Compendium Specialty Series: Focus on Nutrition by davidpsu

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Regulation Pet Foods of

❯❯ David A. Dzanis, DVM, PhD, DACVNa Dzanis Consulting & Collaborations

Santa Clarita, California

in the United States

Abstract: In the United States, pet foods (including treats, edible chews, and supplements) are subject to regulation at both federal and state levels. Products found to be adulterated or misbranded are subject to enforcement action. Veterinarians play a key role in helping ensure pet food safety by reporting possible adverse effects to authorities in a timely manner.

n 2007, the widely reported recall of dog and cat foods due to contamination with melamine and related compounds brought renewed public scrutiny of the pet food industry. The Internet is replete with sites that disparage the nutritive value and safety of commercial pet food products, often implicating poor regulatory oversight. Because pet owners often consult veterinarians on matters relating to pet food, it behooves practitioners to be familiar with the topic of pet food regulation.

Who Regulates Pet Foods?

At a Glance Who Regulates Pet Foods? Page 324

Government Oversight of Pet Foods Page 326

Oversight of Veterinary-Dispensed Products Page 326

The Veterinarian’s Role Page 327

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The US Department of Agriculture oversees meat and poultry products intended for human consumption; however, the same products, intended for animal consumption, fall within the authority of the US Food and Drug Administration (FDA). FDA’s Center for Veterinary Medicine has primary jurisdiction over all animal feed in interstate commerce (including imports).1 “Animal feed” includes pet food, which further encompasses complete and balanced foods, treats and snacks, supplements, edible chews (e.g., rawhides, bones), and the ingredients intended to be incorporated into these products. “Interstate commerce” of a product is determined by the Dr. Dzanis is a consultant for the pet food and related industries on matters pertaining to nutrition, labeling, and regulation. He formerly served as the veterinary nutritionist for the US Food and Drug Administration and represented the agency on the Association of American Feed Control Officials Pet Food Committee.

origins of its ingredients, the location where the product was manufactured, and the point of sale or receipt of the product. Most pet foods contain at least some ingredients obtained from sources outside of the state where they are manufactured; therefore, virtually all pet foods fall under federal authority. Individual state governments also exercise authority over animal feed and pet food distributed within their jurisdiction. This constitutes another layer of regulatory oversight that is more extensive than is required for most human food items. Each state’s laws and regulations are enforced by the state feed control official, typically an employee in the state’s department of agriculture or chemist’s office. While the acronym AAFCO commonly appears on “complete and balanced” dog and cat food labels, few in the public understand the nature and role of the Association of American Feed Control Officials (AAFCO) in pet food regulation. AAFCO is neither a government body empowered to act under authority of law nor a trade association whose goal (as ascribed by its critics) is to mitigate the impact of regulation on industry. Rather, it is a private body wholly comprised of federal, state, and foreign gov-

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Contributed by The American College of Veterinary Nutrition About ACVN ernment officials.2 Essentially, its role is to provide a Model Bill and Regulations, establish ingredient definitions, and set other standards (such as guidelines for use of the term natural and the AAFCO Dog and Cat Nutrient Profiles and feeding trial protocols), via policy or guidance, that represent a consensus among regulators about what constitutes the appropriate regulation of animal feed. Nothing AAFCO publishes has any power of law unless subsequently adopted by individual state legislatures, and not all states follow AAFCO models. However, enough do that AAFCO has nationwide influence.

Representatives of industry and consumer groups can provide information to committees and working groups within AAFCO and are free to voice their opinions at public AAFCO meetings. However, they are not allowed to be members of AAFCO and hence, cannot hold office, make motions, or cast votes on any matter under consideration.

Founded in 1988, the primary objective of the American College of Veterinary Nutrition (ACVN) is to advance the specialty area of veterinary nutrition and increase the competence of those who practice in this field by establishing requirements for certification in veterinary nutrition, encouraging continuing professional education, promoting research, and enhancing the dissemination of new knowledge of veterinary nutrition through didactic teaching and postgraduate programs. For more information, contact: American College of Veterinary Nutrition, c/o Dawn Cauthen, Administrative Assistant, School of Veterinary Medicine: Dept. of Molecular Biosciences One Shields Avenue Davis, California 95616-8741 Telephone: 530-752-1059 Fax: 530-752-4698 Email: dawncauthen@yahoo.com Web: acvn.org

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QuickNotes State feed control officials often inspect pet stores and other retail outlets that sell pet foods, including veterinary clinics.

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Government Oversight of Pet Foods With regard to pet food, the federal and state governments’ mandate is to enforce pertinent laws relating to pet food manufacture and distribution. This includes products sold through retail outlets, veterinary clinics, catalogs, and Web sites. The Federal Food, Drug, and Cosmetic Act of 1938 (FFDCA) and equivalent state laws prohibit the distribution of foods that are either adulterated or misbranded.3 The term adulterated may refer to the presence of a chemical, microbiologic, or physical contaminant, including any substance that is not generally recognized as safe, an approved food additive, or an otherwise sanctioned ingredient (e.g., via the AAFCO Feed Ingredient Definition process) for use in pet foods. Failure of a product to meet stated nutrient guarantees or conform to ingredient or nutritional representations is also a form of adulteration.2 The term misbranded relates to false or misleading claims and to labeling that is not in compliance with federal or state regulations. “Drug claims,” which are defined as claims that a product can (1) treat, prevent, mitigate, or otherwise affect a disease or condition or (2) affect the structure or function of the body in a manner beyond what is normally ascribed to food, for which the product is not approved, can be considered a form of misbranding.1 Most enforcement efforts are conducted by state feed control officials. This is because many state laws (particularly those that follow AAFCO models) mandate periodic (usually annual) product registration and/or company licensure as a condition of distributing in the state.2 Typically, the process requires submission of product labels for review by the feed control official. Sale of any product found to be misbranded may be denied in that state, affecting not only distribution of the product within the state, but also deliveries from outside the state based on catalog or online sales. While this action would appear to affect only one jurisdiction, in practice, it is infeasible for pet food companies to distribute products in different states with different labels. Hence, labeling found to be objectionable by one state may result in revision of the labeling for nationwide sale of a product. In addition to their registration/licensure functions, state feed control officials often inspect pet stores and other retail outlets that

sell pet foods, including veterinary clinics. Wholesale distribution points within the state are also subject to inspection. Inspectors may search for products that are not properly registered or have been previously denied sale. Samples of products may be obtained from the location for label review and/or laboratory analysis for nutrient content and contamination. Depending on the egregiousness of any violations found, the product may be seized by the regulator, or the company may be notified and allowed time to remedy the violation. Compared with individual states, FDA conducts little direct enforcement. While FDA can seize product or take other enforcement measures, there are no federal product registration or company licensure requirements at this time (except registration of food manufacturing facilities under the Bioterrorism Act). However, FDA is intimately involved in the process of state enforcement efforts, assisting states with scientific, technical, and regulatory expertise in support of contemplated enforcement actions. For example, feed control officials often refer questionable claims or ingredients to FDA for assessment before taking action, or they may require a company to first obtain FDA’s acceptance as a condition of distribution of its product in their state. Also, FDA has taken direct action when it was deemed more effective than a single state’s action, such as in cases involving catalog and online sales.

Oversight of Veterinary-Dispensed Products Veterinarians frequently dispense therapeutic pet foods as part of normal practice. As noted

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above, a pet food label bearing a drug claim is subject to enforcement action. However, FDA often exercises “enforcement discretion” in the case of veterinary therapeutic diets. In other words, it allows companies to convey information to veterinarians on the function of a product as it relates to disease processes, provided that the product is sold under a valid veterinarian/client/patient relationship.4 This discretion is based on the premise that veterinarians’ medical and scientific training is sufficient to enable safe and appropriate use of the product by clients. However, most veterinarians are not aware that the diet/disease claims made by the company most often have not been reviewed and verified by FDA. This is not to imply that such products lack benefit or are unsafe when used as clinically appropriate. On the contrary, manufacturers of therapeutic diets may have extensive documentation. The Veterinary Oral Health Council (VOHC), an organization under the auspices of the American Veterinary Dental College, provides protocols and reviews data from companies with regard to dental plaque and tartar control claims and allows use of its seal of acceptance for products that pass muster in this regard. However, other than VOHC, there are no independent organizations that scrutinize therapeutic diet claims for products sold in the United States. Many veterinarians also distribute pet supplement products to clients. The Dietary Supplement Health and Education Act of 1994 (DSHEA) diminished FDA’s authority over dietary supplements (a subcategory of foods) by allowing the inclusion of ingredients that were previously prohibited in food products as well as broadening the scope of permissible

claims relating to function. This act affects only products that meet the statutory definition of dietary supplements, not foods in “conventional” form. Regardless, FDA has given notice of its determination that DSHEA only applies to products intended for human consumption, so that FFDCA still applies to all pet products, whether in conventional (e.g., a complete and balanced pet food) or supplement (i.e., “dosage”) form.5 In response, some manufacturers of pet supplement products containing unapproved food additives (such as many herbs, botanicals, metabolites, and other compounds) have opted for labeling such products as drugs rather than as foods. While still under the authority of FDA and “animal remedy” laws in some states, products so labeled may escape scrutiny by many state feed control officials. Further, although FDA does allow some products on the market as “unapproved drugs of low regulatory priority” based on its determination of reasonable expectations of safety, it is not obvious by their labeling which products have passed FDA muster in this regard and which have not. As a result, some products on the market may not have received adequate review by regulatory officials.

