RNJ Field Inc d/b/a Thunderhead Corporation Fife – FDA Warning Letter, Mar 30, 2021

On March 26, 2021, the FDA issued a Warning Letter to Jinhyung Lee of Thunderhead Vapor, located at 5009 Pacific Hwy E, Ste. 4, Fife, WA 98424. The letter stemmed from a review of the website https://www.thunderheadvapor.com, which revealed the manufacture and sale of e-liquid products to U.S. customers.

The FDA determined that e-liquid products, including "Thunderhead e-liquids: Zen Peach, Zen Vanilla Shake, and Zen Blueberry Fluff," are tobacco products under section 201(rr) of the FD&C Act (21 U.S.C. § 321(rr)). These products are subject to FDA jurisdiction and must comply with the FD&C Act.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization order, as mandated by section 910(a) of the FD&C Act (21 U.S.C. § 387j(a)). Since these e-liquids were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization, they are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&