FDA WARNING_LETTER - Westside Vapor / Vapor Station - August 07, 2021

The FDA issued a Warning Letter to Westside Vapor / Vapor Station following a website review (https://westsidevapor.com) and a retail establishment inspection on August 7, 2021. The FDA determined that the company manufactures and sells Electronic Nicotine Delivery System (ENDS) products, which are regulated as tobacco products.

Violations include: 1. **Marketing of New Tobacco Products Without Authorization:** Westside Vapor Mint/Ice/Menthol Flavors (Peppermint and Spearmint e-liquids) were offered for sale without required FDA marketing authorization. These are considered "new tobacco products" as they were not commercially marketed before February 15, 2007, and lack a marketing authorization order or exemption. This renders them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. The company's Premarket Tobacco Product Application (PMTA) STN PM0001038, covering 313 products, received a Marketing Denial Order on September 9, 2021. 2. **Sale to Underage Individual:** On August 7, 2021, an ENDS product (Hyde Aloe Grape) was sold to a person under 21 years of age at the Massillon, OH retail location. This violates Section 906(d