FDA WARNING_LETTER - Solace Technologies, LLC d/b/a Solace Vapor - June 07, 2019

This joint FDA and FTC Warning Letter, dated June 7, 2019, was issued to Brendan McDermott of Solace Vapor following a review of the company's website and social media accounts (including those of influencer Pandora Blue) advertising e-liquid products. The FDA determined that Solace Vapor's e-liquid products, such as Solace Black Sea Salt Blueberry and Solace Salts Peach, are misbranded under sections 903(a)(7)(B), 903(a)(1), and/or 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c). This misbranding stems from the failure of their labeling and advertising to include the required nicotine warning statement, "WARNING: This product contains nicotine. Nicotine is an addictive chemical," as mandated by 21 C.F.R. § 1143.3(a) and (b). The FTC identified two primary concerns under Section 5 of the FTC Act (15 U.S.C. § 45). First, the failure to disclose the addictive nature and associated risks of nicotine in social media postings raises concerns of unfair or misleading practices. Second, the company failed to clearly and conspicuously disclose material connections between endorsers, such as social media influencers, and Solace Vapor in advertisements, violating the FTC’s Endorsement Guides (16 C.F.R. § 255.5). Solace Vapor is required to submit a written response to the FDA within 15 working days detailing corrective actions, including discontinuing violative practices and a compliance plan. Concurrently, the FTC must be notified within 15 days of actions taken to address their concerns. Non-compliance could lead to severe consequences, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, injunction, and import detention.