CVM ATTENDS GEORGIA MEETING ON ANTIBIOTIC RESISTANCE
by Linda Tollefson, D.V.M., M.P.H., Marcia Headrick, D.V.M., M.P.H., Roger Jones, Ph.D., and Joseph Paige, D.V.M., M.P.H.
Several Center for Veterinary Medicine (CVM) officials attended the Emerging Antibiotic Resistance in Food Borne Enteric Pathogens: Epidemiology, Public Health Risks, and Control Strategies symposium in Athens, Georgia, August 31 - September 3. A wide variety of presentations on antibiotic resistance including animal health and industry perspectives provided impetus for animated discussion. The symposium was co-sponsored by the United States Department of Agriculture’s (USDA) Agricultural Research Service (ARS), the Food and Drug Administration’s (FDA) CVM, and the Center for Disease Control and Prevention (CDC).
Dr. Jane Robens, USDA ARS, opened the conference with an overview of the National Academy of Sciences (NAS) report on The Use of Drugs in Food Animals. Dr. Robens reported that the NAS report praised the interagency cooperation between FDA, CDC, and USDA in carrying out the activities of the National Antimicrobial Resistance Monitoring System.
The first session focused on the Animal Health Industry perspective and was moderated by Dr. Scott Wells, USDA ARS. Representatives from the pork, beef, dairy, and poultry industries described their efforts to provide a safe, wholesome food supply while minimizing the opportunity for antimicrobial resistance development. Efforts described by industry representatives to prevent antimicrobial resistance development in food animals included on-farm research, support of the prudent use of antibiotics, an established and mandated withdrawal period, use of competitive exclusion products, good management practices, and quality assurance programs. Dr. Jarrett, President of the Bovine Practitioners Association, described the United States food supply as the most wholesome and least expensive food supply in the world.
CVM’s Dr. Linda Tollefson chaired a session on Public Health Perspectives that included representatives from several national consumer organizations; Dr. Lieberman represented the Center for Science in the Public Interest, Dr. Mellon represented the Union of Concerned Scientists, and Dr. Goldberg represented the Environmental Defense Fund. Dr. Sharon Thompson also participated in this session and gave an excellent overview of CVM's approach to the antibiotic resistance issue and CVM’s plans to address it.
Data from the National Antimicrobial Resistance Monitoring System was highlighted as well as results from the Canadian, Danish and German systems. An entire day was devoted to excellent presentations on the epidemiology of various food borne pathogens and approaches for prevention and control.
Of particular interest was a presentation by USDA ARS scientist Dr. Norman Stern describing an ongoing National Poultry Epidemiology Study. The study is a collaborative effort between USDA ARS, USDA Food Safety Inspection Service (FSIS), and the broiler producers. The National Poultry Epidemiology Study includes the collection of a variety of microbiological samples from poultry and their environment in five representative regions of the U.S. The one-year study includes five of the 20 largest integrated poultry producers and samples two poultry houses per operation. Salmonella and Campylobacter isolates will be identified and collected from sample cultures. Antimicrobial sensitivity testing will be conducted on the Salmonella and Campylobacter isolates through the National Antimicrobial Resistance Monitoring System. A survey is also being conducted as part of the study that includes determination of antibiotic use practices in poultry. The study results will help determine on-farm antimicrobial resistance prevalence and possible risk factors for resistance development. USDA hopes to continue the study for an additional year, but funding is uncertain at this time.
A session entitled "Approaches for Prevention and Control" chaired by Dr. Stan Bailey, addressed Campylobacter, Salmonella, and E. coli 0157:H7 control during animal production. Several presentations on competitive exclusion (CE) culture (a.k.a. probiotics) methods for reducing two of the above pathogens were included in the session.
Dr. Mike Doyle discussed the use of bovine probiotic E. coli cultures to reduce or eliminate carriage of Shiga toxin-producing enterohemorrhagic E. coli (EHEC), including 0157:H7, 026:H11, and 0111:NM in cattle. Dr. Doyle’s research demonstrates that many of these probiotic cultures show potential both as prophylactic and therapeutic agents in calves.
Dr. Stan Bailey presented evidence from his research in competitive exclusion culture use in poultry. Dr. Bailey’s work demonstrates that mixed microbial cultures derived from pathogen-free chickens can effectively colonize newly hatched chicks; thus preventing colonization from ubiquitous Salmonella.
Dr. Robin Anderson provided information on the use of CE cultures primarily in swine in a talk entitled "Competitive Exclusion: Potential for and Environmentally Compatible Pathogen Control Strategy." CE culture intervention strategies look very promising for reducing Salmonella shedding in swine.
EXTRA-LABEL USE OF BAYTRIL 100 PROHIBITED, INCLUDING USE IN DAIRY CATTLE OR VEAL CALVES
In the Federal Register of September 14, 1998, FDA’s Center for Veterinary Medicine announced the approval of a new animal drug application for the use of a fluoroquinolone product, enrofloxacin. This product, trade name Baytril 100 Injectable Solution, is approved for use by prescription only in cattle and only for the treatment of bovine respiratory disease (BRD) associated with Pasteurella haemolytica, Pasteurella multocida, and Haemophilus somnus. Any extra-label use of fluoroquinolones, including Baytril 100, in food animals is prohibited under Title 21, Part 530.41, of the Code of Federal Regulations.
Baytril 100 is not approved for use in those cattle intended for dairy production or calves to be processed for veal. The term "cattle intended for dairy production" refers to all classes of cattle involved in the dairy farm operation including calves reared as dairy cow replacements, heifers, lactating and non-lactating (dry) dairy cows, and bulls maintained for breeding purposes. Baytril 100 may be used to treat BRD only in dairy breed animals (e.g., dairy breed feedlot steers, bulls, heifers) maintained for beef production.
The restriction on use of Baytril 100 in cattle intended for dairy production and calves to be processed for veal is based on human food safety concerns. These concerns include the increased prevalence of certain pathogens with zoonotic potential (such as Salmonella) on dairy farms, the higher level of human-animal contact on dairies, and concerns about meat and milk safety.
Because of these human food safety concerns, Baytril 100 should not be used to treat cattle intended for dairy production or stored in dairy farm drug cabinets. FDA Regional Milk Specialists will be looking for the presence of the drug during dairy farm inspections conducted under the Grade A Pasteurized Milk Ordinance. Causing the use or using this drug in cattle intended for dairy production or calves to be processed for veal may result in regulatory action by FDA and/or State regulatory authorities.
Baytril 100 should be used only in the appropriate classes of cattle when BRD is diagnosed. Veterinarians should be particularly prudent in the selection of therapy for BRD (as for any disease) when concurrent diseases are present. Concurrent disease, such as enteric disease, is of concern because it may be associated with organisms that may be transferred to humans.
