What We Regulate
The Food and Drug Administration is responsible for regulating animal drugs, feeds/foods, devices, and most animal health products; however some classes of animal products come under the jurisdiction of other Federal or State government agencies. This is a quick guide to clarify which agency has responsibility for these products.
EPA and the states (usually the State Department of Agriculture) register or license pesticides for use in the United States. In addition, anyone planning to import pesticides for use in the U.S. must notify EPA. EPA receives its authority to register pesticides under the Federal Insecticie, Fungicide, and Rodenticide Act (FIFRA).
Information about EPA pesticide programs may be found on their website at: http://www.epa.gov/pesticides/.
The term “veterinary biologics” includes all viruses, serums, toxins, or analogous products of natural or synthetic origin which are intended for use in the treatment of animals and which act primarily through the direct stimulation, supplementation, enhancement, or modulation of the immune system or immune response. Such products include but are not limited to vaccines, bacterins, allergens, antibodies, diagnostics, antitoxins, toxoids, immunostimulants, antigenic or immunizing components of microorganisms intended for use in the prevention, diagnosis, management or cure of disease in animals. The Veterinary Biologics Staff, Animal and Plant Health Inspection Service, U.S. Department of Agriculture, is responsible for regulating veterinary biologics for purity, safety, potency and effectiveness. Additional information can be found at http://www.aphis.usda.gov/animal_health/vet_biologics/.
FDA regulations which apply to pet foods as well as other animal feed products are published in Title 21, Parts 501, 573, 579, 582, 584, and 589 of the Code of Federal Regulations.
As with human food, pet foods may not be adulterated or misbranded. Pet foods may not contain any poisonous or deleterious substances or residues of pesticides in excess of established tolerances. They may not be stored in any containers which may render the contents injurious to health because of any poisonous or deleterious substance and may not contain any color additives or food additives which are unsafe. To ensure safety, canned pet food must be manufactured and registered in accordance with the FDA regulations for low-acid canned foods. Pet food labeling may not be false or misleading in any particular. Damage or inferiority may not be concealed in any manner. Pet food may not be sold under the name of any other food and may not have any valuable constituents omitted or extracted.
Although pet food products do not need to have premarket approval by FDA, these products are subject to the requirements of the Act and pet food manufacturers are subject to individual annual product registration in most States.
State laws may require that pet food labels bear, in addition to the mandatory information required by Federal law, a label statement of "guaranteed analysis" for minimum protein and fat content, and maximum fiber and moisture content, a nutritional adequacy statement, and feeding directions. Additional information concerning State registration and labeling requirements may be obtained from the individual states where the products will be distributed or from the Official Publication of the Association of American Feed Control Officials, Inc. c/o Sharon Krebs, Assistant Secretary, AAFCO, P.O. Box 478, 104 East McConnell Street, Oxford, Indiana, 47971. AAFCO’s website is http://www.aafco.org/.
Pet foods are also subject to the labeling requirements of the Fair Packaging and Labeling Act, which governs certain aspects of consumer product labeling. AAFCO has developed definitions for certain nutrient content claims for calories and fat, such as "low calorie," "less or reduced calories," "low fat," and "less or reduced fat."
A medical device, as defined in the Act (Section 201(h)), is:
an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component part, or accessory, which is ….. intended for use in the diagnosis of disease, or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body of man or other animals and which does not achieve any of its principal intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its principal intended purposes.
There are currently no requirements for FDA pre-market approval of medical devices intended for animal use. Animal medical devices and diagnostic aids are, however, subject to the general provisions of the Act that relate to misbranding and adulteration. For example, an animal medical device is misbranded if the labeling is false or misleading (21 U.S.C. 352(b)). An animal medical device may be considered misbranded if the labeling fails to bear adequate directions for use by the layperson (21 U.S.C. 352(f)(1)). An animal device is misbranded if it is dangerous to animal or human health when used in the manner prescribed, recommended, or suggested in labeling (21 U.S.C. 352(j)). The FDA relies on veterinarians and other users to report unsafe animal medical devices.
Articles such as screening test kits for drug residues are regulated as animal medical devices. One example of screening tests is the test used to screen milk for the presence of drug residues. As with other animal medical devices, screening tests must bear adequate directions for use, the labeling may not be false or misleading, and the manufacturer should have data adequate to demonstrate that use of the screening kit in accord with label directions will yield consistent and reliable results.
If adequate directions cannot be written for lay use, the animal medical device is deemed unsafe for use except under the supervision of a licensed veterinarian. The FDA, therefore, requires that the label bear the statement: "Caution: Federal law restricts this device to sale by or on the order of a licensed veterinarian" (21 CFR 801.109). Examples of animal medical devices which are required to bear the prescription legend include transcutaneous electronic nerve stimulators, pulse magnetic field devices, and lasers.
The animal counterpart of a cosmetic is commonly referred to as a "grooming aid." The Act defines a cosmetic as pertaining only to human use (21 U.S.C. 321(i)). Therefore, products intended for cleansing or promoting attractiveness of animals are not subject to FDA control. However, if such products are intended for any therapeutic purpose or if they are intended to affect the structure or function of the animal, they are subject to regulation as new animal drugs under the Act.
FDA is responsible for programs and regulatory actions aimed at preventing illegal drug residues in human food products derived from treated animals. (For regulatory purposes, live animals are considered unprocessed food.) Illegal drug residues in edible products can constitute a hazard to the health of persons consuming such food. Failure to observe label withdrawal periods before slaughter or processing, or failure to withhold milk is the principal cause of illegal drug residues. Other causes may include failure to follow other label directions, poor feed manufacturing practices, and human negligence.
FDA is also responsible for ensuring that contaminants of feed origin do not result in unsafe contamination in human food of animal origin. Regardless of the cause, it is FDA's policy to hold responsible any individual in the production and marketing chain who can be shown to have caused (by an act of commission or omission) illegal residues or other contaminants in edible animal products. If a veterinarian prescribes, dispenses, or treats an animal(s) with a drug which results in the occurrence of an illegal drug residue in edible products from the treated animal, the veterinarian may be held responsible for having caused a violation of law.
Additional information on residue avoidance and withdrawal times can be found in the Food Animal Residue Avoidance Databank (FARAD).