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Bluum Lab LLC manufactured and distributed electronic nicotine delivery system (ENDS) products through their website without obtaining required premarket authorization from the FDA. As newly deemed tobacco products under the Family Smoking Prevention and Tobacco Control Act, these ENDS products were required to have a marketing authorization order in effect before being legally sold in the United States, which the company had failed to obtain. The Center for Tobacco Products determined the company's products were in violation of the Federal Food, Drug, and Cosmetic Act and applicable regulations governing tobacco product marketing and distribution.