The Veterinarian’s Role Notwithstanding the adverse attention pet foods have received since the 2007 recall, in general, pet foods have a good safety record.6 Regardless, future contamination incidents are always possible. Clinicians are in an excellent position to detect and report potential pet foodborne illness before a larger outbreak occurs. Suspected or confirmed contamination should be reported to appropriate regulatory agencies (Table 1)

QuickNotes FDA often exercises “enforcement discretion” in the case of veterinary therapeutic diets.

table 1

Reporting Suspected or Confirmed Pet Food Contamination or Adverse Eventsa

Whom to Contact

How to Contact

Alternate Contact Method

Pet food manufacturer

Call “800” telephone number on label.

Visit company Web site.

FDA

Call your FDA district office consumer complaint coordinator. Telephone numbers for district offices are listed at fda.gov/opacom/ backgrounders/complain.html.

Call the telephone number listed in the blue pages (for federal agencies) in the telephone directory.

State feed control official (state agency varies but is usually the department of agriculture or chemist’s office)

Call an AAFCO member in your state. Telephone numbers are listed in the AAFCO membership directory at www.aafco.org/Directory/ MembershipDirectory/tabid/62/Default.aspx.

Call the telephone number listed in the blue pages (for state agencies) in the telephone directory.

Dzanis DA. Anatomy of a recall. Topics Companion Anim Med 2008;23(3):133-136. Reproduced with permission.

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QuickNotes Veterinarians must practice due diligence in assessing the clinical need for a given supplement in an individual animal.

as well as the manufacturer, which may be in the best position to recognize a pattern of complaints suggesting a safety problem. Pertinent information to relate to regulators and companies includes the product name (including variety) and package size, as well as the universal product code (UPC) number to help identify the exact product in question. Regulators and companies can also use lot or date codes to help pinpoint the production batch(es) of highest concern. The date and place of purchase of the suspect food, as well as relevant medical information regarding the animal, are also helpful. Proper handling of samples of the suspect food as legal evidence may be critical if there is a possibility of a lawsuit at a later date.6 Therapeutic pet foods must meet the same processing, ingredient, and labeling standards as any other pet food, including substantiation of nutritional adequacy. A food labeled “This product is intended for intermittent or supplemental feeding only” should not be considered sufficient for long-term feeding as the sole source of nutrition. In consideration of the lack of regulatory review of efficacy References

1. Benz SA. FDA’s regulation of pet food. Accessed December 2008 at fda.gov/cvm/petfoodflier.html. 2. 2008 AAFCO Official Publication. Oxford, IN: Association of American Feed Control Officials; 2008. 3. Federal Food, Drug, and Cosmetic Act. Washington, DC: Government Printing Office; 1999. 4. Intended use of therapeutic diets as drugs dictates VCPR requirement. JAVMA 2003;222(7):923.

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claims for therapeutic diets, it is prudent for clinicians to carefully scrutinize data supplied by companies in support of the reported benefits of their products. Outcomes of feeding these diets should be closely monitored. Before using or recommending any supplement product, veterinarians must practice due diligence in assessing the clinical need for a given supplement in an individual animal; evaluating the strength, quality, and source of data to support the use of the supplement; and judging the integrity and competence of the manufacturer. Veterinarians must also objectively assess outcomes of supplement administration and be open to revising use or recommendations as necessary. Any observed adverse effects should be reported to the appropriate regulatory officials as well as the manufacturer. Members of the National Animal Supplement Council (NASC)—a trade organization representing the interests of supplement manufacturers—that receive adverse event reports must convey that information to the council to be included in its database.7 NASC allows federal and state regulators, but not the general public, to review this database.

5. Inapplicability of the Dietary Supplement Health and Education Act to Animal Products. Federal Register 1996;61(78):17706-17708. 6. Miller EP, Cullor JS. Food safety. In: Hand MS, Thatcher CD, Remillard RL, Roudebush P, eds. Small Animal Clinical Nutrition. 4th ed. Topeka, KS: Mark Morris Institute; 2000:183-198. 7. National Animal Supplement Council. Frequently asked questions. Accessed December 2008 at: nasc.cc/index.php?option=com_ content&task=view&id=29&Itemid=38.

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Important Information: How Supplied: SevoFlo is packaged in amber colored bottles containing 250 mL sevoflurane. Indications: SevoFlo is indicated for induction and maintenance of general anesthesia in dogs. Warnings, Precautions, and Contraindications: Like other inhalation anesthetics, sevoflurane is a profound respiratory depressant. Respiration must be monitored closely in the dog and supported when necessary with supplemental oxygen and/or assisted ventilation. Due to sevoflurane’s low solubility in blood, increasing concentration may result in rapid hemodynamic changes compared to other volatile anesthetics. SevoFlo is contraindicated in dogs with a known sensitivity to sevoflurane or other halogenated agents. Adverse Reactions: The most frequently reported adverse reactions during maintenance anesthesia were hypotension, followed by tachypnea, muscle tenseness, excitation, apnea, muscle fasciculations and emesis. See package insert for full prescribing information. See Page 4 for Product Information Summary SEVO-186 June 2008 ©2008 Abbott Laboratories

Using a Diet History to Improve Adherence to Dietary Recommendations ❯❯ Kathryn E. Michel, DVM, MS, DACVN,* University of Pennsylvania Proper dietary management is essential to pet health, yet changing pet owners’ feeding practices is often difficult. Taking a diet history provides an opportunity to open a dialogue about animals’ dietary needs as well as invaluable information that will aid in tailoring specific dietary interventions to the needs and preferences of patients and their caregivers. ommunicating effectively with people the household? Do any of them spend all day about the nutrition and dietary manage- with the pet? Inquire whether there are other ment of their pets can be difficult, par- pets in the home and whether they are—or ticularly when the goal is to persuade them to can be—fed separately from the patient. Can alter their feeding practices. However, circum- the patient get into the other pets’ food? Ask stances frequently arise in which a change in whether the pet is confined indoors or is feeding management may be in the best inter- allowed outside. If the pet is allowed out, is ests of a pet. Obtaining a complete diet history is it supervised while it is outside? Does it have the essential first step in the process of altering the opportunity to steal food, get into garbage, feeding practices to suit a pet’s needs. The diet scavenge, or hunt? history provides information about what the pet is being fed and whether this food is complete, The Principal Diet, Feeding Routines, balanced, and appropriate to the pet’s life stage and Eating Behaviors and health status. Just as important, the history Obtain the precise names (including flavor, if provides information about how food is used appropriate) and brands of all commercial pet in interactions between the pet and the other foods that the patient is receiving and the spemembers of the household. Understanding this cific amounts fed. Often, caregivers cannot prorelationship is a key element when designing vide this information accurately by recall alone dietary interventions that meet the health and and need to check labels and measure feeding nutritional needs of the patient and are accept- portions. Also, pet owners who use a scoop to measure dry food often do not realize the true able to the pet’s caregivers. size of their measuring device. If the pet is eatElements of the Diet History ing a canned diet, ask what size can the owner A complete diet history gives an accurate account buys. Some varieties of pet food are sold in of all foods fed to a pet on a typical day. It is an multiple can sizes (e.g., 5.5 and 12 oz), so the opportunity to evaluate all the ways that food size used by the client is important informais involved in interactions between the pet and tion. Make sure to ask whether the food the pet the other members of its household. It should is currently eating is its usual diet and, if not, also be an opportunity for the pet’s caregivers when the diet change was implemented. to offer their viewpoints regarding the propoIf the pet is eating a commercial pet food, sition of modifying their feeding practices. ask if the diet is being supplemented with any human foods. If this is the case, it is important The Household to get accurate details, including measured Begin by asking about who lives with the amounts of all foods routinely given to the pet. How many adults and children are in pet. If the pet is being fed a home-prepared

QuickNotes Information from the diet history is essential for determining whether a patient is receiving an appropriate and adequate diet.

*Dr. Michel discloses that she has received ﬁnancial support from Nestlé Purina PetCare Company and Royal Canin.

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CONTRIBUTED BY THE AMERICAN COLLEGE OF VETERINARY NUTRITION About ACVN diet, ask for the recipe, including measured amounts of all the ingredients. Some owners do not use a standard recipe when making a home-prepared diet. It is useful to ask these owners to keep a diary of all food fed to the pet for 5 to 7 days. Be certain to inquire whether the pet is receiving any dietary supplements. If possible, have the client bring in the supplements—or at least the label information—so you can see exactly which nutrients are being supplemented and in what quantities. Ask about the daily routine of feeding the pet. Is the pet fed at certain times of the day, or is food always available? If the pet is fed with other pets, are the meals supervised? Does one person assume responsibility for feeding the pet, or can it vary day-to-day? This is important information, especially when you are making dietary recommendations, because the person who brings the pet to the ofﬁce may not be the person who will be implementing the new plan. Ask about how and where the food is stored (e.g., in a sealed container, in the refrigerator). If the pet is fed a dry food, is the food bought in large quantities, and how long does it take to use up a bag of food? Food can lose its freshness over time, especially if it is not stored under optimal conditions. Inquire about the pet’s normal feeding behavior. Is the pet an “easy keeper” or a picky eater? Does the pet eat the food as soon as it is offered, or is it content to graze throughout the day? Does the pet usually eat all the food that is offered? Does the pet beg for food between meals? If the pet is not eating as it normally does, ﬁnd out what has changed and for how long the behavior has been altered.

