I. Background
Foods 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 tissues from animals
that have died other than by slaughter are adulterated under Section 402(a) of the Federal Food, Drug, and
Cosmetic Act (FFDCA) and animal tissues otherwise unfit for human consumption may be adulterated if not further
processed to remove pathogenic contaminants.
Previously it was presumed that raw meat or raw animal tissues were primarily purchased and used by zoos, mink
farms, dog racing facilities, or other professional establishments, and that these entities were aware of the potential
risks of using such products, from both a food safety and nutritional deficiency perspective, and could take
measures to mitigate those risks. However, an increasing trend is for use of raw meat foods for companion and
captive noncompanion animals by owners who may not be as aware of the potential for harm. FDA is issuing this
guidance because of the health risks and potential for adulteration including, but not limited to, when raw meat
foods are used by pet owners.
FDA does not believe raw meat foods for animals 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. Objective data derived specifically from commercial raw meat pet foods are sparse for quantifying the
magnitude of risk to human and animal health from such products. Therefore, CVM also reviewed data on the risks
to humans, both from food-borne pathogens in general and from food-borne pathogens relating to raw foods for
humans. These data are relevant because people are exposed to food borne pathogens in animal feed when they
come in contact with that feed, and animals, in general, are affected by pathogens in the same manner as people.
Based on these data, CVM believes the risk to public health from feeding raw meat products to animals warrants
taking the precautionary measures described in this guidance.
* This guidance has been prepared by the Office of Surveillance and Compliance in the Center for Veterinary
Medicine, Food and Drug Administration.
The Centers for Disease Control and Prevention has estimated that known food borne pathogens account for 14
million illnesses, 60,000 hospitalizations and 1,800 deaths to humans in the United States each year.1 Total food
borne illness from both known and unknown pathogens is likely to be responsible for 76 million cases, 325,000
hospitalizations and 5,000 deaths annually.1 Although Salmonella spp. and Escherichia coli, are often thought of
as causes of food borne illness, likely because of their propensity to cause severe disease, current data indicate
viruses, particularly Noroviruses (Norwalk-like viruses), are estimated to account for two-thirds (67%) of all food
borne illnesses.1,2 Known pathogenic bacteria account for 30% of food borne illnesses, with Campylobacter spp.,
frequently associated with poultry, being responsible for the majority of the bacterial cases of food borne illness.
Three percent of the total cases of food borne illness are caused by parasites.1,2 In looking specifically at deaths,
the percentages are much different. Seventy-two percent of the deaths from food borne illness are attributable to
bacteria, 21% to parasites and 7% to viruses.1 The estimated annual cost of food borne illness has been placed in
the range of 6.5 to 34.9 billion 1995 U.S. dollars.3 The scientific literature indicates that the very young (infants and
children), the elderly, the immuno-compromised, and pregnant women are the members of the population at
greatest risk for contracting, and being more severely affected by, food borne illnesses.4,5
The prevalence of pathogenic bacterial contaminants in raw meat and poultry products sold for human
consumption varies greatly, from less than 1 percent to 100 percent, depending on the specific microbial
contaminant, the species of animal used to produce the raw product, the degree to which the raw product has been
processed, the number of times the product has been handled, the facility producing the product, and the methods
used to sample the product and identify the specific microbial contaminant.6-12 Overall prevalence of 10 to 20% is
frequently observed for raw human edible products being contaminated with Campylobacter, Escherichia coli or
Salmonella species,8,9 with products that undergo multiple steps in processing and handling tending to be
contaminated more frequently.6
In looking at data relating to raw foods for animal consumption, two studies are particularly relevant. One study of
112 samples of raw meat diets manufactured for racing greyhounds isolated Salmonella spp. from 50 of the
samples (45%) and determined 70 of 106 samples (66%) to be positive for Salmonella spp. by DNA probe analysis.
13 Another study that cultured 10 raw meat diets based on chicken determined 8 diets (80%) to be contaminated
with Salmonella spp.14
There are published reports of gastroenteritis and death to animals from eating contaminated raw meat foods,15-
17 and the scientific literature makes it readily apparent that instances of food borne illness in people, from food for
human and animal consumption, are underreported and often not associated with the source of infection.1 In
addition to infection by pathogenic organisms from direct contact with the diet itself, there are also reports of the
same pathogens isolated from raw diets fed to dogs being found in the dog’s feces 14,15 and passage of those
organisms to people that have become ill.18,19 Thus, the scientific literature indicates that feeding raw meat
products carries a risk to human and animal health that is significant given the microbiological results from studies
of ingredients that could compose such products and the limited sampling of commercial raw pet foods themselves.
Therefore, for firms choosing to manufacture and market raw meat and raw animal tissue products for animal food,
more specific guidance is warranted for how such products could be manufactured and labeled in order to protect
animals and people coming in contact with the animals and the animal’s food from risks involving food safety. This
guidance also addresses other risks posed by raw diets, such as nutritional deficiency, and is designed to help
ensure compliance with other aspects of the law administered by FDA. The guidance is especially warranted since
these products are foods that do not require pre-marketing approval or certification under current United States
laws.
From US Food and Drug Administration's Guideline 122