FDA WARNING_LETTER - Marlin Steam Co - March 22, 2022

The FDA issued a Warning Letter to Marlin Steam Co., LLC, following a review of their website, marlinsteam.com, which revealed the manufacture and sale of e-liquid products in the U.S. These products, including "Drip Wich Blueberry" and "Drip Wich Strawberry," are deemed "tobacco products" under the FD&C Act.

The core violation is the marketing of "new tobacco products" without the required premarket authorization order, as mandated by section 910(a) of the FD&C Act. These e-liquids were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization, rendering them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

Despite the firm being a registered manufacturer with over 900 products listed and having submitted Premarket Tobacco Product Applications (PMTAs) (e.g., STNs PM0001815 and PM0001822), the FDA issued Marketing Denial Orders for 63 products on September 24, 2021. The letter emphasizes that products with Marketing Denial Orders or no pending applications are high enforcement priorities.

Marlin Steam Co., LLC, is required to submit a written response within 15 working days detailing