Animal & Veterinary
OVERVIEW OF FDA PROGRAMS AFFECTING ZOO ANIMAL FEEDS
by David A. Dzanis, D.V.M., Ph.D., DACVN
FDA Veterinarian Newsletter January/February 1998 Volume XIII, No I
This information was presented to the American Zoo and Aquarium Association Nutrition Advisory Group, Ft. Worth, Texas, on October 19, 1997.
The authority to regulate animal feeds in interstate commerce is granted to the U.S. Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act. This authority includes not only livestock feeds, but also feeds for pets, zoo animals, and even wildlife. Most of the regulatory functions related to animal feeds are carried out by the Center for Veterinary Medicine (CVM). The Division of Animal Feeds within CVM is divided into three teams: Nutrition and Labeling, Animal Feed Safety, and Medicated Feeds. Each team is responsible for matters that may impact foods intended for zoo animals. The Division interacts with other offices within CVM, other FDA Centers, and a wide network of FDA Field offices to achieve its goals.
Nutrition and Labeling
The Nutrition and Labeling Team, as its name implies, is responsible in assuring that animal feeds are labeled in accordance with pertinent laws and regulations, and that any claims related to nutritional value or other aspects of the product are not false and misleading. The Team also reviews Food Additive Petitions, GRAS (Generally Recognized As Safe) Affirmation Petitions and applications for new AAFCO Feed Ingredient Definitions for nutritive substances to ensure that they can be used in animal feed in a safe manner. Because manufacturers of zoo animal feeds are often less familiar with Federal and State labeling regulations than the larger volume animal feed and pet food companies, errors in the fundamental aspects of labeling are common. Mistakes with net weight declarations, statements of responsibility (manufacturer's name and address), and guaranteed analyses are not uncommon. Since ingredients not typically used in domestic animal feeds are often included in formulations, use of proper ingredient declaration terminology can be problematic. Although these aspects may appear to be mere technicalities to some, the regulations are in place to assure truthful, non-misleading information for all animal feeds.
Comparative nutritionists face formidable challenges in their attempts to provide nutritionally adequate diets to zoo animals. Commercially available products for these animals offer many potential benefits. However, there is often a paucity of reliable scientific data on the nutritional needs upon which the owner or caretaker can adequately assess the value of commercially available products specifically intended for these species. This has become an even bigger problem with the increased popularity of exotic animals as pets.
A "complete and balanced" commercial food can offer many advantages to the owner or caretaker in terms of convenience and assurances of adequate nutrient intake. However, a product intended to be offered as the sole source of nutrition that is not, in fact, nutritionally adequate is both misbranded and unsafe. For domestic animals such as dogs and cats, there are standards (AAFCO Dog and Cat Food Nutrient Profiles) which products must meet in order to substantiate nutritional adequacy. There are also some zoo species where the recommendations of the National Research Council may apply (e.g., primates, rodents). For most exotic species, there is no unbiased authority upon which these claims of nutritional adequacy can be validated. Lacking such abilities to verify a claim's truthfulness, some regulators have required companies to remove the claims from the labels. Although this helps protect the consumer from false claims, it can also be a disservice for those products that are truly "complete and balanced."
To help remedy the problem, the Association of Avian Veterinarians has established an ad hoc committee to attempt to set a rudimentary nutrient profile for the most common pet psittacine and passerine birds. Unfortunately, for many other commonly kept exotic animals (e.g., iguanas, other reptiles, many small mammals), establishment of minimum nutrient standards is not in the foreseeable future. Owners or others charged with the responsibility of providing food to exotic animals are advised to view any claim of nutritional completeness for these species with due scrutiny.
Under FDA law, an expressed or implied claim that a product will treat, prevent, or otherwise affect a disease or condition identifies the intent to offer that product as a drug. Furthermore, unless that product has been shown to be safe and effective for its intended use via a New Animal Drug Application (NADA) approval, it is unsafe. Many commercial exotic animal feed labels bear "health" claims that could make them "drugs" under the law. These include references to specific conditions, such as "treats metabolic bone disease" or "cures feather picking," or more generalized promises (e.g., "reduces stress" or "improves health"). When made aware of certain products, FDA has required the manufacturer to remove the claims if the product was to be regulated solely as a food. However, many products bearing unproven drug claims are still prominent on the market. Thus, comparative nutritionists must use their expertise to carefully evaluate the merit of any label health claim before using or recommending the product.
Animal Feed Safety
The Animal Feed Safety Team is responsible for review of Food Additive Petitions, GRAS Affirmation Petitions and AAFCO definition applications for substances that are not intended for their nutritive value (e.g., preservatives, anti-caking agents). It also deals with cases of adulteration, such as chemical or microbiologic contamination, and develops policies regarding food/feed safety issues.
Many commercial diets designed for carnivorous species are comprised of raw meat or by-products obtained from animals that may have died from means other than slaughter (i.e., "4-D meat"). By their very nature, these products have a high risk of containing potentially pathogenic organisms. Depending on handling both before and after sale, the bacteria may proliferate and pose a risk to both the animal and caretaker. Purchasers of such products must be aware of the potential risks, and handle raw meat diets appropriately. "Safe handling" instructions on raw meat product labels would also be a prudent measure.
An important aspect related to animal feed safety is the risk of Bovine Spongiform Encephalopathy (BSE) entering and proliferating in the United States. New regulations designed to help minimize the risk will impact zoo animal feeds. Under the new rules, any feed containing non-exempt mammalian proteins cannot legally be fed to ruminants (including cattle, deer, elk, bison, and antelope). Exempt protein sources include milk and milk products, blood and blood products, and gelatin from all species, meat, meat and bone meal and other proteins derived exclusively from swine and horses, and plate waste. If a product contains any non-exempt proteins, it must carry a warning statement not to feed it to ruminants. Pet foods are excluded from carrying a warning statement under this rule, but zoo animal feeds are not.
The Medicated Feeds Team is responsible for ensuring that an animal feed containing a drug is properly formulated and labeled to comply with the requirements set out in the drug's approval. Medicated feeds are drugs under the law, and they must be subject to an approved NADA before they can be used legally. The NADA specifies the species, conditions, and other restrictions of use necessary to ensure that they are used in a safe and effective manner. Medicated feeds must be manufactured in accordance with current Good Manufacturing Practice regulations (cGMPs) to assure that a uniform product meets the declared potency and is not contaminated with unwanted drug ingredients. FDA's Field investigators conduct routine inspections of medicated feed manufacturers to assure they are meeting these requirements.
A feed containing a drug that is not subject to an approved NADA, or intended for a species or condition not specified by the approval is an adulterated drug. The Animal Medicinal Drug Use Clarification Act (AMDUCA) grants some leeway for veterinarians to use approved drugs in an "extra-label" manner, that is, use the drugs at different dosages or for different species or diseases not specified by the NADA. However, AMDUCA also states that medicated feeds are not covered under the Act. Thus, the extra-label use of medicated feeds is not legally permitted.
CVM works in concert with FDA Field personnel and State feed control officials to ensure that all animal feeds are safe and properly labeled. Anyone who suspects that a feed is potentially unsafe by virtue of adulteration or misbranding should contact the appropriate State feed control official and/or FDA District Office.