Loading…
HTXW LLC d/b/a FOMO Culture was warned for offering electronic nicotine delivery system (ENDS) products for sale through its website without required FDA premarket authorization. The company failed to comply with the Federal Food, Drug, and Cosmetic Act by marketing tobacco products containing nicotine—which fall under FDA jurisdiction whether derived from tobacco or from any other source following 2022 legislative amendments—without obtaining the legally mandated premarket authorization orders. The FDA's review of the company's website identified these violations and determined the products were being distributed to U.S. customers in violation of applicable tobacco product regulations.