FDA WARNING_LETTER - Dell Vapers - October 04, 2022

On October 4, 2022, the FDA issued a Warning Letter to Dell Vapors, identifying violations related to the manufacture and distribution of e-liquid tobacco products. The FDA determined that Dell Vapors manufactures and distributes e-liquid tobacco products, including "Bully Juice D’lish," "Bully Juice Screwdriver," and "Bully Juice Cool Mint," which are considered tobacco products under the FD&C Act.

The core violation is that these e-liquid products are "new tobacco products" because they were not commercially marketed in the United States as of February 15, 2007, and lack the required premarket authorization from the FDA. Specifically, they do not have FDA marketing authorization orders under section 910(c)(1)(A)(i) of the FD&C Act and are not otherwise exempt.

Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as required notice or information was not provided under section 905(j). The failure to provide such reports is a prohibited act under section 301(p), and any act resulting in adulterated or misbranded products held for sale after interstate shipment is prohibited under section 301(k).

Dell Vapors is required to submit a written response within 15