While the Dietary Supplement Health and Education Act (DSHEA) provides a category for human dietary supplements, it does not do the same for "pet dietary supplements." In fact, there are currently no legal provisions for the category of "pet dietary supplements." And yet, the absence of such a category should not be misconstrued to mean that animal foods and drugs are not subject to any regulations. Quite the contrary, they are subject to both federal and state regulations, the violation of which may subject a company to regulatory action at either level.
Regulatory Authorities
Human and animal foods and drugs are regulated at the federal and state level. At the federal level, the Federal Food and Drug Administration (FDA) is charged with the enforcement of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 301. Under the Act, FDA has a responsibility to ensure that human and animal foods and drugs are safe and properly labeled. Within FDA, the Center for Veterinary Medicine (CVM) is responsible for the regulation of animal drugs, medicated feeds, food additives and feed ingredients, including pet foods and special use pet foods such as dietary supplements and nutraceuticals. The federal regulations are found in the Code of Federal Regulations, Title 21, Food and Drugs, Part 500.
Some states have also promulgated and enforce their own animal food and drug regulations. Many of these states (e.g., Texas) follow the model pet food regulations established by the Association of American Feed Control Officials (AAFCO). AAFCO is a non-profit corporation formed, in part, to provide a vehicle through which state and federal officials charged with regulating animal food products may work in a cooperative manner to develop standards for uniform regulatory and enforcement laws and policies. AAFCO's model pet food regulations are found in the Official Publication of the Association of American Feed Control Officials.
Relevant Federal Regulatory Provisions
The Act's definition of food includes "articles used for food or drink for man or other animals...and...articles used for components of any such article" 21 U.S.C. 321(f). Among other things, the Act requires that pet foods, like human foods, be safe, contain no harmful or deleterious substances and be truthfully and properly labeled.
Under provisions of the Act, a drug is, in part, an article "intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animals," or an article "(other than food) intended to affect the structure or any function of the body of man or other animals," 21 U.S.C. 321(g)(1). Courts have determined that the Act's reference to food in this definition of drug should be interpreted to mean a substance that provides nutrition, taste or aroma. When a substance affects the structure or any function of the body of man or other animal by providing nutrition, taste or aroma, it continues to be considered a food, not a drug. In the case of pet food, a pet food may provide nutrients such as calcium for proper bone structure in cats. On the other hand, if a substance affects the structure or function of the body apart from its nutritive value-for example, urine acidification or improvement in the joint function-it may be considered a drug.
In 1958, in response to public concern about the increased use of chemicals in foods and food processing, Congress amended the Act to require the pre-marketing clearance of additives whose safety was not generally recognized. The Act was also amended to deem food unsafe and adulterated if it contains an unapproved food additive. In order to demonstrate to FDA that a food additive is safe for its intended use, it is generally necessary for a company to submit a food additive petition for pre-market clearance of the product.
There are exceptions to this general rule. For example, when qualified scientists determine that a substance added to food is generally recognized as safe for its intended use, such substances, which would have been considered a "food additive," are not "food additives," and therefore are exempt from pre-clearance approval.
Similarly, CVM has exercised regulatory discretion and has not required food additive petitions for substances that do not raise significant safety concerns. Instead, CVM requires the company to submit information necessary to include the ingredient in the Official Publication of AAFCO. CVM reviews the company data to ensure the ingredient serves a purpose and can be manufactured consistently to meet product specifications. Although ingredients used under regulatory discretion are still unapproved food additives, CVM has chosen not to take regulatory action provided that the labeling is consistent with the accepted intended use, the labeling or advertising does not make drug claims and new data are not received that raise questions concerning safety or suitability.
When Congress enacted DSHEA on October 25, 1994, it created a new category of substances (dietary supplements) and a new regulatory scheme that removed certain dietary ingredients from regulation as food additives and from the pre-market approval requirement. However, DSHEA did not apply to substances for use in animals and still does not apply to animal products.
Prior to the enactment of DSHEA, Congress amended the Act when it enacted the Nutrition Labeling and Education Act (NLEA) in 1990. This law required FDA to promulgate regulations to permit health claims on human food. A number of these claims have been approved for various foods.
