KA Vapes, LLC d/b/a Kickin’ Ash Warning Letter Details

Summary

KA Vapes, LLC d/b/a Kickin' Ash was warned for manufacturing and distributing e-liquid tobacco products without required premarket authorization, as mandated under the Family Smoking Prevention and Tobacco Control Act. The FDA determined that the company's e-liquid products met the definition of "new tobacco products" subject to FDA jurisdiction under the Federal Food, Drug, and Cosmetic Act, yet lacked the required premarket approval before being offered for commercial sale in the United States. The warning was issued following FDA review of the company's submissions and inspection records, indicating noncompliance with applicable tobacco product regulations effective August 8, 2016.