FDA WARNING_LETTER - Synergy Mixing Labs, LLC - March 01, 2022

The FDA issued a Warning Letter to Synergy Mixing Labs, LLC on March 1, 2022, following a review of submissions and inspection records. The company manufactures and distributes e-liquid products, which are deemed tobacco products under the FD&C Act and require premarket authorization.

The primary violation is the marketing of "new tobacco products" without the required FDA marketing authorization. Specifically, the products "Cloud Slingers Coco Queen 6mg 120ml," "Cloud Slingers Bad Cop 24mg 30ml," and "Cloud Slingers Black Pearl 18mg 30ml" were found to be commercially marketed after February 15, 2007, without the necessary marketing orders or exemptions. This renders them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The company's Premarket Tobacco Product Application (PMTA), STN PM0001144, submitted on September 10, 2020, received a Marketing Denial Order on September 10, 2021, covering 5,334 products. The FDA emphasizes that new tobacco products without premarket authorization are unlawfully marketed and subject to enforcement, with products lacking pending applications or having received Marketing Denial Orders being high enforcement priorities.

Synergy Mixing Labs, LLC must submit