The Food and Drug Administration issued letters to a trio of Florida-based companies associated with products the agency claims have been wrongly branded as supplements. The warning letters were issued to the heads of HorsePreRace.com, Horse Gold, Inc., and Tri-Star Equine on Oct. 29. HorsePreRace.com is accused of marketing a number of products as supplements when they are in fact “intended for use in the mitigation, treatment, or prevention of disease in animals, which makes them drugs” per federal regulation.
The product list includes, but is not limited to: Omeprazole Oral Paste, Omeprazole/Ranitidine Oral Paste, Gastrotec, Gastromax3, Flunixin, Synedem, Toltrazuril Paste, and Super Tie Up. The difference in classification as “drugs” rather than supplements would require the makers of the substances to complete a new animal drug application unless they are “generally recognized as safe and effective”. The FDA's warning letter informs HorsePreRace.com's Simon Jones that it does not consider these substances to be safe and effective, and that instead the lack of compliance with FDA makes them “unsafe” and “adulterated.”
Dr. Scott Mangini of Horse Gold, Inc., which markets GastroMax3, received a similarly-worded letter regarding that product, which is promoted as “the ultimate in equine ulcer care.” A similar letter also went to Jerry and Harry Glantz of Tri-Star Equine Marketing, LLC regarding Gastrotec. According to promotional language used for Gastrotec, it is “for the care of gastric and colonic ulcers in horses.”
Neither GastroMax3 nor Gastrotec were listed as available for sale on HorsePreRace.com as of Tuesday evening, although they were available elsewhere on the internet. The other HorsePreRace.com products named in the letter to Jones were still available for purchase.
Further, the letter to Jones stated that the FDA had obtained samples of the company's Omeprazole Oral Paste, which is designed to alleviate symptoms associated with gastric ulcers. The amount of the active ingredient (omeprazole) detected in the samples was less than that claimed on the product's label–just 68.1 percent of the label claim, to be exact–which also puts it in violation of federal law.
The product descriptions of the aforementioned drugs available on HorsePreRace.com do not state that a prescription is required to purchase, nor do they encourage purchasers to have veterinarians administer the products, some of which are available as injectables.
All recipients of the letters are informed they have 15 business days to notify the Florida District of the FDA about steps in progress to comply with the laws in question.
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