Further information about the approval of Baytril 100 is contained in the September 14, 1998, Federal Register document (pp. 49002-49003). Any questions concerning the restrictions on the use of Baytril 100 may be directed to Dr. Michael Talley on (215) 597-4390 ext. 4541#. Please note, the number (#) sign must be entered.
FDA PERMITS IMPORTATION OF DRUGS TO TREAT EPM
by Tania D. Woerner, V.M.D.
The Federal Food, Drug, and Cosmetic Act (FFDCA), Sec. 801 (a)(3), states that importation of a new animal drug that is not the subject of an approval in the United States is forbidden. However, the FDA’s Center for Veterinary Medicine recognizes that the lack of certain drugs could result in undue animal suffering. To address this situation, CVM has chosen to exercise regulatory discretion with respect to the personal importation of FDA-regulated new animal drugs providing the following conditions apply:
the drug does not pose a significant risk to animal or human health
the drug is used to treat or prevent a serious disease or condition in an animal
there is no other available source of that drug or alternative drug(s) that is judged by CVM’s veterinary staff to be an adequate substitute
the request for importation is made by a licensed veterinarian within the context of a valid veterinarian-client-patient relationship
a relatively small amount of drug is requested for import
there is no active promotion or marketing of the drug in U.S. markets for the intended use of the product
FDA is committed to working with veterinarians to supply drugs for legitimate medical needs; however, we also caution that drugs purchased outside the U.S. have not been subjected to our high standards for drug manufacturing and quality control, and that drug labeling may not be as detailed and/or comprehensive as U.S. approved products. In addition, the drugs have not been shown to be safe or effective for the intended purpose.
FDA considers equine protozoal myeloencephalitis (EPM) a serious disease; however, we recognize that there are treatments available in the U.S. which have been the standard treatment for the disease, i.e., sulfonamides and pyrimethamine. We also recognize that some horses do not respond to the conventional treatment, thus requiring alternative therapy, often times not available in the U.S. Veterinarians who wish to utilize the Personal Importation Policy for the treatment of EPM should contact Toni Wooten in the Center for Veterinary Medicine’s Division of Compliance at 301 -594-1785. For further information, please contact Dr. Tania D. Woerner, Center for Veterinary Medicine, 7500 Standish Place, Rockville, MD 20855, telephone 301-827-0129.
Note: The veterinarian should be prepared to supply such information as drug name, drug class, name and address of supplier, amount of the drug to be imported and the reason why an approved human or animal drug will not treat the disease condition.
VICH WORKING GROUP MEETS IN JAPAN
by Margaret A. Miller, Ph.D.
The Veterinary International Cooperation on Harmonization (VICH) Ecotoxicity/Environmental Impact Assessment Working Group (Ecotox WG) held its 3rd meeting at the office of JMAFF in Tokyo from 31 August to 3 September. The primary goal of the meeting was to finalize the Phase I guidance document. In 1996, the VICH Steering Committee (VICH SC) authorized formation of a working group to harmonize guidelines for conducting environmental assessments (EAs) for veterinary medicinal products (VMPs ) among the European Union (EU), Japan (JP), and the United States (U.S.). The mandate of the VICH Ecotox WG as set forth by the VICH SC, is as follows:
"To elaborate tripartite guidelines on the design of studies and the evaluation of the environmental impact assessment of veterinary medicinal products. It is suggested to follow a tiered approach based on the principle of risk analysis. Categories of products to be covered by the different tiers of the guideline should be specified. Existing or draft guidelines in the U.S., the EU and Japan should be taken into account."
To accomplish this mandate, the VICH Ecotox WG met twice in 1997; first in Washington, D.C. from 3-5 March and subsequently in London, England from 1-3 September. At the first meeting, the VICH Ecotox WG defined the scope of the VICH Ecotoxicity guideline; areas of agreement and non-overlap for existing legislative, regulatory, and technical EA needs among the EU, JP, and U.S.; and areas that require additional information. Based on discussions at the first meeting and the charge from Steering Committee, the work group concentrated on developing guidance aimed at determining the ecotoxicity effects for veterinary medicinals (VM). The WG also identified both legal and husbandry practices that varied among the three regions and that could interfere with harmonization. Legal differences included difference in the definition of veterinary medicinal, the requirements for an environmental assessment, and the risk standards applied to evaluate products. Regional differences in animal rearing included difference in the species that are considered major or minor, product usage, and the factors used in calculating the predicted environmental concentration. The WG agreed to rely on a scientific framework to construct a Phase I decision tree that both harmonized requirements and protected the environment. Ideally, any difference in environmental assessments would be due to legal or regional differences in husbandry practices and not merely differences in interpretation.
The VICH Ecotox WG defined the key elements (questions and decision criteria) of the Phase I decision tree during its meeting in London and subsequently through correspondence. Consistent with the mandate, a tiered or phased approach was adopted by the VICH Ecotox WG for conducting EAs for VMPs. Two phases were defined: Phase I and Phase II. In Phase I, the potential risk of the VMP to the environment is assessed given its intended use and predicted levels of environmental exposure. The results of environmental fate and effects studies are not needed in Phase I. Products covered by Phase I have limited environmental introduction and, therefore, limited potential for environmental impact. Phase I is also used to identify products which require a more extensive EA under Phase II. This approach focuses drug development and regulatory resources on the VMPs having greatest potential for environmental concern. Importantly, this approach for conducting EAs for VMPs was adapted to accommodate existing legislative/regulatory mandates in the EU, JP and U.S.
In Japan, the majority of the time was spent reviewing and refining the Phase I guidance document. This document was signed by all working group members on the last day of the meeting and submitted to the VICH Steering Committee (SC) as a Step 2 document. The VICH steering committee will be meeting later this year. If the document is accepted by Steering, it will be available for public comment prior to adoption.
Arguably, Americans are reading food labels and choosing products more carefully than ever before. Recent amendments to laws and FDA regulations for nutrition labeling of human foods are designed to help people make more informed food choices. Many people are extending this scrutiny to food for their pets as well, but pet foods are regulated by different rules than are foods for human consumption. Thus, in order for consumers to be able to read and understand pet food labels and enable them to make proper food choices for their pets, they must also be made aware of the rules regarding pet food labeling.
Pet food labeling is regulated at two levels. The federal regulations, enforced by the FDA’s Center for Veterinary Medicine (CVM), establish standards applicable for all animal feeds: proper identification of product, net quantity statement, manufacturer's address, and proper listing of ingredients. Some States also enforce their own labeling regulations. Many of these follow the model pet food regulations established by the Association of American Feed Control Officials (AAFCO). These regulations 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.
This article is divided into two parts. Part 1 will cover the rules that apply to all pet food products, but focuses on "complete and balanced" pet foods that are intended for general use in healthy animals. Part 2, which will appear in the January/February 1999 issue of the FDA Veterinarian, will discuss the special considerations for the labeling of products intended for special dietary circumstances, such as treats, veterinary medical foods and dietary supplements.
