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FDLI MEMBER MAGAZINE | WWW.FDLI.ORG | MARCH/APRIL 2016 FOOD AND DRUG LAW INSTITUTE IN THIS ISSUE Advertising, Antitrust, Labeling, Biosimilars, Cybersecurity, First Amendment, Data Integrity, DQSA 2016 Annual Conference, May 5-6 Plus Interview with Mark McClellan FDAAA-Mandated Updated Standards for Pet Food LLLLLLLaaaaaaabbbbbbbeeeeeeellllllliiiiiiinnnnnnnggggggg By Jeannie Perron and Jessica P. O’Connell n September 2007, in the wake of the melamine in of the Association of American Feed Control Officials pet food crisis that had erupted a few months earlier, (AAFCO), which, among other things, promulgates model ICongress passed and the President signed into law the laws and regulations for animal feed and pet food labeling. Food and Drug Administration Amendments Act of 2007 ose model regulations include pet food labeling rules aer (FDAAA). Notably, FDAAA mandated the establishment of which many states have fashioned their own state labeling updated labeling standards for pet food but did not address regulations. e state regulations, in conjunction with labeling of other animal feed or human food. FDAAA federal regulations in 21 C.F.R. Part 501, encompass the Section 1002(a) provided: requirements for pet food labeling. [T]he Secretary of Health and Human Services … , in Pet food labels differ from those for human food in consultation with the Association of American Feed a number of important respects. Unlike human foods, Control Officials and other relevant stakeholder groups, pet food labels do not contain a standardized Nutrition including veterinary medical associations, animal health Facts Box, and FDA’s regulations currently have no organizations, and pet food manufacturers, shall by specific requirements regarding how to provide nutrition regulation establish— information; these requirements come entirely from state … regulations. Instead, the AAFCO model pet food regulations (3) updated standards for the labeling of pet food that require pet food labels to bear a “Guaranteed Analysis,” include nutritional and ingredient information. which must list particular guarantees in a particular order, Both the Food and Drug Administration (FDA) under but which otherwise does not have a prescribed format federal law and regulations, and state feed control officials and therefore may vary from label to label in appearance 1 under individual state authority, regulate animal feed, and location. For complete and balanced pet foods, as including pet food. Both FDA and the states are members Jeannie Perron is a partner in the food & Jessica P. O’Connell is special counsel in drug practice group of Covington & Burling the food & drug practice group of Covington LLP in Washington, DC. Dr. Perron also holds & Burling LLP in Washington, DC, here a degree in veterinary medicine and has she advises on issues related to food, dietary practiced as a veterinarian. She specializes supplements, cosmetics, C drugs, and in animal food and drug la, representing animal products. Previously, essica ored companies that manufacture feed including in D’s ffice of Chief Counsel. pet food, feed ingredients, drugs, iologics, and medical devices for animals. 18 UPDATE March/April 2016 fdli.org Food distinguished from products such and minerals included to balance Pet Food Institute, a trade association as vitamin or mineral supplements, the diet and support health can have for the pet food industry, worked with the Guaranteed Analysis must list lengthy chemical names—and can AAFCO to establish the first AAFCO minimum amounts of “crude protein” find the ingredient statement to be Model Pet Food Regulations, which and “crude fat,” maximum amounts incomprehensible. e fact that many initially appeared as a tentative entry in 5 of “crude fiber” and moisture, and can pet food products contain a long list the 1968 AAFCO OP. ose tentative optionally guarantee “ash” as well as of ingredients only exacerbates the model rules contained the requirement other nutrients. It seems a pretty safe problem. that crude protein, crude fat, and crude bet that consumers do not know what e AAFCO model pet food labeling fiber guarantees appear on the label.6 “crude protein,” “crude fat,” “crude regulations date back to the mid-1960s e model rules had been adopted fiber,” or “ash” are or how much of and began as “Statements for Uniform formally by the time the 1969 AAFCO 7 each their pet should (or should not) Interpretation and Policy,” which OP was published. eat. served as guidance to state feed control While these new model pet 3 e Model Pet Food regulations officials and pet food manufacturers. food regulations and the resulting also require that all ingredients appear ese statements covered a few standardization represented a in descending order by weight.2 requirements for ingredient listing and significant improvement over the is creates another problem in that pet food naming. Otherwise, pet food earlier guidance models, and although consumers are unfamiliar with a labels were expected to comply with the regulations have been amended number of the ingredients used in the then-extant labeling requirements a number of times since, some of 4 pet food—as even many vitamins for other animal feed products. e the original, nearly 50-year-old CURRENT INGREDIENT STATEMENT PROPOSED INGREDIENT