Smoke-Free Planet, LLC d/b/a Smoke Free Nation

Warning LetterOpen

Gerald Reed Owner Smoke-Free Planet, LLC d/b/a Smoke Free Nation 11100 Liberty Road, Suite N Randallstown , MD 21133 United States jerryreedjr@msn.comIssued Apr 27, 2022Center for Tobacco Products

View Letter

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

Violations1

Issue DateApr 27, 2022

Product TypeTobacco

StatusOpen

Letter Details

Firm: Smoke-Free Planet, LLC d/b/a Smoke Free Nation
Location: Gerald Reed Owner Smoke-Free Planet, LLC d/b/a Smoke Free Nation 11100 Liberty Road, Suite N Randallstown , MD 21133 United States jerryreedjr@msn.com
FEI Number: N/A
Country: United States
Issue Date: April 27, 2022
Issuing Office: Center for Tobacco Products
Product Type: Tobacco
Status: Open

Summary

Smoke-Free Planet, LLC was cited for manufacturing and distributing e-liquid 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 governing deemed tobacco products (electronic nicotine delivery systems), which have been subject to FDA jurisdiction since August 8, 2016. The e-liquid products were being offered for sale or distribution in the United States without the necessary premarket review that the FD&C Act requires for new tobacco products.

Smoke-Free Planet, LLC d/b/a Smoke Free Nation FDA Warning Letter, April 27, 2022