CVM GFI #122 Manufacture and Labeling of Raw Meat Foods for Companion and Captive Noncompanion Carnivores and Omnivores | Guideline Explorer

Description

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.

Scope & Applicability

Product Classes

2

Raw Meat Foods

Guidance for the manufacture and labeling of foods containing raw meat or animal tissues; manufacture and labeling of raw meat diets for companion animals

Raw meat foods for animals

subject of the guidance regarding manufacture and labeling

Stakeholders

3

Companion Carnivores

Target consumer population including dogs and cats

Captive Noncompanion Carnivores

Target consumer population including zoo animals and mink

Manufacturer

Entity responsible for submitting NDINs

Regulatory Context

Attributes

2

Keep Frozen

required storage statement for raw frozen meat products

Nutritional adequacy

requirement for sole source foods

Identified Hazards

Hazards

5

Salmonella spp.

Environmental pathogen linked to low-moisture foods; Pathogen of concern in low-moisture foods; Study evaluated survival of Salmonella on inert contact surfaces.

Escherichia coli

indicator of fecal contamination

Campylobacter spp.

Potential hazard for raw milk and various cheeses

Noroviruses

Viruses estimated to account for the majority of food borne illnesses

Microbial contamination

risk in multidose drug products

Related CFR Sections (2)

21CFR501.4§ 501.4 Animal food; designation of ingredients.
(a) Ingredients required to be declared on the label of a food, including foods that comply with standards of identity that require labeling in compliance with this part 501, except those exempted by § 501.100 , shall be listed by common or usual name in descending order of predominance by weight onRead full regulation →
21CFR102.5§ 102.5 General principles.
(a) The common or usual name of a food, which may be a coined term, shall accurately identify or describe, in as simple and direct terms as possible, the basic nature of the food or its characterizing properties or ingredients. The name shall be uniform among all identical or similar products and maRead full regulation →

Related Warning Letters (10)

CGMP/Food for Animals/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
J.D. Heiskell Holdings LLC
2025-07-08
CGMP/Medicated Feeds/Adulterated
Appleton City Feed Service LLC
2024-04-16
CGMP/Medicated Feeds/Adulterated
Furst-McNess Company
2024-03-19
CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food for Animals (PCAF)/Adulterated
Battle Creek Co-op/CHS, LLC dba Progressive Nutrition
2024-02-13
CGMP/Medicated Feeds/Adulterated
Nutra Blend, LLC subsidiary of Land O’Lakes
2023-12-12
CGMP/Medicated Feeds/Adulterated
Suther Feeds, Inc.
2023-10-24
CGMP/Medicated Feeds/Adulterated
Land View, Inc.
2022-12-27
CGMP/Medicated Feeds/Adulterated
CHS Inc./CHS River Plains
2022-12-20
CGMP/Medicated Feeds/Adulterated
Effingham Equity
2022-11-22
Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Chaur Fong Inc. dba 888 Food Company
2022-09-13