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U.S. Department of Health and Human Services

Animal & Veterinary

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CVM Issues Draft Guidance on Raw Meat Diets

by Linda Grassie
FDA Veterinarian Newsletter January/February 2003 Volume XVIII, No 1

FDA's Center for Veterinary Medicine (CVM) has issued for comment a draft guidance for industry entitled "Manufacture and Labeling of Raw Meat Diets for Companion and Captive Noncompanion Carnivores and Omnivores" (Guidance #122). This draft provides specific guidance on the manufacture and labeling of diets that contain raw meat, or other raw animal tissues, for consumption by dogs, cats, other companion or pet animals, and captive noncompanion animal carnivores and omnivores.

Draft Guidance #122 is posted on CVM's Home Page. Single copies of the guidance may be obtained by writing to the FDA Veterinarian.

Please send a self-addressed adhesive label to assist in processing your request.

FDA, and other agencies within the Department of Health and Human Services do not believe raw meat diets are consistent with the goal of protecting the public from significant health risks, particularly when such products are brought into the home and/or used to feed domestic pets.

Diets for carnivorous and omnivorous animals containing raw meat or other raw animal tissues have been on the market for many years for use by zoos, mink farms, dog racing facilities, and other professional establishments. Some of these products may have included meat and other tissues from mammals or poultry that have died other than from slaughter or have otherwise been unfit for human consumption. Products containing such tissues are adulterated under the Federal Food, Drug, and Cosmetic Act (FFDCA). However, a FDA Compliance Policy Guide (CPG 7126.23) stipulates that investigation of such products should only be conducted as a follow-up to complaints or reports of injuries.

FDA presumes that when raw meat or raw animal tissues are purchased and used by zoos, mink farms, dog racing facilities, or other professional establishments, the purchaser is aware of the potential risks of using such products, from both a food safety and nutritional deficiency perspective. FDA also thinks that these purchasers can take measures to mitigate those risks. However, the new trend is toward use of raw meat diets for companion and captive noncompanion animals by owners who may not be as aware of the potential for harm.

Under current law, these products are classified as "foods" and do not require pre-marketing approval or certification. While objective data derived specifically from commercial raw meat pet foods are sparse; the potential for risk to public health from such products is undeniable given the microbiological results from studies of ingredients that could compose such products and the limited sampling of commercial raw pet foods.

Therefore, FDA believes that specific guidance for industry is warranted for how such products could be manufactured and labeled in order to protect pet owners and pets from risks involving food safety and nutritional deficiency.

In addition to bacterial contamination issues, the draft guidance warns about the dangers of dental or gastrointestinal trauma when bone is included in other than ground form. It also recommends measures to minimize contamination and disease transmission through the use of irradiation, proper transport and storage of product by manufacturers, distributors, and retailers; participation in USDA's voluntary inspection program; and the development and implementation of a Hazard Analysis and Critical Control Point program by manufacturers.

This guidance represents the Agency's current thinking on these products. It does not create or confer any rights for or on any person and does not operate to bind the FDA or the public. An alternate approach may be used as long as it satisfies the requirements of applicable statutes and regulations.

Comments and suggestions regarding this document should be sent to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5600 Fishers Lane, Room 1061, Rockville, MD 20852. All comments should be identified with the Docket No. 02D-0468.

Additional information about the guidance may be found in the December 18, 2002, Federal Register, and from Dr. William J. Burkholder, Division of Animal Feeds, (HFV-228), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 301-827-0179 (bburkhol@cvm.fda.gov).

Linda Grassie is Deputy Director of CVM's Communications Staff.