The product name is the first part of the label noticed by the consumer, and can be a key factor in the consumer's decision to buy the product. For that reason, manufacturers often use fanciful names or other techniques to emphasize a particular aspect. Since many consumers purchase a product based on the presence of a specific ingredient, many product names incorporate the name of an ingredient to highlight its inclusion in the product. Consumers are often confused, however, as to how much of a named ingredient is actually in the product. The percentages of named ingredients in the total product are dictated by four AAFCO rules.
The "95 percent" rule applies to products consisting primarily of meat, poultry or fish, such as some of the canned products. They have simple names, such as "Beef for Dogs," or "Tuna Cat Food." In these examples, at least 95 percent of the product must be the named ingredient (beef or tuna, respectively), not counting the water added for processing and "condiments." Counting the added water, the named ingredient still must comprise 70 percent of the product. Since ingredient lists must be declared in the proper order of predominance by weight, "beef" or "tuna" should be the first ingredient listed, followed often by water, and then other components such as vitamins and minerals. If the name includes a combination of ingredients, such as "Chicken 'n Liver Dog Food," the two together must comprise 95 percent of the total weight. The first ingredient named in the product name must be the one of higher predominance in the product. For example, the product could not be named "Lobster and Salmon for Cats" if there is more salmon than lobster in the product. Because this rule only applies to ingredients of animal origin, ingredients that are not from a meat, poultry or fish source, such as grains and vegetables, cannot be used as a component of the 95 percent total. For example, a "Lamb and Rice Dog Food" would be misnamed unless the product was comprised of at least 95 percent lamb.
The "25 percent" or "dinner" rule applies to many canned and dry products. If the named ingredients comprise at least 25 percent of the product (not counting the water for processing), but less than 95 percent, the name must include a qualifying descriptive term, such as "Beef Dinner for Dogs." Many descriptors other than "dinner" are used, however. "Platter," "entree," "nuggets" and "formula" are just a few examples. Because, in this example, only one-quarter of the product must be beef, it would most likely be found third or fourth on the ingredient list. Since the primary ingredient is not always the named ingredient, and may in fact be an ingredient that is not desired, the ingredient list should always be checked before purchase. For example, a cat owner may have learned from his or her finicky feline to avoid buying products with fish in it, since the cat doesn’t like fish. However, a "Chicken Formula Cat Food" may not always be the best choice, since some "chicken formulas" may indeed contain fish, and sometimes may contain even more fish than chicken. A quick check of the ingredient list would avert this mistake.
If more than one ingredient is included in a "dinner" name, they must total 25 percent and be listed in the same order as found on the ingredient list. Each named ingredient must be at least 3 percent of the total, too. Therefore, "Chicken n' Fish Dinner Cat Food" must have 25 percent chicken and fish combined, and at least 3 percent fish. Also, unlike the "95 percent" 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 percent.
The "3 percent" or "with" rule was originally intended to apply only to ingredients highlighted on the principal display panel, but outside the product name, in order to allow manufacturers to point out the presence of minor ingredients that were not added in sufficient quantity to merit a "dinner" claim. For example, a "Cheese Dinner," with 25 percent cheese, would not be feasible or economical to produce, but either a "Beef Dinner for Dogs" or "Chicken Formula Cat Food" could include a side burst "with cheese" if at least 3 percent cheese is added. Recent amendments to the AAFCO model regulations now allow use of the term "with" as part of the product name, too, such as "Dog Food With Beef" or "Cat Food With Chicken." It is important to note that even a minor change in the wording of the name has a dramatic impact on the minimum amount of the named ingredient required. Sitting on the store shelf next to each other, a can of "Cat Food With Tuna" could be confused with a can of "Tuna Cat Food," but whereas the latter example must contain at least 95 percent tuna, the first needs only 3 percent. Therefore, the consumer must now be particularly astute and read labels carefully before purchase to ensure that the desired product is obtained.
Under the "flavor" rule, a specific percentage is not required, but a product must contain an amount sufficient to be able to be detected. There are specific test methods, using animals trained to prefer specific flavors, that can be used to confirm this claim. In the example of "Beef Flavor Dog Food," the word "flavor" must appear on the label in the same size, style and color as the word "beef." The corresponding ingredient may be beef, but more often it is another substance that will give the characterizing flavor, such as beef meal or beef by-products. This is different than the other rules discussed above, wherein the name of the ingredient in the product name should be the same as that declared in the ingredient list (For example, a product including "lamb meal" cannot be called a "lamb" pet food).
With respect to flavors, pet foods often contain "digests," which are materials treated with heat, enzymes and/or acids to form concentrated natural flavors. Only a small amount of a "chicken digest" is needed to produce a "Chicken Flavored Cat Food," even though no actual chicken is added. Stocks or broths are also occasionally added. Whey is often used to add a milk flavor. Often labels will bear a claim of "no artificial flavors." Actually, artificial flavors are rarely used in pet foods. The major exception to that would be artificial smoke or bacon flavors, which are added to some treats.
In this discussion on the use of ingredients in product names, it must be noted that the ultimate purpose of dog and cat foods is to supply needed nutrients, not specific ingredients. Since the nutritional requirements can be met using a wide variety of ingredients, the presence or absence of a particular ingredient doesn’t need to be a driving factor. However, if one chooses to purchase a product on this basis, it is important to keep these rules in mind. In addition to scrutiny of the product name, one should also read the ingredient list to ensure that the preferred ingredient is present in a desirable amount.
The net quantity statement tells you how much product is in the container for what you're paying. There are many FDA regulations dictating the format, size and placement of the net quantity statement. None of these do any good if the consumer does not check the quantity statements, especially when comparing the cost of products. Today, many canned products are sold in non-standardized sizes, so even though the products look the same size, one may be a better buy. For example, a 14-ounce can of food may look identical to the one-pound can of food right next to it. Also, dry products may differ greatly in density, especially some of the "lite" products. Thus, a bag that may typically hold 40 pounds of food may only hold 35 pounds of a food that is "puffed up." Thus, a cost-per-ounce or per-pound comparison between products is always prudent.
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" ("kg" or "g"), may also be required to appear on the label. Many pet food labels already bear both measurements.
Manufacturer's Name and Address
The "manufactured by..." statement identifies the party responsible for the quality and safety of the product and its location. If the label says "manufactured for..." or "distributed by...," the food was manufactured by an outside manufacturer, but the name on the label still designates the responsible party. Not all labels include a street address along with the city, State, and zip code, but by law, it should be listed in either a city directory or a telephone directory. Many manufacturers also include a "800" telephone number on the label for consumer inquiries. If a consumer has a question or complaint about the product, he or she shouldn’t hesitate to use this information to contact the responsible party.
