June 15, 2016

 

 FDA finalizes guidance on therapeutic pet food

​Posted June 1, 2016

The Food and Drug Administration has finalized guidance that the agency drafted in response to the increasing number of therapeutic pet diets and increasing marketing of such products directly to pet owners without veterinary direction.

On April 29, the FDA released the guide on “Labeling and Marketing of Dog and Cat Food Diets Intended to Diagnose, Cure, Mitigate, Treat, or Prevent Diseases.”

The FDA considers such products to be drugs as well as food, but most have not gone through the agency’s drug approval process. In the past, FDA generally exercised enforcement discretion with regard to these products.

The guide lists the factors that the agency will consider in determining whether to take enforcement action against manufacturers of therapeutic diets. The FDA is less likely to initiate action if certain factors are present, including the following:

  • The product is made available to the public only through licensed veterinarians or through retail or Internet sales to individuals purchasing the product under the direction of a veterinarian.
  • The product label does not include representations that it can be used to treat or prevent disease (e.g., obesity, renal failure).
  • Distribution of labeling and other manufacturer communications that contain representations that the product is intended for treatment or prevention of disease is limited so that it is provided only to veterinary professionals.
  • Electronic resources for the dissemination of labeling information and other manufacturer communications related to the intended use of the product are secured so that they are available only to veterinary professionals.  

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