Animal & Veterinary
How FDA Protects the Safety and Quality of Your Pet’s Food
by Suzanne Sechen, Ph.D., Office of New Animal Drug Evaluation
FDA Veterinarian Newsletter 2006 Volume XVII, No IV
The growing popularity of pets in U.S. households has led to an enormous increase in varieties of pet foods available at grocery and convenience stores and especially in stores dedicated solely to pet needs. Pet owners may be aware that the Food and Drug Administration (FDA) is responsible for protecting the safety of the food they themselves eat, but they may not know that FDA also makes sure that animal foods, including pet foods, are safe and properly labeled. FDA’s regulation of pet food includes not just the classic canned cat and dog food, but also the flakes sprinkled in an aquarium, chow for hamsters, seeds for pet canaries, and even the coating on packaged crickets to be fed to pet reptiles.
FDA enforces the Federal Food, Drug, and Cosmetic Act (FFDCA), which defines foods as “articles used for food or drink for man or other animals…and articles used for components of any such article.” The FFDCA requires that pet foods, like human foods, be pure and wholesome, contain no harmful or deleterious substances, and be truthfully labeled. The responsibility for regulation of animal foods, including pet foods, is handled by FDA’s Center for Veterinary Medicine (CVM).
Under the FFDCA, drugs and food are defined and regulated differently. The Act defines drugs, in part, as articles intended to diagnose, cure, mitigate, treat, or prevent disease, or to affect the structure or function of the body in a manner other than food. Drugs, including drugs intended for use in animals, must be approved by FDA before they can be marketed.
Based on the FFDCA definition, “food” is something that provides nutrition, taste, or aroma. If a food affects the structure or function of the body, it does so by these properties. For example, food may provide nutrients such as protein and calcium for proper muscle and bone structure. There is no requirement that pet foods have pre-market approval by FDA. However, FDA regulates the ingredients that may be used in pet foods and works collaboratively with State regulators to ensure that products are safe and accurately labeled.
Pet food ingredients
Pet food manufacturers may only use ingredients that are deemed wholesome and safe for their intended use. Ingredients become acceptable for use in pet food via several different routes. Many ingredients used in pet foods, such as meat, poultry, grains, and their byproducts are considered traditional and safe “foods.” Manufacturers may use these ingredients in pet foods with no premarket approval. Manufacturers of pet foods may also use ingredients “generally recognized as safe” (GRAS) for their intended purposes. Substances are classified as GRAS after consensus determinations by experts, qualified by training to make such determinations about the safety of substances added to foods, based on data published in the scientific literature, or in some cases because of a long history of safe use in foods. Substances that are GRAS for specific purposes in the manufacture of animal foods are listed in the Code of Federal Regulations, Title 21 (21 CFR), Part 582. They include ingredients such as mineral and vitamin sources, flavorings, spices, and essential oils. Also listed are general purpose food additives and agents that provide nutrients or serve as anticaking or emulsifying agents, sequestrants, stabilizers, or preservatives.
Sponsors may gain approval to use a new food additive not considered GRAS by submitting to FDA a Food Additive Petition (FAP). FDA reviews the petition to determine whether the new food additive is safe for its intended use and has “utility,” meaning that it performs its intended use. As described in 21 CFR 571, a FAP must contain a description of the chemical identity, manufacturing process and controls, analytical methods, utility data, human food safety data, target animal safety data, product labeling, and in some cases an environmental assessment. If the FAP is approved by FDA, the additive is listed in 21 CFR 573, which describes the intended use of the additive and the specific conditions under which the additive may be safely used. Once listed, any manufacturer may use the food additive for its intended purpose unless the sponsor of the FAP has patent protection for use of the additive.
In addition to the GRAS and FAP routes for allowing food additives to be used in animal food, CVM uses regulatory discretion to permit the use of substances that do not raise any safety concerns. Rather than requiring a FAP for these substances, the new ingredient is permitted to be used in animal feed if sufficient information is available to establish a definition in the Official Publication of the Association of American Feed Control Officials (AAFCO). This -includes -information on the safety and utility of the ingredient for the intended purpose and manufacturing process and control. If the information is acceptable and no safety or utility questions are raised, the ingredient is listed in the Official Publication for AAFCO. AAFCO is an association of Federal and State regulatory officials that provides a forum to deliberate and discuss issues affecting the sale and distribution of animal feed. CVM provides the scientific review for the new ingredients on behalf of AAFCO. A substance accepted through this AAFCO “Ingredient Definition Process” is still considered to be an unapproved food additive. However, under FDA regulatory discretion, it may be used for the intended purpose by any manufacturer.
