FDA WARNING_LETTER - cigarsvape.com - June 13, 2025

On June 13, 2025, the FDA's Center for Tobacco Products issued a Warning Letter to cigarvape.com (MARCS-CMS 710839) for offering for sale or distribution in the U.S. unauthorized Electronic Nicotine Delivery System (ENDS) products. The FDA reviewed the website https://cigarvape.com and identified ENDS products as "tobacco products" under section 201(rr) of the FD&C Act, subject to FDA jurisdiction.

The primary violation is the marketing of "new tobacco products" without required premarket authorization, as mandated by section 910(a) of the FD&C Act. Specifically, the products "ELF VPR 18000 Puffs Disposable Vape – Rainbow Candy" and "ELF Vape VPR 7000 Ultra Disposables – Tropical Rainbow Blast" were identified as new tobacco products not commercially marketed in the U.S. before February 15, 2007, and lacking FDA marketing authorization orders or exemptions. This renders them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required premarket notification.

The letter emphasizes that all new tobacco products require premarket authorization to be legally marketed. Failure to address these violations may result in regulatory actions