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FDA Renews Modified‑Risk Status for IQOS Devices and HEETS Sticks

The agency says the renewals are backed by evidence of lower exposure to harmful chemicals.

Overview

  • U.S. regulators, who renewed the orders Saturday, kept IQOS and HEETS in the FDA’s Modified Risk Tobacco Product category, allowing reduced‑exposure messaging to adults 21 and over.
  • The decision covers IQOS 2.4 and 3.0 holders and chargers, plus HEETS Amber, Green Menthol, and Blue Menthol tobacco sticks.
  • The FDA said available evidence points to a likely, measurable drop in disease or death for users, while noting the products still deliver addictive nicotine and are not risk‑free.
  • PMI can continue marketing to adult smokers under the MRTP rules as the FDA continues to review Premarket Tobacco Product Applications for the newer IQOS ILUMA devices.
  • Heated tobacco warms tobacco instead of burning it, which the company’s filings say cuts many harmful chemicals found in cigarette smoke, and PMI says it has invested over $16 billion since 2008 to shift smokers to non‑combustion products.