FDA WARNING_LETTER - Good Karma Cigar LLC - August 30, 2024

The FDA issued a Warning Letter to Good Karma Cigar LLC on August 29, 2024, following a review of inspection records. The FDA determined that Good Karma Cigar LLC manufactures, sells, and/or distributes pipe tobacco products, which are subject to FDA jurisdiction under the FD&C Act.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. Specifically, the product "Fine Tobacco Butter Rum 1.3 oz." was cited as a new tobacco product that was not commercially marketed in the United States as of February 15, 2007, and lacks an FDA marketing authorization order. This renders the product adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required notice or information under section 905(j).

The letter emphasizes 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/or injunction. Good Karma Cigar LLC is required to submit a written response within 15 working days detailing actions taken to address the violations, including discontinuation dates for violative sales and a plan for future compliance.