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Gorilla Vapes of East Brunswick manufactured and distributed e-liquid tobacco products containing nicotine without the required premarket authorization orders mandated by the Family Smoking Prevention and Tobacco Control Act. The company failed to comply with FDA requirements applicable to "new tobacco products" under section 910 of the Federal Food, Drug, and Cosmetic Act, which requires premarket authorization before such products can be legally marketed in the United States. The FDA's jurisdiction over these products was clarified by 2022 legislation that extended regulatory authority to all nicotine-containing products, regardless of whether the nicotine was derived from tobacco or other sources.