As mentioned above, ingredients are required to be listed in descending order of predominance by weight. The weights of ingredients are determined as they are added in the formulation, including their inherent water content. This latter fact is important when evaluating relative quantity claims, especially when ingredients of different moisture contents are compared.
For example, one pet food may list "meat" as its first ingredient, and "corn" as its second. The manufacturer doesn't hesitate to point out that its competitor lists "corn" first ("meat meal" is second), suggesting the competitor’s product has less animal-source protein than its own. However, meat is very high in moisture (approximately 75 percent water). On the other hand, water and fat are removed from meat meal, so it is only 10 percent moisture (what’s left is mostly protein and minerals). If we could compare both products on a dry matter basis (mathematically "remove" the water from both ingredients), one could see that the second product had more animal-source protein from meat meal than the first product had from meat, even though the ingredient list suggests otherwise.
That is not to say that the second product has more "meat" than the first, or in fact, any meat at all. Meat meal is not meat per se, since most of the fat and water have been removed by rendering. Ingredients must be listed by their "common or usual" name. Most ingredients on pet food labels have a corresponding definition in the AAFCO Official Publication. For example, "meat" is defined as the "clean flesh of slaughtered mammals and is limited to...the striate muscle...with or without the accompanying and overlying fat and the portions of the skin, sinew, nerve and blood vessels which normally accompany the flesh." This is pretty close to what most people would define as "meat," although maybe not in such terms. On the other hand, "meat meal" is "the rendered product from mammal tissues, exclusive of any added blood, hair, horn, hide trimmings, manure, stomach and rumen contents." Thus, in addition to the processing, it could also contain parts of animals one would not think of as "meat." Meat meal may not be very pleasing to think about eating yourself, even though it's probably more nutritious. Animals do not share in people’s aesthetic concerns about the source and composition of their food. Regardless, the distinction must be made in the ingredient list (and in the product name). For this reason, a product containing "lamb meal" cannot be named a "Lamb Dinner."
Further down the ingredient list, the "common or usual" names become less common or usual to most consumers. The majority of ingredients with chemical-sounding names are, in fact, vitamins, minerals, or other nutrients. Other possible ingredients may include artificial colors, stabilizers, and preservatives. All should be either "Generally Recognized As Safe (GRAS)" or approved food additives for their intended uses.
If scientific data are presented that show a health risk to animals of an ingredient or additive, CVM can act to prohibit or modify its use in pet food. For example, propylene glycol was used as a humectant in soft-moist pet foods, which helps retain water and gives these products their unique texture and taste. It was affirmed Generally Recognized As Safe (GRAS) for use in human and animal food before the advent of soft-moist foods. It was known for some time that propylene glycol caused Heinz Body formation in the red blood cells of cats (small clumps of proteins seen in the cells when viewed under the microscope), but it could not be shown to cause overt anemia or other clinical effects. However, recent reports in the veterinary literature of scientifically sound studies have shown that propylene glycol reduces the red blood cell survival time, renders red blood cells more susceptible to oxidative damage, and has other adverse effects in cats consuming the substance at levels found in soft-moist food. In light of this new data, CVM amended the regulations to expressly prohibit the use of propylene glycol in cat foods.
Another pet food additive of some controversy is ethoxyquin. Ethoxyquin was approved as a food additive over thirty-five years ago for use as an antioxidant chemical preservative in animal feeds. Approximately ten years ago, CVM began receiving reports from dog owners attributing the presence of ethoxyquin in the dog food with a myriad of adverse effects, such as allergic reactions, skin problems, major organ failure, behavior problems, and cancer. However, there was a paucity of available scientific data to support these contentions, or to show other adverse effects in dogs at levels approved for use in dog foods. More recent studies by the manufacturer of ethoxyquin showed a dose-dependent accumulation of a hemoglobin-related pigment in the liver, as well as increases in the levels of liver-related enzymes in the blood. Although these changes are due to ethoxyquin in the diet, the pigment is not made from ethoxyquin itself, and the health significance of these findings is unknown. More information on the utility of ethoxyquin is still needed in order for CVM to amend the maximum allowable level to below that which would cause these effects, but which still would be useful in preserving the food. To that end, more studies are being conducted to ascertain a more accurate minimum effective level of ethoxyquin in dog foods. In the interim, CVM has asked the pet food industry to voluntarily lower the maximum level of use of ethoxyquin in dog foods from 150 ppm (0.015 percent) to 75 ppm. Regardless, most pet foods that contained ethoxyquin never exceeded the lower amount, even before this recommended change.
At minimum, a pet food label must state guarantees for the minimum percentages of crude protein and crude fat, and the maximum percentages of crude fiber and moisture. The "crude" term refers to the specific method of testing the product, not to the quality of the nutrient itself.
Some manufacturers include guarantees for other nutrients as well. The maximum percentage of ash (the mineral component) is often guaranteed, especially on cat foods. Cat foods commonly bear guarantees for taurine and magnesium as well. For dog foods, minimum percentage levels of calcium, phosphorus, sodium, and linoleic acid are found on some products. The company may be willing to provide additional information on particular nutrients that are not guaranteed on the label.
Guarantees are declared on an "as fed" or "as is" basis, that is, the amounts present in the product as it is found in the can or bag. This doesn’t have much bearing when the guarantees of two products of similar moisture content are compared (for example, a dry dog food versus another dry dog food). However, comparing the guaranteed analyses between dry and canned products, one will note that the levels of crude protein and most other nutrients are much lower for the canned product. This can be explained by looking at the relative moisture contents. Canned foods typically contain 75-78 percent moisture, whereas dry foods contain only 10-12 percent water. To make meaningful comparisons of nutrient levels between a canned and dry product, they should be expressed on the same moisture basis.
The most accurate means of doing this is to convert the guarantees for both products to a dry matter basis. The percentage of dry matter of the product is equal to 100 percent minus the percentage of moisture guaranteed on the label. Thus, a dry food is approximately 88-90 percent dry matter, while a canned food is only about 22-25 percent dry matter. To convert a nutrient guarantee to a dry matter basis, the percent guarantee should be divided by the percentage of the dry matter, then multiplied by 100. For example, a canned food guarantees 8 percent crude protein and 75 percent moisture (or 25 percent dry matter), while a dry food contains 27 percent crude protein and 10 percent moisture (or 90 percent dry matter). Which has more protein, the dry or canned? Calculating the dry matter protein of both, the canned contains 32 percent crude protein on a dry matter basis (8/25 X 100 = 32), while the dry has only 30 percent on a dry matter basis (27/90 X 100 = 30). Thus, although it looks like the dry has a lot more protein just from the label, when the water is counted out, the canned actually has a little more.
This method, although the most accurate, can be cumbersome when trying to compare products at the time of purchase. Even with a calculator, comparing multiple products in the middle of a grocery or pet store aisle by this means can be time consuming and inconvenient. An easier way is to remember that the amount of dry matter in the dry food is about four times the amount in a canned product. Thus, to compare guarantees between a dry and canned food, multiply the guarantees for the canned food times four first.
