May
2008
Too Much Information?
New Labeling Regulations for 2008
By Cynthia Kupper, RD, CD
Today’s Dietitian
Vol. 10 No. 5 P. 8
Suggested CDR Learning Codes: 4030, 5110,
7100, 7120; Level 1
Food labeling regulations continue to multiply,
and we can anticipate two major additions this fall when the
USDA country of origin labeling (COOL) law will be fully implemented
and the gluten-free labeling law, mandated under the Food Allergen
Labeling and Consumer Protection Act (FALCPA), takes effect.
While these regulatory changes are designed to provide consumers
with better information, enabling them to make informed buying
decisions, their sheer complexity and use of unfamiliar terminology
can confuse the average food purchaser.
Dietitians are uniquely positioned to explain
what the new information means and why it has been included
on packages. But first, they need to fully understand the new
regulations.
Country of Origin Labeling
Recent news stories of bovine spongiform encephalopathy (mad
cow disease), “downer” cows being slaughtered for
human consumption, and Escherichia coli contamination of hamburger
meat and produce have led Americans to be more concerned about
the safety of the food supply. Although the United States has
had comprehensive regulation and inspection protocols in place
for decades, globalization and free trade mean that more food
comes from sources outside U.S. government jurisdiction.
In 2002, Congress passed the Farm Security and
Rural Investment Act (Public Law 109-97), which created mandatory
COOL for products under USDA jurisdiction. The law was intended
to provide consumers with information needed to make informed
decisions about their purchases related to the product’s
origin and to promote U.S. food products, which in most cases
are assumed to be better regulated. The law required that “a
retailer of a product covered under this ruling inform consumers
of the country of origin” beginning September 30, 2004.
Initially, the guidelines were voluntary, but COOL became mandatory
for wild and farm-raised fish and shellfish on September 30,
2006. After at least two delays in implementation, other retailers
must now comply by September 30, 2008.1
The commodities covered by this law include
beef, lamb, and pork (muscle cuts and ground); fish and shellfish
(farm raised and wild); perishable agricultural commodities
(fresh and frozen fruits and vegetables); and peanuts. The retailer
is responsible for providing this information to the consumer
rather than the producer, who may be in another country. The
law exempts the following:
• foodservice establishments such as restaurants
(even those within a retail business, such as a deli within
a grocery store), cafeterias, and food stands;
• companies with less than $230,000 in
annual sales of the specified commodity;
• exporters; and
• butcher shops and fish markets.
Similarly, certain classes of commodities are exempt, including
foods that are processed (where the processing results in a
“change in the character” of the commodity) and
foods that have been combined with at least one other covered
commodity or other substantive food component.
Processing that results in a change in character
includes cooking, curing, smoking, and restructuring (eg, emulsifying
and extruding, compressing into blocks, and cutting into portions).
Examples of excluded commodity items include fish sticks, surimi,
mussels in tomato sauce, seafood medley, coconut shrimp, soups,
stews, chowders, sauces, pâtés, smoked salmon,
marinated fish fillets, canned tuna, canned sardines, canned
salmon, crab salad, shrimp cocktail, gefilte fish, sushi, and
breaded shrimp. Also excluded are poultry and poultry products.2
COOL does not apply to ingredients in cereals, soups, or any
other foods processed in the United States, no matter where
they originate.
The country of origin information can be provided
by use of a label, stamp, mark, placard, or other clear and
visible sign either on the commodity, the package, the display,
or the holding unit or bin containing the product at the point
of consumer sale. Fish must also indicate whether it is farmed
or wild. The only requirement for positioning of the label is
that the COOL must appear separately from the product’s
name or ingredients list.
COOL has the following three distinct categories:
• “U.S. only origin”: primarily
for animals that are born, raised, and processed or slaughtered
exclusively in the United States (Products of Hawaii and Alaska
can carry this designation only if they spend less than 60 days
in transit through Canada to the mainland.);
• “Foreign only origin”: for
those products, primarily animals, that are produced and processed
entirely outside the United States; and
• “Mixed origin”: a commodity
must be labeled of mixed origin according to the country of
birth, raising, and slaughter.
This last category can cause confusion. A mixed
origin label would read as follows:
“Born in Country X, Raised in Country Y, and Slaughtered
in the U.S.” This labeling requirement also applies to
mixed or blended products, such as ground beef, if it comes
from different countries of birth, raising, or slaughter. A
product that is blended or comingled, such as a bag of mixed
frozen fruits in which the fruits were imported from a number
of countries and processed in the United States, must be labeled
“from [all countries], processed in the United States,”
with each country listed alphabetically. Too much information
to be useful?
