FDA WARNING_LETTER - Affordable Vapor d/b/a Vapor Related - January 07, 2020

The FDA's Center for Tobacco Products issued a Warning Letter to Norman Richter concerning e-liquid products sold on vaporrelated.com, which are classified as "tobacco products" under section 201(rr) of the FD&C Act. The primary violation identified is the failure of the website's advertising for several e-liquid products, including CAPTKRUNCH and LuckyCharmer, to display the mandatory nicotine warning statement, "WARNING: This product contains nicotine. Nicotine is an addictive chemical," as stipulated by 21 C.F.R. § 1143.3(b). This omission renders the e-liquid products misbranded under two sections of the FD&C Act: 903(a)(7)(B), for violating regulations under section 906(d), and 903(a)(7)(A), as the advertising is deemed false or misleading due to the failure to disclose material facts about the product's use, per section 201(n). The FDA demands immediate corrective actions, including discontinuing all violative advertising and sales, and submission of a comprehensive plan for maintaining compliance across all platforms. A written response detailing these actions is required within 15 working days. Non-compliance could lead to severe enforcement measures, such as civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, or injunction.