D & J Vapors, LLC-Horse Cave

Warning LetterOpen

James Lacy Owner D & J Vapors, LLC-Horse Cave 115 South Dixie Street Horse Cave , KY 42749 United States gracielacy789@hotmail.comIssued Jan 25, 2022Center for Tobacco Products

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Violations1

Issue DateJan 25, 2022

Product TypeTobacco

StatusOpen

Letter Details

Firm: D & J Vapors, LLC-Horse Cave
Location: James Lacy Owner D & J Vapors, LLC-Horse Cave 115 South Dixie Street Horse Cave , KY 42749 United States gracielacy789@hotmail.com
FEI Number: N/A
Country: United States
Issue Date: January 25, 2022
Issuing Office: Center for Tobacco Products
Product Type: Tobacco
Status: Open

Summary

D & J Vapors, LLC-Horse Cave manufactured and distributed e-liquid tobacco products without obtaining required premarket authorization from the FDA, in violation of the Family Smoking Prevention and Tobacco Control Act. The company failed to comply with FD&C Act requirements applicable to newly deemed tobacco products (e-cigarettes and e-liquids), which have been subject to FDA jurisdiction since August 8, 2016. The inspection and submission review determined the e-liquid products were being manufactured and offered for sale in the United States without the mandatory premarket approval required for new tobacco products under section 910 of the FD&C Act.

D & J Vapors, LLC-Horse Cave FDA Warning Letter, January 25, 2022