The Vape Corner, Inc. – FDA Warning Letter, Feb 26, 2021

The FDA's Center for Tobacco Products issued a Warning Letter to Gino Sugapong after reviewing thevapecorner.com, identifying e-liquid products manufactured and offered for sale in the U.S. These e-liquids are classified as "new tobacco products" under section 201(rr) of the FD&C Act and are subject to FDA regulation, including 21 C.F.R. § 1100.1. The primary violation is the marketing of e-liquid products, such as Krunchy Pebbles, Frooty Loops, and Papa Bear, without the required premarket marketing authorization order under section 910(c)(1)(A)(i) 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 lack of required notice or information under section 905(j). The letter stresses the firm's responsibility to ensure all tobacco products comply with the FD&C Act and FDA regulations. A written response is required within 15 working days, detailing corrective actions, including discontinuing violative sales and advertising, and a plan for future compliance. Non-compliance may result in regulatory actions such as civil money penalties, product seizure, injunctions, and import refusal.