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FDA Panel Reviews Philip Morris Bid to Market Zyn as Lower-Risk Option for Smokers

A preliminary FDA analysis says the proposed reduced-risk claim appears scientifically accurate.

Overview

  • The FDA convened its Tobacco Products Scientific Advisory Committee on Jan. 22 to assess evidence, consumer understanding, and population impacts of Zyn’s modified-risk application.
  • If approved, the MRTP would allow messaging that completely switching from cigarettes to Zyn lowers the risk of six major smoking-related diseases.
  • Agency materials cite testing showing far lower levels of harmful chemicals in Zyn, with 36 of 42 carcinogens undetected or extremely low and the remainder below expected risk thresholds.
  • Regulators are evaluating the potential for youth or nonsmoker uptake linked to viral social-media promotion, though recent federal data indicate teen pouch use remains relatively low.
  • Zyn holds more than two-thirds of the U.S. nicotine pouch market with about $3.24 billion in sales last year, and the FDA has not set a deadline for a final MRTP decision.