FDA WARNING_LETTER - Yuni Wholesale, Inc. d/b/a Blow Disposables - January 25, 2022

On January 21, 2022, the FDA issued a Warning Letter to Mohammad Awad regarding the sale and distribution of Electronic Nicotine Delivery System (ENDS) products on the website https://blowdisposable.com. The FDA determined that products like "Blow Disposables Blue Raspberry Lemon XXL," "Blow Disposables Blue Slushy XXL," and "Blow Disposables Triple Apple Chill XXL" are new tobacco products under section 201(rr) of the FD&C Act and require premarket authorization.

The identified ENDS products were found to be adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act because they were not commercially marketed in the U.S. as of February 15, 2007, and lack the required FDA marketing authorization order. A previously submitted Premarket Tobacco Product Application (PMTA) (STN PM0003870) for six products was refused by the FDA on September 30, 2021.

The FDA requires a written response within 15 working days detailing actions taken to address the violations, including discontinuing the sale and distribution of the non-compliant products and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.