FDA WARNING_LETTER - Chain Vapez LLC - February 01, 2022

The FDA issued a Warning Letter to Adam Le of Chain Vapez on January 21, 2022, following a review of their website, https://www.chainvapez.com. The FDA determined that Chain Vapez manufactures and offers e-liquid products for sale in the U.S., which are classified as tobacco products under the FD&C Act.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. Specifically, the e-liquid products Sunset Sherbert, Why So Cereal?, and XXX were found to be new tobacco products not commercially marketed before February 15, 2007, and lacking an FDA marketing authorization order. This renders them 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 PM0003238) was submitted on September 9, 2020, it received a Marketing Denial Order on September 14, 2021, covering 69 products. The FDA emphasizes that products with a Marketing Denial Order are among their highest enforcement priorities.

Chain Vapez is required to submit a written response within 15 working days detailing actions taken to address the violations, including discontinuing the sale and distribution of the non-compliant products