Smokalo, Inc.

Warning LetterOpen

Mr. Bartholomew J. Harmata Owner Smokalo, Inc. 730 Bonnie Lane Elk Grove Village , IL 60007-2201 United States claptonvapor@gmail.comFEI 3015462552Issued Jun 15, 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 3015462552.

Letter Details

Firm: Smokalo, Inc.
Location: Mr. Bartholomew J. Harmata Owner Smokalo, Inc. 730 Bonnie Lane Elk Grove Village , IL 60007-2201 United States claptonvapor@gmail.com
FEI Number: 3015462552
Country: United States
Issue Date: June 15, 2022
Issuing Office: Center for Tobacco Products
Product Type: Tobacco
Status: Open

Summary

Smokalo, Inc. manufactured and distributed e-liquid tobacco products without obtaining required premarket authorization from the FDA, in violation of the Family Smoking Prevention and Tobacco Control Act. The company's e-liquid products, classified as newly deemed tobacco products subject to FDA jurisdiction since August 2016, were being offered for commercial sale in the United States without the mandated marketing authorization orders for new tobacco products as defined under section 910 of the Federal Food, Drug, and Cosmetic Act. The FDA's inspection records and review of the company's submissions determined that Smokalo failed to comply with applicable tobacco product regulations governing e-cigarettes and related nicotine delivery systems.