Treats, Supplements, and Exercise When inquiring about treats, ask the question several times in different ways. Ask speciﬁcally about which commercial treats are used—not just the brand name but also the ﬂavor, variety, and size. Ask about human foods and table scraps. Ask about products or foods that are used to promote chewing and dental hygiene or to alleviate boredom. Also inquire about different ways food may be used as a reward, such as for performing tricks or for good behavior during walks. Owners do not always

consider such items treats, and many of the products and foods used for these purposes are high in calories. It is important to remember to inquire whether the pet routinely receives any supplements or medications that are disguised with food. Human foods that are typically used to pill a dog or cat, such as cheese, lunch meats, or peanut butter, are often high in sodium, fat, and calories. For example, one study evaluating dogs with cardiac disease showed that 62% of the owners used human or pet food for pill administration and that many of these foods were high-sodium table foods such as cheese or lunch meats.1 One further point to ask about is the pet’s level of activity and opportunity to exercise. Is the pet walked regularly? How often, and how far? Find out whether the pet goes outside, has a fenced-in yard—and if so, how large— or participates in regular activities that involve exercise, such as going to a dog park or an agility class. See if you can gauge whether increasing the opportunity to exercise would be feasible in the household. This information is especially valuable when you are designing a weight reduction program for a patient.

Founded in 1988, the primary objective of the American College of Veterinary Nutrition (ACVN) is to advance the specialty area of veterinary nutrition and increase the competence of those who practice in this ﬁeld by establishing requirements for certiﬁcation in veterinary nutrition, encouraging continuing professional education, promoting research, and enhancing the dissemination of new knowledge of veterinary nutrition through didactic teaching and postgraduate programs. For more information, contact: American College of Veterinary Nutrition, c/o Dawn Cauthen, Administrative Assistant, School of Veterinary Medicine: Dept. of Molecular Biosciences One Shields Avenue Davis, California 95616-8741 Telephone: 530-752-1059 Fax: 530-752-4698 Email: dawncauthen@yahoo.com Web: acvn.org

Gathering the Information This may seem like a great deal of information to gather in a routine office visit, but the process can be expedited by having a diet history form available for clients to fill out while they are in the waiting room. As previously mentioned, the client may not be able to recall all of the information in the office and may need to take the form home. If your practice has a Web site, you can have a link to a downloadable version of the form so that clients can fill it out before the office visit. To help expedite the WEB EXCLUSIVE process, a veterinary technician familiar with taking diet histories can either gather Photocopy the diet history form the pertinent information on pages 47 and 48 for your clients, directly from a client during or download a customizable PDF the visit or review the diet of the same form from history form for completeness and accuracy once the CompendiumVet.com. client has filled it out.

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Negotiating a Diet Change

QuickNotes Making an effort to talk with pet owners about their beliefs, concerns, and expectations can result in better adherence to recommendations.

The information obtained in the diet history will be invaluable for making appropriate and, hopefully, acceptable dietary recommendations for your patients. Knowing a pet’s current diet and any recent changes to it will inform your decision about what kind of dietary modification may be necessary to address the pet’s health condition and what kind of diet the pet may find most acceptable. Being aware of owner preferences and potential obstacles to change will help you tailor your recommendations not only to the pet but also to the entire household to ensure the greatest probability of success and adherence. Understanding the client’s attitude toward, and concerns about, the dietary management of pet dogs and cats will present you with the opportunity to open a dialogue with the client about pet nutrition and educate him or her about the reasons for your recommendations. Investigations in human medicine have found that when physicians make an effort to talk with patients about their knowledge, beliefs, concerns, and expectations about their condition, the result is better adherence to treatment regimens.2 Exploration of all of these issues from a patient’s perspective on his or her illness permits the attending health professional to address deficiencies in knowledge or understanding of the condition and its treatment and the patient’s ability and willingness to pursue a particular course of therapy. In veterinary medicine, the owner speaks for the patient, but the same principle applies. With regard to dietary practices, despite a basic uniformity in nutritional requirements and physiologic needs, there is considerable variation in what humans eat. In the case of pet dogs and cats, their owners largely determine what they eat on a daily basis. Yet in many, if not most, cases, client education alone will not succeed in changing habits and behaviors relating to how a pet is fed. Just as a person’s social and cultural context will influence his or her own dietary habits, it will also have an impact on how and what that person feeds a pet. Therefore, it is important to consider the social and cultural aspects of owners’ food consumption in order to communicate effectively with them about their pets’ nutritional needs and appropriate dietary management, particularly if you are attempting to change current feeding practices.3

HEALTHY BITES

To get an accurate account of the foods fed to a pet on a typical day: Find out if you are speaking to the person responsible for feeding the pet. Have a diet history form available that the client can take home so he or she can check the labels and measure the amounts of food that the pet is fed (see pages 47 and 48 or CompendiumVet.com for a sample diet history form). Request that dry pet foods be measured with an 8-oz kitchen measuring cup. Ask speciﬁcally about the different treats and supplemental foods a pet might receive (e.g., commercial treats, table foods and scraps, oral hygiene products, foods used as rewards, foods used for administering pills, dietary supplements).

Conclusion The information that can be obtained from a diet history can greatly facilitate the process of implementing dietary therapy for a patient. It can help not only in making an appropriate diet selection and accurate feeding recommendations but also in understanding the pet owner’s rationale for current feeding practices and assessing any concerns that may arise from a diet change. By anticipating problems, you should be able to craft the dietary intervention in a way that will be acceptable to the pet’s household or, at the very least, to communicate more effectively with the pet owner about the rationale for the changes in feeding management. You will be in a better position to explain why you feel the changes you are proposing are in the pet’s best interest and to look for compromise when your recommendations and the pet owner’s preferences are in conﬂict. References 1. Freeman LM, Rush JE, Markwell PJ. Dietary patterns of dogs with cardiac disease. J Nutr 2002;132:1632S-1633S. 2. The “why”: a rationale for communication skills teaching and learning. In: Kurtz S, Silverman J, Draper J. Teaching and Learning Communication Skills in Medicine. 2nd ed. San Francisco: Radcliffe Publishing; 2005:13-27. 3. Michel KE. Unconventional diets for dogs and cats. Vet Clin North Am Small Anim Pract 2006;36:1269-1281.

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Letters The Curious Case of the Cat with the Munchies We found the article “Five Common Toxins Ingested by Dogs and Cats” extremely interesting and practical. We recently treated a 5-month-old domestic shorthaired cat for marijuana toxicity following ingestion of a “hash brownie.” The cat presented with perplexing sudden-onset neurologic signs and hypothermia (temperature 94.5°F [34.7°C]). With gentle coaxing, the owners admitted the source of the problem. (The brownie had been carefully wrapped in plastic ﬁlm and hidden but had disappeared while the patient was alone in the house. Clawed plastic and crumbs were found at the scene.) At the time, we found little information in the literature speciﬁcally on cases of feline marijuana ingestion. To our knowledge (and anecdotally), marijuana toxicity in cats is more likely to occur via inhalation when owners blow smoke in the cat’s face, rather than via dietary indiscretion, as is more common in dogs. In this case, we did not ascertain the ingested dose and did not know how long the patient would take to recover. Hypothermia persisted for approximately 24 hours. One of the signs not mentioned in the article by Drs. Luiz and Heseltine was marked polyphagia. During hospitalization, our patient ate ravenously. At one point, the patient defecated, passing a piece of a shoelace. This may have been ingested as a result of the cat’s marijuana-enhanced appetite before hospitalization, suggesting that gastrointestinal foreign bodies are a potential side effect of marijuana toxicity (as is chocolate toxicity, if marijuana is ingested in a brownie). The patient was discharged 3 days later when the neurologic signs resolved, although the owner reported that the cat had a “lazy eye” for 2 weeks after discharge.

Drs. Luiz and Heseltine mentioned drug testing as a means of confirming the diagnosis. We did not do this at the outset due to the client’s financial constraints. When we undertook a detailed literature search and realized so little was known about feline toxicity due to Cannabis sativa, we offered to cover the cost of toxicology testing. The owners allowed us to collect a urine sample from the patient via cystocentesis; however, the sample, collected 14 days after ingestion, returned a negative result. THC may be detectable in human urine samples for 4 to 6 weeks, but the time frame in which it remains detectable in samples from companion animal species is not known, according to the pathologist at the laboratory to which we submitted the sample (Dr. Bruce Duff at Symbion Vetnostics). The recommended time frame for submission of samples is within 48 hours of exposure to the toxin. In this case, we are confident the patient was suffering from marijuana toxicity. The negative urinalysis result may be due to the fact that a young, lean cat can metabolize marijuana relatively rapidly. Fortunately, these cases

CE Article #1

Five Common Toxins Ingested by Dogs and Cats Julie Ann Luiz, DVM University of Hawaii at Hilo

Johanna Heseltine, DVM, MS, DACVIM Oklahoma State University

ABSTRACT: Substances that are toxic to pets are present in most households. Early identification of intoxication is crucial to preventing or minimizing gastrointestinal absorption of toxins.The history, clinical signs, and laboratory test results can be used to make a presumptive diagnosis and begin therapy. nce absorbed from the gastrointestinal (GI) tract, many toxins lack a specific antidote and are associated with severe systemic effects that are difficult to treat. Therefore, prompt decontamination is the first step in managing patients that have ingested toxic materials. If the toxin ingested is known, therapy should be initiated before clinical signs develop. This article discusses the general principles for minimizing GI absorption of ingested toxins and the clinical presentation and management of toxicosis caused by five commonly ingested household substances: anticoagulant rodenticides, ethylene glycol (EG), marijuana, chocolate, and metaldehyde.

