FDA WARNING_LETTER - Broken Coil - August 17, 2021

The FDA issued a Warning Letter to Broken Coil, an e-liquid manufacturer and distributor, following a review of submissions and inspection records. The FDA determined that Broken Coil's e-liquid products are tobacco products under section 201(rr) of the FD&C Act and are subject to FDA jurisdiction.

The primary violation identified is the manufacturing, sale, and/or distribution of the "Broken Coil Vape Lounge World Star 6mg 50ml" e-liquid product without required premarket marketing authorization. This product is deemed a "new tobacco product" because it 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 adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the lack of required notice or information under section 905(j). Prohibited acts include holding for sale an adulterated or misbranded product (section 301(k)) and failing to provide a required report (section 301(p)).

Broken Coil, a registered manufacturer with over 3,100 listed products, is responsible for ensuring compliance. Failure to address these violations may result in regulatory actions such as civil money penalties, seizure, and/or injunction. The FDA requires a written