McCraney Enterprises Corporation d/b/a Vapors Heaven

Warning LetterOpen

Tammy Slaton Owner McCraney Enterprises Corporation d/b/a Vapors Heaven 14391 Highway 43 Russellville , AL 35653 United States Tmccraney14@gmail.comIssued Jun 23, 2022Center for Tobacco Products

View Letter

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

Violations1

Issue DateJun 23, 2022

Product TypeTobacco

StatusOpen

Letter Details

Firm: McCraney Enterprises Corporation d/b/a Vapors Heaven
Location: Tammy Slaton Owner McCraney Enterprises Corporation d/b/a Vapors Heaven 14391 Highway 43 Russellville , AL 35653 United States Tmccraney14@gmail.com
FEI Number: N/A
Country: United States
Issue Date: June 23, 2022
Issuing Office: Center for Tobacco Products
Product Type: Tobacco
Status: Open

Summary

McCraney Enterprises Corporation d/b/a Vapors Heaven manufactured and distributed e-liquid tobacco products without required premarket authorization, violating the Family Smoking Prevention and Tobacco Control Act. The FDA determined that the company's e-liquid products, which fall under the definition of electronic nicotine delivery systems, were not in compliance with Federal Food, Drug, and Cosmetic Act requirements that mandate "new tobacco products" obtain premarket approval before commercial distribution. The inspection identified that these products were being offered for sale in the United States without the necessary FDA authorization that has been required since August 8, 2016.

McCraney Enterprises Corporation d/b/a Vapors Heaven FDA Warning Letter, June 23, 2022