reducing regulations overall, as does a Republican-controlled Congress.
Scott Ballin, past chairman of the Coalition on Smoking or Health, said the application for the iQOS technology was estimated at more than 2 million pages.
The FDA debuted Aug. 8 its latest round of heightened regulations on tobacco product innovations. With the application, PMI enters a regulatory pipeline that could last until the end of 2018.
The manufacturer has expressed optimism for debuting the heat sticks in the U.S. by late 2017 or early 2018.
Bonnie Herzog, a Wells Fargo Securities analyst, said in October that U.S. retailer interest was growing for a heat-not-burn product even though the only one in the market, R.J. Reynolds Tobacco Co.’s Eclipse, is in limited distribution.
Philip Morris International said the application for iQOS represents the next step in building a reduced-risk product portfolio “that meets a broad spectrum of adult smoker preferences and rigorous regulatory requirements.” It has invested more than $2 billion in reduced-risk product development.
“While this designation could be very powerful from a global public health standpoint, (the manufacturer) will need to file a premarket tobacco product application to commercialize the product in the U.S. via an exclusive licensing agreement with Philip Morris USA,” Herzog said.
The premarket application would allow PMI to market the heat sticks in the U.S. without making a health claim — similar to how it is sold in a test market in Japan.
Herzog said she expects PMI to file the premarket application in the first quarter and get an answer from the FDA by late summer.
“We continue to believe iQOS is a positive catalyst for both manufacturers, providing a unique competitive advantage,” Herzog said.
“Based on our analysis, we think 25 percent to 30 percent of the U.S. combustible cig market could be converted to iQOS by 2025, resulting in incremental volume for Philip Morris USA as it could take up to 9 share points and reach 60 market share by 2025.”
Last week, Andre Calantzopolous, chief executive of PMI, told BBC that iQOS has the potential to allow the manufacturer to phase out making combustible cigarettes.
Herzog said she believes iQOS has strong potential “to break the mold” gives its “overwhelming success in Japan, its strong margin profile since it is taxed 20 percent below conventional cigs there, tax benefits in other markets, and growing consumer acceptance/conversion rates in other key markets.”
Herzog said iQOS could play a pivotal role in spurring the reuniting of the two Philip Morris companies, along with the potential purchase of Reynolds American Inc. by British American Tobacco Plc.
“We reiterate our belief that PMI would benefit from owning the U.S. market outright, rather than receive just a revenue and royalty stream from the sale of iQOS to Philip Morris USA,” Herzog said.
The potential U.S. entrance of Marlboro HeatStick comes about 16 months after R.J. Reynolds Tobacco Co. acknowledged in August 2015 that it was discontinuing its second attempt in 12 years at marketing a heated cigarette, Revo.
Reynolds shelved Revo after launching a test market in Wisconsin in February. The product sold at retail for about $6 a pack. Susan Cameron, Reynolds’ chief executive and president, had expressed confidence that heat-not-burn “finally finds its time.”
Although Cameron stressed Reynolds is not exiting the heat-not-burn category, the repeat failure did not appear to surprise analysts, who have questioned the level of demand for heated cigarettes, particularly given the inability to match the taste that comes from a traditional cigarette.
“We believe we are the experts in the area of heat-not-burn, given our more than two decades of research and innovation in the category,” Reynolds spokesman David Howard said in October.
Eclipse, the company’s first national attempt at the heat-not-burn category from 2003 to 2007, also ended because the product struggled to gain traction with adult smokers.