Tthere are many regulations at both the federal and state level governing the labeling of pet foods. With increasing health-consciousness with respect to diet, many Americans are now reading and scrutinizing food product labels more than ever. This task becomes cumbersome when the same efforts are applied to pet food labels.
As the rules for pet food and human food labels are different in many respects, attempting to translate the meaning of certain claims on pet food labels may be frustrating to some consumers. Therefore, knowledge of the unique rules for pet foods is needed for the consumer to understand labels more thoroughly and make the correct dietary choices for his or her pets. Below we discuss the requirements covering foods intended for special uses.
Treats and Chews
Snacks and treats for pets are implicitly intended to be offered on an occasional basis and by no means should be fed as the mainstay of the diet. Although pet treats must meet all the other FDA and state regulations for labeling of pet foods, they are exempt from the need to include an AAFCO nutritional adequacy statement.
“Biscuits” are not exempt, unless they are identified as a “snack” or “treat” as well. Regardless, some treats and biscuits are formulated to be nutritionally complete and some are not. If the pet owner is going to give his or her pet treats or biscuits more than only occasionally, or as a large proportion of the diet, it is best to feed a product that bears an AAFCO nutritional adequacy statement. In this way, the treat or biscuit would not disrupt the nutritional balance of the whole diet.
Dog chews made from rawhide, bone or other animal materials or parts (for example, pig ears) are still considered “food” under FDA law, as they are comprised of materials that are consumable by the pet. However, as long as the label for the chew does not include any reference to nutritional value (such as “high protein”), it may not have to follow the AAFCO pet food regulations.
So many labels for chews may not have a guaranteed analysis or follow the AAFCO rules for product names. However, they should still bear the information required under FDA regulations, such as the net quantity statement, the manufacturer’s name and address and the ingredient list (if it contains more than one ingredient or the single ingredient is not declared in the product name). For products sold in bulk, the required information should appear in a placard on the bin or container.
Many of the products intended for special uses involve the dietary management of a disease or condition. Recent laws have affected the way FDA regulates these types of products for human consumption. For example, the Nutrition Labeling and Education Act (NLEA) provides for specified “health claims” (claims that state that consumption of a food may help in the reduction of risk for disease) to appear on human food product labels.
The Dietary Supplement Health and Education Act (DSHEA) has allowed for the boom of dietary supplements available for human use, many of which include claims of “nutritional support” for specific organs or body functions.
As pet foods follow many similar marketing trends to foods for human consumption, it is not surprising that many pet food and supplement labels also bear these types of claims. However, as the rules for pet foods are very different, some of these claims are not legally allowed.
The Federal Food, Drug and Cosmetic Act (FFDCA) defines “food” as an article used for food or drink for man or other animals. On the other hand, a “drug” is, in part, an article intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease, or an article (other than food) intended to affect the structure or function of the body of man or other animals.
“Food”, in the parenthetical “other than food”, has been further interpreted by the courts as a substance that provides “taste, aroma or nutritive value”. If a food affects the structure or function of the body, it does so by these properties (for example, a food may provide nutrients such as calcium for proper bone structure, or taurine for healthy heart function in cats).
However, if a product affects the structure or function of the body apart from its nutritive value, such as urine acidification or improvement in joint function, it may be considered a drug.
The legal distinction between food and drug is critical in terms of FDA’s regulatory authority. A new drug, whether for humans or other animals, must be subject to an approval process prior to marketing. Adequate data from controlled scientific studies to demonstrate safety and efficacy for its intended use are required before a drug product may be approved.
Unapproved drugs on the market are deemed adulterated drugs and may be subject to regulatory action. In contrast, the law does not require a food to be subject to a similar premarket approval process unless it is considered to be a food additive.
The legal definitions of food and drug become intertwined when a food label bears a claim that consumption of the product will treat, prevent or otherwise affect a disease or condition, or to affect the structure or function of the body in a manner distinct from what would normally be described as from its “nutritive value”.
In effect, such a claim establishes an intent to offer the product as a drug (i.e., it makes a “drug claim”). Furthermore, as the product was not subject to the normal premarket clearance mechanism to demonstrate safety and efficacy as required for drugs, it is unsafe by definition.
Therefore, pet food products with labels bearing drug claims are subject to regulation as drugs as well as foods. A pet food company must then remove these claims to restore its regulatory status to simply food.
The criteria for what constitutes a drug claim extend beyond the specific wording that a product will “treat” or “prevent” a disease. An implied drug claim can be any claim that suggests that use of the product will be of therapeutic benefit. Therefore, any discussion of a medical condition on a food label implies that the product will affect that condition and could be a drug claim.
Reference to a product as equivalent to a drug (for example, “the herbal alternative to cortisone”) may also be a drug claim. In addition to text, symbols or other depictions that may imply medical benefit (EKG tracings, medical insignia) may be drug claims.
