Firehouse Vapes LLC d/b/a Zaelynn’s Vape & CBD

Warning LetterOpen

Frank Vanhorn Owner Firehouse Vapes LLC d/b/a Zaelynn’s Vape & CBD 908 East Main Street Willow Springs , MO 65793 United States firehousevapes@outlook.comIssued Jul 7, 2022Center for Tobacco Products

View Letter

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

Violations1

Issue DateJul 7, 2022

Product TypeTobacco

StatusOpen

Letter Details

Firm: Firehouse Vapes LLC d/b/a Zaelynn’s Vape & CBD
Location: Frank Vanhorn Owner Firehouse Vapes LLC d/b/a Zaelynn’s Vape & CBD 908 East Main Street Willow Springs , MO 65793 United States firehousevapes@outlook.com
FEI Number: N/A
Country: United States
Issue Date: July 07, 2022
Issuing Office: Center for Tobacco Products
Product Type: Tobacco
Status: Open

Summary

Firehouse Vapes LLC d/b/a Zaelynn's Vape & CBD manufactured and distributed e-liquid tobacco products without required premarket authorization, violating the Family Smoking Prevention and Tobacco Control Act. The company failed to comply with FDA regulations for newly deemed tobacco products (effective August 8, 2016), which require e-liquids and electronic nicotine delivery systems to obtain premarket approval before commercial distribution in the United States. The FDA's inspection and review of the company's submissions determined that the e-liquid products were being manufactured and offered for sale without the legally mandated authorizations under the Federal Food, Drug, and Cosmetic Act.

Firehouse Vapes LLC d/b/a Zaelynn’s Vape & CBD FDA Warning Letter, July 7, 2022