COOL Audit Trails
Retailers and suppliers are required to maintain detailed records
of the source(s) of the commodities they sell. The law requires
suppliers and retailers to maintain records to establish and
identify the immediate previous source and immediate subsequent
recipient of a commodity for one year from the date of the transaction.
The record must be unique to the individual product (eg, an
individual item purchased by a consumer). The USDA requires
retailers at the point of sale to be able to show documentation
of a product’s country or countries of origin and the
method(s) of production (eg, farm-raised or wild fish). The
U.S. Secretary of Agriculture can require that any person who
prepares, stores, handles, or distributes a commodity for retail
sale also maintain a verifiable record-keeping audit trail.
When it concerns animal products, this includes records of birth,
where an animal was raised, death, and the processing of each
animal.3
While it may seem comprehensive, COOL is not
required for FDA-regulated commodities—essentially anything
but animal products. However, some companies are voluntarily
including COOL-like information on labels but not always following
the intent of the USDA guidelines.
Both USDA- and FDA-imported products are already
required to label the country of origin to inform the “ultimate
purchaser,” the last U.S. person who will receive the
article in the form in which it was imported. Under that guideline,
processed foods could be labeled in a somewhat deceptive manner—for
example, olive oil labeled as a “Product of Italy”
but made from olives grown in Greece, processed in Algeria,
stored in Spain, and bottled in Italy. As a rule of thumb, imported
canned fruits and vegetables labeled as “Product of ______”
are merely packed, not necessarily grown and processed, in the
specified country. Packing is important, of course, but most
consumers are more concerned with where a fruit or vegetable
is grown, which may tell them what kinds of fertilizer, pesticide,
or additives it contains.
Needless to say, implementing COOL is costly,
time consuming, and could require updated tracking systems.
Imagine the complexity of tracking an individual hog, not only
“from farrow to finish” on a farm but also through
slaughter, processing, packing, transport, packaging, storing,
wholesaling, and retailing of more than a dozen different pork
products.
The Agricultural Marketing Service has estimated
that it would cost producers, food handlers, and retailers nearly
$2 billion in the first year to comply with new record-keeping
requirements for certain products sold at retail and labeled
by their country of origin. The estimated compliance costs were
broken down as follows: $1 billion for farmers and ranchers;
$340 million for about 100,000 food handlers, including packers,
processors, importers, wholesalers, and distributors; and $627
million for retailers.
Although retailers are ultimately held accountable
by the USDA for compliance, the Food Marketing Institute is
advising retailers to pass some or all of the cost and liability
of implementation and responsibility to their suppliers. Companies
such as Hormel Foods and Wal-Mart have been discussing new policies
and procedures for compliance with their suppliers. Some companies
are also discussing passing any fines back to their suppliers—the
farmers. This shift could create a lower profit margin for farmers—or,
more likely, higher prices all along the supply chain.
As COOL goes into effect, key players in the
food industry are now advocating for a system that is just as
effective but less costly to comply with. In the short term,
however, we will see more information on our supermarket shelves.
Gluten-Free Labeling
The regulation of gluten-free labeling has been a hot topic
of discussion for several years. Both consumers and the food
industry are awaiting formal regulations from the FDA, which
are expected this fall.
At about the same time, the World Health Organization’s
Codex Alimentarius Commission should adopt the “Draft
Revised Standard for Foods for Special Dietary Use for Persons
Intolerant to Gluten” (formerly known as the “Draft
Revised Codex Standard for Gluten-Free Foods”). In November
2007, the Codex Alimentarius Commission established a revised
definition for gluten-free foods and requested comments from
government and international organizations before April 1, 2008.
In July 2008, it is expected to adopt the definition as the
standard.
In 1981, the first Codex standard for gluten
free was published. Since 1998, the Codex Alimentarius Commission
has been reviewing and revising the definition standards for
gluten free. In the most recent revisions, the definition has
been modified to state that products could be made from naturally
gluten-free ingredients (no wheat, rye, barley, oats, or hybrids)
and could contain no more than 20 parts per million gluten or
could be made from gluten-containing grains that had been rendered
gluten free and contain no more than 200 parts per million.
