Exploring the petfood jungle (Proceedings)

Article

The massive amount of information and misinformation about petfoods on the World Wide Web, in books and publications, and elsewhere has led to considerable concern and confusion by the pet owning public.

The massive amount of information and misinformation about petfoods on the World Wide Web, in books and publications, and elsewhere has led to considerable concern and confusion by the pet owning public. The unprecedented recall of petfoods in 2007 has increased scrutiny about how petfoods are manufactured and regulated. The veterinary technician must be knowledgeable of issues surrounding the petfood industry to effectively communicate with clients.

Regulation of petfoods

Petfoods are regulated at two levels. The US Food and Drug Administration (FDA) oversees all petfoods in interstate commerce (virtually everything on the market). Products that are adulterated or misbranded are subject to enforcement action. Federal regulations dictate basic labeling requirements, and lists of approved food additives and GRAS (generally recognized as safe) substances. There are no specific petfood regulations in the Code of Federal Regulations.

Most states also have authority over petfoods distributed in their jurisdictions, typically through the state's department of agriculture or chemist's office. Many require some sort of licensure of companies or registration of products before petfoods may be distributed in that state. Each applies its own set of regulations pertaining to labeling, ingredients, and other matters. The states often coordinate efforts with FDA, with FDA agency offering scientific, nutritional, and technical expertise to the states, and the states initiating the enforcement actions. Even though the state only has jurisdiction within that state's borders, an action against a company to change a product formulation or label by even just one state can have nation-wide impact.

To foster uniformity in regulation between the states, many have adopted the Model Bill along with associated regulations and ingredient definitions published by the Association of American Feed Control Officials (AAFCO). AAFCO is not a government agency, nor does it have any enforcement authority. However, all its members must be government employees. Contrary to many assertions, industry representatives do not have any voting rights within AAFCO, though they can serve as "committee advisors." Model AAFCO petfood regulations address issues of nutrient content, nutritional adequacy, and many other aspects not covered in FDA regulations. While these have no power of law in and of themselves, states that subsequently adopt the models do have the power to enforce them. The number of states that do follow the AAFCO models is sufficient so that they effectively apply to any product in interstate distribution.

Petfood requirements

Under FDA and AAFCO regulations, petfoods are subject to a host of labeling requirements that dictate acceptable product names, proper ingredient lists, nutritional content claims, and declarations of net weight and the manufacturer's or distributor's name and address. Other regulations or guidance dictate the nature and extent of claims such as "low calorie," "natural," and "veterinarian recommended." Claims that expressly or implicitly imply the treatment or prevention of a disease or condition, or to affect the structure or function of the body beyond normal nutrition may be deemed a "drug claim," which is not permitted on products intended to be sold as "foods." Under the law, the therapeutic dog and cat diets often distributed through veterinary facilities could be considered "unapproved drugs." However, FDA generally tolerates their presence in the market as long as claims regarding diet and disease are intended for the veterinarian, not the consumer, and/or the product is only distributed by means of a valid veterinarian/client/animal relationship. Inappropriate use of therapeutic diets by untrained persons without veterinary oversight may be harmful to the animal.

Products designated as "complete and balanced" must be substantiated for nutritional adequacy by one of several means. One method is by formulation to meet minimum and maximum nutrient levels as dictated by the AAFCO Dog and Cat Food Nutrient Profiles. Another means is for the product to pass feeding trials following AAFCO protocols. Under the "product family" criteria, products that can be established as "nutritionally similar" to a product that has successfully passed a feeding trial are also considered complete and balanced without undergoing feeding tests themselves. Depending on the method, a verbatim statement attesting to the substantiation of nutritional adequacy must appear on the label. However, products within a product family that were not directly tested by feeding trials typically bear the same statement as one that was actually tested. In any case, regulators do not conduct these methods of substantiation directly. Rather, either the companies or a third-party facility performs the necessary procedures. Data to support the claim must be kept on file and be available for regulatory review. Products that do not meet any of the above criteria for nutritional adequacy must be labeled "for intermittent or supplemental feeding only." An exception is made for products conspicuously identified as "snacks," "treats" or "supplements." Therapeutic diets must meet the same nutritional adequacy standards as any other petfood.

