FDA WARNING_LETTER - Crystal Canyon Vapes LLC - May 03, 2022

The FDA Center for Tobacco Products issued a Warning Letter to Marc and Gordon Foumberg regarding e-liquid products sold on https://www.ccvapes.com. The FDA determined that products like "Red Licorice" and "Tiki Sunrise" are "new tobacco products" under the FD&C Act because they were not commercially marketed in the U.S. as of February 15, 2007.

These products are being sold without the required premarket authorization order, making them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. The letter emphasizes that new tobacco products marketed without statutory premarket authorization are unlawful and subject to enforcement actions, including civil money penalties, seizure, and/or injunction.

The FDA requires a written response within 15 working days detailing actions taken to address violations, including discontinuing the sale and distribution of non-compliant products and a plan for maintaining compliance. The letter also states that this is not an exhaustive list of violations and that all tobacco products and related advertising must comply with the FD&C Act and FDA regulations.