Brew City Juice, LLC

Warning LetterOpen

Philip M. Allen, Jr. Owner Brew City Juice, LLC 2018 South 1st Street, Suite 333 Milwaukee , WI 53207-1102 United States pj@brewcityjuice.comFEI 3011627320Issued Aug 4, 2022Center for Tobacco Products

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3011627320.

Violations1

Issue DateAug 4, 2022

Product TypeTobacco

StatusOpen

Letter Details

Firm: Brew City Juice, LLC
Location: Philip M. Allen, Jr. Owner Brew City Juice, LLC 2018 South 1st Street, Suite 333 Milwaukee , WI 53207-1102 United States pj@brewcityjuice.com
FEI Number: 3011627320
Country: United States
Issue Date: August 04, 2022
Issuing Office: Center for Tobacco Products
Product Type: Tobacco
Status: Open

Summary

Brew City Juice, LLC was warned for manufacturing and distributing e-liquid tobacco products without obtaining required premarket authorization from the FDA. The company's e-liquid products, classified as newly deemed tobacco products under the Family Smoking Prevention and Tobacco Control Act, were found to be in violation of federal requirements mandating premarket review and approval before commercial distribution. The FDA determined that these electronic nicotine delivery system products did not comply with section 910 of the Federal Food, Drug, and Cosmetic Act, which requires all new tobacco products to have FDA authorization in effect prior to market entry.

Brew City Juice, LLC FDA Warning Letter, August 4, 2022