FDA finalizes therapeutic vet diet compliance guide
Guide explains criteria the agency will consider when determining whether to take enforcement action
The US Food and Drug Administration has released a Compliance Policy Guide (CPG) that explains the criteria FDA will consider when determining whether to take enforcement action regarding dog and cat food diets intended to treat a disease.
The CPG, “Labeling and Marketing of Dog and Cat Food Diets Intended to Diagnose, Cure, Mitigate, Treat, or Prevent Diseases,” explains to FDA staff and industry that the agency intends to exercise enforcement discretion over the labeling and marketing of these diets under certain circumstances. The CPG also sets out the factors FDA will consider when determining whether or not to initiate enforcement action if the diets are sold or marketed inappropriately.
Pet food diets labeled with therapeutic claims are specially formulated to address specific diseases (for example, urinary tract disease in cats). In the past, these diets were sold through and used under the direction of licensed veterinarians. However, FDA has observed an increase in marketing of these diets directly to pet owners over the internet and in retail stores. This shift toward direct marketing, without veterinary direction or involvement, concerns FDA because these diets are formulated for specific health needs and may not be suitable for all pets.
In the interest of animal safety, dog and cat food diets labeled with therapeutic claims (e.g., renal failure, diabetes) should be available only through licensed veterinarians or through retailers and internet sellers under the direction of a veterinarian. In addition, comprehensive labeling information and other manufacturer communications for these diets should be made available only through licensed veterinarians.