FDA WARNING_LETTER - Discount Vape Pen - September 14, 2023

On September 14, 2023, the FDA's Center for Tobacco Products issued a Warning Letter to Markel Pitt regarding the website https://discountvapepen.com. The FDA determined that the website offers electronic nicotine delivery system (ENDS) products for sale or distribution in the United States, which are classified as tobacco products under section 201(rr) of the FD&C Act.

The key violation identified is the marketing of "new tobacco products" without the required premarket authorization. Specifically, the website offers Elf Bar BC5000 (Rainbow Cloudz and Summertime) and Lava Plus Vape 2600 Puff Disposable (Strawberry Ice) ENDS products. These products are considered "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007, and lack the necessary FDA marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act.

Consequently, these products are deemed 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 on the market without statutory premarket authorization are unlawful and subject to enforcement action, including civil money penalties, seizure, and/or injunction.

The FDA requires