FDA’s authority to prohibit drug claims extends beyond what is commonly considered the product “label”. The FFDCA defines “labeling” as all labels and other written, printed or graphic matter upon any article or any of its containers or wrappers or accompanying such article.
Therefore, brochures, flyers, signs or similar promotional material found at the point of sale may be labeling and subject to the same laws. Also, although food advertising is not regulated by the FDA, but by the Federal Trade Commission, FDA does have some authority.
Advertisements or even verbal representations that establish the “intended use” of the product can be used as relevant evidence that it is a drug. The aforementioned aside, FDA recognizes that there is an integral relationship between diet and disease.
Congress also acknowledged this relationship in 1990, when it passed the Nutrition Labeling and Education Act (NLEA). Among other food labeling changes, the NLEA required the promulgation of regulations to allow for certain “health claims” on foods for human consumption.
These are claims wherein discussion of intake of a certain food with the reduction of risk of a disease could appear on the label without automatically rendering the product a “drug”. For example, the relationship of dietary fat, saturated fat and cholesterol intake with the reduction of risk of cardiovascular disease could appear on some foods low in these factors. Other relationships, such as calcium and osteoporosis, and salt and hypertension, are also mentioned in the NLEA.
A similar relationship between diet and disease can be argued for pet foods. The specific diet / disease relationships as spelled out in the NLEA would not necessarily apply to nonhuman animals. For example, the same “fat / heart disease” claim on a pet food would be misleading, as dogs and cats do not suffer the same incidence of atherosclerosis and myocardial infarct as do humans. Still, the principle could be the same.
The NLEA did not expressly include animal feeds or pet foods in the new law, so it would be difficult to promulgate Federal regulations to allow for similar “health claims” on pet food labels at this time.
Much efforts have focused on label claims related to cat foods and the prevention of Feline Lower Urinary Tract Disease (FLUTD). The exact causes of FLUTD are still unclear and a number of dietary and non-dietary factors may be involved.
With respect to dietary factors, the ability for a cat food to produce an appropriately acidic urine, and to a lesser degree to limit the amount of dietary magnesium, may beneficially affect the incidence of the disease. Although FLUTD occurs in less than one percent of the cat population, it is of tremendous concern to cat owners.
Therefore, many veterinarians and cat owners look for these qualities in making choices about cat food products and cat foods designed specifically to address this issue are on the market. Label claims to prevent or reduce the risk of FLUTD, cystitis, urinary problems or similar verbiage are drug claims and are not allowed under the law.
However, in an effort to get some meaningful health-related information to the consumer, no regulatory action is taken against products that bear claims akin to “reduce urine pH to help maintain urinary tract health” or to have low magnesium levels.
With respect to urine pH claims, this discretion is contingent upon adequate controlled studies to demonstrate that consumption of the product results in an appropriately acidic urine. Since too much acidification of the urine can also result in serious health problems, data to demonstrate safety of the product are reviewed as well.
With respect to dietary magnesium levels, the “cut-off” criteria to support a “low magnesium” claim are less than 0.12 percent on a dry matter basis and less than 25 mg per 100 kilocalories of metabolizable energy.
Companies submit the results of proximate analyses (including crude protein, crude fat, crude fiber, moisture and ash) and magnesium analyses of a number of production runs of the product. Demonstration that the product formulation consistently meets the cut-off criteria supports the label claim.
The estimation of magnesium content, as calculated by using guaranteed analysis values on the product label, must also meet the criteria. The only exception to this last requirement is if a valid AAFCO calorie content statement is also on the label, wherein the calorie content is higher than would be estimated from the guarantees.
In order to be most useful in reducing the risk of FLUTD, products must also be used correctly. If the product is mixed with other foods or “meal fed” (offered for only a short period of time per day), it might not be able to maintain the proper urine pH to be beneficial.
Therefore, feeding directions are added to recommend the product be fed alone and to be made available throughout the day. Also, the nutritional adequacy statement on the label must be for adult maintenance only. It must be noted that this disease occurs primarily in young to middle-aged adults and the most serious problems occur in males. As the safety of these products for kittens and pregnant or nursing females has not been established, it is recommended not to use these products for these life stages.
Another FLUTD-related claim, “low ash”, is not allowed on cat food labels. The current scientific consensus is that ash per se is not related to the incidence of FLUTD. There are no valid reasons to reference ash on the product label (other than in the guaranteed analysis), except in regard to this outdated theory. Therefore, “low ash” or similar claims, even without reference to FLUTD, are inherently false and misleading, which render the product misbranded and subject to regulatory action.
Weight Control Products
Obesity in pets is probably the most common nutritional problem today. Therefore, it is not surprising that reduced calorie products have been on the market for many years. However, following the lead of marketing niches for human foods, more and more “lite” pet food products are now available.
