FDA WARNING_LETTER - Hi Lyfe Vaporz - April 13, 2021

The FDA Center for Tobacco Products issued a Warning Letter to Jostin A Iriarte, operating as Hi Lyfe Vaporz, on April 9, 2021, following a review of their website, https://hilyfevaporz.com. The review determined that e-liquid products, including Vape With Aloha e-Liquids: Hula Hoopz, Lucky, and P.B Smash, were being manufactured and offered for sale or distribution in the United States.

These e-liquids are classified as tobacco products under section 201(rr) of the FD&C Act and are subject to FDA jurisdiction. The FDA stated that these products are "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007.

The primary violation identified is the marketing of these new tobacco products without the required premarket authorization order, as mandated by section 910(a) of the FD&C Act. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, due to the absence of required notice or information under section 905(j).

The letter emphasizes the firm's responsibility, as a registered manufacturer with over 100 products listed with FDA, to ensure compliance with all applicable provisions of the