FDA releases guidance on therapeutic diets

April 29, 2016

Document outlines criteria agency staff will use to determine if enforcement action on sales of therapeutic diets by pet stores and online retailers is needed.

The U.S. Food and Drug Administration (FDA) has released a Compliance Policy Guide (CPG) that details the criteria the agency will use when determining whether or not to take enforcement action in regards to pet food intended to treat a disease, according to an agency release.

The CPG, titled “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 on the labeling and marketing of these diets in certain circumstances. It also overviews the factors the agency will consider when determining if it will initiate enforcement action if the diet is sold or marketed inappropriately, the release states.

The agency notes that diets labeled with therapeutic claims are formulated to address specific diseases, such as urinary tract disease in cats. These diets have been sold through, and used with the guidance of, licensed veterinarians. However, the FDA has seen an increase in the marketing of these diets directly to pet owners in pet stores and online. This shift concerns the FDA, because the diets are intended for specific health needs and may not be suitable for all pets, it says.  

The FDA recommends that pet diets labeled with therapeutic claims should be available only through a licensed veterinarian or retailers and Internet vendors under the direction of a veterinarian, with comprehensive labelling information and other manufacturer communication available only through veterinarians.

The CPG states that in general, FDA's guidance documents do not establish legally enforceable responsibilities. Instead, they describe the agency's current thinking on various topics and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word “should” in agency guidance documents means that something is suggested or recommended, but not required.