FDA WARNING_LETTER - Planet of the Vapes, LLC - October 07, 2021

The FDA Center for Tobacco Products issued a Warning Letter to Planet of the Vapes, LLC d/b/a Planet of the Vapes, identifying that their e-liquid products are tobacco products subject to FDA jurisdiction. The letter states that certain e-liquid products, specifically KISS PEACH 120ML 70VG 3MG/ML, KISS RASPBERRY 120ML 70VG 3MG/ML, PLANET’S POTIONS fresh baked 60VG 6MG/ML, and PLANET’S POTIONS poe-tion 52 60VG 3MG/ML, are "new tobacco products" that were not commercially marketed in the U.S. as of February 15, 2007.

These products are being manufactured, sold, and/or distributed without the required FDA marketing authorization orders, making them adulterated under section 902(6)(A) of the FD&C Act and misbranded under section 903(a)(6) of the FD&C Act. The failure to provide a required report under section 905(j) is also a prohibited act under section 301(p).

The firm is a registered manufacturer with over 1,200 products listed. While Premarket Tobacco Product Applications (PMTAs) were submitted for some products, STN PM0001