FDA WARNING_LETTER - DealsBoxes d/b/a CloudKK Inc. - April 30, 2019

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Record Details

The FDA issued a Warning Letter to Dong Hua Wang on April 26, 2019, following a review of the website https://cloudkk-com.3dcartstores.com, which offers e-liquid products for sale in the U.S. The FDA determined these e-liquids are tobacco products under the FD&C Act.

The letter identifies two primary violations: 1. **Sales to Minors:** The "Burst Duo Kiwi Strawberry" e-liquid product was sold to a person younger than 18 years of age, violating 21 C.F.R. § 1140.14(b). This renders the product misbranded under section 903(a)(7)(B) of the FD&C Act. 2. **Missing Nicotine Warning Statement:** Several e-liquid products, including "Burst Duo Kiwi Strawberry," "Sugoi Vapor Sakura," and "Chubby Bubble Vapes Bubble Strawberry," lacked the required nicotine warning statement ("WARNING: This product contains nicotine. Nicotine is an addictive chemical.") in their labeling and/or advertising. This violates 21 C.F.R. § 1143.3(a) and/or (b), leading to misbranding under sections 903(a)(7)(B), 903(a)(1), and/or 903(a)(7

Company: DealsBoxes d/b/a CloudKK Inc.
Inspection Date: April 30, 2019
Product Type: Tobacco
Office: Center for Tobacco Products
Person: Ann Simoneau (Director)

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ID · 46a7f7f4-6416-46da-af37-3144fc0ae92c

Violation Codes10

21 CFR 1100.221 U.S.C. 321(rr)21 U.S.C. 387a(b)21 U.S.C. 387c(a)(7)(B)21 U.S.C. 387c(a)(1)21 U.S.C. 387c(a)(7)(A)21 U.S.C. 321(n)21 CFR 1140.14(b)21 CFR 1143.3(a)21 CFR 1143.3(b)

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