FDA WARNING_LETTER - Custom Vapor Blends LLC - November 02, 2021

The FDA Center for Tobacco Products issued a Warning Letter to Custom Vapor Blends LLC on October 22, 2021, following a review of their website, customvaporblends.com. The FDA determined that e-liquid products, specifically "Acid on Ponies" and "Snickerdoodle," are manufactured and sold without required marketing authorization.

These e-liquid products are classified as "new tobacco products" under section 201(rr) of the FD&C Act because they were not commercially marketed in the U.S. as of February 15, 2007. Consequently, they are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act for lacking the necessary FDA marketing authorization order or exemption.

While Custom Vapor Blends is a registered manufacturer with over 5,600 products listed, their Premarket Tobacco Product Application (PMTA) STN PM0003893, covering 1,260 products, received a Marketing Denial Order on September 7, 2021. The FDA emphasizes that products without premarket authorization, especially those with a Marketing Denial Order, are high enforcement priorities.

The company must submit a written response within 15 working days detailing actions taken to address violations, including discontinuing the sale and distribution of non-compliant products