FDA WARNING_LETTER - Planet Vapor - March 30, 2021

On March 26, 2021, the FDA issued a Warning Letter to Karen and David Saylor of Planet Vapor, following a review of their website, https://www.planetvapor.com. The FDA determined that e-liquid products, including "Jawbreaker," "Beetlejuice," and "Hop Scotch," were manufactured and offered for sale or distribution in the United States.

These e-liquids are classified as "new tobacco products" under section 201(rr) of the FD&C Act because they were not commercially marketed in the U.S. as of February 15, 2007. The FDA found that these products lacked the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act, making them adulterated under section 902(6)(A). Additionally, they are misbranded under section 903(a)(6) because the required notice or information under section 905(j) was not provided.

Planet Vapor, a registered manufacturer with over 1,000 listed products, is responsible for ensuring compliance with the FD&C Act and FDA regulations. Failure to address these violations may result in civil money penalties, seizure, and/or injunction. The company must submit a written response within 15 working days detailing corrective actions, including discontinuing violative sales and a plan