FDA Warning Letters for Three Ulcer Products

Companies are believed to be marketing drugs without FDA approval.
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Companies are believed to be marketing drugs without FDA approval.

Three Florida companies marketing products for equine ulcers have been warned by the FDA that they are not in compliance with FDA regulations. The letters were sent to: Horse Gold Inc., Horse Prerace, and Tri-Star Equine Marketing LLC.

Credit: Thinkstock Photo

Credit: Thinkstock Photo

All three companies are alleged to be marketing products as "intended for use in the mitigation, treatment, or prevention of disease in animals." In the FDA's view, this makes these products drugs. Drugs intended for use in animals require an approved new animal drug application, unless they are generally recognized as safe and effective, which the FDA maintains is not the case. The FDA letters can be found here.

One product was cited for not containing the amount of active ingredient the label represented, based on FDA testing of samples.

The companies have 15 business days from the Oct. 29, 2014, date of their warning letters to bring their businesses into compliance with the law.

Note that this does not necessarily mean if you've been using these products that your horse may be harmed. It's simply a warning to these companies that they are promoting their products in ways that fall under the FDA's definition of a drug and, if they intend to do that, they must go through the proper channels by submitting a new animal drug application and await FDA approval. 

Interestingly, the FDA generally considers products that are marketed as drugs to be unsafe until proven safe. However, products marketed as dietary supplements - with no claims that state the product is intended for use "in the mitigation, treatment or prevention of disease" - can be sold until proven unsafe.

Most of us are familiar with the term "nutraceutical," a product that walks on the thin line between drug and supplement. A common nutraceutical is glucosamine. For more information on the definition of a nutraceutical, click here. However, the FDA does not allow statements on nutraceutical products that make them sound like drugs. An excellent resource for further information on the marketing of equine supplement is the National Animal Supplement Council.

Bottom Line: If you've been using these products, we advise you to consult your own veterinarian.