FDA WARNING_LETTER - Boardwalk Elixir - August 11, 2022

On August 11, 2022, the FDA issued a Warning Letter to Boardwalk Elixir for manufacturing and distributing e-liquid products, specifically "BE SELECT BREAKFAST CLUB F. Loops 3MG e-liquid," without required marketing authorization. The FDA determined these products are "new tobacco products" under section 201(rr) of the FD&C Act, as they were not commercially marketed in the U.S. as of February 15, 2007, and contain nicotine from any source, making them subject to FDA jurisdiction.

The identified violations include the sale and distribution of the e-liquid product without a premarket authorization order, rendering it adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. The failure to provide a required report under section 905(j) is also cited as a prohibited act.

Boardwalk Elixir 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 and outlining a plan for maintaining compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.