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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 a er
(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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