FDA WARNING_LETTER - D&A Distribution, LLC d/b/a Strictly E-cig - October 06, 2023

The FDA issued a Warning Letter to D&A Distribution, LLC d/b/a Strictly E-cig on October 6, 2023, based on a review of inspection records. The company imports and distributes Electronic Nicotine Delivery Systems (ENDS) products, which are classified as tobacco products under the FD&C Act.

The primary violation identified is the marketing of a "new tobacco product," specifically "EB Design BC5000 Disposable Pod Device Lemon Mint 40mg/ml," without the required premarket authorization. This product was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order or exemption.

Consequently, the product is 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). Introducing or delivering adulterated or misbranded tobacco products into interstate commerce, or failing to provide required reports, constitutes prohibited acts under sections 301(a), 301(c), and 301(p) of the FD&C Act.

The FDA requires a written response within 15 working days detailing actions taken to address violations, including discontinuation of violative sales/distribution and a plan for future compliance. Failure to comply may result