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Yuni Wholesale, Inc. d/b/a Blow Disposables was warned for manufacturing and selling electronic nicotine delivery system (ENDS) products through its website without required premarket authorization. The company failed to comply with FDA regulations requiring "new tobacco products" to obtain premarket approval orders before being legally marketed in the United States, as mandated by the Family Smoking Prevention and Tobacco Control Act and the FD&C Act. The FDA determined that the ENDS products offered on blowdisposable.com were subject to FDA jurisdiction and tobacco product regulations but lacked the necessary compliance documentation for lawful distribution.