Jinhyung Lee
RNJ Field Inc d/b/a Thunderhead Corporation Fife
5009 Pacific Hwy E, Ste. 4
Fife , WA 98424
United States
staff@thunderheadvapor.comIssued Mar 26, 2021Center for Tobacco Products
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.
Violations1
Issue DateMar 26, 2021
Product TypeTobacco
StatusClosed
Closeout LetterJul 7, 2021
Letter Details
Firm
RNJ Field Inc d/b/a Thunderhead Corporation Fife
Location
Jinhyung Lee
RNJ Field Inc d/b/a Thunderhead Corporation Fife
5009 Pacific Hwy E, Ste. 4
Fife , WA 98424
United States
staff@thunderheadvapor.com
FEI Number
N/A
Country
United States
Issue Date
March 26, 2021
Issuing Office
Center for Tobacco Products
Product Type
Tobacco
Status
Closed
Closeout Letter
July 07, 2021
Summary
RNJ Field Inc d/b/a Thunderhead Corporation Fife manufactured and sold e-liquid tobacco products through its website without required premarket authorization from the FDA. The company failed to comply with the Family Smoking Prevention and Tobacco Control Act by marketing "new tobacco products" that were not commercially available as of February 15, 2007, without obtaining the legally required marketing authorization orders. E-liquids, classified as tobacco products under FDA jurisdiction since the August 8, 2016 deeming rule, must meet all Federal Food, Drug, and Cosmetic Act requirements prior to commercial distribution in the United States.
RNJ Field Inc d/b/a Thunderhead Corporation Fife FDA Warning Letter, March 26, 2021