Str8Vape, LLC

Warning LetterOpen

Nicole Simpson Owner Str8Vape, LLC 310 Calhoun Avenue, Suite H Greenwood , SC 29649 United States greenwoodstr8vape@gmail.comIssued Apr 13, 2023Center for Tobacco Products

View Letter

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

Letter Details

Firm: Str8Vape, LLC
Location: Nicole Simpson Owner Str8Vape, LLC 310 Calhoun Avenue, Suite H Greenwood , SC 29649 United States greenwoodstr8vape@gmail.com
FEI Number: N/A
Country: United States
Issue Date: April 13, 2023
Issuing Office: Center for Tobacco Products
Product Type: Tobacco
Status: Open

Summary

Str8Vape, LLC manufactured and distributed e-liquid tobacco products containing nicotine without the required premarket authorization mandated by the FDA for new tobacco products. The company failed to comply with the Federal Food, Drug, and Cosmetic Act requirements applicable to tobacco products, particularly following the March 2022 legislation that extended FDA jurisdiction to products containing nicotine from any source, not just tobacco-derived nicotine. The Center for Tobacco Products determined the products were being offered for sale and distribution in the United States without proper regulatory authorization.