FDA WARNING_LETTER - Veterinary Select Formula dba Allergic Pet - November 12, 2024

On November 12, 2024, the FDA issued a Warning Letter to Adam Gore regarding the marketing of unapproved new animal drugs, Vet Select© Nuroplex Capsules and Vet Select Nuroplex© - 2oz homeopathic Spray, on the website https://www.allergicpet.com/.

The FDA reviewed the website from October to November 2024 and determined that the products are drugs under section 201(g)(1) of the FD&C Act [21 U.S.C. 321(g)(1)] due to claims indicating their intended use for diagnosis, cure, mitigation, treatment, or prevention of disease in animals, or to affect the structure or function of an animal's body. Examples of claims cited include alleviating symptoms of chronic seizures and epilepsy, being a natural alternative to traditional drug therapy, and helping to control and reduce the quantity, duration, and severity of seizures in dogs and cats.

These products are considered new animal drugs under section 201(v) of the FD&C Act [21 U.S.C. 321(v)] because they are not generally recognized as safe and effective by experts. To be legally marketed, new animal drugs require an approved new animal drug application, conditional approval, or index listing under sections 512, 571, and 572 of the FD&C Act. Since