FDA WARNING_LETTER - Visible Vapors, LLC - July 28, 2021

The FDA Center for Tobacco Products issued a Warning Letter to Visible Vapors after reviewing their website, visiblevapors.com, and identifying e-liquid products manufactured and sold in the U.S. These products, including "Visible Vapors Irish Potato 100mL" and "Visible Vapors Peanutbutter Banana Bacon Maple (The King) 100mL," are deemed tobacco products under the FD&C Act.

The key violation is that these e-liquid products are "new tobacco products" (not commercially marketed before February 15, 2007) and lack the required premarket marketing authorization order from the FDA. Consequently, they are considered adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act because the necessary notice or information was not provided as required by section 905(j).

Visible Vapors, a registered manufacturer with over 15 million products listed with the FDA, is responsible for ensuring compliance across all its tobacco products, labeling, and advertising. Failure to address these violations may result in regulatory actions such as civil money penalties, seizure, or injunction. The company must submit a written response within 15 working days detailing corrective actions, including discontinuing the violative products and outlining a plan for future compliance.