FDA WARNING_LETTER - HorsePreRace

On October 29, 2014, the FDA issued a Warning Letter to Mr. Simon Jones of Horse PreRace regarding the marketing and sale of several products, including Omeprazole Oral Paste, Omeprazole/Ranitidine Oral Paste, Gastrotec, Gastromax3, Flunixin, Synedem, Toltrazuril Paste, and Super Tie Up, on horseprerace.com.

The FDA determined these products are intended for use in the mitigation, treatment, or prevention of disease in animals, classifying them as drugs under section 201(g)(1)(B) of the FD&C Act. These drugs are considered "new animal drugs" under section 201(v) because they are not generally recognized as safe and effective. Consequently, they are deemed unsafe under section 512(a)(1) and adulterated under section 501(a)(5) of the FD&C Act, as they lack required FDA approval, conditional approval, or index listing.

Furthermore, FDA testing of Omeprazole Oral Paste revealed it was sub-potent, containing only 68.1% of the stated omeprazole strength, rendering it adulterated under section 501(c) of the FD&C Act. The letter cites specific product claims from the website and labeling as evidence of intended use.

Horse PreRace must notify the FDA within fifteen working days