SIMPLYEJUICE, LLC d/b/a Simply E-Juice

Warning LetterOpen

SIMPLYEJUICE, LLC d/b/a Simply E-Juice Steven Manley 950 Freeway Dr. N. Columbus , OH 43229 United States steve@simplyejuice.netIssued Apr 23, 2021Center for Tobacco Products

View Letter

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

Violations1

Issue DateApr 23, 2021

Product TypeTobacco

StatusOpen

Letter Details

Firm: SIMPLYEJUICE, LLC d/b/a Simply E-Juice
Location: SIMPLYEJUICE, LLC d/b/a Simply E-Juice Steven Manley 950 Freeway Dr. N. Columbus , OH 43229 United States steve@simplyejuice.net
FEI Number: N/A
Country: United States
Issue Date: April 23, 2021
Issuing Office: Center for Tobacco Products
Product Type: Tobacco
Status: Open

Summary

Simply E-Juice was warned that its e-liquid products, which are tobacco products under FDA jurisdiction, were being manufactured and offered for sale without required premarket authorization orders. The company failed to comply with the Family Smoking Prevention and Tobacco Control Act's requirement that "new tobacco products" obtain marketing authorization before being legally sold in the United States. The FDA determined that the e-liquids listed on the company's website did not have the necessary premarket approval required under Section 910 of the Federal Food, Drug, and Cosmetic Act.

SIMPLYEJUICE, LLC d/b/a Simply E-Juice FDA Warning Letter, April 23, 2021