Regardless of how a potential pet food ingredient becomes acceptable for use, it may only be used for its intended purpose. Manufacturers may not use the ingredient for a different purpose unless it first becomes GRAS, approved via a FAP, or listed by AAFCO for the new intended use.
Regulation of Pet Food Labeling
With so many products available, accurate labeling of pet foods is important so that consumers can best choose an economical product appropriate for their pet. In fact, pet food labeling is regulated at both the Federal and State level so that consumers can make accurate decisions.
CVM regulates pet food labeling at the Federal level. Federal regulations apply to all animal feeds and establish standards for proper identification of the product, the net quantity statement, proper listing of ingredients, and the manufacturer’s name and address.
Some States also enforce their own labeling regulations. Many of these are adapted from model pet food regulations established by AAFCO. These regulations are more specific than the Federal ones and cover aspects of labeling, such as the product name, the guaranteed analysis, the nutritional adequacy statement, feeding directions, and calorie statements.
The AAFCO rules dictate the product name of the pet food based on the percentage of ingredients. The “95 per cent rule” typically applies to canned foods that contain primarily meat, poultry or fish. The name of the pet food is simple, such as “Beef for Dogs” or “Tuna Cat Food,” and the primary ingredient (beef or tuna, respectively) must make up at least 95 per cent of the product, excluding water added for processing, and at least 70 per cent of the total product weight (including water). The “25 per cent rule” applies to many canned and dry products. Excluding water added for processing, the named ingredient comprises at least 25 per cent, but less than 95 per cent, of the pet food, and at least 10 per cent of the total product weight (including water). The name of the product in this case will state the ingredient, followed by terms such as “dinner,” “platter,” “entree,” or “formula,” such as “Beef Dinner for Dogs.” The
“3 per cent rule” allows manufacturers to add a sidebar or include in the product name the term “with” followed by an ingredient comprising 3 to 25 per cent of the product, excluding water added for processing, for example, “Beef Dinner for Dogs, with Cheese” or “Cat Food with Chicken.” Finally, under the “flavor rule,” a flavoring must be detectable, typically by using trained animals, although a specific percentage of the flavoring is not required. The “flavor” may actually be the stated ingredient (e.g., “beef flavor”) or a substance that mimics the stated flavor.
Despite these rules on naming a pet food, consumers should still carefully read the ingredient list to be aware of all ingredients in the pet food and their relative predominance in the product. Regulations require that ingredients be listed in order of predominance by weight. With the “95 per cent naming rule,” the main ingredient included in the product name is usually the first one listed in the ingredient list. However, with the remaining naming rules, the ingredient stated in the name may not be the primary component of the pet food. Carefully reading the ingredient list will prevent pet owners from purchasing a product with an ingredient that their pet does not like or tolerate or that pet owners do not wish to feed.
State feed regulations generally require a pet food label to have a “guaranteed analysis” for certain nutrients, specifically the minimum percentage of crude protein and crude fat, and the maximum percentages of crude fiber and moisture. (The term “crude” refers to a specific method of testing, not the quality of the nutrient.) Some manufacturers also will include guarantees for other nutrients. Pet food manufacturers may voluntarily include the calorie content per kilogram of product on labeling. Consumers should bear in mind that the guaranteed analysis and calorie content are presented on an “as-fed” or “as-is” basis, meaning that they are not corrected for moisture content. Canned pet foods tend to have about four times more moisture than dry foods. Consequently, nutrient percentages will be lower for canned (moist) pet foods versus dry products.
Savvy shoppers should pay attention to the “net quantity statement” on pet food labels. A 14-ounce can may look identical to a 16-ounce can, and similar sized bags may contain different weights of dry food. Consumers can make a more accurate comparison of cost per unit of product by checking the net quantity statement on product containers. FDA regulations dictate the format, size, and placement of net quantity statements.
