The U.S. Food and Drug Administration has renewed its Modified Risk Tobacco Product authorization for Philip Morris International’s IQOS heated‑tobacco system and related sticks.
The decision lets PMI continue selling IQOS as a reduced‑harm alternative— a market that public‑health officials watch closely for its impact on smoking rates.
The agency said scientific studies show that switching completely from conventional cigarettes to the IQOS system significantly reduces users’ exposure to harmful or potentially harmful constituents.
"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 …" said U.S. Food and Drug Administration.
Under the renewed order, PMI is authorized to market two IQOS device versions[1] and three tobacco consumable variants[1] in the United States.
The MRTP clearance allows PMI to promote IQOS with reduced‑risk messaging, subject to strict labeling and marketing rules. Retailers can now stock the authorized models nationwide, and the company plans to expand distribution through its existing channels.
Public‑health groups said that while reduced exposure is a positive step, the overall health impact depends on whether smokers completely switch away from combustible cigarettes. The FDA’s finding rests on evidence that full substitution, not dual use, delivers the exposure benefit.
What this means: The renewal keeps IQOS legally available as a reduced‑harm alternative, giving adult smokers a regulated option that may lower toxicant intake, while regulators continue to monitor real‑world use patterns to assess public‑health outcomes.
“"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 …"”
The renewed MRTP status means IQOS can remain on U.S. shelves with claims of reduced exposure, offering adult smokers a regulated alternative while health officials track whether the product truly shifts users away from traditional cigarettes.
