Nicfixed, LLC d/b/a Good Karma Vapor

Warning LetterOpen

Daniel Donahue Owner Nicfixed, LLC d/b/a Good Karma Vapor 249 U.S. Highway 46 Saddle Brook , NJ 07663 United States goodkarmavapor@gmail.comIssued May 27, 2021Center for Tobacco Products

View Letter

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

Violations1

Issue DateMay 27, 2021

Product TypeTobacco

StatusOpen

Letter Details

Firm: Nicfixed, LLC d/b/a Good Karma Vapor
Location: Daniel Donahue Owner Nicfixed, LLC d/b/a Good Karma Vapor 249 U.S. Highway 46 Saddle Brook , NJ 07663 United States goodkarmavapor@gmail.com
FEI Number: N/A
Country: United States
Issue Date: May 27, 2021
Issuing Office: Center for Tobacco Products
Product Type: Tobacco
Status: Open

Summary

Nicfixed, LLC d/b/a Good Karma Vapor manufactured and distributed e-liquid tobacco products without obtaining required premarket authorization from the FDA. The company's e-liquid products, which are electronic nicotine delivery systems deemed tobacco products under the Family Smoking Prevention and Tobacco Control Act effective August 8, 2016, violated section 910 of the Federal Food, Drug, and Cosmetic Act by being marketed without the necessary marketing authorization order. The FDA determined that these products qualified as "new tobacco products" requiring premarket approval before commercial distribution in the United States.

Nicfixed, LLC d/b/a Good Karma Vapor FDA Warning Letter, May 27, 2021