Premium eJuice USA LLC d/b/a Vapor Lab – FDA Warning Letter, Oct 8, 2019
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
ID · 9383a0b0-1339-40cc-971b-84e418acd427
Full citation text and observation details available on the Dashboard.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.