FDA WARNING_LETTER - lousquare.com

On June 13, 2025, the FDA's Center for Tobacco Products issued a Warning Letter to lousquare.com (999 Brickell Ave, Ste 410, Miami, FL 33131) via UPS and electronic mail (hi@lousquare.com, lou@lousquare.com). The letter, reference RW2502299, concerns the sale and distribution of tobacco products, specifically Electronic Nicotine Delivery System (ENDS) products.

The FDA reviewed lousquare.com and found that ENDS products were offered for sale to U.S. customers. These products are classified as tobacco products under section 201(rr) of the FD&C Act (21 U.S.C. § 321(rr)) due to containing nicotine from any source and being intended for human consumption. The letter highlights the March 15, 2022, amendment to the FD&C Act, expanding the definition of "tobacco product" to include nicotine from any source.

The primary violation identified is the marketing of "new tobacco products" without required premarket authorization. The specific products cited are "Fume Infinity Plus 4000 Puffs – Miami Mix" and "Fume Recharge 5000 Puffs – Peach Watermelon." These products are considered "new tobacco products" because they were not commercially marketed