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101: LABELS AND REGULATION

Cailin R. Heinze, VMD, MS, Diplomate ACVN Chief Academic Officer Mark Morris Institute P.O. Box 2097 Topeka, KS 66601

Pet food labels serve as marketing devices, as legal documents, and as sources of limited nutritional information. Unfortunately, these purposes are often at odds as the current regulatory environment reflects the evolution of companion pet diets from livestock diets rather than from human . It is important for veterinarians to understand what information is legally required to be on a label and how to use this information to help clients make informed decisions regarding pet foods. Regulation In the US, pet foods are regulated both nationally and at the individual state level. Two main organizations are involved: the Food and Drug Administration (FDA) and the Association of American Feed Control Officials (AAFCO). The FDA regulates pet foods nationally through the Center for Veterinary Medicine (CVM). The Federal Food, Drug, and Cosmetic Act (FFDCA) requires that pet foods, like human foods, be “pure and wholesome, safe to eat, produced under sanitary conditions, contain no harmful substances, and be truthfully labeled”. The FDA has some basic requirements for pet food labels: proper identification of the product, net quantity (weight) statement, name and place of business of the manufacturer or distributor, and an ingredient list ordered from most to least, based on weight. The FDA is also responsible for evaluating product claims on labels – i.e. hairball prevention, urinary tract care, etc. The FDA has enforcement power to pursue violations in labeling and manufacturing processes, including prohibiting the sale of certain products and even enforcing jail terms for individuals repeatedly found to be in violation. AAFCO is not a governmental regulatory organization; however, its members are all US state or federal government officials that meet to review the current knowledge and regulations on pet food and make recommendations. AAFCO committees may be advised by outside individuals from industry and academia. AAFCO is responsible for setting guidelines not just for and food, but for feeds for all domestic animals. It is important to keep this in mind as some of the information in their annual publication, especially some ingredient definitions, may apply to livestock rather than to . The states adopt AAFCO regulations as their own to varying degrees and enforce them through their state feed control officials. AAFCO itself has no enforcement power and also does not “approve” pet foods. AAFCO publishes yearly guidelines which can be purchased online from their website. AAFCO publications include guidelines for pet food labels, ingredient definitions, tests of nutritional adequacy, additives, and recommended levels in diets for various life stages of and .

Key Elements of a Pet Food Label Manufacturer or distributor info – all labels must include an address to contact the manufacturer or distributor. Although a telephone number, email address or website address are not required to be on the label, it is best to avoid companies that do not include at least one of these methods of contact as it is often impossible to get timely information by mail only. Beware of foods that just list the store as the manufacturer – big box stores and grocery stores do not make their own food. It can be very difficult to get any information on these diets by contacting the corporate office of the store that sells them and the stores are often unwilling to release information about the true manufacturer. Nutritional adequacy statement – AKA “AAFCO statement”. All pet foods marketed in states adopting AAFCO guidelines must have one of the following statements clearly printed on the bag: 1. This product is intended for intermittent and supplemental feeding only 2. Animal feeding tests using AAFCO procedures substantiate that Product X provides complete and balanced for [species, life stage]. (Life stages include maintenance, growth, gestation and lactation and all life stages) 3. Product X is formulated to meet AAFCO nutrient profiles for [species, life stage] Diets that are “formulated to meet” do not have to be fed to any animals before being put on the market. Additionally, diets that fail AAFCO feeding trials could technically still be marketed under a “formulated to meet” statement. Feeding trial protocols are detailed in the AAFCO guidelines and specify that a certain number of animals are fed the for a set time period, that data is collected on weight, blood values, reproductive performance and growth (growth or all life stages), and that no detrimental effects are noted. Feeding trials may also be used by manufacturers to collect digestibility or other data for foods although this information is not required. While most diets that have passed feeding trials are also “formulated to meet”, they do not have to be. For example, Hill’s Prescription Diet canine k/d has passed feeding trials for adult maintenance but is too low in protein and phosphorus to carry a “formulated to meet AAFCO” statement. There is a fourth statement, “Product X provides complete and balanced nutrition for (species, life stage), and is comparable in nutritional adequacy to a product with has been substantiated using AAFCO feeding tests.”. This statement is uncommon and is often a red flag – it can be used in situations where the diet doesn’t meet AAFCO nutrient profiles but the company is trying to save money by only testing one product with a feeding trial instead of testing all products. The most recent recommendations include a variation of the statement for large and giant breed puppies. In the future, all diets with an AAFCO statement for growth or all life stages will need to indicate: “except growth of large size dogs (70 lbs or more as an adult)” or “including growth of large size dogs (70 lbs or more as an adult)”. Note the very subtle difference in wording! These statements are currently being phased in and are not yet present on all applicable diets. Calorie content – Required on all food and packaged treats except “animal part treats”; no minimum or maximum calorie rules unless a product is marketed using the terms “lower calorie” or “light” in which case a maximum applies. Calories must be in kcal/kg as well as kcal/cup or can. Ingredient list – ingredients must follow standard definitions (in AAFCO publication) and be listed in order of weight. Moisture is included in the weight, so high moisture foods (like and fresh ) will be heavier than drier foods (grains, meals). Exact amounts are not included and cannot accurately be estimated from the ingredient list. Ingredients lists are often subject to marketing whims and do not necessarily reflect the quality or nutritional adequacy of a diet. They may, however, reflect expense in the case of unusual (and unnecessary) ingredients such as quail eggs, pomegranate, and bison. Product name - there are strict rules for naming products. For example, “ for dogs” must legally contain >95% beef on a dry matter (DM) basis and >70% as fed. “Beef dinner”, “beef platter”, and “beef entrée” require that beef be >25% total weight. “With beef” means that the product is at least 3% beef. “Beef flavor” generally means that there is less than 3% beef. Moisture may not exceed 78% unless the terms “in sauce”, “in aspic” or “in gravy” appear in the product name. Designator - “”, “for cats” – states diet use Feeding guidelines – usually based on standard maintenance energy requirement (MER) equations with a safety margin. Animals should be fed to meet caloric and nutrient needs to maintain an ideal body condition, regardless of the feeding directions on the label. However, be aware of patients that are consuming less than ~75% of the recommended amount for their ideal weight as they may be consuming inadequate and should be fed a diet with a lower energy density/higher nutrient density. Guaranteed analysis (GA) – only minimum protein, minimum fat, maximum fiber and maximum moisture must be included unless the manufacturer adds statements such as “now with omega-3s” or “with added ” to the packaging, in which case the amount of the specified ingredient must also be listed. The amounts listed are “as fed” amounts, meaning as the food comes out of the package or how it is intended to be fed. These “crude” amounts may vary from the actual amounts in the food and cannot easily be used to compare two different diets without conversion of the values to standardized units (such as grams per 1000 kcal; Mcal). Net Weight - the amount of food in the bag. Keep in mind that the caloric density is more important than the weight of the food when determining feeding costs as foods can vary in caloric density (35 pounds of one food may have the same calories as 18 pounds of another).

