FUNCOOL Technology Co., Limited d/b/a RAZ Vape

Warning LetterOpen

Junhui Pan FUNCOOL Technology Co., Limited d/b/a RAZ Vape 27041 W Bethel Rd. Coppell , TX 75261-4015 United States service@raz-vape.comIssued Sep 12, 2024Center for Tobacco Products

View Letter

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

Violations1

Issue DateSep 12, 2024

Product TypeTobacco

StatusOpen

Letter Details

Firm: FUNCOOL Technology Co., Limited d/b/a RAZ Vape
Location: Junhui Pan FUNCOOL Technology Co., Limited d/b/a RAZ Vape 27041 W Bethel Rd. Coppell , TX 75261-4015 United States service@raz-vape.com
FEI Number: N/A
Country: United States
Issue Date: September 12, 2024
Issuing Office: Center for Tobacco Products
Product Type: Tobacco
Status: Open

Summary

RAZ Vape was found to be offering electronic nicotine delivery system (ENDS) products for sale in the United States without required premarket authorization, in violation of the Family Smoking Prevention and Tobacco Control Act. The FDA determined that these products, containing nicotine from any source, are classified as tobacco products subject to FDA jurisdiction and must comply with premarket review requirements for "new tobacco products" that were not commercially marketed in the U.S. as of February 15, 2007. The company's website was reviewed and found to be distributing products without the necessary regulatory authorization required under the Federal Food, Drug, and Cosmetic Act.

FUNCOOL Technology Co., Limited d/b/a RAZ Vape FDA Warning Letter, September 12, 2024