Health
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.