FDA WARNING_LETTER - yeager one inc - April 13, 2022

The FDA issued a Warning Letter to Yeager One Inc d/b/a The Vaper's Ring after reviewing submissions and inspection records, determining the firm manufactures and distributes e-liquid products, specifically "The Vaper’s Ring Menthol 3mg 60ml e-liquid product," which are deemed tobacco products subject to FDA regulation. The primary violation is the marketing of this e-liquid product as a "new tobacco product" without the required premarket authorization order under section 910(a) and 910(c)(1)(A)(i) of the FD&C Act. Consequently, the product is 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). 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 statutory premarket authorization are unlawful and subject to enforcement, including civil money penalties, seizure, and injunction. The firm, a registered manufacturer with over 1,900 listed products, must submit a written response within 15 working days detailing actions taken to address these violations, including discontinuation dates and a plan for future compliance.