The AAFCO model pet food regulations also cover the “nutritional adequacy statement” on pet food labels. If the label states that the product is “complete,” “balanced,” “100% nutritious,” or similar, the statement must be supported either through feeding trials using AAFCO protocols or through formulation with ingredients to provide levels of nutrients that meet a nutritional profile recognized by AAFCO for the species that the product is intended. The product label must indicate which method was used to substantiate nutritional adequacy. The nutritional adequacy statement may also state for which life stage(s) of the animal the product is suitable, such as “for maintenance” or “for growth.”
Pet foods that are identified as being intended as snacks, treats, or feed supplements do not need to include a nutritional adequacy statement. Dog “chews,” which are typically made from rawhide, bone or other animal materials, are generally exempt from all AAFCO model labeling regulations. However, FDA labeling regulations still apply, including the need for an ingredient list, net quantity statement, and manufacturer’s name and address.
Consumers should not be misguided by terms such as “premium” or “gourmet” often seen on pet food labels. Feed regulations do not require that these products contain any higher quality ingredients or hold them to any higher nutritional standards compared to other pet foods. AAFCO has defined the term “natural” and published guidelines on its use in labeling pet and specialty pet products. The term “organic” refers to the conditions under which the ingredients used in products, and the product itself, were produced and must be consistent with regulations developed by U.S. Department of Agriculture. Current regulations covering organic products do not apply to pet foods, but USDA is developing regulations for the labeling of pet foods as organic.
Health information in pet food labeling
Manufacturers of pet foods are not allowed to include drug claims in product labeling, such as stating that their product will prevent or reduce the risk of a disease. This is because feed products have not undergone the rigorous testing for safety and effectiveness required for the approval of new animal drugs. However, CVM is permitting some meaningful health-related information on pet food labels. For example, Feline Lower Urinary Tract Disease is a concern for cat owners. CVM allows the labeling on cat food products to bear claims such as “to reduce urine pH to help in maintaining urinary tract health” if the sponsor provides data to demonstrate that consumption of the product is safe for cats and results in an appropriately acidic urine.
With the increased problem of obesity in pets, AAFCO model regulations permit terms such as “lite” or “low calorie” based on standard calorie references for the specific pet food product, species, and life stage. Products labeled as being lite or low calorie also must state how many calories are contained in a kilogram of food and may also list the number of calories in a familiar household measure, such as a cup or can of the product. Also, if a company makes a high calorie product and a lower calorie alternative, it may make statements such as “25% less calories than our regular product.” There are also specific model regulations setting standards for pet food products claiming to be “low” or “reduced” fat products. Low or reduced fat products must provide both minimum and maximum guarantees for crude fat, and the maximum guarantee cannot exceed specified standards for specific product types. However, the model regulations do not require that calorie content be declared on low or reduced fat products.
Claims to treat or prevent gingivitis or periodontal disease are drug claims and should not appear on pet food labels. However, CVM has allowed plaque and tartar control claims for products that achieve their effects by mechanical actions, such as dry biscuits.
Pet food labels often promise “healthy skin” or a “glossy coat.” Although these claims are not officially validated, they should be true for any complete and balanced product that provides adequate nutrition for a normal animal. However, statements that a pet food will benefit the skin and coat beyond normal nutritive value or is “hypoallergenic” are considered drug claims.
Both FDA and State regulators monitor marketed pet food products for unacceptable ingredients, untruthful labeling, drug claims, and other violations. If violations are found, the manufacturer may receive an untitled or Warning Letter from FDA or State regulators or the product may be refused entry or distribution in a particular State or the United States until the manufacturer corrects any violations to the product’s -formulation or labeling. Persistent, egregious violations that pose health and safety risks to pets could also result in court proceedings against the manufacturer.
Although pet foods do not need pre-market approval by FDA, the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 requires domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States to register with FDA. This law also defines the types of records these facilities must establish and maintain.
If consumers have questions or problems concerning a pet food, they may contact the manufacturer listed on product labeling or their FDA Consumer Complaint Coordinator. The contact information for the FDA Consumer Complaint Coordinator in a person’s state can be found on the internet at http://www.fda.gov/opacom/backgrounders/complain.html. CVM also has information on the regulation of pet food at its Web site http://www.fda.gov/cvm/petfoods.htm.
The combined efforts of FDA and State regulators help ensure that pet foods are safe and accurately labeled. By carefully reading pet food labeling, consumers can make informed decisions in choosing the best products for their pets.