FDA WARNING_LETTER - White Horse Vapor Store, LLC - April 26, 2022

On April 15, 2022, the FDA issued a Warning Letter to Dino Baccari regarding e-liquid products sold on vapewh.com. The FDA determined that products like "Barney Beats" and "Sea Biscuit" are "new tobacco products" under section 201(rr) of the FD&C Act (21 U.S.C. § 321(rr)) because they were not commercially marketed in the U.S. as of February 15, 2007.

These products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act because they lack the required premarket authorization order under section 910(c)(1)(A)(i) and are not otherwise exempt. The firm's Premarket Tobacco Product Applications (PMTA) STN PM0003879 and PM0003894, covering 13 products, received a Refuse to File determination on March 18, 2022.

The FDA requires a written response within 15 working days detailing actions taken to address violations, including discontinuing the sale and distribution of non-compliant products and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.