Under the law, all ingredients in petfoods must be either GRAS (generally recognized as safe) substances, approved food additives, or otherwise sanctioned (e.g., AAFCO-defined) for its intended use in animal feed. Some ingredients in petfoods, such as many human food ingredients, may be implicitly GRAS by virtue of their long histories of safe use as food. For new ingredients, though, each method of approval requires rigorous evaluation of the ingredient and submission of data to show its utility and safety.

Many opponents of the petfood industry cite existing AAFCO definitions as proof of unsuitable materials in petfoods. Granted, some names evoke unpleasant reactions, such as "restaurant food waste" (AAFCO #60.97), "dried poultry litter" (AAFCO #74.3) and "unborn calf carcasses" (AAFCO 9..67). Properly processed, these ingredients may be very useful in animal feeding (e.g., poultry litter as a source of non-protein nitrogen and fiber to ruminants), but simply have no use in petfoods. Regardless, what opponents fail to note is that if these ingredients were in a petfood, by law they would have to be declared on the label by their official AAFCO names. However, those ingredients are never seen on petfood labels, hence can be reasonably assumed not to be in petfoods.

Unconventional petfoods

Under AAFCO definitions, a "natural" product excludes all ingredients that are chemically synthetic. However, it is highly infeasible to formulate a complete and balanced product without reliance on some synthetic trace nutrients like vitamins, minerals, and taurine. Thus, use of the term in most cases require further qualification by use of a disclaimer, e.g., "natural with added vitamins and minerals." Thus, the bulk of ingredients in a "natural" petfood and a traditional petfood may be the same. However, "natural" petfoods may not contain chemically synthetic non-nutritive ingredients, such as preservatives, flavors, or colors (except in amounts that may be unavoidable through good manufacturing practices). Often, "natural" preservatives, such as mixed tocopherols (extracted) or citric acid (fermented) are used in formulations. There is little scientific basis to show that "natural" products are safer, healthier or more nutritious.

"Organic" is not the same as "natural." Rather, it describes a whole system of production and manufacturing of ingredients and products that in general, excludes use of genetic engineering, synthetic pesticides, herbicides, or fertilizers, and antibiotics, steroids or other drugs. Third-party certifying bodies accredited by the US Department of Agriculture inspect plants and records to confirm compliance. These rules are not considered by the government to be a means to ensure safer, healthier or more nutritious foods. Rather, it is viewed as a confirmation of the organic production process, and the purchaser is left to his or her own determination as to whether the costs merit the perceived benefits.

Raw petfoods are a unique deviation from conventional petfoods. Many people have very strong opinions about the merits of raw petfoods, either for or against. The truth may lay somewhere in the middle. Proponents of raw petfoods attest to their nutritional superiority compared to their thermally-processed counterparts, but there is little scientific study to support their contentions. The major concern on the opponents' side is that even with good sourcing of ingredients, strict manufacturing hygiene, and proper storage and transport, there is always a potential risk of microbial contamination. Although dogs and cats can suffer the consequences of pathogenic bacteria present in food, the real concern is to people handling the product. Since the storage and preparation areas, utensils, etc., that are used for human foods in a household are likely to be the same as to where the raw petfood is held, prepared or served, the need for proper sanitation is paramount. FDA has issued guidance as to the manufacturing and labeling of raw petfoods. It suggests safe handling instructions similar to what appears on raw met and poultry products for human consumption under USDA authority.

Other unconventional petfoods include vegetarian formulations, which can range from absence of meat and poultry products to completely vegan formulations. Theoretically, diets to meet the nutritional needs of carnivores can be formulated without animal products, but it's not easy in practice. Palatability of products that do not contain any animal-source ingredients must also be considered. New products on the market include "fresh" petfood, which is cooked similarly to cold cuts and must be kept refrigerated. They are often confused with semi-moist products that may be in similar "salami" form. However, those do not require refrigeration, at least before opening. Because of the need for refrigeration, "fresh" petfoods may also be confused with raw products. One major petfood company is due to release a complete and balanced dog food in a compressed bone shape, which the dog chews like a typical treat product (only much bigger!). Essentially, it eliminates the need for a bowl to feed the animal.

