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Ask Dr. Dunham: Answers to Some of CVM’s Most Frequently Asked Questions

Posted Dec 16 2010 7:14am

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by Bernadette Dunham, DVM, PhD, Director, Center for Veterinary Medicine, FDA

While CVM’s website is home to tons of information about FDA-regulated animal products, CVM also receives questions from consumers daily, via both e-mail and phone. Each of the questions below is based on several inquiries CVM has received from consumers on the same topic.

A pet store near me is selling baby turtles. Is it true that it’s illegal to sell turtles smaller than 4 inches? Who should I contact to report the pet store?

You are correct. In the United States, it is illegal to sell turtles smaller than 4 inches. FDA enforces the provision of the Public Health Service Act that bans the sale of turtles with shells less than 4 inches long. The ban has been in effect in the United States since 1975 because of public health concerns about the strain of Salmonella found on many turtle shells and in turtle habitats. Please contact your local FDA Consumer Complaint Coordinator to report the pet store.

I read online that a supplement can treat my dog’s illness. Is the supplement safe to give to my pet?

Your veterinarian is the best source of information about your pet’s health. You and your veterinarian should discuss how to best treat your pet for any illness.

If the label on the supplement suggests that the product can “treat” or “prevent” a disease, the manufacturer is making a drug claim and the supplement should be regulated by FDA as an animal drug. If the product is an animal drug but has not been reviewed under FDA’s approval process, it is an unapproved animal drug. Unapproved animal drugs may not meet FDA’s strict standards for safety and effectiveness. With no review by FDA, there is no way for pet owners and veterinarians to know if the supplement is safe or if the claims on the label are true.

Why are prescriptions required for “prescription pet diets”? What makes these products different from regular pet food I can buy in the store?

Prescription pet diets are labeled and marketed with the intent to cure, treat, or prevent disease in animals. Therefore, these diets are considered drugs under the Federal Food, Drug, and Cosmetic Act. Because they are food products, they also meet the definition of a food.

Although prescription pet diets are animal drugs, they have not gone through FDA’s animal drug approval process. This means that the safety and effectiveness of these products for their intended uses have not been evaluated by FDA. FDA asked the manufacturers of prescription pet diets to restrict the sale of these products so that a pet owner must buy the food through a licensed veterinarian with a valid prescription. Requiring a valid prescription and restricting the sale of the food through a licensed veterinarian are safeguards against unintended harmful effects. Because the manufacturer requires a prescription, the food cannot be sold or marketed like the pet food you see in stores.

Prescription pet diets are for individual pets with specific needs. They may not be tolerated by some pets and may not be appropriate if other treatments are being used at the same time. Only your veterinarian can determine the need for a prescription pet diet for your pet and decide which one is most appropriate. Only your veterinarian can properly evaluate your pet’s response to the diet.

Contact CVM with any questions by e-mailing AskCVM@fda.hhs.gov  or calling 240-276-9300.
 

    
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