DECONTAMINATION STRATEGIES FOR ORALLY INGESTED TOXINS GI decontamination techniques are used to prevent or limit the absorption of ingested toxins. Because many toxins lack a specific antidote, decreasing the amount of toxin absorbed may be life saving, and decontamination strategies should begin as soon • Take CE tests as possible after ingestion of a • See full-text articles toxic substance. Most decontCompendiumVet.com amination methods practiced COMPENDIUM

in veterinary medicine are derived from the human medical literature. Decontamination and treatment strategies for the toxins discussed in this article are summarized in Table 1.

Emesis Induction If the owner suspects toxicosis and calls the clinic before presenting the animal, the veterinarian must consider the risks and benefits of instructing the owner to administer an emetic.1 Productive emesis requires the presence of food or liquid in the stomach, especially for retrieval of small volumes of toxin.2 Removal of the poison from the stomach is most effective within 1 hour of ingestion, is useful up to 2 hours after ingestion, and is of limited benefit more than 4 hours after ingestion.2,3 Early emesis may remove up to 80% of the ingested material.3 Induction of emesis is contraindicated for corrosive and caustic materials, as well as for petroleum distillates and other volatile materials that may result in aspiration pneumonia. 2,3 Vomiting should not be induced in patients that are depressed or have decreased consciousness or those that have seizures or are likely to seizure.2,3 Emetics should not be administered if the patient has already vomited.2

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November 2008

are rare and—when they do occur— carry a good prognosis. Nonetheless, we encourage colleagues treating known or strongly suspected cases of marijuana toxicity to submit samples for toxicology screening and to share their data. Drs. Anne Fawcett and Angela Phillips Sydney Animal Hospitals Inner West Stanmore, NSW Australia

DO YOU HAVE SOMETHING TO SAY? Send your letters, suggestions, comments, or questions to E-MAIL editor@ CompendiumVet.com FAX 800-556-3288 WRITE Compendium, Veterinary Learning Systems 780 Township Line Road, Yardley, PA 19067

More letters are online at CompendiumVet.com

CompendiumVet.com | January 2009 | Compendium: Continuing Education for Veterinarians®

Antioxidants in Cancer Treatment: Helpful or Harmful? ❯❯ Lisa M. Freeman, DVM, PhD, DACVN,a Tufts University

Abstract: Nutrition is an important component of the care of dogs and cats with cancer, and dietary supplement use is common in this patient population. Antioxidants are thought to be among the most commonly used supplements. While antioxidants have potential benefi ts for cancer patients, they also may have detrimental effects. Therefore, information regarding the overall diet, including dietary supplements, should be collected for every cancer patient and carefully assessed, with specific attention to antioxidants, to identify areas in which the patient’s medical care can be optimized. eterinarians are commonly faced with to avoid excesses of overall calories and indiquestions from pet owners about nutri- vidual nutrients. Obesity resulting from excestion, but when an animal has cancer, sive caloric intake is a common problem in such questions are even more likely. Most own- animals with cancer.1,2 Body weight, body ers of dogs and cats with cancer want to know condition score, and muscle condition (i.e., everything from whether diet contributed to whether muscle loss is occurring) should be the development of the cancer to whether assessed at each visit. Obtaining a thorough they should change their pet’s diet to whether diet history allows the veterinarian to deterdietary supplements should be administered mine whether the animal is eating an approas part of their pet’s treatment. Advertisements priate diet, whether deficiencies or excesses for dietary supplements abound in magazines are likely to occur, and whether components for pet owners and veterinarians alike, and it of the diet are working with or against the can be tempting for owners of pets with can- selected therapeutic plan for the patient. This cer to believe the claims of disease treatments information can then be used to make necesor cures that are supposed to come from a sary modifications to ensure optimal care. few pills. If owners do not ask their veterinarians questions about these claims, they often The Importance of Diet History use the Internet to try to get the answers for Dietary supplementation is extremely comthemselves. Therefore, it is important to be mon in today’s society. More than half of all aware of both the potential benefits and risks Americans take dietary supplements on a regular basis.4–6 Fewer pets in the general populaof dietary supplements. tion receive dietary supplements; in one study Nutrition in Pets With Cancer of pet owners, approximately only 10% of dogs Nutrition should be an integral part of the and cats were receiving supplements, with management of every cancer patient. Cancer multivitamins, chondroprotectives, and fatty patients may be predisposed to weight loss, acid supplements being the most common.7 malnutrition, and specific nutrient deficien- However, in populations with disease condicies during treatment. Therefore, it is impor- tions, dietary supplement use is higher. Dietary tant to maintain optimal weight and prevent supplements are used in 31% of dogs and 13% nutritional deficiencies in these patients to of cats with cardiac disease, respectively,8,9 and improve their outcome.1–3 It is also important in >50% of dogs and cats with cancer.10 People

QuickNotes It is important to maintain optimal weight and prevent nutritional deﬁciencies in cancer patients to improve their outcome.

Dr. Freeman discloses that she has received research funding from Nestlé Purina PetCare, Boehringer Ingelheim, and the Waltham Centre for Pet Nutrition and that she has served on a Nestlé Purina Scientiﬁc Advisory Council.

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Compendium: Continuing Education for Veterinarians® | April 2009 | CompendiumVet.com

What do dogs who take e VETORYL (trilostane) have in common? ®

Results like these.

Prior to VETO RYL treatment

Effective treatment for Cushing’s syndrome is now FDA approved. You now have easy access to the most powerful weapon in the fight against canine Cushing’s syndrome. VETORYL Capsules are the only licensed treatment available for both pituitary-dependent and adrenal-dependent hyperadrenocorticism.

treatment Following 3 months of with VETORYL

VETORYL Capsules contain the active ingredient trilostane, which blocks the excessive production of cortisol. Daily administration of VETORYL can greatly reduce the clinical signs associated with Cushing’s syndrome, enhancing the quality of life for both dog and owner. For more information, visit www.VETORYL.com. Contact your local veterinary distributor to order VETORYL Capsules today!

Following 9 months of treatment with VETO RYL

(trilostane)

Photographs courtesy of Carlos Melian, DVM, PhD

VETORYL is a trademark of Dechra Ltd. ©2009, Dechra Ltd. NADA 141-291, Approved by FDA As with all drugs, side effects may occur. In field studies, the most common side effects reported were poor/reduced appetite, vomiting, lethargy, diarrhea, and weakness. Occasionally, more serious side effects, including severe depression, hemorrhagic diarrhea, collapse, hypoadrenocortical crisis, or adrenal necrosis/rupture may occur, and may result in death. VETORYL Capsules are not for use in dogs with primary hepatic or renal disease, or in pregnant dogs. Refer to the prescribing information for complete details or visit www.VETORYL.com. VTYL0209-01-47122-CPD

See Page 156 for Product Information Summary

VETORYL Capsules (trilostane) ®

30 mg and 60 mg strengths Adrenocortical suppressant for oral use in dogs only

with chronic diseases use supplements even more commonly than the general population, and only a small proportion of these patients tell their health care providers about their supplement use.11 With the increase in supplement use in populations with diseases comes an increased risk for interaction between supplements or between supplements and medications. Because animals with cancer are one of the most likely populations to be receiving dietary supplements, an important part of a thorough diet history is to specifically ask owners if they are giving supplements to their pets. A thorough diet history is one of the keys to providing optimal care for animals with cancer. Questions should include the specific food (brand and specific type), amounts and frequency of feeding, types and amounts of treats and table foods, whether the animal is eating an unconventional diet (e.g., homemade, raw meat), and whether dietary supplements are being used. Dietary supplements can be a particular issue because owners often do not consider them to be either drugs or part of the diet. Therefore, if owners are not specifically questioned about the use of dietary supplements, they usually do not mention them. Veterinarians should ask about the types, brands, and doses of supplements being administered. This information can help to determine whether supplements are being used and dosed appropriately and whether they might interact with any drugs or nutrients being used as therapy.

