cloud dreams, inc. – FDA Warning Letter, Jan 24, 2023

The FDA issued a Warning Letter to Donald and Brianna Montgomery of Rx Vape on August 19, 2022, after reviewing their website, https://rxvape.com. The FDA determined that e-liquid products offered for sale, specifically "TFN Virginia Tobacco Nicotine Salts E-liquid Vape – 60 mL (Big Mouth Unicorn)" and "TFN Virginia Tobacco Nicotine Salts E-liquid Vape – 30 mL (PET)," are tobacco products under section 201(rr) of the FD&C Act, as amended on March 15, 2022, to include nicotine from any source.

These products are considered "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007. The primary violation is the manufacturing and offering for sale of these e-liquid products without 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 lack of required notice or information under section 905(j).

The FDA has not received an application for marketing authorization for these products. The letter states that failure to address these violations may lead to