Elk River Vapor Shop, which manufactures and distributes e-liquid products containing nicotine, was found to be in violation of the Family Smoking Prevention and Tobacco Control Act for failing to obtain required premarket authorization orders before marketing these tobacco products in the United States. The company's e-liquid products, which fall under FDA jurisdiction as tobacco products containing nicotine from any source following the 2022 legislative expansion of FDA authority, were not in compliance with applicable Federal Food, Drug, and Cosmetic Act requirements. The FDA's inspection determined that the company was manufacturing, selling, and distributing these products without the necessary marketing authorization, rendering them adulterated and/or misbranded under federal law.