FDA OKs IQOS Marketing as Modified Risk Product

Altria unit Philip Morris can market the tobacco alternative system with a reduced exposure claim.

July 09, 2020

NEW YORK—Altria Group Tuesday won approval from the U.S. Food and Drug Administration to market the IQOS tobacco heating system as a modified risk product with a reduced exposure claim. IQOS is the first next-generation inhalable tobacco product to be authorized as a modified risk tobacco product.

Altria unit Philip Morris USA, under an exclusive licensing agreement with Philip Morris International, markets IQOS in the United States. The FDA’s authorization follows completion of the agency’s substantive scientific review of the IQOS MRTP applications, a review that began in December 2016.

The IQOS system heats tobacco but doesn’t burn it like combustible cigarettes.

“We’re delighted that the FDA authorized IQOS to be marketed as a modified-risk tobacco product,” said Billy Gifford, CEO of Altria. “This authorization gives PM USA an opportunity to communicate additional benefits of switching to IQOS, and this decision is an important step for adult smokers. Our 10-year vision is to responsibly lead the transition of adult smokers to a non-combustible future. IQOS is a key part of that future as we develop our portfolio of FDA-authorized, non-combustible products and actively switch adult smokers to them.”

Mitch Zeller, director of the FDA’s Center for Tobacco Products, said in a statement that “Data submitted by the company shows that marketing these particular products with the authorized information can help addicted adult smokers transition away from combusted cigarettes and reduce their exposure to harmful chemicals, but only if they completely switch.” Zeller added that the agency will closely monitor how customers use IQOS “to determine if these products meet this potential and do not cause increased use among youth.”

Separately, Philip Morris International said it believes cigarettes sales may disappear in some markets in the next decade as smokers switch to alternative products for nicotine, according to Bloomberg.

“I am convinced it is possible to completely end cigarette sales in many countries within 10 to 15 years,” said Andre Calantzopoulos, CEO, Philip Morris, in a sustainability report published Tuesday. But he added that the help of regulators is needed to make that possible.

Philip Morris, maker of Marlboro and Chesterfield cigarettes, sees a “smoke-free future” and is predicting a concrete timeline. The company is a leader in smoking alternatives with its IQOS heated-tobacco device. The company receives about a fifth of its revenue from non-combustible products.

Three years ago, Philip Morris set a target that at least 40 million adult smokers will have given up traditional cigarettes and switched to its smoke-free products by 2025. The company estimates nearly 14 million consumers were IQOS users at the end of 2019, with almost 10 million having quit cigarettes. There are some 1.3 billion tobacco users globally, according to the World Health Organization.