FDA WARNING_LETTER - Catnip Cocktail - April 09, 2019

The FDA issued a Warning Letter to Mr. David Bunata regarding the veterinary product "Catnip Cocktail," marketed for dogs and cats. The FDA reviewed the product's websites, www.buycatnipcocktail.com and www.catnipcocktail.com, and its label.

The product is marketed with claims such as "The ultimate mood enhancer," "Helpful pain relieving properties," and "anxiety relief," with the label specifically stating, "This product is intended solely for the treatment of anxiety in cats and dogs." Based on these intended uses, the FDA determined "Catnip Cocktail" is a drug under section 201(g)(1) of the FD&C Act [21 U.S.C. § 321(g)(1)].

Furthermore, it is classified as a new animal drug under section 201(v) of the FD&C Act [21 U.S.C. § 321(v)] because its safety and effectiveness are not generally recognized by experts. The product lacks an approved new animal drug application, conditionally approved new animal drug application, or index listing under sections 512, 571, and 572 of the FD&C Act [21 U.S.C. §§ 360b, 360ccc, and 360ccc-1].

Consequently, "Catnip Cocktail" is