Xtreme Vapour

Warning LetterOpen

Serop Tersakian Owner Xtreme Vapour 6690 West Cactus Road, Suite 100 Glendale , AZ 85304 United States infoxtremevapour@gmail.comIssued Apr 8, 2021Center for Tobacco Products

View Letter

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

Letter Details

Firm: Xtreme Vapour
Location: Serop Tersakian Owner Xtreme Vapour 6690 West Cactus Road, Suite 100 Glendale , AZ 85304 United States infoxtremevapour@gmail.com
FEI Number: N/A
Country: United States
Issue Date: April 08, 2021
Issuing Office: Center for Tobacco Products
Product Type: Tobacco
Status: Open

Summary

Xtreme Vapour was warned for manufacturing and distributing e-liquid tobacco products without required premarket authorization under the Family Smoking Prevention and Tobacco Control Act. The company failed to obtain a marketing authorization order for its e-liquid products, which are classified as "new tobacco products" subject to FDA jurisdiction since the August 8, 2016 deeming rule that extended regulatory authority to electronic nicotine delivery systems. The violation involved offering tobacco products for commercial distribution in the United States without the legally mandated premarket review and approval from the Center for Tobacco Products.