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WARNING LETTER
•Vape Orb/Slackers Brew Enterprise•March 24, 2020

FDA WARNING_LETTER - Vape Orb/Slackers Brew Enterprise - March 24, 2020

Record Details

The FDA issued a Warning Letter to Kim Po Lim of vapeorb.com on December 6, 2019, following a review of their website, which advertised and sold e-liquid products to U.S. customers. The FDA determined these products are tobacco products under the FD&C Act.

The "Intensed Juice - Oreo Dunked!" e-liquid product was cited for being misbranded under sections 903(a)(1) and/or 903(a)(7)(A) of the FD&C Act because its labeling and advertising imitate food products, specifically those appealing to children (e.g., Nabisco OREO Chocolate Sandwich Cookies), posing a risk of accidental ingestion and nicotine poisoning.

Additionally, the "Intensed Juice - Oreo Dunked!" e-liquid was misbranded under section 903(a)(7)(B) for being sold to a person younger than 18 years of age, violating 21 C.F.R. § 1140.14(b).

Furthermore, several other e-liquid products advertised on the website (e.g., Final Fantasy Orange, Play More - Cooling Watermelon) were misbranded under sections 903(a)(7)(B) and 903(a)(7)(A) because their advertising failed to include the required nicotine warning statement: "WARNING: This product contains nicotine. Nic

Company
Vape Orb/Slackers Brew Enterprise
Inspection date
March 24, 2020
Product type
Tobacco
Office
Center for Tobacco Products
Person
  • Ann Simoneau (Director)
View Company Profile

ID · 35d1e12a-f6df-4f5e-97d6-344f61570f3b

Violation Codes9
21 CFR 1100.221 U.S.C. 321(rr)21 U.S.C. 387a(b)21 U.S.C. 387c(a)(1)21 U.S.C. 387c(a)(7)(A)21 U.S.C. 387c(a)(7)(B)21 CFR 1140.14(b)21 CFR 1143.3(b)21 U.S.C. 321(n)

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