FDA WARNING_LETTER - lousquare.com - June 17, 2025

On June 13, 2025, the FDA's Center for Tobacco Products issued a Warning Letter to "To Whom It May Concern" regarding the sale of unauthorized electronic nicotine delivery system (ENDS) products on the website https://lousquare.com. The FDA determined that products offered for sale, specifically Fume Infinity Plus 4500 Puffs – Miami Mix and Fume Recharge 5000 Puffs – Peach Watermelon, are "new tobacco products" as defined by section 910(a) of the FD&C Act (21 U.S.C. § 387j(a)), meaning they were not commercially marketed in the U.S. as of February 15, 2007.

These products lack the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act (21 U.S.C. § 387j(c)(1)(A)(i)) and are not otherwise exempt. Consequently, they are deemed adulterated under section 902(6)(A) of the FD&C Act (21 U.S.C. § 387b(6)(A)) and misbranded under section 903(a)(6) of the FD&C Act (21 U.S.C. § 38