FDA WARNING_LETTER - MULTIVET USA, Inc.

This FDA Warning Letter to Multivet USA, Inc. concerns the marketing of their product, Gastro37 OTC. The FDA reviewed the firm's website (multivetusa.com) and tested product samples.

The FDA determined that Gastro37 OTC is an unapproved new animal drug, making it unsafe and adulterated. The product is intended for disease mitigation, treatment, or prevention in animals, specifically for "treatment and prevention of equine stomach ulcers" and stating "Omeprazole has been demonstrated to be a potent inhibitor of gastric acid secretion in horses," thus classifying it as a drug under section 201(g)(1)(B) of the FD&C Act. As a new animal drug, it requires an approved new animal drug application, conditional approval, or index listing (sections 512, 571, 572), which Gastro37 OTC lacks. This renders it unsafe under section 512(a)(1) and adulterated under section 501(a)(5) of the FD&C Act.

Furthermore, FDA testing revealed the product's strength differed from its label claim; it was sub-potent at 82.8% of the stated omeprazole potency. This constitutes adulteration under section 501(c) of the FD&C Act.

Multivet USA, Inc. must respond in writing within fifteen working days, outlining corrective actions taken to achieve