FDA WARNING_LETTER - JOCOR Enterprises LLC d/b/a VOLCANO eCigs - October 07, 2021

The FDA Center for Tobacco Products issued a Warning Letter to Cory Smith regarding e-liquid products sold on volcanoecigs.com. The FDA determined that products like "VOLCANO – Aloha Apple 30ml" and "VOLCANO – Grape Escape 30ml" are tobacco products under the FD&C Act, subject to FDA jurisdiction. These e-liquid products are considered "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007.

The primary violation is the sale and distribution of these new tobacco products without the required premarket authorization order from the FDA, as mandated by section 910(a) of the FD&C Act. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

Although a Premarket Tobacco Product Application (PMTA) (STN PM0003051) was submitted on September 9, 2020, it received a Marketing Denial Order on September 1, 2021, covering 70 products. The FDA emphasizes that products without required premarket authorization, especially those with a Marketing Denial Order or no application, are high enforcement priorities.

The letter requires a written response within 15 working days detailing actions taken to address violations, including