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Regulatory News | 11 November 2014 | By Alexander Gaffney, RAC
For the second time in as many weeks, the US Food and Drug Administration (FDA) is warning marketers of veterinary products, saying several are promoting their equine ulcer drugs without first having obtained FDA approval.
Last week FDA sent three Warning Letters (1, 2, 3), all to marketers of equine ulcer drugs, saying their products had been promoted in ways that caused them to be "intended for use in the mitigation, treatment or prevention of disease in animals."
As with their human equivalents, marketing veterinary products in this way causes them to fall under the Federal Food, Drug and Cosmetic Act (FD&C Act) and to be defined as drug products requiring FDA to approve them before they can be marketed.
Now FDA has sent Warning Letters to four more companies, again for marketing drugs intended to treat equine ulcers—a common ailment in horses, and especially racehorses.
In its four letters—to GenericFrontlinePlus.com, Abler Inc., Multivet USA, and Cox Veterinary Laboratory—FDA accuses the companies are marketing their products without first having obtained FDA approval, a violation of Section 501 and 512 the FD&C Act.
By failing to obtain proper regulatory approval from FDA, the companies' drugs were both adulterated (Section 501(a)(5)) and found to be "unsafe" (Section 512(a)(1)) under federal law.
In addition, three of the company's drugs were found to have potency problems. FDA testing found two (1, 2) to be "sub-potent," meaning their products did not contain as much of the active ingredient as advertised, while another company's product was "super-potent," meaning the drug contained more of the active ingredient than claimed on the label.
All four companies were ordered to immediately comply with FDA's Warning Letters and respond to FDA within 15 days regarding the status of their compliance.
Tags: Veterinary, Equine Ulcer, Horse, Horses, Warning Letter