FDA WARNING_LETTER - Douglas J Gordon

The FDA issued a Warning Letter to Mr. Douglas J. Gordon concerning the product UlcerCure OTC, marketed on Ulcercureotc.com. The FDA determined UlcerCure OTC is an unapproved new animal drug under the Federal Food, Drug, and Cosmetic Act (FD&C Act), intended for disease mitigation, treatment, or prevention in animals.

Violations include marketing UlcerCure OTC without an approved new animal drug application, rendering it unsafe under section 512(a)(1) and adulterated under section 501(a)(5) of the FD&C Act. The product is not generally recognized as safe and effective. Furthermore, FDA testing revealed the product's strength differed from its label claim, specifically being 135.0% super-potent for omeprazole, making it adulterated under section 501(c) of the FD&C Act.

The letter cites website statements like "UlcerCure OTC will treat your horse for ulcers" and "Each 20cc dose of UlcerCure OTC contains 2.28 grams of buffered omerprazole" as evidence of drug intent.

Mr. Gordon must notify the FDA within fifteen working days of steps taken to correct these violations. Failure to comply may result in enforcement actions, including product seizure and injunctions.