The U.S. Food and Drug Administration sent a warning letter to an online veterinary company for its marketing of new equine drugs that are unapproved. The FDA is warning the Australia based Ceva Animal Health Pty Ltd. regarding several products under the Nature Vet brand name.
Included are the products Omoguard Paste, Thiazine 100 Injection, Glucosamine 200 Injection, Gentamax 100 Injection, and Ferrocyl Injection.
The products are sold on the website horsemedsonline.com.
According to the FDA, the referenced products are only a “sampling of the violative products” the company is marketing to the public.
The company is accused by the government agency of marketing the gastric ulcer product, sedative, anti-inflammatory, and the other products as “intended for the use in the mitigation,
treatment, or prevention of disease in animals,” which under the law makes their products
drugs. The drugs are not FDA approved, a violation of Section 501 and 512 the FD&C Act.
The drugs are also considered new as well by the agency as defined under section 201 of the FD&C Act. The drugs are “not generally recognized among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling,” according to the FDA.
To be legally marketed, a new animal drug must have an approved new animal drug application, conditionally approved new animal drug application, or index listing.
The company has 15 days to respond regarding its compliance status. Click here to view the warning letter.