Raven Route

Warning LetterOpen

Raven Route United States support@ravenroute.com support@raven.comIssued Sep 20, 2023Center for Tobacco Products

View Letter

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

Violations1

Issue DateSep 20, 2023

Product TypeTobacco

StatusOpen

Letter Details

Firm: Raven Route
Location: Raven Route United States support@ravenroute.com support@raven.com
FEI Number: N/A
Country: United States
Issue Date: September 20, 2023
Issuing Office: Center for Tobacco Products
Product Type: Tobacco
Status: Open

Summary

Raven Route was cited for offering electronic nicotine delivery system (ENDS) products for sale on its website without required premarket authorization, violating the Federal Food, Drug, and Cosmetic Act. The company failed to comply with FDA regulations requiring "new tobacco products" to obtain a marketing authorization order before legal distribution in the United States. This violation applied to all ENDS products containing nicotine from any source, including those derived from non-tobacco sources under the expanded definition enacted in March 2022.

Raven Route FDA Warning Letter, September 20, 2023