William Connolly and Ryan Wunderlich
Castle Rock Vapor LLC
6075 Otis Street
Arvada , CO 80003
United States
bill@castlerockvapor.com
ryfi@castlerockvapor.comIssued Jan 15, 2021Center for Tobacco Products
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.
Violations1
Issue DateJan 15, 2021
Product TypeTobacco
StatusClosed
Closeout LetterJun 8, 2021
Letter Details
Firm
Castle Rock Vapor LLC
Location
William Connolly and Ryan Wunderlich
Castle Rock Vapor LLC
6075 Otis Street
Arvada , CO 80003
United States
bill@castlerockvapor.com
ryfi@castlerockvapor.com
FEI Number
N/A
Country
United States
Issue Date
January 15, 2021
Issuing Office
Center for Tobacco Products
Product Type
Tobacco
Status
Closed
Closeout Letter
June 08, 2021
Summary
Castle Rock Vapor LLC was cited for manufacturing and selling e-liquid tobacco products without obtaining required premarket authorization orders as mandated by the Family Smoking Prevention and Tobacco Control Act. The FDA determined that e-liquids sold through the company's website were deemed tobacco products subject to FDA jurisdiction under the Federal Food, Drug, and Cosmetic Act, and as "new tobacco products," they required premarket approval before being legally marketed in the United States. The company had failed to comply with these regulatory requirements for product authorization prior to commercial distribution.
Castle Rock Vapor LLC FDA Warning Letter, January 15, 2021