FDA WARNING_LETTER - E-Smoke Ireland - June 13, 2023

On May 25, 2023, the FDA issued a Warning Letter to Paul Nevin and Sabrina McGonigle of e-smokeireland.com, following a review of their website. The FDA determined that e-liquid products, specifically Wingnuts Mango Melon Kool and Wingnuts Vampire Kiss, were offered for sale and distributed to customers in the United States. These products are classified as tobacco products under section 201(rr) of the FD&C Act and are subject to FDA jurisdiction.

The primary violation identified was the sale of these e-liquid products to an individual under 21 years of age, which constitutes misbranding under section 903(a)(7)(B) of the FD&C Act, as it violates section 906(d)(5) prohibiting sales to persons under 21.

The FDA requires the company to ensure all tobacco products, labeling, and advertising comply with the FD&C Act and FDA regulations. Failure to address these violations may result in regulatory actions, including civil money penalties, seizure, or injunction. The letter also noted that "new tobacco products" require premarket authorization.

The company must submit a written response within 15 working days detailing actions taken to address the violations, including dates of discontinued sales and a plan for maintaining compliance. The reference number for the response is RW2301923.