Wheat starch is an example of an ingredient rendered gluten
free. The current definition reduces the previously accepted
parts per million for products rendered gluten free from 200
to 100.
On January 1, 2006, FALCPA, passed and signed
in 2004, became law. FALCPA includes two particularly important
sections. The first mandates the labeling of the top eight allergenic
foods—milk, eggs, fish (eg, bass, flounder, cod), crustacean
shellfish (eg, crab, lobster, shrimp), tree nuts (eg, almonds,
pecans, walnuts), wheat, peanuts, and soybeans—by their
common or usual name on all foods regulated by the FDA. Of notable
exception is any highly refined oil derived from a food specified
as an allergen and any ingredient derived from such highly refined
oil. FALCPA’s requirements apply to all packaged foods
sold in the United States that are regulated under the federal
Food, Drug, and Cosmetic Act, including both domestically manufactured
and imported foods. FALCPA, through the FDA, regulates all foods
except meat, fish, poultry, and egg products and does not extend
to drugs.
The second part of FALCPA requires the FDA to
issue a proposed rule to define and permit use of the term gluten
free on labels. This rule is to be made public no later than
two years after the date of FALCPA’s enactment. No later
than four years after the date of enactment, the FDA shall issue
a final rule to define and permit use of the term gluten free
on food labels. Such labeling will be voluntary and does not
include products regulated by the USDA. Thus, 2008 is a watershed
year for gluten-free labeling.
Table 1 offers a comparison of Codex and the
proposed FDA regulation. It is important to note that both definitions
are based on celiac disease research.
Table 1
| |
Codex |
FDA |
Definition
of gluten free |
1. Gluten-free foods are dietary foods
consisting of or made only from one or more ingredients
that do not contain wheat (eg, all Triticum species, such
as durum wheat, spelt, and kamut), rye, barley, oats,
or their crossbred varieties, and the gluten level does
not exceed 20 mg/kg in total, based on the food as sold
or distributed to the consumer.
2. Gluten-free foods are dietary
foods consisting of one or more ingredients from wheat
(eg, all Triticum species, such as durum wheat, spelt,
and kamut), rye, barley, oats, or their crossbred varieties,
which have been specially processed to remove gluten,
and the gluten level does not exceed 20 mg/kg in total,
based on the food as sold or distributed to the consumer. |
1. A food that does not contain ingredients
from prohibited grain (grains from the genus of wheat,
rye, or barley).
2. A food that contains an ingredient
derived from a prohibited grain and has been processed
to remove gluten.
3. A food that contains an ingredient
derived from a prohibited grain and has been processed
to remove gluten, if the use of that ingredient results
in the presence of 20 ppm or more gluten in the food (eg,
20 mcg or more gluten per gram of food).
4. A food that contains no more than 20
ppm glute |
Special definitions
|
Foods specially processed to reduce
gluten content to a level above 20 and up to 100 mg/kg.
These foods consist of one or more ingredients
from wheat (eg, all Triticum species such as durum wheat,
spelt, and kamut), rye, barley, oats, or their crossbred
varieties, which have been specially processed to reduce
the gluten content to a level above 20 and up to 100 mg/kg
in total, based on the food as sold or distributed to
the consumer. |
None |
Oats |
Oats can be tolerated by most, but not
all, people who are intolerant to gluten. Therefore, the
allowance of oats that are not contaminated with wheat,
rye, or barley in foods covered by this standard may be
determined at the national level. |
Although oats are inherently free of gluten
as defined in this proposed rule, the FDA proposes to deem
misbranded a food made from oats that bears a gluten-free
labeling claim if the claim refers to all such foods as
being gluten free or if it contains 20 ppm or more gluten.
By “food made from oats,” the FDA means oats,
any food that contains oats, and any food that contains
any ingredient derived from oats. The proposed gluten-free
labeling claim restriction is based on evidence of the presence
of gluten from prohibited grains in a number of commercially
available brands of foods made from oats. In light of that
evidence, the FDA believes a gluten-free labeling claim
that suggests all foods made from oats are gluten free would
be misleading. |
Labeling |
1. “Gluten free” can be
used only on products that meet the standard of less than
20 ppm.
2. Foods specially processed to reduce
gluten content to a level of 20 to 100 ppm may not be
labeled gluten free. Use of alternative labeling such
as “very low gluten foods,” “low gluten
foods,” or “gluten-reduced foods” may
be determined at a national level.
