FDA WARNING_LETTER - Juice Co. - November 03, 2025

The FDA"s Center for Tobacco Products issued a Warning Letter to earthsbountyjuice.com on November 14, 2025, after a review of its website revealed the unauthorized marketing of e-liquid products. The primary violation centers on the company"s sale and distribution of "new tobacco products," specifically Earths Bounty E-Juice, Strawmelon Max and Earths Bounty E-Juice, White Rabbit, which lack the required premarket authorization orders. Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), products introduced after February 15, 2007, must obtain such authorization. The regulatory framework, expanded in March 2022, now includes all products containing nicotine from any source. Due to the absence of marketing authorization, these e-liquids are deemed adulterated and misbranded under the FD&C Act. earthsbountyjuice.com is required to take prompt action to address these violations, including immediately ceasing the sale and distribution of these products. A written response is mandated within 15 working days, detailing the corrective actions taken and outlining a comprehensive plan for maintaining full compliance with the FD&C Act and its regulations.