FDA WARNING_LETTER - Packs Pod - October 30, 2024

The FDA Center for Tobacco Products issued a Warning Letter after reviewing packspod.com, determining that electronic nicotine delivery system (ENDS) products, specifically Craftbox V-Play 20K Disposable Cherry Pop and Strawberry Blowpop, are offered for sale or distribution in the United States without required premarket authorization. Under sections 201(rr) and 901(b) of the FD&C Act, these products are considered tobacco products and must comply with FDA regulations, including the requirement for marketing authorization for "new tobacco products" under section 910(a). The FDA found these products to be adulterated under section 902(6)(A) and misbranded under section 903(a)(6) due to the absence of required marketing authorization and failure to provide necessary information under section 905(j). The FDA also expressed concern that the products' labeling and advertising, which imitate gaming products and smart technology, may be particularly attractive to youth and help conceal their nature as tobacco products. The firm is required to submit a written response within 15 working days, detailing actions taken to address these violations, including discontinuing sales and distribution, and outlining a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.