Pet food labels: Cracking the code (Proceedings)
Petfood labels are regulated at both the federal and state levels.
Petfood labels are regulated at both the federal and state levels. The regulations promulgated by the US Food & Drug Administration (FDA) cover basic aspects of animal feed labeling, including requirements for a statement of identity (e.g., "dog food"), an ingredient declaration, a net content declaration, and the manufacturer's or distributor's name and address. At this time, they do not address issues such as nutrient content or nutritional adequacy. However, states that follow the Model Regulations for Pet Food and Specialty Pet Food as developed and published by the Association of American Feed Control Officials (AAFCO) enforce additional requirements with respect to nutritive value and other aspects.
Several rules within AAFCO regulations dictate the use of ingredient names that comprise a part of product names depending on the relative proportion of the named ingredient in the product. Under the "95%" rule, only products containing at least 95% of the named meat, poultry of fish ingredient(s) can be declared by the ingredient name(s) without qualification (e.g., "beef dog food," "tuna & shrimp for cats"). Water added for processing is excluded from the 95% percentage calculation, but in such a case the product must still contain at least 70% of the named ingredient(s). The ingredient names in the product name and ingredient list must match. For example, "chicken by-products" or "chicken meal" do not support a product name "chicken dog food." When more than one ingredient is named, they must be declared in the product name in the same order as which they appear in the ingredient list. Also, each must be at least 3% of the product formulation. This rule applies primarily to a small number of canned foods and some dried meat treats.
The "25%" or "dinner" rule applies to a much broader spectrum of petfoods. In this case, the named ingredient(s), which could be either from plant or animal origin, must comprise at least 25% of the total formulation, exclusive of water for processing (at least 10% inclusive of added water). However, such product names must include a qualifying term to advise the consumer that the product may contain other major ingredients (e.g., "beef dinner for dogs," "rice and chicken meal formula cat food"). The qualifying term must be the same size, color and style as the ingredient name(s) in the product name. Other qualifying terms, such as "entrée," "recipe," and "platter" are also acceptable, but terms that connote form but not a mixture of ingredients (e.g., "slices," "chunks") are not sufficient. Again, the ingredient names in the product name and ingredient list must match, and if more than one ingredient is named, they must be declared in the same order as in the ingredient list and each must be at least 3% of the formulation.
Whether part of the product name or elsewhere, ingredient claims preceded by "with" or like terms must contain at least 3% of each of the named ingredient(s). There are exceptions in the case of nutrients and condiments, so that a "with calcium" claim does not require a minimum of 3% calcium. The qualifying term must be the same size, style, color and letter case as the named ingredient(s). For example, "with REAL BEEF" would not be acceptable. There are also maximum font size limitations on "with" claims to preclude overemphasis of minor ingredients.
There are no minimum percentage requirements for an ingredient when used as part of a "flavor" claim. Also, the named flavor does not necessarily have to match the name of the ingredient in the ingredient list, as long as it can reasonably be expected to impart that flavor. For example, a "fish flavor cat food" may contain fish, or it may contain fish meal, fish by-products, fish digest or other suitable flavor source. The term "flavor" must be the same size and equal degree of conspicuousness as the named flavor. This is actually more stringent than in human food labeling, which only requires the term "flavor" to be half the height of the named flavor.
Regulations under FDA require that each ingredient be declared by its "common or usual" name. One of the functions of AAFCO is to define standards for common animal feed ingredients so that declarations on a label are consistent between products, and FDA recognizes those definitions as constituting the "common or usual" name as contemplated by federal law. So, where AAFCO names and definitions for ingredients exist, ingredients in petfoods must be declared by that terminology. Names such as "chicken," "chicken by-products," "chicken meal" and "chicken by-product meal" each have expressly defined qualities, so any deviation from an accurate representation in the ingredient list would be considered false or misleading and subject to regulatory action.
Since AAFCO definitions focus on animal feed ingredients, many petfood ingredients, such as common human foods, may not have existing AAFCO-defined names. In that case, the "common or usual" name is still required. Names may be modified to a limited degree by incorporation of an AAFCO-recognized feed term (e.g., "dried apples," "oat flour"). Issues surrounding the melamine contamination incident last year involved ingredients constructed in this manner but not formally AAFCO-defined (i.e., "wheat gluten," "rice protein concentrate"), so that provision may be reconsidered in the near future. Finally, AAFCO does not allow use of brand or trade names in the ingredient list, nor references to quality or grade (e.g., "grade A milk").
