FDA WARNING_LETTER - Magic Vape Shop - August 31, 2021

The FDA Center for Tobacco Products issued a Warning Letter to James Lettig and Joseph Lettig concerning e-liquid products, specifically "Magic Vape 100 Point Buck" and "Magic Vape Enter the Dragon," sold on magicvapeshop.com. The FDA determined these e-liquids are "new tobacco products" under the FD&C Act, subject to regulation since August 8, 2016. The review revealed the firm manufactures and offers these products for sale without the required premarket marketing authorization order, as mandated by section 910(a) of the FD&C Act for products not commercially marketed before February 15, 2007. 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 absence of required notices under section 905(j). The FDA emphasized the firm's responsibility, as a registered manufacturer with over 2,500 products, to ensure compliance. The company must submit a written response within 15 working days detailing corrective actions, including discontinuation of violative sales and a plan for future compliance. Failure to address these violations could result in significant regulatory actions, such as civil money penalties, no-tobacco-sale orders, seizure, or injunction.