FDA WARNING_LETTER - A1 WAREHOUSE - November 04, 2025
On November 12, 2025, the U.S. Food and Drug Administration (FDA) issued a Warning Letter to A1 WAREHOUSE, citing significant violations identified through a review of inspection records. The company is being cited for the illegal sale and distribution of unauthorized electronic nicotine delivery system (ENDS) products, specifically identifying "FLAMINGO SKB25000 WATERMELON ICE 5% NICOTINE." Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), these products are considered "new tobacco products" because they were not commercially marketed before February 15, 2007, and have not received the mandatory premarket authorization from the FDA. Without this authorization, these products are deemed unlawfully marketed, making them both adulterated and misbranded under federal law. The FDA requires A1 WAREHOUSE to promptly discontinue the sale and distribution of all such violative products. Furthermore, the company must submit a detailed written response within 15 working days from the letter"s receipt. This response should describe all corrective actions taken, including the dates when the illegal sales were stopped, and outline a comprehensive plan to maintain continuous compliance with the FD&C Act. Non-compliance could lead to further enforcement measures, including civil money penalties or product seizure.
ID · 76b33b92-2393-463b-b3b6-f476e5c844a0
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