Three Florida-based companies have found themselves in hot water with the U.S. Food and Drug Administration (FDA) over claims that some of their products being marketed as supplements are actually drugs, as defined by the Federal Food, Drug, and Cosmetic Act.
Warning letters were sent to HorsePreRace.com, Horse Gold, Inc. and Tri-Star Equine on October 29, 2014, giving the companies 15 days to respond in writing regarding they ways in which they plan to correct the issues and move into compliance with federal regulations.
Each letter notes that certain products advertised by the companies as supplements are actually drugs because they are “intended for use in the mitigation, treatment, or prevention of disease in animals” and, as such, require approved new animal drug applications.
True supplements are defined as being “generally recognized as safe and effective,” which the FDA does not consider these products to be.
HorsePreRace.com’s offending 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. Horse Gold, Inc.’s letter targeted GastroMax3 and Tri-Star Equine Marketing, LLC’s was regarding Gastrotec – both marketed as ulcer care products by the companies.
Read the letters below for more information: