FDA WARNING_LETTER - Kidney Puncher LLC - March 30, 2021

The FDA issued a Warning Letter to Craig Larsen, owner of kidneypuncher.com, on March 26, 2021, following a review of their website. The FDA determined that e-liquid products manufactured and sold by the company are "tobacco products" under the FD&C Act, making them subject to FDA jurisdiction and regulations.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. Specifically, the e-liquid products "Formal – Rockstar Breakfast," "KP Blue Brew," and "Potion Seller – Crimson Monk" were found to be new tobacco products not commercially marketed in the U.S. as of February 15, 2007, and lacking FDA marketing authorization. This renders them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The letter emphasizes the firm's responsibility, as a registered manufacturer with over 1,000 listed products, to ensure compliance with the FD&C Act and FDA regulations. Failure to address these violations could lead to civil money penalties, seizure, and/or injunction. The company 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 the non-compliant products and outlining a plan for maintaining compliance.