Do you have questions about the foods, drugs, and other issues involving your pet?
The Food and Drug Administration’s (FDA) Center for Veterinary Medicine (CVM) may be able to answer them. FDA regulates animal drugs, animal food (including pet food), and medical devices for animals, and conducts research that helps shape regulatory decisions, among other activities.
Below are CVM’s answers to seven questions it often receives from consumers about their pets.
Q: How do I know if a drug I am giving my pet is FDA-approved?
A: Look at the drug's label. All FDA-approved animal drugs have a New Animal Drug Application (NADA) number or, for generic animal drugs, an Abbreviated New Animal Drug Application (ANADA) number. Many drug manufacturers list the six-digit NADA or ANADA number and the statement, “Approved by FDA,” on the drug’s label, although they aren’t required to do so. If you don’t see the NADA or ANADA number on the label, most FDA-approved animal drugs are listed in Animal Drugs@FDA, a searchable online database. There is more detailed information on this subject on FDA’s website.
Q: My pet had a bad reaction to a drug. How do I report this?
A: “If you suspect your animal has had a bad reaction after taking a drug, the first thing to do is to contact your veterinarian immediately,” says FDA veterinarian Carmela Stamper.
FDA also encourages both pet owners and veterinarians to report adverse drug experiences and product failures to the agency. “Data from these reports help FDA to keep tabs on product safety and look into potential drug-related problems. Every report that comes to us is important,” Stamper notes.
There are three ways you can report bad reactions, lack of effectiveness, or other product defects (like broken tablets and leaky dispensers):
1. Call the drug company to report an adverse event for an FDA-approved drug. You can usually find the company’s phone number on the product labeling. Give the reason for your call and ask to speak to a technical services veterinarian.
2. Submit FORM FDA 1932a (download PDF). The Form FDA 1932a is a pre-addressed, prepaid postage form that can be completed and dropped in the mail.
3. Call the Center for Veterinary Medicine: 1-888-FDA-VETS. Leave your name, address, phone number, and the brand name of the drug involved. Ask to have a Form FDA 1932a sent to you or ask for the phone number of the drug company you should call to report the problem. Any report you make to FDA is confidential.
Q: Why do I need a prescription from my veterinarian to purchase pet drugs from an online pet pharmacy?
A. Under the Federal Food Drug and Cosmetic Act, the law which provides much of FDA’s regulatory authority, an online pet pharmacy can’t sell you a veterinary prescription drug without a valid prescription or other type of order from a licensed veterinarian. Prescription drugs are prescription for a reason: They require professional veterinary expertise to diagnose the condition being treated, to monitor the response to treatment, and to monitor the patient for signs of adverse reactions. If the online pet pharmacy tells you that you don’t need a prescription to buy a veterinary prescription drug, it is breaking the law. In that case, you may want to find another online pet pharmacy to use.
Over-the-counter pet medicines do not require a prescription, but make sure to review the label or check the FDA website to ensure they are FDA-approved.
Q: Which products are considered “grooming aids,” and does FDA regulate them?
A: The animal counterpart of a cosmetic is commonly called a "grooming aid" and is not regulated by FDA. These include products solely intended for cleansing or promoting attractiveness of animals, such as a dog or cat shampoo simply used for cleansing. Depending on the product’s claimed intended use, however, the product could be considered an animal drug. For example, if a product is intended for any therapeutic (medical) purpose, such as to control fungal infection or itching caused by allergies, it would be regulated by FDA as a drug.
Q: I suspect my pet had a reaction to a food. How can I report this?
Have information ready such as:
- product name, type of package, lot number, where purchased;
- a description of the problem such as odor, color, foreign object found; and
- a description of your animal, such as weight, age, and breed.
Stamper says that pet treats are also considered pet foods and are regulated by FDA.
Q: I want to make pet treats at home. What should I know?
A: It’s okay to make pet treats at home for your own animal’s use. However, the manufacture and sale of treats—whether at a local market, a farmer’s market, a retail store, or on the internet—are subject to federal, state, and local regulation. You can learn more about requirements for selling pet treats from the Association of American Feed Control Officials (AAFCO).
If you’re making treats for your pets, be aware that certain ingredients may be harmful, Stamper says. According to the American Society of Prevention of Cruelty to Animals (ASPCA), harmful foods may include chocolate, avocado, raw bread dough, alcohol, raisins and grapes, macadamia nuts, onions and garlic.
“Most pet treats are not designed to be nutritionally complete,” Stamper says. “It’s like a person eating a cupcake.”
Q: I’m taking my pet overseas. What do I need to know?
A: Information on taking a pet overseas can be found on the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service website.
If you have other questions regarding your pet, you can ask CVM’s experts by e-mail or telephone: (240) 276-9300.
This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.
December 17, 2014