FDA WARNING_LETTER - Fantasia Distribution Inc. - February 01, 2022

The FDA issued a Warning Letter to Randy Bahbah of Fantasia Distribution on January 25, 2022, following a review of their website, https://www.fantasiadistribution.com. The review determined that the company manufactures and offers for sale or distribution ENDS (Electronic Nicotine Delivery Systems) products, specifically "Fantasia Vape PRO Unit WILD MANGO" and "Fantasia Vape PRO Unit PINK LEMONADE," to U.S. customers.

These ENDS products are classified as "new tobacco products" under section 910(a) of the FD&C Act because they were not commercially marketed in the U.S. as of February 15, 2007. The primary violation is that these products are being marketed without the required premarket authorization order from the FDA, as mandated by 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, as no notice or information was provided as required by section 905(j).

Although Fantasia Distribution submitted a Premarket Tobacco Product Application (PMTA) (STN PM0002312) on September 9, 2020, it received a Refuse to