FDA WARNING_LETTER - SJ Trading LTD d/b/a Cloud Chasers Club - December 19, 2024

On December 18, 2024, the FDA's Center for Tobacco Products issued a Warning Letter to Souraya Jaafar regarding the sale of Electronic Nicotine Delivery System (ENDS) products on cloudchasersclub.com. The FDA determined that products like "Juicy J J7K - Exotic Paan (Bounce it)" and "Juicy J J7K - Mango Mania (SOS Syrup)" are tobacco products under section 201(rr) of the FD&C Act, as amended to include nicotine from any source.

These ENDS products are considered "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007, and lack the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required notice or information under section 905(j).

The FDA requires prompt action to address these violations, including discontinuing the sale and distribution of the non-compliant products. A written response detailing corrective actions and a plan for maintaining compliance must be submitted within 15 working days of receipt. Failure to comply may result in regulatory actions such as civil money penalties