Dr Crimmy LLC d/b/a Dr. Crimmy’s V-Liquid

Warning LetterClosed

Kevin Lynch Dr Crimmy LLC d/b/a Dr. Crimmy’s V-Liquid 2100 Thompson Bridge Rd. Gainesville , GA 30501 United States CustomerService@DrCrimmy.com CustomerService@gmail.com MNOE@MNSERVICELLC.comIssued Jan 15, 2021Center for Tobacco Products

View Letter

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 16, 2021

Letter Details

Firm: Dr Crimmy LLC d/b/a Dr. Crimmy’s V-Liquid
Location: Kevin Lynch Dr Crimmy LLC d/b/a Dr. Crimmy’s V-Liquid 2100 Thompson Bridge Rd. Gainesville , GA 30501 United States CustomerService@DrCrimmy.com CustomerService@gmail.com MNOE@MNSERVICELLC.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 16, 2021

Summary

Dr. Crimmy LLC was warned for manufacturing and selling e-liquid tobacco products without obtaining required premarket authorization from the FDA, which became mandatory for newly deemed tobacco products effective August 8, 2016. The company's website offered e-liquids for sale in the United States without compliance with the Family Smoking Prevention and Tobacco Control Act and applicable regulations under 21 C.F.R. § 1100.1. As "new tobacco products" not commercially marketed before February 15, 2007, the e-liquids required an FDA marketing authorization order before legal distribution in the U.S. market.

Dr Crimmy LLC d/b/a Dr. Crimmy’s V-Liquid FDA Warning Letter, January 15, 2021