Loading…
Marlin Steam Co was cited for manufacturing and distributing e-liquid tobacco products without obtaining required premarket authorization orders as mandated by the Family Smoking Prevention and Tobacco Control Act. The FDA determined that the company's e-liquids, marketed through their website, qualified as newly deemed tobacco products subject to FDA jurisdiction under section 901(b) of the Federal Food, Drug, and Cosmetic Act, and therefore required premarket review and approval before legal marketing in the United States. The company failed to comply with the August 8, 2016 deeming rule that extended FDA regulatory authority to electronic nicotine delivery systems and their associated liquids.