Homemade pet diets

Although the feeding of human food scraps to dogs as the main source of nutrition has been a practice for millennia, the introduction of commercial petfoods has greatly diminished the custom. However, there has always been interest in homemade formulations by a segment of the pet owning public who are skeptical of the safety or wholesomeness of commercial products. At the same time, developing countries with growing middle classes may be recognized by a shift from homemade pet diets to commercial petfood products.

Convenience (or lack thereof) of home preparation is a deficit. That aside, the major concern is assurance of nutritional adequacy. Publications, web sites, and other sources abound with recipes that simply have not been shown by scientific means to be suitable for long-term feeding, and often recipes are obviously deficient at first glance. For those clients intent on feeding a homemade formulation, there are services offered by experts trained in nutrition that can offer complete and balanced recipes to meet the individual pet's needs.

Dietary supplements

Passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA) dramatically changed the market for both human and pet supplement products. This is because while the Act doesn't legally apply to products intended for animals, the massive influx of new and different products in the human supplement market as a result of DSHEA has not unexpectedly crossed over to products for pets.

Simply put, DSHEA changed the law so that products meeting the definition of "dietary supplement" no longer had to follow all the regulatory requirements for conventional foods. Many ingredients that are not GRAS or otherwise allowed in foods could be in dietary supplements without proof of safety prior to marketing. "Drug" claims regarding the effects on the structure or function of the body beyond normal nutrition (but not disease treatment/prevention) are also allowed for supplements under DSHEA.

However, as noted above, DSHEA does not apply to products intended for animals, and the law that prevailed prior to DSHEA still applies. Thus, products that contain ingredients that are not GRAS substances, approved food additives or otherwise sanctioned (e.g., defined by AAFCO) could be subject to enforcement action as an "adulterated food." Similarly, claims that state or imply function beyond provision of normal nutrition (including treatment, but not prevention of recognized nutritional deficiencies) could be considered "adulterated drugs." Pet supplement products that contain and are intended to provide essential nutrients such as vitamins and minerals have existed for many years, and have continued to do so unfettered after passage of DSHEA. These products must be labeled in accordance with FDA and AAFCO animal feed labeling regulations.

In the case of supplements intending to provide nutrients other than those recognized as essential, their regulatory status depends on the regulatory status of the individual ingredients and associated claims. Ascorbic acid and beta-carotene, for example, are not recognized as essential in the dog or cat, but are still codified as GRAS for use in animal feed under FDA regulations. As such, they are frequently components of pet supplement products. Claims for functionality are generally restricted, though, and the label guarantees for either substance must include the disclaimer that they are "Not recognized as an essential nutrient by the AAFCO Dog (or Cat) Food Nutrient Profiles." A similar disclaimer must appear on dog, but not cat product labels that include supplemental taurine.

Glucosamine and chondroitin sulfate, substances frequently found in both pet supplements and complete petfoods, are not GRAS or approved for use in animal feeds. However, most states tolerate their inclusion as long as they are disclaimed as "not essential nutrients" and the claims are not egregious (e.g., "helps maintain healthy joints," but not "prevents hip dysplasia" or "treats arthritis").

A pending guidance document from FDA may conclude that glucosamine and chondroitin are "drugs" by definition, hence challenging their inclusion in any animal feed or petfood product. However, it is anticipated that the agency will deem them "unapproved drugs of low regulatory priority." Like many other products on the market with this status (e.g., petrolatum-containing hairball remedies), this would allow the products to be marketed without formal approval as a drug as long as certain provisions are met. Some products have already been revised to accommodate its "unapproved drug" status. In fact, some manufacturers are labeling other supplements containing unapproved food additives such as herbs and botanicals as "drugs." In any case, due caution is advised with any use or recommendation of dietary supplement products in animals.

Selected sources of information

www.fda.gov/cvm

www.aafco.org

www.petfoodinstitute.org

www.afia.org

www.appma.org

www.nasc.cc

www.PetDIETS.com

www.Balanceit.com

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