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Packs Pod was cited for offering electronic nicotine delivery system (ENDS) products for sale in the United States without required premarket authorization, in violation of the Family Smoking Prevention and Tobacco Control Act. The FDA determined that these products, containing nicotine from any source, fall under FDA jurisdiction as tobacco products and must comply with section 910 of the Federal Food, Drug, and Cosmetic Act, which requires "new tobacco products" to obtain a marketing authorization order before legal distribution. The company's website demonstrated ongoing commercial distribution of these unapproved tobacco products, constituting a failure to meet mandatory premarket review requirements that have been in effect for over a decade.