CVM has incorporated the philosophy of NLEA in its policies in order to permit meaningful health information on pet foods. Examples include the use of urinary tract health claims for cat food diets, development of AAFCO regulations relating to reduced calorie/reduced fat pet food and non-enforcement activity relating to the cat foods, which control hairballs.
Pet Food Labeling
CVM promulgates standards applicable to all animal feeds: proper identification of product, net quantity statement, manufacturer's address and listing of ingredients. Some states also establish and enforce their own labeling regulations. State regulations, which incorporate the model pet food regulations established by AAFCO, are more specific in nature, covering aspects of labeling such as the product name, the guaranteed analysis, the nutritional adequacy statement, feeding directions and calorie statements.
Certain rules apply to all pet food products. "Complete and balanced" pet foods are intended for general use in healthy animals. Certain rules provide special considerations for the labeling of products intended for special dietary circumstances, such as treats, veterinary medical foods and dietary supplements.
General rules applicable to all pet food products, including dietary supplements and nutraceuticals, as described by FDA:
Product name. The "statement of identity of the commodity"-more commonly known as the product name-is likely the first and primary feature of the label noticed by the consumer. Accordingly, manufacturers often use "fanciful" names or other techniques to emphasize a particular aspect of the product. Many product names incorporate the name of an ingredient to highlight its inclusion in the product.
AAFCO prescribes four rules for incorporating the ingredient name in the product name. These four rules are based on the percentages of named ingredients in the total product. These rules include the "95%" rule; the "25%" or "dinner" rule; the "3%" or "with" rule and the "flavor" rule.
The "95%" rule applies to animal foods consisting primarily of meat, poultry or fish. Examples include canned products with names such as "Beef for Dogs" or "Tuna Cat Food." In these examples, at least 95% of the product name must be the named ingredient (beef or tuna, respectively), excluding the water added for processing and condiments. If the name includes a combination of ingredients, such as "Chicken 'n Liver Dog Food," the two together must comprise 95% of the total weight. This rule also provides other specific requirements, such as those relating to a product which includes the added water in the percentage of total weight, or those relating to the ordering of ingredients in the product name when there is more than one primary ingredient (for example, "Chicken 'n Liver Dog Food" versus "Liver 'n Chicken Dog Food").
The "25%" or "dinner" rule applies to many canned and dry products. If the named ingredients comprise at least 25% of the product (not counting the water for processing), but less than 95%, the name must include a qualifying descriptive term, such as "dinner," "platter," "entree," "nuggets" and "formula," as in the examples "Beef Dinner for Dogs" and "Chicken Formula Cat Food." In these examples, only 25% of the products must be beef in the case of the "Beef Dinner" product or chicken in the case of the "Chicken Formula" product, and would most likely be found third or fourth on the ingredient list of each product. Accordingly, a "Chicken Formula Cat Food" may contain more fish than chicken, which may be a potential problem for consumers purchasing for cats who do not like fish.
If more than one ingredient is included in a "dinner" (or other such descriptive term) name, they must total 25% and be listed in the same order as found on the ingredient list. Each named ingredient must be at least 3% of the total, too. Therefore, "Chicken n' Fish Dinner Cat Food" must have 25% chicken and fish combined-at least 3% fish and at least 3% chicken. Also, unlike the "95%" rule, this rule applies to all ingredients, whether of animal origin or not. For example, a "Lamb and Rice Formula for Cats" would be an acceptable name as long as the amounts of lamb and rice combined totaled 25%, and as long as there is at least 3% of each of the ingredients of lamb and rice in the product.
Generally speaking, the "3%" or "with" rule permits manufacturers to highlight minor ingredients which are included in the product but which are not present in amounts large enough so as to warrant a "dinner" claim. For example, a "Beef Dinner for Dogs" or "Chicken Formula for Cat Food" could include a side burst "with cheese" if at least 3% cheese is added. Recent amendments to the AAFCO model regulations now also permit use of the term "with" as part of the product name, as in "Dog Food With Beef" or "Cat Food With Chicken."
