FDA WARNING_LETTER - Ceva Animal Health Pty Ltd

The FDA issued a Warning Letter to Ceva Animal Health Pty Ltd regarding the marketing of several Nature Vet brand products, including Omoguard Paste, Thiazine 100 Injection, Glucosamine 200 Injection, Gentamax 100 Injection, and Ferrocyl Injection, promoted on horsemedsonline.com.

The FDA determined these products are unapproved new animal drugs under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Violations stem from product claims on the website and labeling indicating intended use for disease mitigation, treatment, or prevention, and/or affecting animal body structure/function. Examples include Omoguard Paste for gastric ulcers, Thiazine 100 Injection as a sedative/analgesic, Glucosamine 200 Injection as an anti-inflammatory, Gentamax 100 Injection as a broad-spectrum antibiotic, and Ferrocyl Injection for anemias.

These products are considered "new animal drugs" because they are not generally recognized as safe and effective. Without an approved new animal drug application, conditionally approved application, or index listing, they are deemed unsafe under section 512(a)(1) and adulterated under section 501(a)(5) of the FD&C Act. Introducing adulterated drugs into interstate commerce is prohibited under section 301(a).

Ceva Animal Health Pty Ltd must notify the FDA in writing within fifteen