Jeremy Harris
PBDragon LLC
2921 50th St E
Inver Grove Heights , MN 55076
United States
info@pbdragon.com
(b)(6)
vaportoolbar@gmail.comIssued Feb 11, 2022Center for Tobacco Products
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.
Violations1
Issue DateFeb 11, 2022
Product TypeTobacco
StatusClosed
Closeout LetterJun 22, 2022
Letter Details
Firm
PBDragon LLC
Location
Jeremy Harris
PBDragon LLC
2921 50th St E
Inver Grove Heights , MN 55076
United States
info@pbdragon.com
(b)(6)
vaportoolbar@gmail.com
FEI Number
N/A
Country
United States
Issue Date
February 11, 2022
Issuing Office
Center for Tobacco Products
Product Type
Tobacco
Status
Closed
Closeout Letter
June 22, 2022
Summary
PBDragon LLC was warned that its e-liquid products sold through pbdragon.com constituted tobacco products subject to FDA jurisdiction under the Family Smoking Prevention and Tobacco Control Act, requiring premarket authorization orders before legal marketing in the United States. The company had failed to obtain the required marketing authorization under section 910(c)(1)(A)(i) of the Federal Food, Drug, and Cosmetic Act for these "new tobacco products" that were not commercially marketed in the U.S. as of February 15, 2007. The Center for Tobacco Products determined that the e-liquids were being manufactured and offered for sale or distribution without the necessary FDA premarket approval, constituting violations of applicable tobacco product regulations.
PBDragon LLC FDA Warning Letter, February 11, 2022