Center for Veterinary Medicine _CVM_ monitors and establishes

David Bane – Resume Summary    Education  B.S. and DVM University of Illinois  Ph.D. University of Minnesota Employment history  Carthage Veterinary Service, Ltd.  University of Illinois Department Veterinary Clinical Medicine  Elanco Animal Health  Private Consultant and Food Animal Producer Research Interest  Objective assessment of animal/population wellness Regulatory Aspects of Veterinary Practice without Antibiotics David Bane, DVM, Ph.D. Sidney, IL Veterinary product use  Bane   Feed Water Parenteral  Karreman  Regulatory perspective of veterinary practitioners     Is the product effective? Is the product safe? Are there residues or withholding times? Is the product legal? Regulatory perspective of industrial veterinarian  What product usage claims can be legally made?    Scientist to scientist Scientist to Layperson Layperson to layperson  What additional claims are possible? From: Davidpbane@aol.com [mailto:Davidpbane@aol.com] Sent: Wednesday, July 23, 2008 11:07 AM To: Dunham, Bernadette M; McChesney, Daniel G Subject: Regulatory aspects of non-approved products used in organic food animals Greetings: I am organizing the second Boundary Waters Veterinary Conference: Food Animal Production without Antibiotics (www.bwcaw-vetconf.com), August 14-16, 2008, in Ely, MN. The objective of the conference is to provide valuable, science-based information to veterinarians serving clients that produce and market natural and organic food animals. At this conference there will be discussions of regulatory and legal aspects of non-approved products and procedures used for disease prevention and therapy in naturally and organically-produced food animals. Please direct me to papers and/or websites that outline current FDA/CVM guidelines for veterinarians in this area. Also, please recommend an individual(s) willing to speak to these issues at meetings or on an individual case basis. Regards, David Bane, DVM, Ph.D. Conference coordinator Subj:RE: Regulatory aspects of non-approved products used in organic food animals Date:7/25/2008 2:03:21 PM Central Daylight Time From:daniel.mcchesney@fda.hhs.govTo: Davidpbane@aol.com, bernadette.dunham@fda.hhs.govDavid CVM will not able to attend the meeting. I suggest you go to our web site http://www.fda.gov/cvm/ ; for our most current views related to unapproved products. In general products use to treat or prevent disease or claim to treat or prevent disease and that (with the exception of vaccines for animals which are licensed by USDA) have not gone through the FDA approval process are considered adulterated because they have not been shown to be safe and effective. FDA regulated products that are adulterated or misbranded are subject to regulatory action. Regards Dan Daniel G. McChesney, Ph.D. Director, Office of Surveillance & Compliance Center for Veterinary Medicine, FDA 7519 Standish Place Rockville, MD 20855 240-453-6830 (telephone) 240-453-6880 (facsimile) E-mail: Daniel.McChesney@fda.hhs.gov Internet: www.fda.gov/cvm Center for Veterinary Medicine (CVM)     Monitors and establishes standards for feed contaminants Approves safe food additives Manages the Food and Drug Administration's (FDA) medicated feed and pet food programs. Any product that is intended to be used as an animal feed ingredient, to become part of an ingredient or feed, or added to an animal's drinking water is considered a "food" and thus, is subject to regulation. Implementation of uniform policies for regulating the use of animal feed products    FDA cooperates with the Association of American Feed Control Officials (AAFCO) and the states This includes the establishment of uniform feed ingredient definitions and proper labeling to assure the safe use of feeds. The ingredient definitions are important because animal feeds and feed ingredients must be correctly and truthfully labeled when they enter commerce. A feed label   Should contain information describing the feed product and any details necessary for the safe and effective use of the feed. The Federal Food, Drug, and Cosmetic Act (FFDCA) defines "labeling" as all labels and other written, printed or graphic matter upon any article or any of its containers or wrappers, or accompanying such articles. Includes:  promotional brochures and promotional pamphlets  testimonials, product information sheets, books, etc.  information on the internet A feed label    CVM has incorporated the philosophy of the Nutrition Labeling Education Act (NLEA) in its policies to permit meaningful "health" information on the label of some animal food products. For example, the use of "urinary tract health" and "dental health" claims on cat food diets falls under this policy. Feed manufacturers provide substantiation that the desired statement is truthful and not misleading. CVM review and acceptance of the claim is needed before the claim is utilized on product labeling. Generally Recognized as Safe (GRAS)   Foods that animals consume, e.g., grains, hays, etc., are considered safe. Most mineral and vitamins are generally recognized as safe as sources of nutrients A list of GRAS substances can be found at www.cfsan.fda.gov/~dms/grasguid.html A substance that does not become a component of feed but that is used in preparing an ingredient of the food to give it a different flavor, texture, or other characteristic may be a food additive Use of a food ingredient that is neither GRAS nor an approved food additive can cause a "food" to be adulterated, which cannot be legally marketed in the United States.    