FDA issues guidance on therapeutic diets for pets
Posted Oct. 3, 2012
The Food and Drug Administration has issued guidance in response to the increasing number of therapeutic pet diets and increasing marketing of such products directly to pet owners without veterinary direction.
On Sept. 10, the FDA released a draft guide on “Labeling and Marketing of Nutritional Products Intended for Use to Diagnose, Cure, Mitigate, Treat or Prevent Disease in Dogs and Cats.”
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 draft guide lists the factors that the agency will consider in determining whether to take enforcement action against manufacturers of therapeutic diets. The FDA does not generally intend to take action if certain factors are present, including the following:
- Manufacturers make the products available to the public only through veterinarians or through retail or Internet sales to individuals purchasing the product under the direction of a veterinarian.
- Manufacturers do not include indications for a disease claim on the label of the products.
- Manufacturers limit distribution of material with any disease claims for the products only to veterinary professionals.
- Manufacturers make electronic resources for the dissemination of labeling information and promotional materials available only to veterinary professionals.
The FDA is inviting input on the draft guide through Nov. 9. Parties can submit comments by visiting
www.regulations.gov and searching for “690.150.“