FDA WARNING_LETTER - Oregon Vapor LLC - April 13, 2021

The FDA Center for Tobacco Products issued a Warning Letter to Allison Stubbert of Oregon Vapor LLC on April 9, 2021, following a review of the website https://www.oregonvapor.com. The review determined that e-liquid products, including "Pink Bunny," "Caramel Apple," and "Banana Cream," were manufactured and offered for sale or distribution in the United States.

These e-liquid products are classified as "tobacco products" under section 201(rr) of the FD&C Act and are subject to FDA jurisdiction. The FDA found that these products are "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007, and lack the required premarket marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as no notice or information was provided as required by section 905(j).

Oregon Vapor LLC, a registered manufacturer with over 100 products listed with FDA, is responsible for ensuring compliance. The letter warns that failure to address these violations may lead to regulatory actions, including civil money penalties, seizure, and/or injunction. The company must submit