Half Moon Mods LLC

Warning LetterOpen

Jeffery R. Murphy Owner Half Moon Mods LLC 5b Fanaras Drive Salisbury , MA 01952 United States murph@halfmoonmods.comFEI 3013861106Issued Mar 10, 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 3013861106.

Violations1

Issue DateMar 10, 2022

Product TypeTobacco

StatusOpen

Letter Details

Firm: Half Moon Mods LLC
Location: Jeffery R. Murphy Owner Half Moon Mods LLC 5b Fanaras Drive Salisbury , MA 01952 United States murph@halfmoonmods.com
FEI Number: 3013861106
Country: United States
Issue Date: March 10, 2022
Issuing Office: Center for Tobacco Products
Product Type: Tobacco
Status: Open

Summary

Half Moon Mods LLC, a manufacturer of electronic nicotine delivery systems (ENDS), was found to be distributing tobacco products without required premarket authorization as mandated under the Family Smoking Prevention and Tobacco Control Act. The company failed to comply with FDA regulations requiring "new tobacco products" to obtain premarket approval before commercial distribution in the United States. As ENDS products were deemed subject to FDA jurisdiction effective August 8, 2016, Half Moon Mods LLC's continued manufacturing and sale of these products without proper authorization constituted violations of the Federal Food, Drug, and Cosmetic Act.

Half Moon Mods LLC FDA Warning Letter, March 10, 2022