FDA WARNING_LETTER - Vape Papa - February 28, 2024

The FDA's Center for Tobacco Products reviewed vapepapa.com and determined that electronic nicotine delivery system (ENDS) products are offered for sale or distribution to U.S. customers. These products, including Elf Bar BC5000, Lost Mary MO5000, Funky Republic Ti7000, and Hyde Curve Max, are considered tobacco products under the FD&C Act, which now includes nicotine from any source. The FDA found that these are "new tobacco products" lacking the required premarket authorization order under section 910(a) of the FD&C Act. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required information under section 905(j). The firm is required to submit a written response within 15 working days, detailing actions taken to address these violations, including discontinuing the sale and distribution of the non-compliant products, and outlining a plan for maintaining compliance. Failure to comply may result in regulatory actions such as civil money penalties, product seizure, injunctions, and import detentions.