Loading…
Boosted LLC was warned for manufacturing and distributing e-liquid tobacco products without required premarket authorization. The FDA determined that the company's e-liquid products listed on its website contained nicotine and met the definition of tobacco products under the Federal Food, Drug, and Cosmetic Act, making them subject to FDA jurisdiction and requiring compliance with tobacco product regulations. The warning emphasized that under legislation signed in March 2022, FDA's jurisdiction expanded to include all products containing nicotine from any source, not just tobacco-derived nicotine, and that such products must obtain marketing authorization orders before legal distribution in the United States.