FDA issues warning letter to company marketing unapproved canine cancer drugs

In late October, the FDA notified CanineCare.us, LLC, based in Collegeville, Pa., that the company was marketing unapproved new animal drugs in violation of the law.

The warning letter sent to CanineCare.us, LLC, said the agency had visited the company's website and reviewed product labeling for Tumexal Capsules, Tumexal Liquid, and Tumexal Transdermal - products marketed as treatments for canine cancer.  

According to the FDA, its review of the marketing materials offered by CanineCare.us, LLC, turned up multiple statements that have not been evaluated by the FDA, including:

  • "... TumexalTM is effective against a wide array of canine cancers."
  • "In fact, TumexalTM will almost always restore a cancer-stricken dog's appetite, spirit and energy!"
  • "TumexalTM blocks canine cancer growth by restoring the activity of the p53 tumor suppressor pathway."

Those statements and others indicated that the products are intended for use in the mitigation, treatment, or prevention of disease in animals, despite not being approved or listed by the FDA, the agency said.

The FDA indicated in the warning letter that CanineCare.us, LLC, would face enforcement actions including seizure of violative products and/or injunctions against the products' manufacturers and distributors if the company fails to promptly correct the violations.

The company was given 15 days after receipt of the warning letter to notify the FDA that it brought its company into compliance with the law.

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