Under FDA and AAFCO regulations, ingredients must be declared in descending order of predominance by weight as they are added to the product formulation. There are exceptions under the federal law, though, namely when an ingredient that has an established common or usual name or standard of identity is comprised of two or more ingredients. In that case, an acceptable alternative is to declare the ingredient followed by a listing of the components of that ingredient parenthetically. Other exceptions exist for ingredients such as flavorings and colorings.
It is important to note that the order of predominance includes the inherent water content of the ingredients. So, for example, an ingredient with a high inherent moisture content such as chicken (75% moisture) may appear higher on an ingredient list than a relatively dry ingredient such as chicken meal (10% moisture) when both are added at levels to provide equivalent amounts of protein. While declaration of ingredients on a dry matter basis would prevent this arguably misleading practice, it would be extremely infeasible to implement. Also, it could create new opportunities for potentially deceiving the consumer, e.g., inclusion of large quantities of "poultry stock," which is primarily composed of water, would appear as only a trivial amount on the dry matter ingredient declaration.
Under AAFCO regulations, petfoods must declare the minimum percentages of crude protein and crude fat and the maximum percentages of crude fiber and moisture. There are some exceptions in the case of products where a product is not intended and does not provide a particular nutrient, e.g., protein in a pure fatty acid supplement product. However, there is no provision to exempt the maximum percentage moisture guarantee from any petfood or pet supplement labels.
Other guarantees may be required depending on claims. A "low fat" or "less fat" claim requires a maximum as well as minimum percentage fat guarantee. Claims for the inclusion of specific nutrients, such as taurine, calcium, or vitamin A, generally mandates supporting minimum guarantees. Companies may also voluntarily guarantee nutrient levels for those believed of interest to the consumer (e.g., magnesium in cat foods). In either case, guarantees for recognized essential nutrients must be declared in the order and units used in the AAFCO Dog or Cat Food Nutrient Profiles. Guarantees for substances not recognized as essential, such as ascorbic acid or carnitine, must be declared last and accompanied by a disclaimer informing the consumer of the fact that they are not essential nutrients.
Nutritional adequacy statement
Except for products prominently identified as a "snack," "treat" or "supplement," dog and cat foods labeled as per AAFCO regulations must bear a nutritional adequacy statement. There are three means to substantiate nutritional adequacy. The first is to formulate the product to contain nutrient levels to meet all minimums and maximums prescribed for the intended life stage(s) in the AAFCO Dog or Cat Food Nutrient Profiles. This can be accomplished by accurate calculation of content based on ingredients in the formula, or by chemical analysis of the finished product. The statement required verbatim is "[Complete product name] is formulated to meet the nutritional levels established by the AAFCO Dog (or Cat) Food Nutrient Profiles for [life stage(s)].
The second means is for the product to be subject to a feeding trial as prescribed by AAFCO protocols. Depending on the intended life stage(s), the product is fed as the sole source of nutrition (except for water) to a specified number of animals for a specified period, during which specific physical, hematological and biochemical parameters are measured. The animals on test must either meet prescribed standards for each parameter or meet the performance of a historical or concurrent control group fed a diet that has already passed the feeding trial. These products are labeled with the verbatim statement "Animal feeding tests using AAFCO procedures substantiate that [complete product name] provides complete and balanced nutrition for [life stage(s)]."
A third, but much less publicly known means of substantiation of nutritional adequacy is to establish "product families," in which only the "lead member" is subject to the complete feeding trials. Family members must meet certain criteria, including that they must be the same processing type and equivalent in metabolizable energy content to the lead product. Also, upon analysis, they must meet the levels of specified "key nutrients" that are in the lead product, and either meet the levels of the lead member or the appropriate AAFCO Profile for all other nutrients. There are no ingredient restrictions between the lead and family members. However, as long as metabolizable energy is determined by short-term digestibility trials, a family member that meets the above criteria can declare nutritional adequacy by the same "animal feeding tests..." statement that is used for the lead product that actually passed the trial.
