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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 ...

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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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...Fdli member magazine www org march april food and drug law institute in this issue advertising antitrust labeling biosimilars cybersecurity first amendment data integrity dqsa annual conference may plus interview with mark mcclellan fdaaa mandated updated standards for pet lllllllaaaaaaabbbbbbbeeeeeeellllllliiiiiiinnnnnnnggggggg by jeannie perron jessica p o connell n september the wake of melamine association american feed control ocials crisis that had erupted a few months earlier aafco which among other things promulgates model icongress passed president signed into laws regulations animal administration amendments act ose include rules er notably establishment many states have fashioned their own state but did not address e conjunction or human federal c f r part encompass section provided requirements he secretary health services labels dier from those consultation number important respects unlike foods relevant stakeholder groups do contain standardized nutrition including veteri...

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