FDA WARNING_LETTER - Cosmic Fog Vapors Operating Company, LLC - December 28, 2021

The FDA issued a Warning Letter to Brant Peto, Peter Koch, and Jeffrey Nelson of Cosmic Fog Vapors on December 20, 2021, following a review of their website, cosmicfogvapors.com. The FDA determined that their e-liquid products, specifically "Cosmic Fog Kryp," are tobacco products subject to FDA jurisdiction and the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The primary violation identified is the marketing of a "new tobacco product" without the required premarket authorization order. "Cosmic Fog Kryp" was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order or exemption. This renders the product adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The company is a registered manufacturer with over 2,000 products listed with FDA. Their Premarket Tobacco Product Application (PMTA) STN PM0002376, submitted August 30, 2020, received a Marketing Denial Order on September 15, 2021, covering 26 products.

The FDA requires a written response within 15 working days detailing actions taken to address violations, including discontinuing the violative marketing and a plan for future compliance