Loading…
Vapor Boss was warned that its electronic nicotine delivery system (ENDS) products listed on vaporboss.com were being manufactured and offered for sale in the United States without required premarket authorization orders, in violation of the Family Smoking Prevention and Tobacco Control Act. The company failed to comply with FDA requirements that "new tobacco products" obtain marketing authorization before being legally sold, as ENDS products have been subject to FDA jurisdiction since the August 8, 2016 deeming rule. The warning letter indicated the company was distributing tobacco products without the necessary premarket approval required under section 910 of the Federal Food, Drug, and Cosmetic Act.