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