Under the "flavor" rule, a product must contain an amount large enough so that trained animals can detect the specific flavor, and thus the claim can be confirmed. In addition, where the word "flavor" is used as part of the product name, as in the example of "Beef Flavor Dog Food," the word "flavor" must conform to specific type size, style and color requirements. Moreover, there are provisions relating to the permissible substances-not just beef-that may be used to give the characterizing flavor.
Net quantity statement. The net quantity statement describes the amount of product in the container. FDA regulations set forth the format, size and placement of the net quantity statement.
New FDA regulations are being considered to require "dual declarations" on pet food labels (as well as other consumer goods). Currently, labels must only bear the customary "pound" or "ounce" declarations. In the future, a unit of metric measurement, such as "kilogram" or "gram" may also be required to appear on the label. The current FDA regulations do not prohibit the inclusion of the net quantity statement in metric terms and many pet food labels already bear both measurements.
Manufacturer's name and address. The product label must include a statement which identifies the party responsible for the quality and safety of the product and its location. For example, the label may say "manufactured by...," "manufactured for..." or "distributed by..." to identify the responsible party.
Ingredient list. Ingredients are required to be listed in descending order by weight. If scientific data are presented of an ingredient or additive's potential health danger to animals, CVM may prohibit or modify its use in pet food. For example, CVM prohibits the use of propylene glycol in cat foods.
Guaranteed analysis. A pet food label must provide guarantees for the minimum percentages of crude protein and crude fat and the maximum percentages of crude fiber and moisture. "Crude" refers to the method of testing the pet food, not to the quality of the nutrient itself. Manufacturers may also include guarantees for other nutrients. Guarantees are declared on an "as fed" or "as is" basis, which are the amounts present in the product as it is found in the can or bag.
Under AAFCO regulations, the maximum percentage moisture content for a pet food is 78%, except for products labeled as a "stew," "in sauce," "in gravy" or similar terms. The extra water gives the product the qualities needed to have the appropriate texture and fluidity.
Nutritional adequacy statement. Any claim that a product is "complete," "balanced," "100% nutritious" or similarly suggests that a product is suitable for sole nourishment that is not, in fact, nutritionally adequate on its own is viewed by FDA as a potentially unsafe product. For this reason, FDA considers an AAFCO nutritional adequacy statement as one of the most important aspects of a dog or cat food label. A "complete and balanced" pet food must be substantiated for nutritional adequacy by one of two means. The first method is for the pet food to contain ingredients formulated to provide levels of nutrients that meet an established profile. Presently, the AAFCO Dog or Cat Food Nutrient Profiles are used. Another way to substantiate nutritional adequacy is to test the product following the AAFCO Feeding Trial Protocols.
Feeding directions. Feeding directions instruct the consumer on how much product should be offered to the animal. At minimum, they should include verbiage such as "feed ___ cups per ___ pounds of body weight daily."
Calorie statement. If manufacturers make a calorie statement on the label, it must be expressed on a "kilocalories per kilogram" (kcal/kg) basis. Calories may also be expressed in familiar household units along with the required statement (for example, "per cup" or "per can"). As with the guaranteed analysis, the calorie statement is made on an "as fed" basis, so corrections for moisture content must be made as described above.
Requirements For Foods For Special Uses
In terms of health claims 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 different from what would normally be described as providing "nutritive value." In effect, such a claim would be viewed by FDA as evidencing an intent to offer the product as a drug (because, it would be making a drug claim). Pet food products with labels bearing drug claims are subject to regulation by FDA's CVM as drugs as well as foods. A pet food company would be required to remove these claims to restore its regulatory status to that of a food only and not also as a drug.
As previously stated, the NLEA required the promulgation of regulations to allow for certain health claims on foods for humans, but not for animal consumption because the specific diet/disease relationships under the NLEA would not necessarily apply to nonhuman animals. And yet, while it would be difficult to promulgate federal regulations to allow for similar health claims on pet food labels at this time, FDA's CVM has incorporated some of the NLEA's philosophy to allow for meaningful health-related information on pet food labels to reach the consumer without violating the intent of the law.
