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Reynolds introduces unapproved Vuse vapes amid criticism of FDA policy

Reynolds American is selling unauthorized Vuse Pro vapes following softened federal enforcement guidance, STAT reports.

The short version

  • Reynolds American has rolled out new Vuse Pro vape products in Ohio and other states without FDA authorization.[STAT]
  • Critics argue the FDA invited rule violations by loosening enforcement guidance earlier this year.[STAT]
  • Public health experts caution that Reynolds' decision may encourage other tobacco manufacturers to bypass regulatory review.[STAT]

Key facts

  • Reynolds American has placed new Vuse Pro vape products on sale in Ohio and select other states without clearance from the FDA.[STAT]
  • Critics and former officials argue that the agency's softened May enforcement guidance prompted manufacturers to introduce unauthorized products.[STAT]
  • Former FDA official Mitch Zeller contended that the marketing of unauthorized products highlights flaws in the current enforcement policy.[STAT]
  • Cristine Delnevo warned that Reynolds' strategy could lead other manufacturers frustrated by agency review delays to market unauthorized items.[STAT]

Sources

Outlet counts describe coverage, not independent confirmation. Reports may share a wire service or original source.