FDA WARNING_LETTER - East Coast Liquids d/b/a Planet Vapor - June 23, 2022

The FDA issued a Warning Letter to East Coast Liquids d/b/a Planet Vapor on June 23, 2022, for manufacturing and distributing e-liquid products without required marketing authorization. The FDA determined that "Space Cowboy 3MG 30ML" e-liquid is a "new tobacco product" as it was not commercially marketed in the U.S. before February 15, 2007, and lacks an FDA marketing authorization order. This renders the product adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The company is a registered manufacturer with over 3,600 listed products. Their Premarket Tobacco Product Application (PMTA), STN PM0003705, submitted on September 8, 2020, covering 978 products, received a Refuse To Accept determination on June 29, 2021. The FDA states that all new tobacco products on the market without premarket authorization are unlawfully marketed and subject to enforcement actions, including civil money penalties, seizure, and/or injunction.

East Coast Liquids must submit a written response within 15 working days detailing actions taken to address violations, including discontinuation dates for violative sales and distribution, and a plan for maintaining compliance.