FDA regulations, promulgated under the NLEA, established the rules for human products labeled as “lite”, “low calorie” or similar terms, but do not apply to pet foods.
Under AAFCO regulations, however, the term “lite” must be based on a standard reference for all products, regardless of manufacturer. For example, a “lite” or “low calorie” dry dog food cannot contain more than 3,100 kilocalories per kilogram (kcal / kg), while a similarly named dry cat food cannot contain more than 3,250 kcal / kg. Canned foods contain much more moisture, so the maximum allowable calories are even lower (900 and 950 kcal / kg for dog and cat foods, respectively).
For products that are reduced in calories, but not enough to merit a “lite” claim, the rules also allow for comparative claims. For example, if a company makes a very high calorie product and a lower calorie alternative, it can still make statements such as “25 percent less calories than our regular product”. A calorie content statement must also appear on any product bearing a calorie-based claim.
In addition to “lite” and “low-calorie” claims, a similar set of rules were established for “lean” and “low fat” products, except based on maximum allowable fat percentages instead of calories.
Despite these new rules, a successful weight loss program takes owner involvement, too. Even a “lite” food can cause weight gain if fed to excess. Therefore, owners should follow the feeding directions suggested for weight loss, be careful not to give their pets snacks or table scraps and even institute an exercise program as the pet’s health dictates. Involvement of the veterinarian in the process is also the most prudent in ensuring both the success of the weight loss program and avoidance of potential health risks.
Label claims for “clean teeth” have been on pet food labels for many years, particularly on dry, hard biscuit products. As the field of veterinary dentistry and the awareness of the importance of proper dental hygiene have grown, a number of products have borne much more explicit claims.
Claims to treat or prevent gingivitis or periodontal disease are drug claims and should not appear on pet food labels. Plaque or tartar control claims may also be implied drug claims, as they directly relate to dental disease.
The Veterinary Oral Health Center, an outside organization formed under the auspices of the American Veterinary Dental College, has developed an experimental protocol for companies to follow to demonstrate that their products are useful in reducing plaque and tartar.
This organization will also review data from companies to verify that the claim is true, and if so, allow them to carry its logo on the package.
Skin and Coat Products
Pet food labels abound with promises for “healthy skin” and “glossy coat”. Any normal animal receiving adequate nutrition through use of a complete and balanced product should have these qualities. However, claims to uncategorically “improve” skin and coat or to cure or prevent disease signs such as dry skin, flaky skin, or itching may be drug claims.
Perhaps most notorious is the claim for a product to be “hypoallergenic”. Elimination diets for the diagnosis and management of food allergies in pets have been on the market for years. An elimination diet is one devoid of food ingredients likely to cause an allergy, often characterized by itchy, inflamed skin.
Resolution of these clinical signs while the animal is on the diet is diagnostic of a food allergy and trial and error then could be used to determine exactly to what the pet was allergic and what ingredients to avoid.
Traditionally, lamb and rice was used as the elimination diet. There is nothing special or unique about these ingredients in terms of allergenicity, and prolonged exposure to these ingredients could also induce an allergic condition. However, they were historically novel sources of protein, as the use of these ingredients was uncommon in commercial dog foods. As such, a pre-existing allergy to lamb or rice would be unlikely.
Consequently, plethora of products containing lamb and rice entered the consumer market. Many of these products were labeled as “hypoallergenic”, or otherwise espoused the benefits of lamb and rice in the treatment or prevention of food allergies and other skin problems. Such claims were made even for products that contained other sources of protein that would disqualify them as effective elimination diets.
This marketing niche was detrimental in two respects. The true nature and incidence of food allergies was clearly overemphasized and misrepresented. Also, the novelty of lamb and rice was diminished, so the usefulness of these ingredients as elimination diets has markedly decreased.
Pet foods that contain lamb or rice in sufficient quantities to meet AAFCO labeling criteria may make claims to the presence of these ingredients. However, any claim to be “hypoallergenic” or any other expressed or implied claim relating these ingredients with benefits to the skin and coat beyond their normal nutritive value is a drug claim.
The same may also be true of other ingredients. For example, many fat sources may contain substances known as Omega-3 fatty acids. There are some studies in the veterinary literature to suggest that when used pharmacologically, these substances may have an effect on inflammatory skin disease. However, Omega-3 fatty acids are not recognized as essential nutrients at this time.
In other words, dogs and cats cannot have an “Omega-3 fatty acid deficiency” and unqualified claims relating to Omega-3 fatty acid content may falsely imply nutritional benefit where none has been established. Therefore, if a product label bears a claim for Omega-3 fatty acids, it must also guarantee its level in the product, accompanied by a disclaimer that it is “not recognized as an essential nutrient by the AAFCO (Dog or Cat) Food Nutrient Profiles”.
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