Loading…
Hashtag Smoke Shop LLC was selling electronic nicotine delivery systems (ENDS) products through its website without the required premarket authorization from the FDA, violating the Federal Food, Drug, and Cosmetic Act. The company failed to comply with FDA requirements for tobacco products containing nicotine from any source, which became subject to FDA jurisdiction following the March 2022 legislative expansion of tobacco product definitions. As a retailer offering these products for sale or distribution in the United States, the company was required to ensure all marketed products had obtained premarket approval before commercialization.