FDA WARNING_LETTER - Heights Vapor Station - September 06, 2022

On August 31, 2022, the FDA issued a Warning Letter to Heights Vapor Station for manufacturing and distributing e-liquid products without required marketing authorization. The FDA determined that e-liquid products, specifically "Apricot" and "Watermelon," are "new tobacco products" under section 910(a) of the FD&C Act because they were not commercially marketed in the U.S. as of February 15, 2007.

These products lack FDA marketing authorization orders under section 910(c)(1)(A)(i) and are not exempt, rendering them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. The failure to provide required reports under section 905(j) is also a prohibited act.

The FDA requires Heights Vapor Station to submit a written response within 15 working days detailing actions taken to address violations, including discontinuation dates for violative sales and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.