FDA WARNING_LETTER - Cencal Vape, Inc. - February 28, 2024

The FDA issued a Warning Letter to Hamad Afzali, operating cencalvape.com, for offering unapproved electronic nicotine delivery system (ENDS) products for sale in the U.S. The FDA reviewed the website and determined that products listed, including EBCreate TE6000 - Juicy Peach, Funky Republic Ti7000 Disposable - Cantaloupe Apple, Lost Mary OS5000 Disposable - Cherry Cola, and Hyde N-Bar Mini 2500 - Minty O's, are "new tobacco products" lacking required premarket authorization.

Under sections 201(rr) and 910(a) of the FD&C Act, these ENDS products are considered tobacco products because they contain nicotine and were not commercially marketed in the U.S. as of February 15, 2007. Since they lack FDA marketing authorization orders, they are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The letter requires a written response within 15 working days detailing actions taken to address violations, including discontinuing sales and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction. The FDA also noted that imported products appearing adulterated or misbranded may be detained or refused admission