FDA WARNING_LETTER - Nicoticket LLC - March 30, 2021

The FDA issued a Warning Letter to Nicoticket.com on March 26, 2021, following a review of their website, which revealed the manufacture and sale of e-liquid products in the U.S. These products, including "Nicoticket Wakonda" and "Nicoticket The Virus," are classified as tobacco products under the FD&C Act.

The primary violation is the marketing of "new tobacco products" without the required premarket authorization order from the FDA. These e-liquids were not commercially marketed in the U.S. as of February 15, 2007, and lack the necessary FDA marketing authorization or exemption. Consequently, these products are deemed 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 6,800 listed products to ensure compliance with the FD&C Act and FDA regulations. Failure to address these violations may result in regulatory actions such as civil money penalties, seizure, or injunction. The company must submit a written response within 15 working days detailing actions taken to address the violations, including discontinuing the sale and distribution of non-compliant products and outlining a plan for future compliance.