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WARNING LETTER
•Aroma Ejuice LLC•July 9, 2019

Aroma Ejuice LLC – FDA Warning Letter, Jul 9, 2019

Record Details

The FDA issued a Warning Letter to Aroma Ejuice LLC on March 6, 2019, following a review of their mobile website, http://www.aromaejuice.com. The FDA determined that Aroma Ejuice LLC's e-liquid products are tobacco products under the FD&C Act.

The company was cited for two primary violations: 1. **Sales to Minors:** Aroma Ejuice LLC sold "Beatle Juice" e-liquid 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. **Failure to Include Required Nicotine Warning Statement:** Several e-liquid products, including "Beatle Juice," "RY 4," and "Sahara," lacked the mandatory warning statement "WARNING: This product contains nicotine. Nicotine is an addictive chemical" on their labeling and/or advertising, as required by 21 C.F.R. § 1143.3. This misbrands the products under sections 903(a)(7)(B), 903(a)(1), and/or 903(a)(7)(A) of the FD&C Act, as the omission of this material fact makes the

Company
Aroma Ejuice LLC
Inspection date
July 9, 2019
Product type
Tobacco
Office
Center for Tobacco Products
People
  • Ann Simoneau (Director)
  • Steven A. Kaiblinger
View Company Profile

ID · 39fd46f4-ee12-49fe-9474-85fe5fce706b

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 CFR 1140.14(b)21 CFR 1140.321 CFR 1143.3(a)21 CFR 1143.3(b)

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