FDA WARNING_LETTER - Vapor Tech Hawaii, Inc. - March 19, 2021

The FDA issued a Warning Letter to Vapor Tech Hawaii, Inc. for manufacturing and distributing an e-liquid product, VAPOR TECH HAWAII Waikikiwi 100ML 3MG, without required premarket authorization. The FDA determined this product is a "new tobacco product" because it was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order or exemption.

This renders the product adulterated under section 902(6)(A) of the FD&C Act and misbranded under section 903(a)(6) for failure to provide required notice or information under section 905(j). Prohibited acts include holding for sale an adulterated or misbranded product (section 301(k)) and failing to provide a required report (section 301(p)).

Vapor Tech Hawaii, Inc. is a registered manufacturer with 3,098 listed products. The FDA requires a written response within 15 working days detailing corrective actions, including discontinuation dates for the violative product, and a plan for maintaining compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.