Loading…
Badfish Drip Co manufactured and distributed e-liquid products without the required premarket authorization from the FDA, violating the Family Smoking Prevention and Tobacco Control Act. As a manufacturer of electronic nicotine delivery systems deemed to be tobacco products as of August 8, 2016, the company was required to obtain marketing authorization orders for these "new tobacco products" under section 910 of the Federal Food, Drug, and Cosmetic Act but failed to do so. The FDA determined that the company's e-liquid products were adulterated and misbranded under federal tobacco regulations because they lacked the necessary premarket approval before being offered for commercial distribution in the United States.