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Talk to a SpecialistTalk to a SpecialistGolden Eagle Distributors LLC was warned for selling and distributing electronic nicotine delivery system (ENDS) products without proper FDA premarket authorization, which is required for all "new tobacco products" under the Federal Food, Drug, and Cosmetic Act. The company's products fall under FDA jurisdiction as tobacco products containing nicotine from any source, and they must comply with applicable FDA regulations before being legally marketed in the United States. The inspection revealed that the company was distributing these products without obtaining the necessary premarket authorization orders required by law.