FDA WARNING_LETTER - Phoenix Vaping Ltd. - June 22, 2023

The FDA issued a Warning Letter to William and Judith Delaney of Phoenix Vaping on June 16, 2023, after reviewing their website, phoenixvaping.co.uk. The FDA determined that the company offers Electronic Nicotine Delivery System (ENDS) products for sale or distribution to U.S. customers. Under the FD&C Act, these products are classified as tobacco products, including those containing nicotine from any source, and are subject to FDA jurisdiction.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. Specifically, the products "Elf Bar 600 Disposable - Strawberry Ice Cream" and "Elf Bar 600 Disposable - Cotton Candy Ice" were found to be new tobacco products, as they were not commercially marketed in the U.S. as of February 15, 2007, and lack an FDA marketing authorization order. This renders them 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 the violations, including discontinuing the sale/distribution of the non-compliant products and a plan for maintaining compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, or injunction.