BRIEF SUMMARY (For Full Prescribing Information, see package insert.) CAUTION: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. DESCRIPTION: VETORYL is an orally active synthetic steroid analogue that blocks production of hormones produced in the adrenal cortex of dogs. INDICATIONS: VETORYL Capsules are indicated or the treatment of pituitary-dependent hyperadrenocorticism in dogs. VETORYL Capsules are indicated for the treatment of hyperadrenocorticism due to adrenocortical tumor in dogs. CONTRAINDICATIONS: The use of VETORYL Capsules is contraindicated in dogs that have demonstrated hypersensitivity to trilostane. Do not use VETORYL Capsules in animals with primary hepatic disease or renal insufficiency. Do not use in pregnant dogs. Studies conducted with trilostane in laboratory animals have shown teratogenic effects and early pregnancy loss. WARNINGS: In case of overdosage, symptomatic treatment of hypoadrenocorticism with corticosteroids, mineralocorticoids and intravenous fluids may be required. Angiotensin-converting enzyme (ACE) inhibitors should be used with caution with VETORYL Capsules, as both drugs have aldosterone-lowering effects which may be additive, impairing the patient’s ability to maintain normal electrolytes, blood volume and renal perfusion. Potassium-sparing diuretics (e.g., spironolactone) should not be used with VETORYL Capsules as both drugs have the potential to inhibit aldosterone, increasing the likelihood of hyperkalemia. HUMAN WARNINGS: Keep out of reach of children. Not for human use. Wash hands after use. Do not empty capsule contents and do not attempt to divide the capsules. Do not handle the capsules if pregnant or if trying to conceive. Trilostane is associated with teratogenic effects and early pregnancy loss in laboratory animals. In the event of accidental ingestion/overdose, seek medical advice immediately and take the labeled container with you. PRECAUTIONS: Hypoadrenocorticism can develop at any dose of VETORYL Capsules. A small percentage of dogs may develop corticosteroid withdrawal syndrome within 10 days of starting treatment. Mitotane (o,p’-DDD) treatment will reduce adrenal function. Experience in foreign markets suggests that when mitotane therapy is stopped, an interval of at least one month should elapse before the introduction of VETORYL Capsules. The use of VETORYL Capsules will not affect the adrenal tumor itself. Adrenalectomy should be considered as an option for cases that are good surgical candidates.

QuickNotes

There is a great deal of controversy among human oncologists as Antioxidants to whether antioxiAntioxidants are thought to be among the most comdants are beneﬁcial, monly used dietary supplements in animals with cancer. They are typically administered with the goal of innocuous, or aiding in the treatment of cancer, enhancing immune detrimental.

function, or reducing treatment toxicity. Endogenous antioxidants include enzymes (e.g., glutathione peroxidase, superoxide dismutase), free radical scavengers (e.g., vitamins A, C, and E), and metal chelators (e.g., transferrin). Normally, these antioxidants compensate for the production of oxidants known as reactive oxygen species (e.g., hydrogen peroxide, superoxide anions, hydroxyl radicals), which are normal by-products of

ADVERSE REACTIONS: The most common adverse reactions reported are poor/reduced appetite, vomiting, lethargy/dullness, diarrhea, and weakness. Occasionally, more serious reactions including severe depression, hemorrhagic diarrhea, collapse, hypoadrenocortical crisis, or adrenal necrosis/rupture may occur, and may result in death. ORY FORM DIET HIST Stamp clinic

information below:

_______ ________________ ________________ ________ Date: ________ ________________ ________________ Case Number: n _______ Owner Informatio ________________ ________________ ________ Name: ________ ________________ ________ ________________ Email address: ________________ ________________ __________ Phone (home): ________________ __________ ________________ Phone (cell): ________________ call:_____________ Best time to

DIET HISTORY FORM Behavior

❏ Yes

❏ No

How does your pet act toward towa food? ❏ Greedy ❏ Indifferen Indifferent ❏ Shows avoidance Has your pet’s attitude toward towa food changed? If so, describe: _______________________ ________________________ ________________________ ____ _______________________ ________________________ ________________________ ____ _______________________ ________________________ ________________________ ____ _______________________ ________________________ ________________________ ____ If you have other pets, is this pet dominant or submissive to them? ❏ Dominant ❏ Submis Submissive Has your pet recently lost or ggained weight? If so, please describe: _______________________ ________________________________________________ ____ ________________________________________________ ____ ________________________________________________ ____ ________________________________________________ ____ Have there been any recent ch changes in activity level? __________ ________________________________________________ ____ ________________________________________________ ____ ________________________________________________ ____ Have you observed any of the ffollowing: Nausea/salivation ❏ Yes ❏ No Diffificulty chewing ❏ Yes ❏ No Diffificulty swallowing ❏ Yes ❏ No Vomiting ❏ Yes ❏ No Diarrhea ❏ Yes ❏ No Constipation ❏ Yes ❏ No Have there been any changes in urination? ❏ Yes ❏ No

the day? for your pet during ed food sources Is food left out other, unmonitor have access to cats)? Does your pet food left for outdoor by neighbor, (e.g., treats fed _______ ❏ Yes ❏ No ________________ ____ describe:_________ If yes, please ________________ ________________ ____ ________________ ________________ ________________ ____ ________________ ________________ ________________ ____ ________ ________ ________________ ________________ to each other’s ________________ _ have access one pet, do they ________________ than Reason for Visit more ________ If you have ____ please describe: ________________ ❏ No If yes, ________________ ___________ ____________ food? ❏ Yes ________________ ________________ ____________ ________ ____ ________ ________________ ________________ ________________ ________________ ________________ ________________ ____________ ________________ ________________ ________ ____ ___ hics ________ ________________ ________________ Household Demograp ? ________ ________________ ____ are in your household are they? ________________ ________________ How many adults , and how old ________________ ____ ____ are in your household ________________ ________________ ________________ How many children ________________ ____ ________________ ____________ ________________ ________________ ________________ ________________ ________ ________ ____ ________ ________________ ________________ ________________ ________________ food? ________ ____ ________________ store your pet’s ____________ How do you ________________ ________________ ________________ ________ ________ ____ ________ ❏ Both ❏ Outdoors ________________ ________________ ________________ ❏ Indoors ________________ pet housed? ____________ please list species ________________ Where is your ❏ No If so, ________________ Yes ❏ ________ other pets? ________________ Do you have or outdoors. ____ they live indoors Diet and specify if ________________ ____ ________________ Activity For each of the following categories, catego ________________ ________________ list the brand names (if appliyour pet? ____ ________________ cable) and amounts of all foods your How active is ❏ Average pet eats daily, as well as how ________________ ________________ Very active ❏ ________ e often each food is fed (e.g., twice ____ ________ twic a day). ❏ Hyperactiv ________________ ________________ ❏ Hardly moves Commercial foods ____ ________________ ❏ Not very active ________________ ________________ your pet walked? ________________________________________________ ________________ ❏ Once a day __ How often is ____ ________________ ❏ 1-2 times/day times/day ________________________________________________ ❏ At least 3 __ ____ ____ ent Never No ❏ ________ ❏ ________________________________________________ ❏ Yes Feeding Managem ❏ Seldom __ ________________ ____ ____ feeds your pet? access to a yard? ________________ ❏ Yes ❏ No ________________________________________________ Who typically Do you have __ pet? ____ ____ ________________ your No ________ ________ exercise ________ ________________________________________________ ________ ❏ Yes ❏ Is it difﬁcult to ___ ________________ ____ __________ be increased? ________________ ❏ Yes ❏ No Commercial treats; dental hygiene products ________________ Can exercise ____ training? pet fed? ________ participated in ________________ When is your ❏ Yes ❏ No ________________________________________________ Has your pet ___ ____ ________________ competition? ____ participated in ________________ ________________ ________________________ Has your pet Systems ___ ________________________ ____ ________________ Learning ____ ________ ________ ©2009 Veterinary ________ ________ ________________________________________________ ___ ________________ ____ ________________ ________________________________________________ ___ ____ ________________________________________________ ___ ____

(trilostane)

n Age: ________ Pet Informatio __________ ________________ ___________ Name: ________ Breed: ________ _____________ ❏ Yes ❏ No Species: ________ Neutered/spayed: ❏ Female _____________ Gender: ❏ Male Usual weight: _____________ Current weight: _____ score (1–9): ❏ Severe Body condition None ❏ Mild wasting ❏ muscle of Evidence

Distributed by: Dechra Veterinary Products 7015 College Boulevard, Suite 525 Overland Park, KS 66211 www.VETORYL.com 866-933-2472 VETORYL is a trademark of Dechra Ltd. © 2009, Dechra Ltd. NADA 141-291, Approved by FDA

Table foods or scraps; home-prepared

foods

________________________________________________ ____ ________________________________________________ ____ ________________________________________________ ____ ________________________________________________ ____ ________________________________________________ ____ Dietary supplements; food used to give pills ________________________________________________ ____ ________________________________________________ ____ ________________________________________________ ____ ________________________________________________ ____ ________________________________________________ ____ List anything else given by mouth (e.g., medications): ________________________________________________ ____ ________________________________________________ ____ ________________________________________________ ____ ________________________________________________ ____ ________________________________________________ ____ ________________________________________________ ____ Is your pet’s current diet a change from its typical diet? ❏ Yes

❏ No

If so, please describe the change and why the diet was changed. ________________________________________________ ____ ________________________________________________ ____ ________________________________________________ ____ ________________________________________________ ____ ________________________________________________ ____ ________________________________________________ ____ Are you open to making a change in your pet’s diet? ❏ Yes ❏ No What are your pet’s food preferences?______________ ________ ________________________________________________ ____ ________________________________________________ ____ ________________________________________________ ____ What foods does your pet refuse? ________________________ _ ________________________________________________ ____ ________________________________________________ ____ ________________________________________________ ____ Are there foods to which your pet is allergic? ❏ Yes ❏ No If so, which foods? ________________________ ____________ ________________________________________________ ____ ________________________________________________ ____ ________________________________________________ ____ ©2009 Veterinary Learning Systems

156

WEB EXCLUSIVE Download a customizable PDF of the diet history form from

CompendiumVet.com.