It is especially important to look at the moisture guarantee for canned foods, even when comparing a canned food with another canned. Under AAFCO regulations, the maximum percentage moisture content for a pet food is 78 percent, 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. Some of these exempted products have been found to contain as much as 87.5 percent moisture. This doesn’t sound like much difference until the dry matter contents are compared. For example, a product with a guarantee of 87.5 percent moisture contains 12.5 percent dry matter, only half as much as a product with a 75 percent moisture guarantee (25 percent dry matter). Although water is a "nutrient," it is virtually free and easy for the consumer to provide himself or herself, so the dry matter content of the product contains all the nutrients for which it is being purchased. Less dry matter may mean less nutrients per can, so more food may have to be fed to meet the pet’s needs. Thus, in addition to price, the amount of moisture in a canned food should be considered in any purchase.
Any claim that a product is "complete," "balanced," "100 percent nutritious," or similarly suggests that a product is suitable for sole nourishment that is not, in fact, nutritionally adequate is a potentially unsafe product. For this reason, an AAFCO nutritional adequacy statement is 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. Products substantiated by this method should include the words, "(Name of product) is formulated to meet the nutritional levels established by the AAFCO (Dog/Cat) Food Nutrient Profiles." This means the product contains the proper amount of protein, calcium, and other recognized essential nutrients needed to meet the needs of the healthy animal. The recommendations of the National Research Council (NRC) were once used as the basis for nutritional adequacy, but they are no longer considered valid for this purpose.
The alternative means of substantiating nutritional adequacy is for the product to be tested following the AAFCO Feeding Trial Protocols. This means that the product, or "lead" member of a "family" of products, has been fed to dogs or cats under strict guidelines and found to provide proper nutrition. These products should bear the nutritional adequacy statement "Animal feeding tests using AAFCO procedures substantiate that (name of product) provides complete and balanced nutrition."
Regardless of the method used, the nutritional adequacy statement will also state for which life stage(s) the product is suitable, such as "for maintenance," or "for growth." A product intended "for all life stages" meets the more stringent nutritional needs for growth and reproduction. A maintenance ration will meet the needs of an adult, non-reproducing dog or cat of normal activity, but may not be sufficient for a growing, reproducing, or hard-working animal. On the other hand, an all life stages ration can be fed for maintenance. Although the higher levels of nutrients would not be harmful to the healthy adult animal, they aren't really necessary. Occasionally a product may be labeled for a more specific use or life stage, such as "senior" or for a specific size or breed. However, there is little information as to the true dietary needs of these more specific uses, and no rules governing these types of statements have been established. Thus, a "senior" diet must meet the requirements for adult maintenance, but no more.
A product that does not meet either of these methods must state that "This product is intended for intermittent or supplemental feeding only." The only exception to this is for products conspicuously identified as a "snack" or "treat," which by common understanding aren’t usually fed exclusively. This regulation is to prevent a consumer from misconstruing that a product is suitable as a long-term sole source of nourishment when it is not. For example, a can of "Tuna Cat Food" may contain added vitamins and minerals to make it complete and balanced, or it may not. This additional requirement helps differentiate the two. This statement may also be found on labels for some "veterinary medical foods," which are described in detail in Part 2.
Some manufacturers may state that one method is superior to another. In truth, either method has its good and bad points. For example, the "profile" method is not as good in assessing the bioavailability of nutrients or palatability as the "feeding test" method. On the other hand, not all products that bear the "feeding test" claim are the ones actually tested. Some may be members of a "family," formulated to be nutritionally similar to the product tested. However, since these "family member" products aren’t directly tested, either, they have the same potential disadvantages as the "profile" products. Regardless, both methods offer excellent assurance that the products will meet the nutritional needs of the dog or cat.
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." On some small cans, this may be all the information that can fit. However, feeding directions for other pet foods are much more elaborate, especially on dry product labels.
The feeding directions should be taken as rough guidelines, a place to start. Breed, temperament, environment, and many other factors can influence food intake. Feeding directions tend to overestimate requirements more often than underestimate them. There can be several explanations for this phenomenon. The more suspicious in nature will assume that the manufacturers simply want to sell more food. However, a more understanding explanation is that due to the wide variations in energy needs among individual animals, the manufacturers attempt to cover almost all contingencies by setting the directions for the most demanding. The best suggestion is to offer the prescribed amount at first, and then to increase or cut back as needed to maintain body weight in adults or to achieve proper rate of gain in puppies and kittens. A nursing mother should be offered all the food she wants to eat.
Pet foods can vary greatly in calorie content, even among foods of the same type (dry, canned) and formulated for the same life stage. Feeding directions vary among manufacturers, too, so the number of calories delivered in a daily meal of one food may be quite different from another. The number of calories in a product roughly relates to the amount of fat, although varying levels of non-calorie-containing components, such as water and fiber, can throw this correlation off. Thus, the best way for consumers to compare products and determine how much to be fed is to know the calorie content. However, until recently, calorie statements were not allowed on pet food labels. New AAFCO regulations were developed to allow manufacturers to substantiate calorie content and include a voluntary statement.
If a calorie statement is made on the label, it must be expressed on a "kilocalories per kilogram" basis. Kilocalories are the same as the "Calories" consumers are used to seeing on food labels. A "kilogram" is a unit of metric measurement equal to 2.2 pounds. Manufacturers are also allowed to express the calories in familiar household units along with the required statement (for example, "per cup" or "per can"). Even without this additional information, however, consumers can make meaningful comparisons between products and pick the product best suited for their animals' needs. 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. To roughly compare the caloric content values between a canned and a dry food, multiply the value for the canned food by four.
If a calorie statement does not appear on the label, the calorie content of a pet food can be roughly estimated by using values given in the guaranteed analysis. To do this, perform the following calculations:
Step 1: Multiply the percent crude protein times 3.5 and write down the result.
Step 2: Multiply the percent crude fat times 8.5 and write down the result.
Step 3: Add the percentages of crude protein, crude fat, crude fiber, moisture and ash, and subtract the total from 100. This gives you the percent nitrogen-free extract (NFE), which is the carbohydrate portion.
Step 4: Multiply the percent NFE from Step 3 times 3.5 and write down the result.
Step 5: Add the results from Steps 1, 2, and 4, and multiply the total times 10.
Example: Crude protein 24% X 3.5 = 84 Crude fat 10% X 8.5 = 85 Crude fiber 3% Moisture 10% Ash 5% 52% NFE (100-2 = 48) 48% X 3.5 = 168 total 337 Calorie content = 337 X 10 = 3370 kcal/kg
Many pet foods are labeled as "premium," and some now are "super premium" and even "ultra premium." Other products are touted as "gourmet" items. However, none of these terms have any official regulatory standing. Products labeled as premium or gourmet are not required to contain any different or higher quality ingredients, nor are they held up to any higher nutritional standards than are any other complete and balanced products.
