Blackout Vapors Inc. – FDA Warning Letter, Jul 26, 2022

On July 15, 2022, the FDA's Center for Tobacco Products issued a Warning Letter to Blackout Vapors after reviewing their website, blackoutvapors.com. The FDA determined that Electronic Nicotine Delivery System (ENDS) products advertised and offered for sale, such as Hush Max Disposable – Strawberry Kiwi and Lucid Air Disposable Vape – Aloe Grape Ice, are misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)).

The violation stems from the failure of the website's advertising for these ENDS products to include the required nicotine warning statement, as mandated by 21 CFR 1143.3(b). This regulation requires advertising for ENDS products containing nicotine to bear the warning: "WARNING: This product contains nicotine. Nicotine is an addictive chemical."

Blackout Vapors is required to immediately correct this violation and any similar issues across all advertising platforms. A written response detailing corrective actions, including dates of discontinued violative activities and a plan for future compliance, must be submitted within 15 working days. Failure to comply may result in regulatory action, including detention and refusal of admission for imported products. The reference number for this case is RW2201790.