FDA WARNING_LETTER - Stone Retail LLC - December 13, 2023

Record Details

The FDA Center for Tobacco Products issued a Warning Letter to Muhammd R Kahn regarding the website https://stonesmokes.com, which offers electronic nicotine delivery system (ENDS) products for sale in the United States. These products are classified as tobacco products under section 201(rr) of the FD&C Act, as amended by the Consolidated Appropriations Act, 2022, to include nicotine from any source.

The inspection revealed that the website sells "new tobacco products" without the required premarket authorization, making them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. Specifically, the products Elf Bar BC5000 Miami Mint, KangVape Max Cherry Lemonade, and Funky Republic TI7000 California Cherry were identified as lacking marketing authorization orders.

The letter requires a written response within 15 working days detailing corrective actions, including discontinuing the sale and distribution of violative products and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, or injunction. The letter emphasizes the firm's responsibility to ensure all tobacco products and related advertising comply with the FD&C Act and FDA regulations.

Company: Stone Retail LLC
Inspection Date: December 13, 2023
Product Type: Tobacco
Office: Center for Tobacco Products
People: Ann Simoneau (Director)
Muhammd R. Khan

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ID · b383edb8-038a-45b1-be54-a1f64d0def13

Violation Codes10

21 U.S.C. 321(rr)21 U.S.C. 387a(b)21 CFR 1100.121 U.S.C. 387j(a)21 U.S.C. 387j(c)(1)(A)(i)21 U.S.C. 387e(j)21 U.S.C. 387e(j)(1)(A)(ii)21 U.S.C. 387e(j)(3)21 U.S.C. 387b(6)(A)21 U.S.C. 387c(a)(6)

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