The term "natural" is often used on pet food labels, although that term does not have an official definition either. For some human foods, it is used to denote that the product is minimally processed. No pet food meets this criterion. It could also mean that the product approximates the natural diet of the animal. Wild dogs and cats eat whole bodies of birds and small mammals. A quick purview of any pet food label will fail to disclose these ingredients. Some interpret it to be equivalent to "no artificial ingredients." However, all complete and balanced products must contain some chemically synthesized ingredients, such as vitamin supplements. Thus, some products will include the disclaimer "natural ingredients with added vitamins and minerals."
For the most part, "natural" can be construed as equivalent to a lack of artificial flavors, artificial colors, or artificial preservatives in the product. As mentioned above, artificial flavors are rarely employed anyway. Artificial colors are not really necessary, except to please the pet owner’s eye. If used, they must be from approved sources, the same as for human foods. Especially for high-fat dry products, some form of preservative must be used to prevent rancidity. Natural-source preservatives, such as mixed tocopherols (a source of vitamin E), can be used in place of artificial preservatives. However, they may not be as effective.
"Natural" is not the same as "organic." The latter term refers to the conditions under which the plants were grown or animals were raised. There are no official rules governing the labeling of organic foods (for humans or pets) at this time, but the United States Department of Agriculture is developing regulations dictating what types of pesticides, fertilizers and other substances can be used in organic farming. Under this plan, a food would have to be comprised of prescribed minimum percentages of organic ingredients to be labeled with claims such as "organic" or "with organic ingredients."
Pet owners and veterinary professionals have a right to know what they are feeding their animals. The pet food label contains a wealth of information, if one knows how to read it. Do not be swayed by the many marketing gimmicks or eye-catching claims. If there is a question about the product, contact the manufacturer or ask an appropriate regulatory agency.
NRSP-7 HOLDS SEMI-ANNUAL COMMITTEE MEETING
by Meg Oeller, D.V.M.
The Minor Use Animal Drug Program, National Research Support Project #7 (NRSP-7) held its semi-annual meeting of the technical committee on September 21 and 22 in Rockville, MD. The spring meeting is hosted each year by one of the four regions, but the fall meeting is usually held in Rockville to provide an opportunity for input from members of FDA’s Center for Veterinary Medicine (CVM).
The purpose of the NRSP-7 Minor Use Animal Drug Program is to address the shortage of minor use animal drugs by funding and overseeing the efficacy, animal safety, and human food safety research and environmental assessment required for drug approval. The scope of the program includes minor species of agricultural importance, and generally excludes companion animals.
The technical committee is made up of a National Coordinator, 4 Regional Coordinators, 4 Regional Administrative Advisors, and liaisons from USDA and FDA. The Regional Coordinators are Dr. Arthur Craigmill (University of California, Davis), Dr. Alistair Webb (University of Florida), Dr. Robert Holland (Michigan State University), and Dr. Paul Bowser (Cornell University). The Administrative Advisors are Dr. Bill Saylor (University of Delaware), Dr. John Nielson (University of Florida), Dr. Garth Sasser (University of Idaho), and Dr. Gerald Buening (University of Missouri). The USDA representative is Dr. Larry Miller (Washington, DC) and the FDA liaison is Dr. Meg Oeller (Rockville, MD). The meeting was also attended by reviewers and managers from FDA/CVM.
This meeting marked the transfer of the National Coordinator position from Dr. Robert Ringer of Michigan State University to Dr. John Babish of Cornell University. Dr. Ringer has served as the National Coordinator since 1993, when he retired from his professorial position at Michigan State University. Dr. Ringer has been with the project since its inception in 1982 and he served as the Regional Coordinator for the North-Central Region for the first 11 years. His extraordinary service to the program was remembered with a plaque and the gratitude of the committee members.
Dr. Babish served as the first Regional Coordinator for the Northeast Region from 1982 to 1993. In 1993, he left Cornell University for the private sector. Dr. Babish’s experience with the development of drugs for human and veterinary use, and his past experience as a Regional Coordinator for the Minor Use Program will be invaluable as he takes over the reins. Dr. Babish believes that the position requires the incumbent to be a facilitator and a promoter of the program. He intends to coordinate the efforts of other programs and individuals with the NRSP-7 projects. He will work closely with FDA and will try to identify delays in the product development process with the goal of streamlining the traffic pattern. He plans to expand electronic information transfer including the NRSP-7 website to enhance communication. He will also continue Dr. Ringer’s work to promote the program through participation in national and regional meetings, such as the Joint Subcommittee on Aquaculture’s working group on Quality Assurance. He intends to draw on committee members' expertise in the development of policies pertaining to issues such as "crop grouping" of species.
Dr. Stephen Sundlof, Director of CVM, provided an overview of several major issues facing the Center in his opening remarks. He gave an update on the progress of the Minor Use/Minor Species Document mandated by Congress under the Animal Drug Availability Act. The document, proposing ways to facilitate the approval of new animal drugs for minor uses, is currently under review at the Agency level. He also discussed antimicrobial resistance concerns and their potential effects on new animal drug approvals. The FDA Modernization Act, and CVM's recent successful stakeholders’ meeting were mentioned. The continuing struggle with a declining budget and workforce in the face of a heavy workload was also noted.
Dr. Larry Miller reported that there was a unanimous vote of the directors of the 4 regional experiment stations to renew the project for another 5 years. He also gave an update on the progress of the program’s appropriations through Congress. He also noted that under the reauthorization of the Farm Bill, special research grants now have a maximum life of 3 rather than 5 years.
There was an update on the status of the draft guidance document, "FDA Approval of Animal Drugs for Minor Uses and for Minor Species". This document has completed a 90-day public comment period. Seven comments were received. Some changes are being made in response to the comments. During the time that the document was available for comment, new environmental regulations were finalized. These have necessitated a rewrite of the environmental sections of the existing draft. This rewrite currently is under review within CVM. Until the document is finalized, the previous draft will remain available (guidance #61). A copy is available on CVM’s website (/cvm) or may be obtained from the FDA Veterinarian.
