FDA WARNING_LETTER - Pretty Women UK LTD T/A Coil2oil and Mad Kingdom Liquids - September 09, 2020

The FDA issued a Warning Letter to Jagmeet Singh, operating coil2oil.co.uk and the Instagram account @mad.kingdom/, for offering Electronic Nicotine Delivery System (ENDS) products for sale or distribution to U.S. customers without required marketing authorization. The FDA reviewed the websites and determined that products like "Ice Menthol 50ml Shortfill by Mad King" are new tobacco products, as they were not commercially marketed in the U.S. before February 15, 2007, and lack FDA marketing authorization. This renders them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

Furthermore, the ENDS products are deemed adulterated as modified risk tobacco products sold without an FDA order, violating section 902(8) of the FD&C Act. The websites explicitly or implicitly claim reduced risk, reduced substance levels, or absence of substances, which requires a modified risk tobacco product application under section 911(d).

The FDA also expressed concern about the "Ice Menthol 50ml Shortfill by Mad King" product featuring cartoon kings, which are appealing to children, potentially encouraging unlawful sales and youth use. The letter requires a written response within 15 working days detailing corrective actions, including discontinuation of violative sales and advertising, and a plan for future compliance. Failure to comply may