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 Sep 14, 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 DateSep 14, 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: September 14, 2022
Issuing Office: Center for Tobacco Products
Product Type: Tobacco
Status: Open

Summary

Freedom Smoke USA International was cited for manufacturing and distributing e-liquid tobacco products without required premarket authorization from the FDA. The company's products, which contain nicotine and are subject to FDA jurisdiction under the Family Smoking Prevention and Tobacco Control Act, failed to comply with federal requirements for new tobacco products to obtain premarket authorization orders before being legally marketed in the United States. The FDA's inspection of the company's website identified e-liquid products being offered for sale or distribution to U.S. customers in violation of these regulations.

Freedom Smoke USA International dba Freedom Smoke USA Inc. FDA Warning Letter, September 14, 2022