FDA WARNING_LETTER - Horse Gold, Inc

On October 29, 2014, the FDA issued a Warning Letter to Horse Gold, Inc. regarding their product, GastroMax3, marketed on horsegold.com. The FDA determined GastroMax3 is an unapproved new animal drug under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The product is deemed a drug under section 201(g)(1)(B) of the FD&C Act because its website and labeling statements, such as "The ultimate in equine ulcer care" and "prevention it needs against gastric ulcers," indicate intent for use in mitigating, treating, or preventing disease in animals.

GastroMax3 is classified as a new animal drug under section 201(v) of the FD&C Act because it is not generally recognized as safe and effective by qualified experts. Since it lacks an approved new animal drug application, conditional approval, or index listing under sections 512, 571, and 572 of the FD&C Act, it is considered unsafe under section 512(a)(1) and adulterated under section 501(a)(5). Introducing an adulterated drug into interstate commerce is prohibited by section 301(a).

Horse Gold, Inc. must notify the FDA in writing within fifteen working days of receipt of the letter, detailing steps taken to correct these violations. Failure to comply may result