FDA WARNING_LETTER - Honest Living Vape Shoppe & Apothecary - December 06, 2021

The FDA issued a Warning Letter to Honest Living Vape Shoppe & Apothecary on December 6, 2021, following a review of submissions and inspection records. The FDA determined that the company manufactures and distributes e-liquid products, specifically "Honest Living Vape Shoppe & Apothecary Mango 3mg e-liquid," which are classified as tobacco products under the FD&C Act.

The primary violation identified is the marketing of a "new tobacco product" without the required premarket authorization. The "Mango 3mg e-liquid" 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) and misbranded under section 903(a)(6) of the FD&C Act, as no required notice or information was provided.

These actions constitute prohibited acts under sections 301(k) and 301(p) of the FD&C Act. The FDA emphasizes that all new tobacco products on the market without premarket authorization are unlawful and subject to enforcement, including civil money penalties, seizure, and injunction.

Honest Living Vape Shoppe & Apothecary must submit a written response within 15 working days detailing actions taken to address violations, including discontinuing sales/distribution and a plan for future compliance. Failure to comply may