FDA WARNING_LETTER - Castle Rock Vapor LLC - January 15, 2021

On January 15, 2021, the FDA issued a Warning Letter to William Connolly and Ryan Wunderlich of Castle Rock Vapor, following a review of their website, shop.castlerockvapor.com. The FDA determined that e-liquid products, specifically "Apple Pie" and "Banana Nut Bread," were being manufactured and offered for sale or distribution in the United States without the required marketing authorization.

Under the FD&C Act, these e-liquids are classified as "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007, and lack an FDA marketing authorization order or exemption. This renders the products 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 FDA emphasized that the firm, a registered manufacturer with over 13,100 listed products, is responsible for ensuring compliance with the FD&C Act and FDA regulations. Failure to address these violations may result in regulatory actions, including civil money penalties, seizure, and/or injunction. The company must submit a written response within 15 working days detailing corrective actions, including discontinuation of violative sales and a plan for future compliance.