STATEMENT with grouped Vitamins and Minerals Ingredients: Ingredients: CHICKEN, CHICKEN BY-PRODUCT MEAL, CHICKEN, CHICKEN BY-PRODUCT MEAL, BREWERS BREWERS RICE, GROUND BARLEY, GROUND RICE, GROUND BARLEY, GROUND SORGHUM, PORK SORGHUM, PORK MEAT & BONE MEAL, ANIMAL MEAT & BONE MEAL, ANIMAL FAT (PRESERVED FAT (PRESERVED WITH MIXED TOCOPHEROLS), WITH MIXED TOCOPHEROLS), PEAS, EGG PRODUCT, PEAS, EGG PRODUCT, NATURAL FLAVOR, OATS, NATURAL FLAVOR SALT, DRIED APPLES, DRIED CRANBERRIES, DRIED CARROTS, POTASSIUM CHLORIDE, MIXED CONTAINS LESS THAN 2% OF EACH OF THE TOCOPHEROLS (A PRESERVATIVE), MINERALS (ZINC FOLLOWING: OATS, SALT, DRIED APPLES, SULFATE, FERROUS SULFATE, ZINC OXIDE, COPPER DRIED CRANBERRIES, DRIED CARROTS, MIXED SULFATE, MANGANESE OXIDE, SODIUM SELENITE, TOCOPHEROLS (A PRESERVATIVE) CALCIUM IODATE, COBALT CARBONATE), VITAMINS (VITAMIN E SUPPLEMENT, VITAMIN A SUPPLEMENT, VITAMINS: VITAMIN E SUPPLEMENT, VITAMIN A BIOTIN, d-CALCIUM PANTOTHENATE, VITAMIN SUPPLEMENT, BIOTIN, d-CALCIUM PANTOTHENATE, B12 SUPPLEMENT, THIAMINE MONONITRATE, VITAMIN B12 SUPPLEMENT, THIAMINE PYRIDOXINE HYDROCHLORIDE, MENADIONE MONONITRATE, PYRIDOXINE HYDROCHLORIDE, SODIUM BISULFITE COMPLEX (SOURCE OF MENADIONE SODIUM BISULFITE COMPLEX VITAMIN K ACTIVITY), RIBOFLAVIN SUPPLEMENT, (SOURCE OF VITAMIN K ACTIVITY), RIBOFLAVIN FOLIC ACID, NIACIN, VITAMIN D3 SUPPLEMENT). SUPPLEMENT, FOLIC ACID, NIACIN, VITAMIN D3 SUPPLEMENT MINERALS: ZINC SULFATE, FERROUS SULFATE, ZINC OXIDE, COPPER SULFATE, MANGANESE OXIDE, SODIUM SELENITE, CALCIUM IODATE, COBALT CARBONATE, POTASSIUM CHLORIDE FDLI March/April 2016 UPDATE 19 Food 8 requirements remain today. Because the U.S. continues to rise. Writing consumers better understand the FDAAA mandates that FDA, working accurate, user-friendly feeding pet foods available to them (and with AAFCO, pet food manufacturers, directions can be a daunting task, thereby make more informed choices and others, establish “updated however, as healthy adult dog weights, for their pets), and could help curb standards for the labeling of pet food for example, can vary from five pounds the pet obesity problem. Pet food that include nutritional and ingredient to well over 100 pounds. Consumers manufacturers and other stakeholders information,” the agency, along with oen simply don’t know how much should engage with FDA to have their industry, is now reexamining pet they should be feeding their pets. One views heard and contribute to the label food labeling requirements. is solution would be to list the feeding update process. FDLI affords an unusual opportunity for directions in increments by weight FDA and interested stakeholders to (such as in ten-pound increments 1. See AAFCO Regulation PF 4, AAFCO revamp pet food labeling to be more for dog food), along with a listing of 2016 Official Publication (OP) at 141. comprehensible—and therefore the calorie requirements for pets of 2. See AAFCO Regulation PF 5, AAFCO more useful—to consumers. A good each weight category and the number 2016 OP at 142. e federal regulation at 21 C.F.R. § 501.4(a) contains the model to follow would seem to be the of cups of the diet those pets should same requirement. Nutrition Facts Box format on human consume per day. In this case, too, 3. See, e.g., AAFCO 1964 OP at 23. foods, with which consumers are very mandating that the feeding directions 4. Id. at 85. 5. See 1968 AAFCO OP at 27. familiar. Establishing a standardized be standardized across products could 6. Id. at 28. Nutrition Facts Box format and help ensure that they are understood 7. See 1969 AAFCO OP at 27. location for pet food would mean the and followed. 8. See Ass’n for Pet Obesity Prevention, product’s nutritional information ese kinds of relatively simple http://www.petobesityprevention.org/. would appear in a familiar way and changes to pet food labels could help make it easier to find on the label. At the same time, the nutrients the manufacturer guarantees could also be Skadden, Arps, Slate, Meagher reflected in more consumer-friendly & Flom LLP and Affiliates terms, such as “protein,” “fat,” and “fiber,” instead of “crude protein,” “crude fat,” and “crude fiber.” With approximately 1,700 attorneys in In the same way, pet food ingredient 23 offices on five continents, Skadden declarations can be revised to make represents health care and life sciences them easier to read and understand. clients from every sector of the industry One way would be to categorize the — pharmaceuticals, medical devices, ingredients into key ingredients, biotechnology, and hospitals and services ingredients present at amounts of less providers — in transactions, litigation, than 2 %, vitamins, and minerals, with regulatory and enforcement matters, and intellectual property issues. appropriate labels designating each group. If ingredients are so categorized, Our rankings include: consumers can more easily understand – Named among Law360’s Health Care and what nutrients a particular product Life Sciences 2014 Groups of the Year. contains and meaningfully compare – Ranked first by value for 2014 in global pharma/medical/biotech M&A by mergermarket. products. Another area of the pet food label in need of an overhaul is the feeding directions section. is is particularly true as the incidence of pet obesity in 20 UPDATE March/April 2016 fdli.org
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