Compendium: Continuing Education for Veterinarians® | April 2009 | CompendiumVet.com

CONTRIBUTED BY THE AMERICAN COLLEGE OF VETERINARY NUTRITION

aerobic metabolism. However, when oxidant production is excessive or antioxidant production is insufficient, an imbalance known as oxidative stress occurs. Excessive oxidants damage DNA, lipids, and proteins and increase the production of inflammatory mediators, among other deleterious effects. It has been hypothesized that oxidative stress increases the risk for certain types of cancer, and it is theorized to play an important role in the aging process. Therefore, antioxidants (both endogenous and supplemental) have been extensively studied in terms of their efficacy in reducing the development of cancer, with variable success. Another area of great interest and controversy is the use of antioxidants during the treatment of cancer, whether alone or in conjunction with chemotherapy or radiation therapy. Antioxidants have a number of potential benefits in cancer patients. Oxidative stress has been associated with increased morbidity and mortality for a number of human cancers, and recent studies have demonstrated oxidative stress in dogs with mammary tumors and lymphoma.12–14 Reactive oxygen species can contribute to malignant transformation and neoplastic cell proliferation and so could contribute to disease progression. Therefore, boosting antioxidant reserves and reducing oxidative stress might reduce tumor growth or metastasis. Another potential benefit of antioxidants is protection against radiation- and chemotherapyinduced adverse effects (e.g., gastrointestinal, renal, and cardiac toxicities); some, but not all, studies in rodent models and people have shown modest benefits. These potential benefits are the rationale behind the high use of various antioxidants during cancer treatment. However, there also are potential detrimental effects of antioxidants in patients undergoing treatment for cancer. The efficacy of radiation therapy and of many chemotherapeutic agents depends on the development of reactive oxygen species. Therefore, reduced treatment efficacy is possible if antioxidants are used concurrently with these therapies. Because of these competing effects, there is a great deal of controversy among human oncologists as to whether antioxidants are beneficial, innocuous, or detrimental.15–17 Antioxidants do not all behave similarly, and some have significantly different effects depending on their dose and form and what other medications and supple-

About ACVN

BOX 1 HEALTHY BITES

Recommended Web Sites www.acvn.org The American College of Veterinary Nutrition Offers a “Nutrition Resources” page that includes contact information for ACVN diplomates who do nutrition consultations or formulate homemade diets. www.consumerlab.com Consumerlab.com This group performs independent testing of dietary supplements for purity, potency, and bioavailability. vm.cfsan.fda.gov/~dms/supplmnt.html The US Food and Drug Administration Center for Food Safety and Applied Nutrition Resource for regulatory and safety issues, adverse event reporting, meetings, and industry information. www.mayoclinic.com/health/ druginformation/DrugHerbIndex The Mayo Clinic Lists information and grades recommendations for the use of some drugs and supplements. nccam.nih.gov National Institutes of Health National Center for Complementary and Alternative Medicine Provides information on research into complementary and alternative healing practices. dietary-supplements.info.nih.gov National Institutes of Health Ofﬁce of Dietary Supplements Includes fact sheets, safety notices, and the International Bibliographic Information on Dietary Supplements database. www.quackwatch.org Quackwatch This site calls itself a “guide to health fraud, quackery, and intelligent decisions.” www.nal.usda.gov/fnic/etext/000015.html The US Food and Drug Administration Food and Nutrition Information Center Includes general supplement and nutrition information and links to a variety of dietary supplement Web sites.

Founded in 1988, the primary objective of the American College of Veterinary Nutrition (ACVN) is to advance the specialty area of veterinary nutrition and increase the competence of those who practice in this ﬁeld by establishing requirements for certiﬁcation in veterinary nutrition, encouraging continuing professional education, promoting research, and enhancing the dissemination of new knowledge of veterinary nutrition through didactic teaching and postgraduate programs. For more information, contact: American College of Veterinary Nutrition, c/o Dawn Cauthen, Administrative Assistant, School of Veterinary Medicine: Dept. of Molecular Biosciences One Shields Avenue Davis, California 95616-8741 Telephone: 530-752-1059 Fax: 530-752-4698 Email: dawncauthen@yahoo.com Web: acvn.org

QuickNotes Once veterinarians determine what foods and supplements owners are giving their pets, they may need to gather additional information about their safety, efﬁcacy, and potential for interaction.

www.usp.org/USPVerified US Pharmacopeia Dietary Supplement Verification Program (voluntary) This group performs independent testing of “dietary supplement finished products” for purity, potency, and quality and awards its Verified Dietary Supplement Mark to products that meet its criteria.

CompendiumVet.com | April 2009 | Compendium: Continuing Education for Veterinarians®

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ments are being concurrently administered. Therefore, evaluating whether one has benefits (or adverse effects) can be a complicated endeavor. In addition to the specific pros and cons of antioxidants are the general issues that are of concern with all human and veterinary dietary supplements: safety, efficacy, dose, bioavailability, dissolvability, and quality control. Until additional data are available, I recommend against the use of antioxidants during radiation therapy or chemotherapy in dogs and cats with cancer.

Conclusion Once veterinarians determine what foods and supplements owners are giving their pets, they may need to gather additional information about their safety, efﬁcacy, and potential for interaction with each other and other therapies. Some of the Web sites listed in BOX 1 can be useful for this purpose. Because there is little governmental regulation of dietary supplements, pet owners should consider selecting dietary supplements that bear the logo of the Dietary Supplement Veriﬁcation Program, which tests human dietary supplements for ingredients, concentrations, dissolvability, and contaminants. Another good resource is Consumerlab.com, which performs independent testing of health and nutrition products (primarily human supplements, but also some pet products). As of 2008 (2009 or 2010 for smaller companies), the US Food and Drug Administration is instituting regulations that require supplements to be made using Good Manufacturing Practices and to meet quality standards.18

References 1. Michel KE, Sorenmo K, Shofer FS. Evaluation of body condition and weight loss in dogs presented to a veterinary oncology service. J Vet Intern Med 2004;18:692-695. 2. Weeth LP, Fascetti AJ, Kass PH, et al. Prevalence of obese dogs in a population of dogs with cancer. Am J Vet Res 2007;68:389-398. 3. Baez JL, Michel KE, Sorenmo K, Shofer FS. A prospective investigation of the prevalence and prognostic significance of weight loss and changes in body condition in feline cancer patients. J Feline Med Surg 2007;9:411-417. 4. Balluz LS, Kieszak MA, Philen RM, et al. Vitamin and mineral supplement use in the United States: results from the third national health and nutrition examination survey. Arch Fam Med 2000;9:258-262. 5. Balluz LS, Okoro CA, Bowman BA, et al. Vitamin or supplement use among adults, behavioral risk factor surveillance system, 13 states, 2001. Public Health Rep 2005;120:117-123. 6. Archer SL, Stamler J, Moag-Stahlberg A, et al. Association of dietary supplement use with speciﬁc micronutrient intakes among middle-aged American men and women: the INTERMAP study. J Am Diet Assoc 2005;105:1106-1114. 7. Freeman LM, Abood SK, Fascetti AJ, et al. Disease prevalence among dogs and cats in the United States and Australia and proportions of dogs and cats that receive therapeutic diet or dietary supplements. JAVMA 2006;229:531-534. 8. Freeman LM, Rush JE, Cahalane AK, et al. Dietary patterns in dogs with cardiac disease. JAVMA 2003; 223:1301-1305.

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9. Torin DS, Freeman LM, Rush JE. Dietary patterns of cats with cardiac disease. JAVMA 2007;230:862-867. 10. Lana SE, Kogan LR, Crump KA, et al. The use of complementary and alternative therapies in dogs and cats with cancer. JAAHA 2006;42:361-365. 11. Ball SD, Kertesz D, Moyer-Mileur LJ. Dietary supplement use is prevalent among children with a chronic disease. J Am Diet Assoc 2005;105:78-84. 12. Szczubial M, Kankofer M, Lopuszynski W, et al. Oxidative stress parameters in bitches with mammary gland tumours. J Vet Med A Physiol Pathol Clin Med 2004;51:336-340. 13. Vajdovich PT, Kriska T, Mezes M, et al. Redox status of dogs with non-Hodgkin lymphomas. An ESR study. Cancer Lett 2005;224:339-346. 14. Winter JL, Barber L, Griessmayr PC, et al. Antioxidant status and biomarkers of oxidative stress in canine lymphoma. J Vet Intern Med 2009;23:311-316. 15. D’Andrea GM. Use of antioxidants during chemotherapy and radiotherapy should be avoided. CA Cancer J Clin 2005;55:319-321. 16. Block KI, Koch AC, Mead MN, et al. Impact of antioxidant supplementation on chemotherapeutic efﬁcacy: A systematic review of the evidence from randomized controlled trials. Cancer Treat Rev 2007;33:407-418. 17. Moss RW. Do antioxidants interfere with radiation therapy for cancer? Integr Cancer Ther 2007;6:281-292. 18. United States Food and Drug Administration. Fact sheet: dietary supplement current good manufacturing practices (CGMPs) and interim ﬁnal rule (IFR) facts. Accessed March 2009 at www.cfsan.fda.gov/~dms/dscgmps6.html.

Compendium: Continuing Education for Veterinarians® | April 2009 | CompendiumVet.com

Bayer_Baytril_USE.qxp:1

3/18/09

2:56 PM

Page 1

. . . trust me! . . . you’ll be ﬁne!

