FDA WARNING_LETTER - Flea Assassin, LLC - March 19, 2019

On March 7, 2019, the FDA issued a Warning Letter to Flea Assassin, LLC, regarding their veterinary products, Flea Assassin Nitenpyram and Flea Assassin Lufenuron, marketed for disease treatment in dogs and cats. The FDA reviewed the firm's website, www.fleaassassin.com, and determined these products are intended for mitigating, treating, or preventing diseases in animals, classifying them as drugs under section 201(g)(1)(B) of the FD&C Act.

The products are considered "new animal drugs" under section 201(v) because they are not generally recognized as safe and effective. They lack an approved new animal drug application, conditionally approved application, or index listing under sections 512, 571, and 572, rendering them unsafe per section 512(a) and adulterated under section 501(a)(5) of the FD&C Act.

Flea Assassin, LLC, must notify the FDA within fifteen working days of receipt of the letter, detailing steps taken for compliance, including documentation. Failure to correct violations may result in enforcement actions like product seizure or injunction.