Freedom Smoke USA International dba Freedom Smoke USA Inc.

Warning LetterOpen

David Dettloff and Pamela Workman-Parker Freedom Smoke USA International dba Freedom Smoke USA Inc. 7493 N Oracle Rd Suite 231A Tucson , AZ 85704 United States freedomsmokeusa@freedomsmokeusa.com (b)(6)FEI 3013938922Issued Feb 11, 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 3013938922.

Violations1

Issue DateFeb 11, 2022

Product TypeTobacco

StatusOpen

Letter Details

Firm: Freedom Smoke USA International dba Freedom Smoke USA Inc.
Location: David Dettloff and Pamela Workman-Parker Freedom Smoke USA International dba Freedom Smoke USA Inc. 7493 N Oracle Rd Suite 231A Tucson , AZ 85704 United States freedomsmokeusa@freedomsmokeusa.com (b)(6)
FEI Number: 3013938922
Country: United States
Issue Date: February 11, 2022
Issuing Office: Center for Tobacco Products
Product Type: Tobacco
Status: Open

Summary

Freedom Smoke USA International was cited for manufacturing and selling e-liquid tobacco products without required premarket authorization under the Family Smoking Prevention and Tobacco Control Act. The company's e-liquids, listed on their website for distribution in the United States, were determined to be deemed tobacco products subject to FDA jurisdiction as of August 8, 2016, but lacked the mandatory premarket authorization orders required for new tobacco products to be legally marketed. The FDA's inspection of the company's website identified these products as unapproved tobacco products in violation of the Federal Food, Drug, and Cosmetic Act.

Freedom Smoke USA International dba Freedom Smoke USA Inc. FDA Warning Letter, February 11, 2022