Comasphere LLC – FDA Warning Letter, May 12, 2020

The FDA issued a Warning Letter to Comasphere LLC on March 19, 2020, based on a review of submissions and inspection records. The FDA determined that Comasphere LLC manufactures and distributes e-liquid products, which are considered tobacco products under the FD&C Act.

The primary violation identified is the manufacturing, sale, and distribution of "new tobacco products" without required marketing authorization orders. The specific e-liquid products cited are: Sharky’s Salt Nic Fruit Chum, Sharky’s Salt Nic Deep Blue Razz, Sharky’s Salt Nic Killer Manberry, Sharky’s Salt Nic Great Rainbow, Smokeless Salt Nic Original Blend, Smokeless Salt Nic Vanilla Beech, Smokeless Salt Nic Menthol Frost, and Smokeless Salt Nic Toucan Crunch. These products were not commercially marketed in the U.S. as of February 15, 2007, and therefore require premarket review and FDA marketing authorization.

Because these products lack the necessary marketing authorization, they are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. The introduction of adulterated or misbranded tobacco products into interstate commerce is a prohibited act under section 301(a), and failure to provide required reports under section 905(j) is a prohibited act under section 301(