FDA WARNING_LETTER - Captivape LLC - September 15, 2023

On September 14, 2023, the FDA issued a Warning Letter to Captivape LLC, identifying violations related to the manufacture and distribution of e-liquid products. The FDA determined that Captivape LLC's e-liquid products, specifically "Captivape CREATIONS STRAWBERRY MILK 6MG/ML 60ML," are "new tobacco products" under section 201(rr) of the FD&C Act because they contain nicotine and were not commercially marketed in the U.S. as of February 15, 2007.

The primary violation is that this product lacks the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, the product is deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) because the required notice or information under section 905(j) was not provided. These actions constitute prohibited acts under sections 301(k) and 301(p) of the FD&C Act.

Captivape LLC 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 non-compliant products and outlining a plan for maintaining compliance. Failure to comply may result in regulatory actions such as civil money