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Avalanche Distribution LLC d/b/a Avalanche Vapes was cited for offering electronic nicotine delivery system (ENDS) products for sale on its website without required premarket authorization from FDA. The company failed to comply with the Family Smoking Prevention and Tobacco Control Act by marketing these tobacco products containing nicotine without obtaining a premarket authorization order, which is mandatory for new tobacco products under the Federal Food, Drug, and Cosmetic Act. The warning letter specifically noted that ENDS products, including those containing nicotine from non-tobacco sources under the 2022 legislative amendment, fall under FDA jurisdiction and must meet all applicable compliance requirements before being legally marketed in the United States.