FLUTD products. CVM's efforts to date have focused on label claims related to cat foods and prevention of Feline Lower Urinary Tract Disease (FLUTD). Label claims to prevent or reduce the risk of FLUTD, cystitis and urinary problems are drug claims and are prohibited. However, in an effort to provide some meaningful health-related information to the consumer, CVM has been exercising discretion in not taking regulatory action against products that include claims relating to a lowered magnesium level or which state "reduce urine pH to help maintain urinary tract health" (based on the existence of adequate controlled studies).
Weight control products. In 1999 AAFCO regulations governing the use of terms such as "lite" became effective. Under these rules, 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 3100 kcal/kg, while a similarly named dry cat food cannot contain more than 3250 kcal/kg.
For products that are reduced in calories but not enough to justify a "lite" claim, comparative claims may be made. For example, if a company makes a very high calorie product and a lower calorie alternative, it can still make statements such as "25% 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.
Dental products. Label claims for "clean teeth" have been on pet food labels for many years, as on dry, hard biscuit products. Generally speaking, claims to treat or prevent gingivitis or periodontal disease are drug claims and not permitted on pet food labels. While plaque or tartar control claims may also be implied drug claims, as they directly relate to dental disease, CVM has exercised some regulatory discretion with respect to these claims.
Skin and coat products. While pet food labels may include promises for "healthy skin" and "glossy coat," it is FDA's position that claims to improve skin and coat or to cure or prevent disease signs (such as dry skin, flaky skin or itching) may be drug claims.
Some pet food products have been labeled as "hypoallergenic" or otherwise have promoted the benefits of lamb and rice in the treatment or prevention of food allergies and other skin problems. CVM does not object to the use of lamb or rice in pet foods, and foods that contain these products 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 typical nutritive value will be viewed as a drug claim.
Veterinary medical foods. There are special rules pertaining to so-called veterinary medical foods (VMF), the discussion of which is beyond the scope of this article. Generally speaking, VMF are regulated as foods and are not subject to the same controls as drugs; however, CVM generally exercises regulatory discretion to a veterinary professional with respect to distribution of truthful information on these products and their use in disease.
Dietary supplements and nutraceuticals. Nutritional supplements for pets have been available for many years. These are products that provide a source of a recognized essential nutrient, such as calcium or vitamin A and are intended to supplement and ensure the nutritional completeness of the diet. It is CVM's position that animals on balanced rations do not need additional nutritional supplementation and may actually experience health problems if given excessive amounts of certain nutrients. Having said that, a 1989 FDA Compliance Policy Guide provides that "CVM does not object to the OTC marketing of dietary supplements in tablet, capsule, powder or liquid form for companion animals [that is, cats, dogs, horses] similar to the special dietary preparations sold for humans. However, such products should provide meaningful amounts of each of the nutrients they are represented to contain and these nutrients should be of known value for the intended or target animal." Therefore, the labeling for nutritional supplements must follow the same rules as for other pet foods as described above. In addition, if the product claims to be a vitamin or mineral supplement, the label must bear guarantees for each vitamin or mineral in the product.
The term dietary supplements describes a much broader range of products. Some provide essential nutrients, such as vitamins and minerals, but others contain substances that are not recognized as essential for the particular animal (for example, vitamin C for dogs and cats or omega-3 fatty acids). Herbs, plant, organ extracts, enzymes and many other substances are also often marketed as dietary supplements.
The market for dietary supplements was boosted by the passage of DSHEA. It must be reiterated that DSHEA only applies to human products, not pet products. Thus, some of the substances allowed for sale as human dietary supplements may not be legally permitted to be sold for animals. Accordingly, the inclusion of a disclaimer statement that the claim has not been evaluated by the FDA and that the product is not intended to diagnose, treat, cure or prevent any disease-required on the label of human dietary supplements-is actually prohibited on a pet product. FDA's reason for this is that while some of the supplements, such as herbal products, may have "thousands of years of history of safe use," this does not include history of use in animals. Animals may react very differently to certain supplements than people do, and even small doses can cause adverse effects. For example, aspirin and chocolate, which are both substances people use every day without ill effect, can be toxic to pets and even cause death. Because of the effects an herb or other supplement may have on pets are unknown, FDA's position is that it is safest not to allow marketing for that use.
