Stuff-N-Puffs 102, LLC d/b/a Stuff-N-Puffs

Warning LetterOpen

Linda Botta Owner Stuff-N-Puffs 102, LLC d/b/a Stuff-N-Puffs 8936 Darrow Road Twinsburg , OH 44087 United States twinsburg.oh@stuffnpuff.comIssued Jun 1, 2023Center for Tobacco Products

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Violations1

Issue DateJun 1, 2023

Product TypeTobacco

StatusOpen

Letter Details

Firm: Stuff-N-Puffs 102, LLC d/b/a Stuff-N-Puffs
Location: Linda Botta Owner Stuff-N-Puffs 102, LLC d/b/a Stuff-N-Puffs 8936 Darrow Road Twinsburg , OH 44087 United States twinsburg.oh@stuffnpuff.com
FEI Number: N/A
Country: United States
Issue Date: June 01, 2023
Issuing Office: Center for Tobacco Products
Product Type: Tobacco
Status: Open

Summary

Stuff-N-Puffs 102, LLC manufactured and distributed e-liquid tobacco products containing nicotine without required FDA premarket authorization, violating the Federal Food, Drug, and Cosmetic Act and FDA regulations governing tobacco products. The company failed to comply with FDA requirements for "new tobacco products," which mandate premarket authorization before legal commercial distribution in the United States. This violation occurred under the expanded FDA jurisdiction that took effect in 2022, which extended regulatory authority to products containing nicotine from any source, not just tobacco-derived nicotine.

Stuff-N-Puffs 102, LLC d/b/a Stuff-N-Puffs FDA Warning Letter, June 1, 2023