FDA WARNING_LETTER - Emerald's Triangle LLC - February 09, 2022

On February 9, 2022, the FDA issued a Warning Letter to Emerald’s Triangle LLC for manufacturing and distributing an e-liquid product, EMERALD’S Custom Vape Juice STRAWBERRY 6mg, without required premarket authorization. The FDA determined this product is a "new tobacco product" under section 910(a) of the FD&C Act because it was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order or exemption.

This renders the product adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as required information under section 905(j) was not provided. The letter states that manufacturing, selling, or distributing such products is a prohibited act under sections 301(k) and 301(p) of the FD&C Act.

Emerald’s Triangle LLC is a registered manufacturer with over 100 listed products. The FDA emphasizes that all new tobacco products marketed without premarket authorization are unlawful and subject to enforcement actions, including civil money penalties, seizure, and/or injunction. The company must respond within 15 working days, detailing actions taken to address violations, including discontinuing sales/distribution and a plan for future compliance.