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U.S. Department of Health and Human Services

Animal & Veterinary

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Ask CVM - May/June 2004

FDA Veterinarian Newsletter May/June 2004 Volume XIX, No 3

Q: We are not comfortable with testing of human and animal pharmaceuticals on animals. It sounds cruel. Can’t the tests be done in other ways that don’t involve animals?

A: At this time, the state of testing technology and the requirements to protect and promote public health require the use of animal testing in some cases. But do not confuse the use of animals for testing products with animal cruelty.

Animal welfare regulations are in place to provide for the humane care and use of animals in research, testing and teaching environments. FDA advocates full observance of all applicable animal welfare regulations and guidelines. Further, all FDA animal care and use programs conform to the stringent standards that the Association for the Assessment and Accreditation of Laboratory Animal Care (AAALAC) uses in its program evaluations. All of FDA’s animal care and use programs have attained and continue to maintain full AAALAC accreditation. AAALAC is an independent peer review organization dedicated to the welfare of animals used in research, teaching and testing.

FDA’s mission is to promote and protect public health by facilitating approval of safe and effective products in a timely manner. Testing pharmaceuticals is essential to protecting the health of humans and animals. It is required under the Federal Food, Drug and Cosmetic Act, which establishes the framework in which FDA fulfills its mission. The Act requires that manufacturers of certain consumer products demonstrate the safety and effectiveness of their products and that the products are properly labeled before the manufacturers can market those products.

FDA regulations describe the type and extent of pre-market safety and effectiveness testing that manufacturers must conduct. Those regulations take into account the applicable legal requirements and the technology available to determine the tests required.
FDA encourages the use of the most reliable scientific evidence in assessing the safety of FDA-regulated products, in part because many of the products are used for children or the elderly. The testing of human products can include chemical and physical studies, non-clinical studies, clinical trials involving humans and animal tests.

The use of animals, which represent intact living systems, is important in the evaluation process for determining the safety and effectiveness of a new drug, biologic or medical device. While many different test methods used in the evaluation process do not involve testing on animals, the toxicological effects of a given drug can best be evaluated in a whole-animal test system. Often a drug may have an effect, good or bad, on an organ system other than the one targeted.

Nonetheless, the use of animals in product safety determinations has been in a steady decline due to advances in science. FDA fully supports the use of alternative methodologies where appropriate, and responsible animal care and use when animal testing is necessary.

Q: Why don’t pet food companies list carbohydrates and calories on their labels? That information would help especially in developing appropriate diets for sick pets.

A: No Federal law or regulation prohibits a company from guaranteeing carbohydrate content, but also no Federal law or regulation requires that they do so.

Some States have adopted AAFCO’s Model Regulation concerning pet food, which allows for guarantees for nonessential nutrients such as carbohydrate, as well as information about calories to be on label.

Keep in mind that, in many cases with sick pets, the consistency of the diet within certain nutrient parameters is more important than just the carbohydrate and caloric content of the product. Consult your veterinarian for advice on nutrient parameters for a pet with an illness.

More information about how FDA regulates pet food may be found of the CVM Website.

Q: I want to buy drugs for my pets from overseas suppliers and bring the drugs into the U.S. Is it legal for me as a citizen to import drugs?

A: Sometimes veterinarians can import animal drugs into the U.S., but only if the drugs are not available in the U.S. But, drugs that have been approved by FDA and are available in the U.S. cannot be imported. The most important reason for this is the safety of your pet. You have no assurances that the drugs manufactured overseas and sold overseas were produced in accordance with FDA requirements.

Q: Do you have a list of discontinued veterinary drugs?

A: No. But our “Green Book,” which is accessible through CVM’s website, contains a list of products voluntarily withdrawn by their sponsors. The list extends back to November 16, 1988. The products are listed in Chapter 6 of the “Greenbook”. (The Greenbook got its name when it was published on paper with green covers.)

Q: Where can I find out about a new tick control medicine I just heard about?

A: You can always check for drug approvals on CVM’s website. Click on the button for the “Greenbook”, which is a database with all drug approvals listed. However, the tick control product you are asking about could be considered a pesticide and fall under the jurisdiction of the Environmental Protection Agency. EPA’s Home Page is: http://www.epa.gov/ . When you get to that page, click on “Pesticides.” Under the “Frequent Questions” section (located at: http://www.epa.gov/pesticides/about/faqs.htm) on the “About Pesticides” page, the site gives the following information:

“If you have questions concerning a specific pesticide product, contact the National Pesticide Information Center (NPIC) either via telephone at 1-800-858-7378, or via e-mail at npic@ace.orst.edu. For more information about NPIC, visit the NPIC Web site, http://npic.orst.edu/.”