The Regional Coordinators reported on the progress of the active projects in their respective regions. NRSP-7 currently has 24 active projects funded. These are summarized in the table below. There are 6 additional projects pending.
| Active NRSP-7 Projects |
|
Drug |
Route of |
Species |
Indication |
| Albendazole | oral | goats | liver flukes |
| Chloramine-T | topical | salmonids | bacterial gill disease |
| Amoxicillin trihydrate | injection | dairy goats | bacterial pneumonia |
| Oxytetracycline | injection | dairy goats(non-lactating) | bacterial pneumonia |
| Oxytetracycline | injection | sheep | bacterial pneumonia |
| Amoxicillin | injection | sheep | bacterial pneumonia |
| Erythromycin | premix | salmonids | bacterial kidney disease |
| Ceftiofur | injection | goats | bacterial pneumonia |
| Ivermectin | pour-on | American bison | GI parasites |
| Lasalocid | oral (feed) | pheasant | coccidiosis |
| Clopidol | oral (feed) | pheasant | coccidiosis |
| Tilmicosin | injection | sheep | respiratory infections |
| Progesteron | CIDR | sheep | eestrus synchronization |
| Hydrogen peroxide | topical | various fish | bacterial gill disease |
| Carp Pituitary | injection | various fish | spawning aid |
| Nitarsone | oral (feed) | partridge | blackhead |
| Zoamix | oral (feed) | pheasant | coccidiosis |
| Fenbendazole | oral (feed) | ostrich | nematodes |
| Fenbendazole | oral (feed) | pheasant, partridge & quail |
gapeworm, capillaria |
| Oxytetracycline | topical | walleye | columnaris |
| MGA / GnRH | feed/injectable | sheep | estrus synchronization |
| Oxytetracycline | topical | Summer flounder | vibriosis |
| Oxytetracycline | topical | tilapia | Streptococcus infection |
In order to foster better communication and cooperation on issues of common interest, the committee invited several people to make presentations to the group. Drs. Bernadette Dunham and Elizabeth Curry-Galvin described the structure and goals of the American Veterinary Medical Association. Dr. Curt Mann spoke about the American Association of Veterinary Medical Colleges. Dr. Mark Wood gave an excellent overview of the Animal Health Institute, an organization made up of the manufacturers of all types of animal health products. Rosalie Schnick, the National INAD/NADA Coordinator for Aquaculture gave an overview of the INAD program and an update on the status of the various projects under her direction. Dr. Shirley Wager-Page of the USDA’s Wildlife Services group described the needs of their biologists for the approval of immobilizing and contraceptive agents for use in wildlife.
Dr. Bert Mitchell of CVM stopped by to acquaint the committee with the newly formed group, The Aquaculture Partnership (TAP). This is an industry/FDA aquaculture partnership whose mission is to coordinate efforts to ensure that farm-raised seafood products are safe and wholesome through enhanced communication between industry and FDA.
The day-and-a-half meeting was an excellent opportunity to provide an update on the status of all aspects of the program as well as an opportunity to expand partnerships with other organizations.
The NRSP-7 Spring meeting will be hosted by the Southern Region and will be held at the end of February near Tallahassee, Florida.
For more information about NRSP-7, please visit our website http://bluehen.ags.udel.edu or call Dr. Meg Oeller (301) 827-7581.
FDA VETERINARY MEDICINE ADVISORY COMMITTEE TO MEET
The Food and Drug Administration's (FDA’s) Veterinary Medicine Advisory Committee will convene on December 10-11, 1998, in the Holiday Inn-Gaithersburg, Two Montgomery Village Avenue, Gaithersburg, Maryland. The meeting will be open to the public.
Antimicrobial products for use in animals must meet stringent standards for safety, efficacy, and quality to be approved. Due to concerns about antimicrobial resistance of public health significance, the safety assessment for these products needs to be updated to include evaluation of resistance development. The focus of the meeting will be to discuss a proposed framework on how to evaluate the potential public health hazard from resistant pathogens and resistance genes associated with the use of antimicrobials in food animals.
Additional information about the meeting will be included on CVM's Internet Home Page (/cvm.) Also, FDA plans to publish a Federal Register (FR) notice announcing this meeting. After publication of the FR notice, FDA will accept requests to speak before the Committee.
An FDA Advisory Committee Information Hotline is available on 1-800-741-8138 (301-443-0572 in the Washington, DC area), Veterinary Medicine Advisory Committee, code 12546. Please call the Hotline for information concerning any possible changes.
The following firms/individuals received warning letters for offering animals for slaughter that contained illegal drug residues:
o Joseph F. Pacheco, Kingsburg, CA
o Kenneth L. Georgeson, Georgeson Dairy, Caruthers, CA
o Andrew DeBos, DeBos Dairy, Corona, CA
o Arthur D. Van Beek, El Monte Dairy, Tipton, CA
o Gerald Koetsier, Oakview Dairy, Tulare, CA
o Samuel A. Stoltzfus, Homer City, PA
o John J. Della, Jr., John Della and Sons Dairy, Porterville, CA
o John M., Terry F., William, and Thomas Hargenrader, Partners, Hargenrader Farms, Marble, PA
These violations involved illegal residues of sulfadimethoxine in dairy cows, tetracycline and sulfadimethoxine in a dairy cow, tetracycline in a cow, tilmicosin in a cow, gentamicin sulfate in a dairy cow, and gentamicin in a cow.
Warning letters were also sent to the following firms/individuals which had a history of offering animals for sale for human food use which were adulterated with drug residues. These warning letters stated that these individuals/firms had offered animals for slaughter that contained illegal drug residues:
o Gregory J. TeVelde, G.J. TeVelde Ranch, Tipton, CA
o William J. Jongsma, William and John Jongsma Dairy, Pixley, CA
o Manuel Goncalves, Dos Palos, CA
o Ted A. Greidanus, Jr., CalfTech Corporation, Tipton, CA
These violations involved illegal residues of sulfadimethoxine in dairy cows, streptomycin in a dairy cow, and gentamicin sulfate in a calf.
Warning letters were sent to the following firms/individuals for violations from Good Manufacturing Practices (GMPs):
o Charles Bobendrier, Pipestone Grain Company, Pipestone, MN
o Bruce Baker, Agri-Nutrition Group, Maryland Heights, MO
On September 14, 1998, the U.S. Marshals Service conducted a seizure of veterinary drugs at the Mortar & Pestle Veterinary Pharmacy, Inc., Des Moines, IA. The seizure included all bulk drugs and finished pharmaceuticals at this firm. The products seized are valued at approximately $284,800. The Food and Drug Administration (FDA) issued a Warning Letter to Mortar & Pestle on June 13, 1997, advising the firm that its products were not in compliance with the Federal Food, Drug, and Cosmetic Act (the Act). When the firm did not make any significant corrections, its drug products were seized under the Act as unapproved new animal drugs and adulterated and misbranded drugs.
In 1996, FDA published a Compliance Policy Guide (CPG) that outlines criteria and boundaries for the compounding of animal drugs. This CPG states that FDA recognizes circumstances exist when it may be necessary for a veterinarian to compound, or direct a pharmacist to compound, an article that will result in an unapproved new animal drug. The Agency will exercise regulatory discretion and ordinarily will not take regulatory action against violations of the Act resulting from the compounding of an unapproved new animal drug if the criteria described in the CPG are met. Among those criteria are:
o There must be a prescription from a licensed veterinarian, and dispensing must be done within the confines of a valid veterinarian-client-patient relationship.
o Advertising, or other solicitation, for specific drug products or classes is not acceptable.
o Products should be produced under good compounding practices using current pharmaceutical and pharmacological standards.
o Products should be labeled with an expiration date that is in line with the treatment period.
