The US Food and Drug Administration Center for Veterinary Medicine recently published statements from CVM Director Dr. Bernadette Dunham that caused enough confusion for the comments to be pulled from the December 15 issue of the Federal Veterinarian.
The confusion came when Dunham addressed the serious nature of therapeutic diets, noting in a Q&A session that petfoods branded as "prescription" or "therapeutic" truly need to come out of a veterinarian's office, released by prescription. “Requiring a valid prescription and restricting the sale of the food through a licensed veterinarian are safeguards against unintended harmful effects," she said. "Because the manufacturer requires a prescription, the food cannot be sold or marketed like the petfood you see in stores.” That statement struck many veterinarians as contrary to their belief that the agency's regulatory purview did not extend beyond legend drugs to include petfoods. It also raised questions concerning whether veterinarians should continue to apply sales tax to therapeutic diets in states that exempt prescription medications.
The confusion incited discussion throughout the veterinary profession, leading Federal Veterinarian to truncate the published responses in the Q&A. "In our attempt to clarify our regulatory authority with regard to therapeutic diets, we unfortunately (and unnecessarily) caused confusion ...," said Laura Alvey, FDA-CVM spokeswoman. "We are looking at ways to provide clearer information."