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WARNING LETTER
•Vape Juice Depot•May 1, 2024

Vape Juice Depot – FDA Warning Letter, May 1, 2024

Record Details

On April 30, 2024, the FDA's Center for Tobacco Products issued a Warning Letter to VapeJuiceDepot.com after reviewing their website and determining they offer electronic nicotine delivery system (ENDS) products for sale in the U.S. These products are classified as tobacco products under section 201(rr) of the FD&C Act, including those with nicotine from any source, as per the Consolidated Appropriations Act, 2022.

The FDA identified three specific ENDS products lacking required premarket authorization: Elf Bar Vape/EB Design TE 6000 Disposable - Strawberry Ice, Funky Republic Vape/Funky Republic Ti7000 Disposable – Mango Kiss, and Lost Mary Vape/Lost Mary OS5000 Disposable – Cherry Peach Lemonade. These are considered "new tobacco products" under section 910(a) of the FD&C Act because they were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization orders or exemptions.

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 authorization and failure to provide necessary information under section 905(j). The letter mandates a written response within 15

Company
Vape Juice Depot
Inspection date
May 1, 2024
Product type
Tobacco
Office
Center for Tobacco Products
Person
  • Jill Atencio (Acting Director)
View Company Profile

ID · 2ecfcdbb-02e5-4579-b8d2-677d4720f337

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)FD&C Act 902(6)(A)21 U.S.C. 387b(6)(A)

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