Comparing Pet Food Nutrient Distributions Using The Label

The information included in the GA is not always very useful when it comes to making decisions about which diet may be appropriate for which patient. It is best to obtain a typical analysis from the manufacturer. At the very least, it is necessary to convert the GA values to values that are standardized for fiber, moisture and caloric density to directly compare diets. An accurate way to compare pet foods is on a metabolizable energy (ME) basis. Metabolizable energy refers to the percentage of the calories of a diet that come from protein, fat, and carbohydrates, taking into account both fiber and moisture. There are several references that show detailed methods [see ‘Further information’, below] for calculating ME for pet foods based on the GA or typical analysis (obtained from manufacturer, actual amounts rather than min and max) as well as online calculators such as the one at: https://secure.balanceit.com/tools/_gaconverter/) To calculate the ME most accurately, the ash content of the diet is required and usually must be obtained directly from the manufacturer. Other nutrients can be compared between diets by expressing them on an energy basis – i.e., grams per Mcal (1000 kcal). Protein, fat and carbohydrate concentrations can also be expressed this way, but it may be less intuitive to clients and technical staff. These units take into account the fact that nutrient requirements are related to body size and that animals of a certain size are expected to consume a similar amount of calories. There is concern that an animal that needs substantially less calories than average for its size may thus become nutrient deficient. For this reason, diets designed for animals with lower energy requirements should contain higher concentrations of nutrients per calorie to compensate for the lower caloric intake. Likewise, high energy diets should contain comparably lower concentrations of nutrients per calorie to avoid excesses. There is a calculator for converting % as-fed to g/100 kcal at http://vetnutrition.tufts.edu/2017/08/nutrient_converter/ Evaluating Pet Foods The American Animal Hospital Association has published nutrition guidelines which include assessment of commercial pet foods: https://www.aaha.org/globalassets/02- guidelines/nutritional-assessment/nutritionalassessmentguidelines.pdf WSAVA also has information on choosing pet foods in their Nutrition Toolkit: https://www.wsava.org/nutrition-toolkit Some additional things to consider are listed below. Label

• Is appropriate contact information listed for the manufacturer – i.e. toll-free phone number or web address? • Ingredient list – does the patient have any known allergies or intolerances to certain ingredients? Is the company using unnecessarily expensive or exotic ingredients as a marketing ploy? • “Quality” descriptors – although commonly used, the terms “premium”, “super premium”, “ultra-premium”, and “gourmet” have no legal meaning and can be used by any manufacturer without any burden of proof • Health claims – all health claims on diets must be evaluated by the FDA. However, it is not uncommon to see unsubstantiated health claims on labels and in marketing materials. If a health claim seems questionable, call the company and ask for written documentation of the claim (i.e. peer-reviewed publications).

Marketing materials Beware of:

• Unverifiable claims – “prevents cancer”, “takes years off your dog”, “increases energy and vitality”, “increases your cat’s nine lives to ten” • Testimonials in lieu of data – ask for documentation of any claims made, remembering that in evidence-based medicine, testimonials mean little and are easily faked. • Inaccurate or misleading nutritional information – i.e. incorrect definition of by-products or other ingredients, misspellings, and propagation of myths such as: grains cause allergies or are “fillers”, high fat diets cause heart disease in dogs, flax is good source of omega-3 fatty acids for cats, etc. • Reliance on the “no list” or bashing other products to market a product • Human nutrition fads or trends – often the science hasn’t caught up with the trend Other factors

• Knowledge of employees when you call on the phone – can they provide requested information in a timely manner?

Further information Hand, M. S., C. D. Thatcher, et al., Eds. (2010). Small Animal , 5th Edition. Topeka, KS, Mark Morris Institute. www.fda.gov/AnimalVeterinary/Products/AnimalFoodFeeds/PetFood/default.htm www.aafco.org/ http://talkspetfood.aafco.org/