Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm422545.htm
Timestamp: 2019-04-20 11:12:00+00:00

Document:
This letter concerns the marketing of several products including, but not limited to, AbGard, Abprazole, Abprazole Plus, Abler Omeprazole, AbButazone, AblerQuant, and AbFen by your firm, Abler, Inc. The U.S. Food and Drug Administration (FDA) reviewed your website at the internet address abler.com, where you promote and sell this product, and obtained and tested samples of your AbGard product.
We have determined that the above referenced products are intended for use in the mitigation, treatment, or prevention of disease in animals, which makes them drugs 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 these drugs are not generally recognized as safe and effective, and are 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 them without approved new animal drug applications. In addition, the drug AbGard 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.
• " ... for treatment and prevention of equine ulcers ... "
• " ... for prevention and treatment of Equine Gastric Ulcers Syndrome ... "
• " ... for the alleviation of inflammation and pain associated with musculoskeletal disorders in adult horses"
• " ... for treatment and prevention of equine worms and parasites . .. "
• " ... to treat parasites that can damage a horse's gastro-intestinal and respiratory tracts."
Because the above referenced products are intended to mitigate, treat, or prevent disease in animals, they are drugs within the meaning of section 201(g)(1)(B) of the FD&C Act [21 U.S.C. § 321(g)(1)(B)]. Further, these products are new animal drugs, as defined by section 201(v) of the FD&C Act [21 U.S.C. § 321(v)], because they are 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.
In addition, testing by FDA of samples of the drug AbGard revealed that the amount of active ingredient (omeprazole) in the drug did not correspond with the amount represented on the labeling. Specifically, the drug was found to be super-potent at 111.3% of the label claim for potency. The drug 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 connect 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.

References: § 321
 § 360
 § 351
 § 351
 § 321
 § 321
 § 351