FDA WARNING_LETTER - Flawless Labs, Inc. d/b/a Flawless Vape Shop - September 07, 2021

The FDA Center for Tobacco Products issued a Warning Letter to Flawless Vape Shop on August 27, 2021, following a review of their website, https://www.flawlessvapeshop.com. The FDA determined that the company manufactures and offers e-liquid products for sale or distribution in the U.S. that are considered "new tobacco products" under the FD&C Act.

Specifically, the e-liquid products "The Merge – Transmission" and "Rype – Mixed Berries Salts" were identified as new tobacco products because they were not commercially marketed in the U.S. as of February 15, 2007. These products lack the required FDA marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act and are not otherwise exempt. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as no required notice or information was provided under section 905(j).

The letter emphasizes the firm's responsibility, as a registered manufacturer with over 2,300 listed products, to ensure compliance with the FD&C Act and FDA regulations for all tobacco products, labeling, and advertising. Failure to address these violations may result in regulatory actions, including civil money penalties, no-tob