The 505 Vapor Room, LLC

Warning LetterOpen

Melanie Estrada Owner The 505 Vapor Room, LLC 1042 South Camino del Pueblo Bernalillo , NM 87004 United States 505vaporroom@gmail.comIssued Jun 2, 2022Center for Tobacco Products

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

Violations1

Issue DateJun 2, 2022

Product TypeTobacco

StatusOpen

Letter Details

Firm: The 505 Vapor Room, LLC
Location: Melanie Estrada Owner The 505 Vapor Room, LLC 1042 South Camino del Pueblo Bernalillo , NM 87004 United States 505vaporroom@gmail.com
FEI Number: N/A
Country: United States
Issue Date: June 02, 2022
Issuing Office: Center for Tobacco Products
Product Type: Tobacco
Status: Open

Summary

The 505 Vapor Room, LLC manufactured and distributed e-liquid products without obtaining required premarket authorization from the FDA, violating the Family Smoking Prevention and Tobacco Control Act. The company's e-liquid products, which qualify as tobacco products under FDA jurisdiction as electronic nicotine delivery systems, failed to comply with FD&C Act requirements that mandate premarket approval for any "new tobacco products" not commercially marketed in the United States prior to February 15, 2007. The inspection found the company was distributing these unapproved tobacco products for commercial sale to customers throughout the United States without the necessary regulatory clearance.

The 505 Vapor Room, LLC FDA Warning Letter, June 2, 2022