Smoke and Vape LLC

Warning LetterOpen

Jared Zigmond Smoke and Vape LLC 108 S Broadway Denver , CO 80209 United States jjlamb303@gmail.comIssued Jun 16, 2023Center 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 16, 2023

Product TypeTobacco

StatusOpen

Letter Details

Firm: Smoke and Vape LLC
Location: Jared Zigmond Smoke and Vape LLC 108 S Broadway Denver , CO 80209 United States jjlamb303@gmail.com
FEI Number: N/A
Country: United States
Issue Date: June 16, 2023
Issuing Office: Center for Tobacco Products
Product Type: Tobacco
Status: Open

Summary

Smoke and Vape LLC was cited for offering electronic nicotine delivery system (ENDS) products for sale through its website without required premarket authorization from the FDA. The company's tobacco products, which contain nicotine from any source, were found to be in violation of the Federal Food, Drug, and Cosmetic Act and its implementing regulations, as they lacked the necessary marketing authorization orders required for "new tobacco products" under FDA jurisdiction. The FDA's enforcement action was issued following a review of the company's website operations in June 2023.

Smoke and Vape LLC FDA Warning Letter, June 16, 2023