FDA WARNING_LETTER - Spongebob Vape - August 23, 2023

The FDA's Center for Tobacco Products reviewed the website https://www.spongebobvape.com and determined that electronic nicotine delivery system (ENDS) products listed there are offered for sale or distribution in the United States. These products, including A+++ SpongeBob Disposable Vape and Elf Bar Disposable Vape BC 5000 Puffs, are considered "new tobacco products" under the FD&C Act, including the expanded definition covering nicotine from any source. The firm is marketing these products without the required premarket authorization order. Consequently, these products are adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act because a notice or other required information was not provided under section 905(j). FDA expressed particular concern that some product labeling and advertising imitate toys, cartoon characters, and food, potentially promoting youth use and concealing the product's nature. The firm must submit a written response within 15 working days, detailing actions to address these violations, including discontinuing violative sales and outlining a plan for maintaining compliance. Failure to comply may result in regulatory or legal actions such as civil money penalties, seizure, injunction, or detention/refusal of imported products.