FDA WARNING_LETTER - Premium eJuice USA LLC d/b/a Vapor Lab - October 08, 2019

Record Details

The FDA issued a Warning Letter to Terry Lee Burkhead of Premium eJuice USA, LLC, on September 27, 2019, following a review of their website, https://ww2.premiumejuiceusa.com. The FDA determined that the e-liquid products sold are tobacco products under the FD&C Act.

The company was cited for two primary violations, resulting in misbranded products under section 903(a)(7)(B) of the FD&C Act: 1. **Sales to Minors:** An FDA investigation revealed that a person younger than 18 years of age purchased "Vapor Lab Apple Fritter" e-liquid from the website, violating 21 C.F.R. § 1140.14(b) which prohibits the sale of covered tobacco products to minors. 2. **Failure to Include Required Nicotine Warning Statement:** The website's advertising for products like "Vapor Lab Apple Fritter" and "Aqua Rainbow Drops" e-liquids failed to display the required nicotine warning statement ("WARNING: This product contains nicotine. Nicotine is an addictive chemical.") in the upper portion of the advertisement, occupying at least 20 percent of the area, as mandated by 21 C.F.R. § 1143.3(b).

The letter requires immediate corrective actions for these and similar violations to

Company: Premium eJuice USA LLC d/b/a Vapor Lab
Inspection Date: October 8, 2019
Product Type: Tobacco
Office: Center for Tobacco Products
Person: Ann Simoneau (Director)

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ID · 9383a0b0-1339-40cc-971b-84e418acd427

Violation Codes9

21 U.S.C. 321(rr)21 U.S.C. 387a(b)21 U.S.C. 387c(a)(7)(B)21 CFR 1140.14(b)21 CFR 1140.321 CFR 1100.221 CFR 1143.3(b)21 CFR 1143.3(b)(1)21 CFR 1143.3(b)(2)

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