My patients rely on me every day. And I rely on Baytril®. Because when it comes to infections, it’s on my side – an eﬀective partner I can count on. Federal (U.S.A.) law restricts this drug to use by or on the order of a licensed veterinarian. In animal safety studies, isolated incidences of vomition and inappetence were reported. © 2009 Bayer HealthCare LLC, Animal Health Division, Shawnee Mission, Kansas 66201. Bayer, the Bayer Cross, Baytril and Right the ﬁrst time are registered trademarks of Bayer.

See Page 158 for Product Information Summary

B090123n

US Pet Food Regulation:

Hot Topics

❯❯ David A. Dzanis, DVM, PhD, DACVNa Dzanis Consulting & Collaborations Santa Clarita, California

Abstract: The US Food and Drug Administration (FDA) Amendments Act of 2007 mandates promulgation of new federal regulations regarding processing, ingredient, and labeling standards for pet foods. Veterinary organizations have submitted comments to assist FDA in this matter. The Association of American Feed Control Ofﬁcials (AAFCO) is also considering changes that will affect state regulation of pet foods, including revision of the AAFCO Dog and Cat Food Nutrient Proﬁles and feeding trial protocols, an American College of Veterinary Nutrition proposal to mandate calorie content statements on all dog and cat food labels, and new Good Manufacturing Practices regulations for all animal feeds.

At a Glance US Food and Drug Administration Page 462

Association of American Feed Control Ofﬁcials Page 463

Dr. Dzanis is a consultant for the pet food and related industries on matters pertaining to nutrition, labeling, and regulation. He formerly served as the veterinary nutritionist for the US Food and Drug Administration and represented the agency on the Association of American Feed Control Ofﬁcials Pet Food Committee.

462

everal changes to the means by which do not specify rules for declaration of nutrient pet foods are regulated are forthcom- content, substantiation of nutritional adequacy, ing. Some of these changes are in reac- or other important aspects of pet food labeltion to the widely reported recall of dog and ing.1 These issues are instead addressed in the cat foods in 2007, while others were under regulations of states that have adopted the way well before the recall. In both cases, vet- Association of American Feed Control Officials erinary organizations are involved in the pro- (AAFCO) Model Bill and Regulations.2 cess. Because pet owners often consult with veterinarians on matters relating to pet food, FDA Amendments Act of 2007 it behooves practitioners to be familiar with Subsequent to a hearing regarding the 2007 recall, the US Congress passed the FDA these developments. Amendments Act of 2007 (FDAAA).3 Most of US Food and Drug Administration the FDAAA does not pertain to pet foods, but The Center for Veterinary Medicine within the what it does include with respect to pet foods US Food and Drug Administration (FDA) has is far-reaching. The responsibility is placed authority over all animal feeds in interstate on FDA to improve its abilities to detect and commerce. While this authority includes pet respond to future incidents involving pet foods (complete and balanced foods, treats, food–borne illness, including better communisupplements, and edible chews), there are no cation with both the public and industry on federal regulations stipulating requirements for the status of recalls. Establishment of a reportpet foods specifically (with minor exceptions, able food registry, wherein pet food compasuch as specifying the conditions of use for nies must promptly report incidents that may iron oxide as a coloring agent in dog and cat lead to unsafe products, is also a component of foods). For example, while FDA regulations set the FDAAA. This mandatory reporting system forth the basic labeling requirements for all ani- went into effect in September 2009.4 While the words themselves are few (BOX 1), mal feeds (e.g., statement of identity, net weight declaration, ingredient declaration, manufac- the FDAAA requirement for FDA to establish turer’s or distributor’s name and address), they specific pet food regulations, especially with

Compendium: Continuing Education for Veterinarians® | October 2009 | CompendiumVet.com

CONTRIBUTED BY THE AMERICAN COLLEGE OF VETERINARY NUTRITION About ACVN regard to nutrition and labeling, may have the biggest impact on commercial pet foods. FDA has invited public comments on this matter, and the American College of Veterinary Nutrition (ACVN), American Academy of Veterinary Nutrition (AAVN), and AVMA have all submitted recommendations. Among the many issues raised by these organizations are the need for calorie content statements, replacement of the crude ﬁber label guarantee with a more nutritionally relevant measure, and wording on therapeutic diet labels to advise veterinarians and the public that efﬁcacy claims for such products may not have been subject to regulatory scrutiny. The complete comments of these groups, as well as those of other organizations and individuals, may be viewed by visiting regulations.gov (search on “FDA-2007-N-0442” in the “Keyword” box). While the FDAAA mandates that these regulations be promulgated by September 2009, the proposed rules had not been made available for public review and comment at the time this article went to press.

Other Actions For years before the 2007 recall, FDA had been developing its Animal Feed Safety System (AFSS), a “comprehensive” and “risk-based” program designed to “identify and address gaps” in the management of risk to human and animal health from exposure to animal feeds (including pet foods).5 Components of the system include the ingredient approval process, contaminant limits, process control (i.e., Good Manufacturing Practices; GMPs), and regulatory oversight. FDA has been intimately involved in the AAFCO process for many years. In August 2007, FDA and AAFCO signed a Memorandum of Understanding with respect to the latter’s Feed Ingredient Deﬁnition procedure.2 While not the same as a formal Food Additive Petition under FDA regulations, this memorandum increases FDA oversight of the AAFCO procedures for new, amended, or deleted ingredients. FDA has also commissioned a report from the National Research Council (NRC) to help in its safety assessment of novel ingredients.6

BOX 1 EXCERPT FROM THE FDAAA AFFECTING PET FOODS3

SEC. 1002. ENSURING THE SAFETY OF PET FOOD. (a) Processing and Ingredient Standards. Not later than 2 years after the date of the enactment of this Act, the Secretary of Health and Human Services (referred to in this title as the “Secretary”), in consultation with the Association of American Feed Control Ofﬁcials and other relevant stakeholder groups, including veterinary medical associations, animal health organizations, and pet food manufacturers, shall by regulation establish (1) ingredient standards and deﬁnitions with respect to pet food; (2) processing standards for pet food; and (3) updated standards for the labeling of pet food that include nutritional and ingredient information.

Association of American Feed Control Ofﬁcials Nutritional Adequacy

Founded in 1988, the primary objective of the American College of Veterinary Nutrition (ACVN) is to advance the specialty area of veterinary nutrition and increase the competence of those who practice in this ﬁeld by establishing requirements for certiﬁcation in veterinary nutrition, encouraging continuing professional education, promoting research, and enhancing the dissemination of new knowledge of veterinary nutrition through didactic teaching and postgraduate programs. For more information, contact: American College of Veterinary Nutrition, c/o Dawn Cauthen, Administrative Assistant, School of Veterinary Medicine: Dept. of Molecular Biosciences One Shields Avenue Davis, California 95616-8741 Telephone: 530-752-1059 Fax: 530-752-4698 Email: dawncauthen@yahoo.com Web: acvn.org

The AAFCO Model Regulations for Pet Food and Specialty Pet Food establish minimum nutritional requirements for dog and cat foods labeled as “complete and balanced” or identiﬁed by similar terminology.2 Before the 1990s, one method of nutritional adequacy substantiation was based on the product meeting NRC recommendations for minimum nutrient content. However, because of problems with using the NRC recommendations (which were largely based on feeding of puriﬁed laboratory diets) as they related to the practicalities

TO LEARN MORE

Dr. Dzanis’ previous article on pet food regulation, “Regulation of Pet Foods in the United States” (July 2009), is available on CompendiumVet.com.

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of commercial pet food production, an expert At the same time, the panel instituted changes panel comprising members from academia to improve the scientific rigor of the AAFCO and the industry was convened by AAFCO to feeding trial protocols (an alternative means of address these issues.7 The result of the pan- substantiating nutritional adequacy). el’s deliberation was the AAFCO Dog and Cat Neither the profiles nor the protocols have Food Nutrient Profiles, which are still in use. been revised since 1995. In 2006, NRC pubBOX 2 ACVN PROPOSAL TO AAFCO REGARDING CALORIE CONTENT STATEMENTS ON DOG AND CAT FOOD LABELSa

QuickNotes A mandatory reporting system for incidents that may lead to unsafe pet food products went into effect in September 2009.