On a case-by-case basis, CVM has reviewed safety information for some substances and allowed them to be used in animal feeds (for example, L-carnitine in dog foods), even though they were officially "unapproved food additives." If included in a pet food or supplement, they must be properly declared on the label. If the substance is not an essential nutrient, the disclaimer "not recognized as an essential nutrient by the AAFCO (Dog or Cat) Food Nutrient Profiles" must also appear on the label.
Enforcement Activities. Presently, FDA will view substances as drugs if the labeling bears claims to treat or prevent disease, or if the intended use as a drug can otherwise be established. Some states are stepping up their enforcement on pet products, mainly because FDA has chosen not to take an aggressive lead position in this regard. Having said this, as recently as October 11, 2000, FDA participated in the first nationwide "Surf Day" sponsored by AAFCO, the purpose of which was to identify internet vendors selling horse feeds and horse feed supplements in violation of federal and state commercial feed regulations. Among the state participants in the initiative was the state of Washington. As a result of the search, that state's Department of Agriculture discovered nine companies selling 20 products for which they are making explicit or implicit drug claims that may not have been approved by FDA. The state Department of Agriculture intended to forward the information to both FDA and AAFCO, and then take regulatory action against offending companies. Among the 20 products were the following: five herbal mixtures claiming to promote calming, or to mitigate excessive bleeding or to cure colitis; and six supplements claiming to reduce irritability, to promote calmness, to allow offspring to reach genetic potential, to act as an anti-inflammatory, to act as a bronchial dilator or to improve performance.
In addition to participating in the "Surf Day" initiative, FDA has issued warning letters to companies advising them, among other things, that their products may be deemed misbranded because of improper labeling. As one example, the Rolf C. Hagan Corporation was sent a letter in 1994 relating to the following statements on its "Vitamin Supplement Conditioner for Birds" container, which said "Regular use will supply caged birds with essential vitamins and iron, which will result in proper growth and healthy, disease-resistant birds. Sick birds, which are unable to obtain regular and proper nourishment, will benefit from daily use of Hagen (sic) Vitamin Supplement Conditioner." According to FDA, "The statements regarding disease-resistance and sick birds are therapeutic claims and should be removed from the label. As labeled, the product is an unapproved new drug." FDA required the company to make correction or to notify it as to why correction could not be made within fifteen working days of receipt of the warning letter.
Companies must be diligent in their marketing of pet products. Not only must a company adhere to the technical requirements of the various regulations, but it also must exercise extreme caution in how it markets the product. It must be careful not to make representations about the product that would be viewed by FDA as "drug claims" even though those claims might be appropriate structure/function claims for dietary supplements. The marketing of a pet food product with such claims-even if inadvertent-could transform a pet food product into an unapproved new drug and subject a company to federal or state enforcement action.
NW
About the author:
Elizabeth Gioiosa Dillabough is an associate with the law firm Ullman, Shapiro & Ullman, which counsels clients on federal and state law relating to foods, drugs, dietary supplements, medical devices and cosmetics. She can be reached at Ullman, Shapiro & Ullman, 299 Broadway, Suite 1700, New York, NY 10007; 212-571-0068; E-mail: egd@usulaw.com.
Bibliography
Official Publication of the Association of American Feed Control Officials, AAFCO (2000).
Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 301.
Code of Federal Regulations, Title 21, Food and Drugs, Part 500.
"FDA Participating in AAFCO Internet Surf Day," published on www.fda.gov/cvm on October 2, 2000.
David A. Dzanis, "Interpreting Pet Food Labels Part 1: General Rules," FDA Veterinarian (November/December 1998).
David A. Dzanis, "Interpreting Pet Food Labels - Part 2: Special Use Foods," FDA Veterinarian (January/February 1999).
Sharon Benz, "FDA's Regulation of Pet Food," FDA Veteri narian (January/February 2000).
FDA Warning Letter to Rolf C. Hagan Corporation (January 21, 1994).
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FDA Warning Letter to The Natural Pet Care Company (September 16, 1994).
"If You Buy Animal Feed Over the Internet, Beware: Unsub stantiated Claims Found On Nine Web-Based Companies Selling 20 Products," Business Wire (October 23, 2000).
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