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FDA approves modified-risk status for three Marlboro HeatSticks styles

FDA approves modified-risk status for three Marlboro HeatSticks styles

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With the U.S. Food and Drug Administration’s approval Tuesday, the international version of heat-not-burn traditional cigarettes can be marketed as modified-risk tobacco products.

Philip Morris International has partnered with Philip Morris USA on the IQOS platform in the United States affecting the regular, smooth and fresh menthol styles of Marlboro HeatSticks.

Heat-not-burn cigarettes typically work this way: Smokers light a carbon tip that heats air that, as it is inhaled, passes over tobacco in a cylinder identical to a standard cigarette. The flavors of tobacco and nicotine are inhaled and then exhaled by smokers.

IQOS works instead by the smoker pushing a button to turn on the heater, and then drawing on the heated tobacco unit to inhale a nicotine-containing tobacco vapor. Once the heated tobacco unit is finished, the consumer removes it from the holder, and then it can be disposed in a waste bin.

By contrast, traditional cigarettes burn the tobacco leaves, which produces carcinogens that can lead to cancer.

It is the first time the FDA has authorized a modified-risk marketing status for a cigarette product.

A modified-risk tobacco-product application seeks authorization to advertise products as reduced harm or reduced risk compared with traditional cigarettes.

“IQOS delivers nicotine in levels close to combustible cigarettes, suggesting a likelihood that IQOS users may be able to completely transition away from combustible cigarettes and use IQOS exclusively,” the FDA said.

“Even with this action, these products are not safe, nor FDA approved — there are no safe tobacco products,” the agency said.

Altria Group Inc., the parent company of Philip Morris USA, said the FDA authorization gives the manufacturer “an opportunity to communicate additional benefits of switching to IQOS.”

“Our 10-year vision is to responsibly lead the transition of adult smokers to a non-combustible future,” said Billy Gifford, Altria’s chief executive.

“IQOS is a key part of that future as we develop our portfolio of FDA-authorized, noncombustible products,” Gifford said.

Stefanie Miller, the managing director of FiscalNote, an industry research firm, said that the IQOS platform “will likely be the only inhaled tobacco or nicotine product on the market with any sort of modified-risk marketing approval for the foreseeable future.”

BAT lawsuit

The FDA ruling represents the end of a 3½-year regulatory gauntlet for Philip Morris USA and Altria that began with the application in December 2016 for premarket tobacco-product status for the IQOS device platform.

Premarket tobacco application standard requires the FDA to consider products’ existing risks and benefits to the population as a whole, including users and nonusers, particularly as those factors compare with traditional cigarettes.

In April 2019, the FDA approved those Marlboro HeatSticks styles for sale under the premarket standard.

In September 2019, Philip Morris USA began selling the products in test markets in Atlanta and Richmond, Va. Philip Morris International said IQOS-based products are available in 53 countries, foremost in Japan.

The FDA authorization allows the modified-risk marketing with the disclaimer “available evidence to date.” Marketing language could include such phrases as:

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

The FDA has put “stringent marketing restrictions on the IQOS-based products in an effort to prevent youth access and exposure.”

The FDA said Philip Morris USA “must request and receive authorization from FDA to continue marketing the products with the same modified exposure information after the initial order expires in four years.”

The FDA said it may withdraw the initial and any potential subsequent exposure-modification orders if it determines that, among other things, the orders are no longer expected to benefit the health of the population as a whole.

Miller said there is a potential legal roadblock for rolling out the Heatsticks products.

On April 9, British American Tobacco PLC and two Reynolds American Inc. affiliates filed a patent-infringement lawsuit against Philip Morris International concerning the technology involved in IQOS.

On May 12, the U.S. International Trade Commission voted to investigate the dispute. An administrative law judge of the commission will hold an evidentiary hearing.

The Reynolds affiliates are requesting a temporary and a permanent injunction against the importation, sale and distribution of IQOS products, as well as “enhanced damages,” alleging “defendants’ infringement has been and continues to be deliberate, willful and unlicensed.”




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