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JP & SN Enterprises Inc. d/b/a eCigs International manufactured and distributed e-liquid tobacco products containing nicotine without obtaining the required premarket authorization from the FDA, in violation of the Federal Food, Drug, and Cosmetic Act. The company's e-liquid products fell under FDA jurisdiction as tobacco products under section 901(b) of the FD&C Act and were subject to compliance requirements, particularly following the March 2022 legislative expansion of FDA authority to regulate all products containing nicotine from any source. The FDA's inspection and review of the company's submissions determined that the products were being manufactured and offered for sale in the United States without the legally required premarket approval.