NOT GRAS    Under the FFDCA, expressed or implied claims that establish the intended use to cure, treat, prevent or mitigate disease, or affect the structure/function of the body in a manner other than food (nutrition, aroma, or taste), identify an intent to offer the product as a "drug." Unless the “drug” product has been shown to be safe and effective for its intended use via approval of a New Animal Drug Application (NADA), it could be subject to regulatory action as an adulterated drug. On a case-by-case basis, CVM has allowed references to "nutritional support" for specific organs or body functions New Animal Drug Application (NADA)  The following subject areas should be addressed:        Human food safety Target animal safety Environmental impact Utility (intended physical, nutritional or other technical effect) Manufacturing chemistry Labeling (cautions, warnings, shelf life, directions for use) Proposed regulation Regulatory Discretion    The use of regulatory discretion to allow specific products to be marketed is done to conserve agency, state and industry resources, without jeopardizing human or animal health or subjecting the consumer to fraud. If a problem is found with a product, which is allowed on the market under regulatory discretion, FDA can quickly act to remove it from the marketplace. Decisions concerning the use of regulatory discretion are made on a case-by-case basis by the Center. Dietary Supplement Health and Education Act (DSHEA) of 1994 Legislative action that protects the right of access of consumers to safe dietary supplements necessary in order to promote wellness Dietary supplement  A product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients:       However, the agency's assessment of the law is that it was not intended and does not apply to animal feed, including pet food. a vitamin a mineral an herb or other botanical an amino acid a dietary substance for use by man to supplement the diet by increasing the total dietary intake Dietary supplement  Congress amended the DSHEA Act to include several provisions that apply only to dietary supplements.  Dietary ingredients used in dietary supplements are no longer subject to the premarket safety evaluations required of other “new” food ingredients or for “new uses” of old food ingredients.  Includes such substances as ginseng, garlic, fish oils, psyllium, enzymes, and mixtures of these  The DSHEA permits certain limited claims to be made about dietary supplements without resulting in the supplement becoming a drug. Dietary supplement  FDA must determine that the product will not leave harmful residues in food before FDA can approve a product for use in a food-producing animal.  Nowhere in its revision of the regulation of ingredients in dietary supplements does the DSHEA address how the effect of supplements on food producing animals and human food safety is to be assessed.  Not only are there human food safety concerns, but when compared with human use of supplements, there is less information on the safe use of dietary supplements in animals. Dietary supplement  In the absence of drug claims, the use of herbal     substances in animal feeds is regarded as a food use. This regulatory status determination is made by CVM on a case-by-case basis. Botanical ingredients allowed in animal feeds, considered GRAS, are listed as flavoring agents These include common herbs such as oregano, thyme, rosemary, etc. These are acceptable for use in animal feeds as flavorings. Most flavorings are used in part-per-million levels. Product Claims    An animal food label must not state and/or imply that the introduction of the product in the animal’s body results in a physiological or therapeutic effect. Claims in or on animal feed products that establish the intended use to cure, treat, prevent or mitigate disease, identify the intent to offer the product as a “drug.” On a case-by-case basis, CVM has allowed references to “nutritional support” for specific organs or body functions.  an animal food product contains vitamin E for prevention of fat oxidation in the feed or serves as an antioxidant in the body Novel Ingredients    Botanicals and herbs are part of a group of substances recognized by Association of American Feed Control Officials (AAFCO) as “novel ingredients.” There are about 180 botanical species currently being marketed or used by animal health care professionals in the United States Since most herbal products contain substances possessing significant pharmacological activity and consequently potential adverse effects including harmful residues, the use of these products in foodproducing animals is a major safety concern. Extralabel Drug Use Algorithm for Veterinarians Diagnosis of disease in the presence of valid Veterinary/Client/Patient relationship. Are the animals to be treated food animals? YES Does the drug labeled for food animals exist? Proper ingredient, dosage and indication? NO There are few restrictions on extralabel Drug used in non-food animals YES You must use this drug per label, as extralabel drug use is unnecessary. Observe label directions and withdrawal time. NO Is there a drug approved for food animals which could be used extralabelly? YES Extralabel use of food animal drug. Establish extended withdrawal time. Maintain records, label drug appropriately. NO Is there a drug approved for non-food animals which could be used extralabelly? Label drug appropriately. YES Is there adequate scientific information available to determine a withdrawal time? NO If compounding of approved drugs will prevent animal suffering, refer to regulations for compounding guidance. YES Extralabel use of non-food animal drug. Establish extended withdrawal time. Maintain records. Label drug appropriately. NO Drug must not be used, or treated animal must not enter food supply.