Imperial Vapors LLC – FDA Warning Letter, Oct 7, 2021

The FDA issued a Warning Letter to Imperial Vapors LLC, identifying that their e-liquid products are tobacco products subject to FDA jurisdiction and the Federal Food, Drug, and Cosmetic Act (FD&C Act). The letter states that Imperial Vapors LLC manufactures and distributes e-liquid products, including "Imperial Vapors beetle juice 1 mg/mL," "Imperial Vapors candyland 1mg/mL," and "Imperial Vapors papa smurf 1mg/mL," without the required premarket authorization.

These products are deemed "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization orders or exemptions. This renders them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. The failure to provide required reports under section 905(j) is also a prohibited act.

Imperial Vapors LLC is a registered manufacturer with over 85,100 products listed. While Premarket Tobacco Product Applications (PMTAs) were submitted for some products (STNs PM0003724 and PM0003802), a Marketing Denial Order was issued for STN PM0003724 on September 1, 2021, covering