In taking this seizure action, FDA consulted frequently with the Iowa Board of Pharmacy. Federal and State authorities working together and independently developed information on violations of their respective laws by Mortar & Pestle Veterinary Pharmacy, Inc. The Iowa Board of Pharmacy has been advised that the firm will surrender its pharmacy license, and is currently waiting to finalize its disciplinary action.
FDA is concerned about what appears to be a proliferation of animal drug compounding operations, many of which are actually manufacturing large quantities of unapproved new animal drugs. The Agency urges any pharmacy that wishes to legally compound animal drugs within the context of a veterinarian-client-patient relationship to become thoroughly familiar with the CPG 608.400, "Compounding of Drugs for Use in Animals." Copies of this CPG may be obtained from FDA's Internet Home Page http://www.fda.gov/ora/compliance_ref/cpg/cpgch6.html or by calling or writing the FDA Veterinarian.
FOOD ADDITIVE REGULATIONS AMENDED
In the October 6, 1998, Federal Register, FDA announced that the regulations of food additives permitted in feed and drinking water of animals is being amended to provide for the safe use of formaldehyde (CAS No. 50-00-0; 37 percent aqueous solution) as an antimicrobial food additive for maintaining animal feeds and feed ingredients Salmonella negative for up to 21 days. This action is in response to a food additive petition) (FAP 2237) filed b Anitox Corp. Additional information is included in the Federal Register and available from Dr. Henry E. Ekperigin, Center for Veterinary Medicine (HFV-222), Food and Drug Administration, 7500 Standish Place., Rockville, MD 20855, 301-827-0174.
|
Company |
Generic and (Brand) Names |
Indications |
Routes/Remarks |
|
Alaco, Inc.
|
Beta-Aminopropionitrile Fumarate (Bapten) Rx
|
Horses. For the treatment of superficial digital flexor tendinitis |
INTRATENDINOUS: The NADA provides for treatment of tendinitis of the superficial digital flexor tendon (SDFT) in the adult horse where there is sonographic evidence of fiber tearing. Do not use in breeding animals. Not for use in horses intended for food.Federal Register 8/19/98.
|
|
Peptech Animal Health Pty, Ltd. (NADA 141-044)
|
Deslorelin Acetate (Ovuplant) Rx
|
Horses and Ponies. For inducing ovulation in estrous mares with an ovarian follicle greater than 30 mm in diameter.
|
SUBCUTANEOUS: The NADA provides for inducing ovulation within 48 hours. One implant per mare. Not for use in horses intended for food.Federal Register 8/19/98.
|
|
Bayer Corp. Agriculture Division, Animal Health
|
Enrofloxacin Sol.
|
Cattle. For the treatment of bovine respiratory disease. Extra-label use in food-producing animals is prohibited. |
SUBCUTANEOUS: A tolerance for Enrofloxacin residues in cattle is set. Do not inject more than 20 ml. at each site. Do not slaughter within 28 days of last treatment. Do not use in cattle intended for dairy production. Do not use in calves to be processed for veal.Federal Register 9/14/98.
|
|
Fort Dodge Animal Health
|
Etodolac Tabs.
|
Dogs. For the management of pain and inflammation associated with osteoarthritis.
|
ORAL - Federal Register 9/25/98.
|
|
Alpharma Inc.
|
Bacitracin Methylene Disalicylate and Decoquinate (BMD)(Deccox) |
Broiler chickens. For prevention of coccidiosis, and for increased rate of weight gain and improved feed efficiency.
|
MEDICATED FEED: Do not feed to laying chickens; feed continuously as sole ration.Federal Register 9/29/98. |
ABBREVIATED NEW ANIMAL DRUG APPROVALS
|
Company |
Generic and (Brand) Names |
Indications |
Routes/Remarks |
|
Phoenix Scientific, Inc. (ANADA 200-254)
|
Iron Hydrogenated Dextran Inj.
|
Baby pigs. For treatment or prevention of iron deficiency anemia.
|
INTRAMUSCULAR: ANADA is a generic copy of Boehringer Ingelheim Vetmedica, Inc.'s NADA 106-772.Federal Register 8/19/98.
|
|
Phoenix Scientific, Inc. (ANADA 200-219)
|
Ivermectin Topical Solution (pour-on)
|
Cattle. For treatment and control of worms, grubs, lice mites, and flies.
|
TOPICAL: ANADA is a generic copy of Merial, Ltd' s NADA 140-841 Ivomec pour-on for cattle.Federal Register 8/19/98. |
|
Phoenix Scientific, Inc. (ANADA 200-248)
|
Pyrantel Pamoate Suspension
|
Dogs. For removal of large roundworms and hookworms and to prevent reinfections of Toxocara canis in puppies and adult dogs.
|
ORAL: ANADA is a generic copy of Pfizer, Inc.'s NADA 100-237 (Nemex and Nemex-2).Federal Register 8/28/98.
|
|
Contemporary Products, Inc. (ANADA 200-197)
|
Streptomycin Oral Solution
|
Chickens, swine, calves. For treatment of nonspecific infectious enteritis in chickens and treatment of bacterial enteritis in swine and calves |
ORAL: ANADA is a generic copy of Veterinary Services, Inc.'s NADA 65-252.Federal Register 9/29/98.
|
|
Lloyd, Inc. (ANADA 200-055)
|
Ketamine Hydrochloride Inj. (VetaKet Rx)
|
Cats and subhuman primates. In cats for restraint or as an anesthetic and in subhuman primates for restraint.
|
INTRAMUSCULAR: ANADA is a generic copy of Fort Dodge Animal Health’s NADA 45-290 (Vetalar).Federal Register 9/29/98.
|
|
Phoenix Scientific, Inc. (ANADA 200-256)
|
Iron Dextran Inj.
|
Baby Pigs. For prevention or treatment of iron deficiency anemia |
INTRAMUSCULAR: ANADA is a generic copy of Boehringer Ingelheim Vetmedica, Inc.’s NADA 134-708.Federal Register 10/6/98.
|
SUPPLEMENTAL ABBREVIATED NEW ANIMAL DRUG APPROVALS
|
Company |
Generic and (Brand) Names |
Indications |
Routes/Remarks |
|
Phoenix Scientific, Inc. (ANADA 200-118)
|
Neomycin Sulfate Soluble Powder & Oral Solution |
Cattle (excluding veal calves) swine, sheep, and goats. For treatment and control of coli bacillosis.
|
ORAL: ANADA is a generic copy of Pharmacia & Upjohn's NADA 011-315, neomix. This is a supplemental ANADA to revise the withdrawal time to make it identical to that of the pioneer product.Federal Register 8/28/98. |
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