Regulation PF9. Statements of Calorie Content (a) Except as required in PF(10), tThe label of a dog or cat food mayshall bear a statement of calorie content when the labeland meets all of the following: (1) The statement shall be separate and distinct from the “Guaranteed Analysis” and appear under the heading “Calorie Content”; (2) The statement shall be measured in terms of metabolizable energy (ME) on an “as fed” basis and must be expressed both as “kilocalories per kilogram” (“kcal/kg”) of product, and may also be expressedas kilocalories per familiar household measure (e.g., cans, cups, poundsbiscuits); and (3) The calorie content is determined by one of the following methods: A. By calculation using the following “Modified Atwater” formula: ME (kcal/kg) = 10[(3.5 × CP) + (8.5 × CF) + (3.5 × NFE)] Where: ME = Metabolizable Energy CP = % crude protein “as fed” CF = % crude fat “as fed” NFE = % nitrogen-free extract (carbohydrate) “as fed” And the percentages of CP and CF are arithmetic averages from proximate analyses of at least four production batches of the product, and the NFE is calculated as the difference between 100 and the sum of CP, CF, and the percentages of crude fiber, moisture, and ash (determined in the same manner as CP and CF); or B. In accordance with a testing procedure established by AAFCO. (4) An affidavit shall be provided upon the request of ____, substantiating that the calorie content was determined by: A. Regulation PF9(a)(3)A in which case the summary data used in the calculation shall accompany the affidavit; or B. Regulation PF9(a)(3)B in which case the summary data used in the determination of calorie content shall accompany the affidavit. (5) The calorie content statement shall appear as one of the following: A. The claim on the label or other labeling shall be followed parenthetically by the word “calculated” when the calorie content is determined in accordance with Regulation PF9(a)(3)A; or B. The claim on the label or other labeling shall be followed parenthetically by the word “fed” when the calorie content is determined in accordance with Regulation PF9(a)(3)B, and tThe value of calorie content stated on the label which is determined in accordance with Regulation PF9(a)(3)B shall not exceed or understate the value determined in accordance with PF9(a)(3)A by more than 15%. (b) Comparative claims shall not be false, misleading, or given undue emphasis and shall be based on the same methodology for the products compared. aAs originally proposed in 2005 (some revisions have been made as deliberations continue). Proposed additions and deletions

are in underline and strikethrough, respectively.

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Compendium: Continuing Education for Veterinarians® | October 2009 | CompendiumVet.com

lished a new document on the nutrient requirements of dogs and cats, including updated scientific information as well as practical considerations pertaining to pet food production.8 Currently, AAFCO has convened a new panel of experts to review the NRC publication and update the profiles as appropriate, as well as to review and revise the feeding protocols to further their scientific soundness. Some portions of the panel’s report are expected to be released for public comment in 2010.

Calorie Content Presently, except for dog and cat food products labeled lite, low calorie, less calories, or like terms, calorie content declarations on pet food labels are voluntary. As a result, many dog and cat food labels do not contain this information, and these values are often difficult to obtain from other sources. Calorie content statements are mandatory for “lite” and similarly labeled pet foods. However, some product labels avoid these specific terms and instead use wording such as weight management formula, for less active dogs, or other, similar phrases. These alternative phrases still imply control of energy intake, but because they do not expressly refer to calories, the labels do not have to declare caloric content. In 2005, ACVN submitted a proposal to AAFCO that, among other things, would mandate calorie content statements on all dog and cat food labels, including snacks and treats (BOX 2). In light of the reported high incidence of overweight and obese pets in the United States, this is a prudent action. Knowledge of calorie content in all types of foods could help veterinarians and owners prevent excess pet weight gain, not just treat the aftermath. Beyond the issue of obesity, knowledge of calorie content for a given product is helpful when determining appropriate feeding amounts for dogs and cats at any life stage, be they growing kittens, working dogs, or lactating dams; hence, limitation of the required label statement to just the “lite” and “less calories” categories of food is insufficient. The ACVN proposal has been endorsed by AAVN, AVMA, and the American Animal Hospital Association. A statistically sound survey of practicing veterinarians found that an overwhelming proportion (97%) would like to see calorie content statements on pet food

labels.9 Despite these facts, the ACVN proposal has been vigorously opposed by segments of the pet food industry. As a result, after 4 years of debate within AAFCO, deliberations on this matter are ongoing.

Good Manufacturing Practices Historically, safety of pet foods has been monitored by regulators through inspection (including sampling for analysis) of the ﬁnished product. Under this practice, a laboratory ﬁnding of product contamination with a pathogenic organism or chemical toxin could be used as evidence of adulteration so that regulatory action could be taken. However, in

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QuickNotes AAFCO has recently enacted new model regulations for GMPs that affect all animal feeds, including pet foods.

the past, regulatory officials have spent little violation of the GMPs could be de facto evidence effort on monitoring the processes that may that a product manufactured under these condilead to contamination. GMPs are in place for tions was adulterated, irrespective or in lieu of a canned products to help prevent safety issues negative laboratory finding of contamination. specifically related to the complicated sterilization process, as well as for medicated feeds Conclusion (feeds containing an approved drug, such as As evidenced by recent changes, steps to further an antibiotic or coccidiostat), but not for ani- ensure the safety of pet foods have become a high-priority matter for regulators. Other conmal feeds or pet foods in general. After a number of years of deliberation, cerns to be addressed in the near future may AAFCO has recently enacted new model reg- include establishment of FDA mandatory recall ulations for GMPs that affect all animal feeds, authority and increased oversight of imported including pet foods. These new rules establish products. By virtue of their expertise in the field additional requirements regarding handling of of animal health, veterinarians are in a unique materials, training of personnel, sanitation, pro- position to contribute their viewpoints as these cessing, transportation, and record keeping. A deliberations continue.

References 1. Code of Federal Regulations, Title 21, Part 501. Washington, DC: Government Printing Office; 2009. 2. AAFCO Official Publication. Oxford, IN: Association of American Feed Control Officials; 2008. 3. Food and Drug Administration Amendments Act of 2007. Accessed August 2009 at http://frwebgate.access.gpo.gov/cgi-bin/ getdoc.cgi?dbname=110_cong_public_laws&docid=f:publ085. 110.pdf. 4. US Food and Drug Administration. Reportable food registry. Accessed September 2009 at fda.gov/Food/FoodSafety/FoodSafety Programs/RFR/default.htm. 5. US Food and Drug Administration. Animal Feed Safety System.

Accessed February 2009 at http://www.fda.gov/cvm/AFSS.htm. 6. National Research Council. Safety of Dietary Supplements for Horses, Dogs and Cats. Washington, DC: National Academies Press; 2009. 7. Dzanis DA. AAFCO dog and cat food nutrient proﬁles. In: Bonagura JD, ed. Kirk’s Current Veterinary Therapy XIII. Philadelphia: WB Saunders; 2000:1228-1230. 8. National Research Council. Nutrient Requirements of Dogs and Cats. Washington, DC: National Academies Press; 2006. 9. Haberl A, Kilgos K, Bufﬁngton CAT. Comparison of owners’ and veterinarians’ perceptions, knowledge, and use of nutritional information on pet food labels. Proc 7th Annu Workshop Pet Food Labeling Regul 2001.

FREE CE Canine Glaucoma: Pathophysiology and Diagnosis

CONTINUED FROM PAGE 452

References 1. Abrams KL. Medical and surgical management of the glaucoma patient. Clin Tech Small Anim Pract 2001;16(1):71-76. 2. Gelatt KN, Brooks DE, Kallberg ME. The canine glaucomas. In: Gelatt KN, ed. Veterinary Ophthalmology. 4th ed. Ames, Iowa: Blackwell Publishing; 2007:753-811. 3. Knollinger AM, La Croix NC, Barrett PM, Miller PE. Evaluation of a rebound tonometer for measuring intraocular pressure in dogs and horses. JAVMA 2005;227(2):244-248. 4. Pauli AM, Bentley E, Diehl KA, Miller PE. Effects of the application of neck pressure by a collar or harness on intraocular pressure in dogs. JAAHA 2006;42(3):207-211. 5. Reilly CM, Morris R, Dubielzig RR. Canine goniodysgenesis-related glaucoma: a morphologic review of 100 cases looking at inﬂammation and pigment dispersion. Vet Ophthalmol 2005;8(4):253-258. 6. Gelatt KN, MacKay EO. Secondary glaucomas in the dog in North America. Vet Ophthalmol 2004;7(4):245-259. 7. Johnsen DA, Maggs DJ, Kass PH. Evaluation of risk factors for development of secondary glaucoma in dogs: 156 cases (19992004). JAVMA 2006;229(8):1270-1274. 8. Lannek EB, Miller PE. Development of glaucoma after phacoemulsiﬁcation for removal of cataracts in dogs: 22 cases (19871997). JAVMA 2001;218(1):70-76.

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9. Biros DJ, Gelatt KN, Brooks DE, et al. Development of glaucoma after cataract surgery in dogs: 220 cases (1987-1998). JAVMA 2000;216(11):1780-1786. 10. Gelatt KN. The canine glaucomas. In: Essentials of Veterinary Ophthalmology. Ames, Iowa: Blackwell Publishing; 2005:165-196. 11. Grozdanic SD, Matic M, Betts DM, et al. Recovery of canine retina and optic nerve function after acute elevation of intraocular pressure: implications for canine glaucoma treatment. Vet Ophthalmol 2007;10(suppl 1):101-107. 12. Martin CL. Evaluation of patients with decreased vision or blindness. Clin Tech Small Anim Pract 2001;16(1):62-70. 13. Broadwater JJ, Schorling JJ, Herring IP, Elvinger F. Effect of body position on intraocular pressure in dogs without glaucoma. Am J Vet Res 2008;69(4):527-530. 14. Miller PE, Pickett JP. Comparison of the human and canine Schiotz tonometry conversion tables in clinically normal dogs. JAVMA 1992;201(7):1021-1025. 15. Gorig C, Coenen RT, Stades FC, et al. Comparison of the use of new handheld tonometers and established applanation tonometers in dogs. Am J Vet Res 2006;67(1):134-144. 16. Miller PE, Schmidt GM, Vainisi SJ, et al. The efﬁcacy of topical prophylactic antiglaucoma therapy in primary closed angle glaucoma in dogs: a multicenter clinical trial. JAAHA 2000;36(5):431-438.

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