FDA WARNING_LETTER - podlix llc - May 01, 2024

The FDA Center for Tobacco Products issued a Warning Letter to Barak Ben Evgi and Ori Gabriel, operating Podlix.com, for illegally marketing Electronic Nicotine Delivery System (ENDS) products in the United States. The FDA reviewed Podlix.com and found ENDS products offered for sale, which are classified as tobacco products under the FD&C Act, including those containing nicotine from any source.

The specific violations involve the sale of "new tobacco products" without required premarket authorization. Products cited include Funky Republic TI7000 Osk Ice, Lost Mary BM5000 Red Apple Ice, and Elf Bar BC5000 Disposable Vape Gumi. These products are considered "new" because they were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization orders or exemptions. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The letter mandates 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.