FDA WARNING_LETTER - Red Shield Reserve Inc. - May 17, 2022

The FDA issued a Warning Letter to Steven Kollias concerning e-liquid products, including "Proton Blueberry" and "Vapor Budz Northern Lights," offered for sale on https://www.electroncig.com. The Center for Tobacco Products determined these are "new tobacco products" under section 201(rr) of the FD&C Act, requiring premarket authorization. The FDA found that these products are being marketed without the necessary marketing authorization order, as required by section 910(a) of the FD&C Act. The firm's Premarket Tobacco Product Application (PMTA) for 134 products, including those cited, received a Refuse to Accept determination. Consequently, these unauthorized e-liquid 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 information under section 905(j). The FDA stated that all new tobacco products on the market without statutory premarket authorization are unlawful and subject to enforcement actions, including civil money penalties, seizure, and injunction. The firm must respond within 15 working days, detailing actions to address violations, discontinue violative activities, and outline a plan for maintaining compliance with the FD&C Act and related regulations.