EVO Brands, LLC and PVG2, LLC d/b/a Puff Bar

Warning LetterOpen

Nicholas Minas Alfaro and Patrick Beltran EVO Brands, LLC and PVG2, LLC d/b/a Puff Bar 251 Little Falls Drive Wilmington , DE 19807 United States info@puffbar.com media@puffbar.com nick@puffbar.comIssued Oct 6, 2022Center for Tobacco Products

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

Violations0

Issue DateOct 6, 2022

Product TypeTobacco

StatusOpen

Letter Details

Firm: EVO Brands, LLC and PVG2, LLC d/b/a Puff Bar
Location: Nicholas Minas Alfaro and Patrick Beltran EVO Brands, LLC and PVG2, LLC d/b/a Puff Bar 251 Little Falls Drive Wilmington , DE 19807 United States info@puffbar.com media@puffbar.com nick@puffbar.com
FEI Number: N/A
Country: United States
Issue Date: October 06, 2022
Issuing Office: Center for Tobacco Products
Product Type: Tobacco
Status: Open

Summary

EVO Brands, LLC and PVG2, LLC (doing business as Puff Bar) were cited for distributing electronic nicotine delivery system (ENDS) products without FDA marketing authorization orders, which is required for all new tobacco products under the Federal Food, Drug, and Cosmetic Act. The company's ENDS products were being received and delivered in the United States in violation of FDA jurisdiction requirements that apply to all products containing nicotine from any source, including those expanded under legislation signed in March 2022. The FDA determined these products were adulterated and misbranded under the Family Smoking Prevention and Tobacco Control Act and related regulations.

EVO Brands, LLC and PVG2, LLC d/b/a Puff Bar FDA Warning Letter, October 6, 2022