China First Union d/b/a Beco Vape Warning Letter Details

Summary

China First Union d/b/a Beco Vape was warned for offering electronic nicotine delivery system (ENDS) products for sale in the United States without premarket authorization as required by the Federal Food, Drug, and Cosmetic Act. The company's products, containing nicotine from any source, were found to be subject to FDA jurisdiction under the expanded tobacco product definition that took effect in March 2022, yet lacked the legally required premarket authorization orders to be marketed in the U.S. The FDA identified the violations through a review of the company's website at becovape.com, which advertised these tobacco products for distribution to U.S. customers.