FDA WARNING_LETTER - Kealani Distribution LLC/Violet Vapor LLC - March 26, 2021

The FDA issued a Warning Letter to Michael Whitehead of Violet Vapor on March 26, 2021, following a review of their website, https://violetvapor.com. The FDA determined that Violet Vapor manufactures and offers for sale e-liquid products, specifically "Gothic Strawberry" and "Dragon Fruit," which are considered tobacco products under section 201(rr) of the FD&C Act.

These e-liquid products are classified as "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007. The primary violation is that these products are being marketed without the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act, nor are they exempt. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as the required notice or information under section 905(j) was not provided.

Violet Vapor, a registered manufacturer with over 4,900 products listed with FDA, is responsible for ensuring all tobacco products and associated labeling/advertising comply with the FD&C Act and FDA regulations. Failure to address these violations may result in regulatory actions including civil money penalties, seizure, and/or injunction. The firm must submit a written response