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Legal
Requirements
for "Low Glycemic" Claims on Pet Foods
Glycemic Research Institute®
LOW GLYCEMIC
CERTIFICATION MARKS
FDA Legal & Regulatory Guidelines
2010 |
The United States Food & Drug Administration
(FDA) is charged with the enforcement of the Federal Food,
Drug, and Cosmetic Act (the Act). Under the Act, a part of
FDA's responsibility is to ensure that human and animal foods
are safe and properly labeled.
Within FDA, the Center for Veterinary Medicine (CVM)
is responsible for the regulation of animal drugs, medicated
feeds, food additives and feed ingredients, including pet
foods.
The Food & Drug Administration
(FDA) has declared that Pet Food Health Claims and labeling
fall under the guidelines of the FDA NLEA (Nutrition Labeling
and Education Act in 1990) and that CVM has incorporated the
philosophy of NLEA in its policies in order to permit meaningful
health information on pet foods.
The regulations based, in part, on this law are found in the
FDA Code of Federal Regulations, Title 21, Food and
Drugs. Under FDA guidelines, food is defined as "articles
used for food or drink for man or other animals...and
articles used for components of any such article."
Any human or pet food label that contains the words “Low Glycemic”
must have authoritative
basis for said claim* and must include the reference
on the label* in order to legally ensure that
the label is truthful and not misleading per FDA 21CFR guidelines.
*
Certified by the Glycemic Research Institute®
BACKED
BY GOVERNMENT
CERTIFICATION MARKS |
For
the past 25 years, the Glycemic Research Institute® has provided
Authoritative and Legal Claim Substantiation
for human and pet food labels, including:
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BOARD CERTIFIFED HUMAN
IN VIVO CLINICAL TRIALS |
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U.S. GOVERNMENT
CERTIFICATION PROGRAM |
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UNITED KINGDOM
GOVERNMENT CERTIFICATION PROGRAM |
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CANADIAN GOVERNMENT
CERTIFICATION PROGRAM |
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CLINICAL STUDIES:
INVESTIGATIONAL TRIALS |
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FDA & FTC
CLAIM SUBSTANTIATION
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Compliance with FDA Code of
Federal Regulations, Title 21, Food and Drug Guidelines |
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Compliance
with Food & Drug Administration
(FDA) Food Health Claims and Labeling Guidelines
of the FDA NLEA (Nutrition Labeling and Education Act) |
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CLINICAL ASSESSMENT
Foods, Beverages, Nutraceuticals & Pharmacueticals |
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PET FOODS: LOW GLYCEMIC
CLAIM SUBSTANTIATION
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Compliance
with FDA Code of Federal Regulations, Title
21, Food and Drugs guidelines (Pet Foods) |
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Compliance
with Food & Drug Administration (FDA) Food Health
Claims and Labeling Guidelines of the FDA NLEA
(Nutrition Labeling and Education Act) and CVM NLEA
policies in health information on pet foods. |
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TO
APPLY FOR PET FOOD CERTIFICATION |
Pet food companies that wish to apply for Low
Glycemic and/or Diabetic Friendly
Certification may contact the Glycemic Research
Institute® Clinical Trials Coordinator at (727) 894-6900.
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United
States Food & Drug Administration
Department
of Health & Human Services
Pet
Food Labels
David A. Dzanis, DVM, Ph.D., DACVN
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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 have adopted 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.
Product Name
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. The percentages of named ingredients
in the total product are dictated by four AAFCO rules.
The "95%" 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% 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%
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% 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% total. For example, a "Lamb
and Rice Dog Food" would be misnamed unless the product
was comprised of at least 95% lamb.
The "25%" or "dinner" rule applies to
many canned and dry products. If the named ingredients comprise
at least 25% of the product (not counting the water for
processing), but less than 95%, 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% and be listed in the same order
as found on the ingredient list. Each named ingredient must
be at least 3% of the total, too. Therefore, "Chicken
n' Fish Dinner Cat Food" must have 25% chicken and
fish combined, and at least 3% fish. Also, unlike the "95%"
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%.
The "3%" 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% 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% 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." Now, even
a minor change in the wording of the name has a dramatic
impact on the minimum amount of the named ingredient required,
e.g., 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% tuna, the first
needs only 3%. Therefore, the consumer must 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.
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 to the food. 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.
Net Quantity Statement
The net quantity statement tells you how much product is
in the container. 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. 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." A cost-per-ounce
or per-pound comparison between products is always prudent.
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 toll-free number on the
label for consumer inquiries. If a consumer has a question
or complaint about the product, he or she should not hesitate
to use this information to contact the responsible party.
Ingredient List All ingredients are required to be listed
in 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% water). On the other hand, water and
fat are removed from meat meal, so it is only 10% 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."
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,
which 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. While studies are being conducted to ascertain
a more accurate minimum effective level of ethoxyquin in
dog foods, 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%) to 75 ppm. Regardless, most pet foods
that contained ethoxyquin never exceeded the lower amount,
even before this recommended change.
Guaranteed Analysis
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.
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, when 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% moisture, whereas dry foods contain
only 10-12% 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%
minus the percentage of moisture guaranteed on the label.
A dry food is approximately 88-90% dry matter, while a canned
food is only about 22-25% 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% crude protein
and 75% moisture (or 25% dry matter), while a dry food contains
27% crude protein and 10% moisture (or 90% dry matter).
Which has more protein, the dry or canned? Calculating the
dry matter protein of both, the canned contains 32% crude
protein on a dry matter basis (8/25 X 100 = 32), while the
dry has only 30% on a dry matter basis (27/90 X 100 = 30).
Thus, although it looks like the dry has a lot more protein,
when the water is counted out, the canned actually has a
little more. 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. 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%, 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% 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% moisture contains 12.5% dry matter, only half as much
as a product with a 75% moisture guarantee (25% dry matter).
Nutritional Adequacy Statement
Any claim that a product is "complete," "balanced,"
"100% 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 are not 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," except if it is conspicuously
identified as a snack or treat.
Feeding Directions
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. The feeding directions
should be taken as rough guidelines, a place to start. Breed,
temperament, environment, and many other factors can influence
food intake. 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. Calorie Statement 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. 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.
Other Label Claims
Many pet foods are labeled as "premium," and some
now are "super premium" and even "ultra premium."
Other products are touted as "gourmet" items.
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 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.
Summary
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.
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