Ohm Centric Coils LLC

Warning LetterOpen

Nicholas P. Dumas Owner Ohm Centric Coils LLC 6 Barker Street Dannemora , NY 12929 United States ndumas83@gmail.comFEI 3014013705Issued Nov 16, 2023Center 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 3014013705.

Violations1

Issue DateNov 16, 2023

Product TypeTobacco

StatusOpen

Letter Details

Firm: Ohm Centric Coils LLC
Location: Nicholas P. Dumas Owner Ohm Centric Coils LLC 6 Barker Street Dannemora , NY 12929 United States ndumas83@gmail.com
FEI Number: 3014013705
Country: United States
Issue Date: November 16, 2023
Issuing Office: Center for Tobacco Products
Product Type: Tobacco
Status: Open

Summary

Ohm Centric Coils LLC, which manufactures electronic nicotine delivery system (ENDS) products, was cited for failing to obtain required premarket authorization before commercially distributing tobacco products containing nicotine. The company did not comply with FDA jurisdiction requirements under the Federal Food, Drug, and Cosmetic Act, which mandate that "new tobacco products" marketed in the United States after February 15, 2007 must have premarket approval in effect. This violation occurred under expanded FDA authority that extended jurisdiction to products containing nicotine from any source, effective April 14, 2022.

Ohm Centric Coils LLC FDA Warning Letter, November 16, 2023