Loading…
Rollin Vapor LLC was cited for selling electronic nicotine delivery system (ENDS) products without the required premarket authorization from the FDA, violating the Family Smoking Prevention and Tobacco Control Act. The company distributed nicotine-containing products that qualify as tobacco products under FDA jurisdiction but lacked the necessary marketing authorization orders required for new tobacco products under section 910 of the Federal Food, Drug, and Cosmetic Act. The inspection found that the company's ENDS products were not in compliance with FDA regulations governing tobacco product marketing and distribution in the United States.