FDA WARNING_LETTER - Sparky’s Electronic Cigarettes - April 28, 2025

On April 24, 2025, the FDA's Center for Tobacco Products issued a Warning Letter to Sparky’s Electronic Cigarettes, identifying violations related to the manufacturing, sale, and distribution of e-liquid products in the United States. The FDA determined that Sparky’s e-liquid products, specifically "Yankee," are "new tobacco products" under section 201(rr) of the FD&C Act because they were not commercially marketed in the U.S. as of February 15, 2007, and contain nicotine.

These products are subject to FDA jurisdiction and require premarket authorization under section 910(a) of the FD&C Act. Sparky's products lack the required marketing authorization orders, are not substantially equivalent to a predicate product, and are not exempt. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The FDA requires Sparky’s Electronic Cigarettes to submit a written response within 15 working days detailing actions taken to address these violations, including discontinuing the sale and distribution of non-compliant products and a plan for maintaining compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.