FDA WARNING_LETTER - m & k on cumberland, inc. - July 26, 2022

The FDA issued a Warning Letter to Naser Mesleh of Bigcloudvape.com on July 15, 2022, following a review of their website. The FDA determined that the electronic nicotine delivery system (ENDS) and e-liquid products advertised and sold on the website are tobacco products under section 201(rr) of the FD&C Act.

The primary violation identified is that the advertising for several ENDS and e-liquid products, including "Posh Plus – Creme Brulee" and "Naked E-Liquid Juice – All Melon," fails to include the required nicotine warning statement, making them misbranded under section 903(a)(7)(B) of the FD&C Act. Specifically, the advertising does not comply with 21 CFR 1143.3(b), which mandates the warning: "WARNING: This product contains nicotine. Nicotine is an addictive chemical."

The FDA requires immediate corrective action to bring all tobacco products, labeling, and advertising into compliance with the FD&C Act and FDA regulations. Failure to address these violations may result in regulatory action, including detention and refusal of admission for imported products. A written response detailing corrective actions, including dates of discontinuation of violative activities and a plan for maintaining compliance, is required within 15 working days.