FDA WARNING_LETTER - Abler Inc

The FDA issued a Warning Letter to Abler, Inc. concerning the marketing of several animal products, including AbGard, Abprazole, Abprazole Plus, Abler Omeprazole, AbButazone, AblerQuant, and AbFen. The FDA reviewed the firm's website (abler.com) and tested samples of AbGard.

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. Specific claims cited include "treatment and prevention of equine ulcers" for AbGard, Abprazole, Abprazole Plus, and Abler Omeprazole; "alleviation of inflammation and pain" for AbButazone; and "treatment and prevention of equine worms and parasites" or "treat parasites" for AblerQuant and AbFen.

These products are considered "new animal drugs" under section 201(v) of the FD&C Act because they are not generally recognized as safe and effective. They lack approved new animal drug applications, conditional approvals, or index listings, making them unsafe under section 512(a)(1) and adulterated under section 501(a)(5) of the FD&C Act.

Furthermore, FDA testing of AbGard revealed it was super-potent at 111.3% of the label claim