This letter concerns your marketing of the product UlcerCure OTC. The U.S. Food and Drug Administration (FDA) reviewed your website at the internet address Ulcercureotc.com, where you promote and sell this product, and obtained and tested samples of your product.
We have determined that UlcerCure OTC is intended for use in the mitigation, treatment, or prevention of disease in animals, which makes it a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) [21 U.S.C. § 321(g)(1)(B)]. Under the FD&C Act, drugs intended for use in animals require an approved new animal drug application unless they are generally recognized as safe and effective. As discussed below, we have determined that your drug is not generally recognized as safe and effective, and is therefore unsafe under section 512(a)(1) of the FD&C Act [21 U.S.C. § 360b(a)], and adulterated under section 501(a)(5) of the FD&C Act [21 U.S.C. § 351(a)(5)], because you are marketing it without an approved new animal drug application. In addition, the drug is adulterated under section 501(c) of the FD&C Act [21 U.S.C. § 351(c)], as testing of the drug revealed that its strength differs from the strength stated on the label.
Statements on your website and product labeling that show the product is intended for use in the mitigation, treatment or prevention of disease in animals include, but are not limited to, the following:
“UlcerCure OTC will treat your horse for ulcers for 28 days or 90-120 days for maintenance using the l0 cc scoop.”
“The most effective treatment for gastric ulcers in horses is omerprazole. Each 20cc dose of UlcerCure OTC contains 2.28 grams of buffered omerprazole.”
“UlcerCure OTC is an affordable solution for treating the ulcers your equine partner is suffering from.”
Because UlcerCure OTC is intended to mitigate, treat, or prevent disease in animals, it is a drug within the meaning of section 201(g)(1)(B) of the FD&C Act [21 U.S.C. § 321(g)(1)(B)]. Further, this product is a new animal drug, as defined by section 201(v) of the FD&C Act [21 U.S.C. § 321(v)], because it is not generally recognized among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling.
To be legally marketed, a new animal drug must have an approved new animal drug application, conditionally approved new animal drug application, or index listing under sections 512, 571, and 572 of the FD&C Act [21 U.S.C. §§ 360b, 360ccc, and 360ccc-1]. UlcerCure OTC is not approved or index listed by the FDA, and therefore the product is considered unsafe under section 512(a)(1) of the FD&C Act [21 U.S.C. § 360b(a)], and adulterated under section 501(a)(5) of the FD&C Act [21 U.S.C. § 351(a)(5)]. Introduction of an adulterated drug into interstate commerce is prohibited under section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].
In addition, testing by FDA of samples of your product revealed that the amount of active ingredient in your product (omeprazole) did not correspond with the amount represented on the labeling. Specifically, your product was found to be super-potent at 135.0% of the label claim for potency. Your product is therefore adulterated under section 501(c) of the FD&C Act [21 U.S.C. § 351(c)], in that its strength differs from that which it purports or is represented to possess.
This letter is not intended to be an all-inclusive review of your products and their promotion. It is your responsibility to ensure that all of your products are in compliance with the Act and its implementing regulations. Failure to promptly correct the violations specified above may result in enforcement action without further notice. Enforcement action may include seizure of violative products and/or injunction against the manufacturers and distributors of violative products.
You should notify this office, in writing, within fifteen (15) working days of the receipt of this letter of the steps you have taken to bring your firm into compliance with the law. Your response should include any documentation necessary to show that correction has been achieved. If corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and the date by which the corrections will be completed. Include copies of any available documentation demonstrating that corrections have been made.
Please direct your response to the U.S. Food and Drug Administration, Denver District Office, Denver Federal Center, Building 20, 6th Avenue & Kipling Street, PO Box 25087, Denver, CO 80225-0087, Attn: Sarah A. Della Fave, Compliance Officer.