FDA WARNING_LETTER - VP Global, LLC d/b/a Super Vape Pirates - June 18, 2024
Discuss this record with AI
The FDA issued a Warning Letter to Khouloud Alqazah, operating supervapepirates.com, for violations related to the sale of electronic nicotine delivery system (ENDS) products. The FDA's review found that ENDS products were offered for sale to U.S. customers.
The primary violations include: 1. **Marketing of New Tobacco Products Without Authorization**: Products like Elf Bar BC5000, Ripe Collection Esco Bars, and U Toob Bar Disposable Vape PFF5000 were identified as "new tobacco products" that were not commercially marketed in the U.S. as of February 15, 2007, and lack the required FDA marketing authorization orders. This renders them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. 2. **Sale to Individuals Under 21**: The website sold ENDS products (Elf Bar BC5000, Ripe Collection Esco Bars) to a person under 21 years of age, and also sent a complimentary U Toob Bar Disposable Vape. This violates section 906(d)(5) of the FD&C Act, making the products misbranded under section 903(a)(7)(B).
The letter emphasizes that all tobacco products, including those containing nicotine from any source, must
ID · 4ce55634-cc18-4129-927a-e270c2bff544
Full citation text and observation details available on the Dashboard.