FDA WARNING_LETTER - Hotspot Vapes - October 07, 2021

The FDA issued a Warning Letter to Hotspot Vapes, identifying their "Hotspot Vapes Watermelon 3mg e-liquid product" as a new tobacco product subject to FDA jurisdiction under the FD&C Act. The FDA determined this product was manufactured, sold, and/or distributed without the required premarket marketing authorization order, as it was not commercially marketed in the U.S. as of February 15, 2007.

This lack of authorization renders the product adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, due to the failure to provide required notice or information under section 905(j). These actions constitute prohibited acts under sections 301(k) and 301(p) of the FD&C Act.

Hotspot Vapes, a registered manufacturer with over 2200 listed products, is responsible for ensuring all tobacco products comply with the FD&C Act and FDA regulations. Failure to address these violations may result in regulatory actions, including civil money penalties, seizure, and/or injunction. The company must submit a written response within 15 working days, detailing actions taken to address violations, including discontinuation of violative sales/distribution, and a plan for maintaining compliance.