Labels of dog and cat food products for which nutritional adequacy has not been established by the above means, and is not otherwise exempt, must bear the verbatim statement "This product is intended for intermittent or supplemental feeding only." Products intended to be distributed through veterinarians are not exempt from the above requirements.
Under AAFCO regulations, all "complete and balanced" dog and cat foods, including snacks and treats, must bear feeding directions. At minimum, they must state a quantitative amount per given body weight and frequency of feeding, e.g., "Feed one can per 10 pounds daily." Feeding directions must be for each intended life stage as indicated in the nutritional adequacy statement unless more prominent intended use is stated elsewhere. For example, an "adult formula" may only need directions for adult maintenance, even if nutritionally adequate for all life stages. Otherwise, feeding directions for growth and gestation/lactation is also needed. Products intended for veterinary distribution only may be labeled "Use only as directed by your veterinarian" in lieu of explicit quantitative feeding directions.
Calorie content statement
At this time, calorie content statements are only required under AAFCO for dog and cat food products labeled with terms such as "low calorie," "lite," or "less calories." The statement must be expressed in terms of kilocalories per kilogram of metabolizable energy as fed, although declaration in terms of kilocalories per familiar unit (e.g., cans, cups) is allowed as supplemental information. Calories can be determined either by conduct of digestibility trials following AAFCO procedures, or by calculation via use of "modified Atwater" values for protein, fat, and nitrogen-free extract (carbohydrate) content. In the latter case, the word "calculated" must appear in the statement.
The American College of Veterinary Nutrition (ACVN) has submitted a proposal to AAFCO to amend these regulations. Proposed changes would make calorie content statements mandatory on all dog and cat food product labels, require both kcal/kg and kcal/familiar unit be declared, and indicate method of determination by the required use of either the term "calculated" or "fed." The College believes these changes would greatly increase the utility of these statements, help the veterinarian and pet owner choose the most appropriate product for an individual animal and use it to its fullest benefit, and ultimately, improve the health and well-being of dogs and cats. However, the proposal has met with strong opposition by some segments of the industry, and its final fate is still in discussion by AAFCO at this time.
Other mandatory labeling
There are extensive FDA regulations dictating the placement, size, and format of net content declarations on petfood labels. It's most often declared in terms of weight, but may be in terms of volume in the case of liquid products or numerical count in the case of pills or capsules. While regulations that would require dual declarations in both avoirdupois (e.g., pound, pint) and metric units are only proposed at this time, that means of declaration has become the standard for the industry for years.
A manufacturer's or distributor's name and address is required on all labels. The address must include the city, state and ZIP Code of the named entity's main place of business, not necessarily the exact site of manufacturing. A physical street address is also required unless the entity's street address appears in a local phone or city directory. In the case where a distributor of a product is not the actual manufacturer, the information must be preceded by terms such as "manufactured for" or "distributed by."
Claims come in a variety of forms, and often can make up a large proportion of the total labeling. AAFCO regulations apply to some of them. As mentioned above, a claim for inclusion of a specific nutrient in a petfood may require additional guarantees, while "lite" dog and cat foods require supporting calorie content statements. Also under AAFCO, any comparative claims (e.g., "Half the fat of ____") must be supported by data and resubstantiated yearly, while "new" or "improved" claims are limited to six months production. Endorsements, graphic representations of products or ingredients, and other claims may not be false or misleading.
Claims that explicitly or implicitly identify use for the treatment, prevention, cure, or mitigation of a disease or condition, or that indicate an effect on the structure or function of the body beyond traditional nutritional precepts, may be considered a "drug claim" under the law. Because the product has not undergone the testing and submission of data required for approval as a drug, petfood labels bearing such claims may be subject to enforcement action as an "adulterated drug." Some FDA policies do grant leeway for a few types of products under specified conditions (e.g., feline urinary tract health claims, plaque and tartar control claims, hairball control claims). While therapeutic petfoods may be legally deemed "drugs," to date FDA has not acted on the basis of claims regarding diet and disease made directly to veterinarians.
AAFCO Official Publication. AAFCO: Oxford, IN, 2008.
Title 21 Code of Federal Regulations Part 501 Government Printing Office: Washington, DC, 2007