3. A food that, by its nature, is suitable
for use as part of a gluten-free diet shall not be designated
“special dietary,” “special dietetic,”
or any other equivalent term. Such a food may bear a statement
on the label that “this food is by its nature gluten
free” provided that it complies with the essential
composition provisions for gluten free as laid out in
section 3.1 and provided that such a statement does not
mislead the consumer. More detailed rules to ensure that
the consumer is not misled may be determined at the national
level. |
The FDA proposes to deem misbranded
any food, with the exception of a food made from oats,
that does not inherently contain any gluten from a prohibited
grain and that bears the claim “gluten free”
in its labeling, unless the food complies with the following
two requirements:
• The wording of the claim in the
labeling of the food clearly indicates that all foods
of the same type, not just the brand bearing this labeling
claim, are gluten free (eg, “milk, a gluten-free
food,” “all milk is gluten free”); and
• The food does not contain 20 ppm
or more gluten.
For foods that are naturally gluten free,
the FDA views the use of a gluten-free labeling claim
for a food inherently free of gluten to be potentially
misleading without the inclusion of additional qualifying
language. Acceptable terms for use on labels to mean the
equivalent to gluten free are “free of gluten,”
“without gluten,” and “no gluten.” |
Analysis methodology |
The quantitative determination of gluten
in foods and ingredients shall be based on an immunologic
method or other method providing at least equal sensitivity
and specificity. The antibody used should react with the
cereal protein fractions that are toxic for persons intolerant
to gluten and should not cross-react with other cereal proteins
or other constituents of the foods or ingredients. Methods
used for determination should be validated and calibrated
against a certified reference material, if available. The
detection limit has to be appropriate according to the state
of the art and the technical standard. It should be 10 mg
gluten/kg or below. The qualitative analysis that indicates
the presence of gluten shall be based on relevant methods
(eg, ELISA-based methods, DNA methods). Method for determination
of gluten: ELISA R5 Mendez method |
The FDA has tentatively concluded that
currently there are no available and appropriate test methods
that can reliably and consistently detect gluten in a variety
of food matrices at levels below 20 ppm. Based on the current
state of technology concerning available and appropriate
analytical methods that can detect one or more gluten proteins
naturally occurring in wheat, rye, and barley, the FDA has
tentatively determined that ELISA-based methods can be used
to reliably and consistently detect gluten at a level of
20 ppm in a variety of food matrices, including both raw
and cooked or baked foods. ELISA-based methods detect the
prolamins in wheat, rye, and barley, which can serve as
a biomarker for the presence of those grains, their crossbred
hybrids, or their other naturally occurring proteins. The
FDA is tentatively considering using an ELISA-based method
that has been validated in Europe at the 20 ppm gluten detection
level and has been published in the peer-reviewed scientific
literature (R5 Mendez method). |
— Sources: Codex Alimentarius Commission.
Report of the 29th session of the Codex committee on nutrition
and foods for special dietary uses. November 16, 2007. Available
at: http://www.codexalimentarius.net/download/report/687/al08_26e.pdf;
Food and Drug Administration. Food labeling: Gluten-free labeling
of foods. January 23, 2007. Available at: http://www.cfsan.fda.gov/~lrd/fr070123.html
Gluten-Free Certification
While manufacturers need to comply with FALCPA and the standards
set by the FDA for labeling foods gluten free, other certification
programs that have grown in the absence of clear legal standards
are also available. Two organizations in the United States now
offer gluten-free certification for products. The Gluten-Free
Certification Organization, a program of the Gluten Intolerance
Group of North America, and the Celiac Sprue Association offer
“Seal of Recognition” programs. These programs are
not regulated by any government agency; rather, they are voluntary
and set a stricter standard for use of their marks on gluten-free
products. Each agency sets the standards of the program, and
food manufacturers must meet these requirements to use the symbol
on their package. Table 2 summarizes the two programs.
Table 2
| |
The Gluten-Free Certification Organization
(GFCO) |
Celiac Sprue Association Seal of
Recognition |
| Parts per million |
10 ppm or less |
Less than 3 ppm |
| Prohibited grains |
Proteins from wheat, rye, barley, and their
hybrids |
Ingredients from wheat, rye, barley, oats,
and their hybrids |
| Audits and testing |
Audits are required. In facility, product
and ingredient testing required, as well as random external
testing by the GFCO. |
Audits may be performed. Samples are sent
out to independent labs for testing. |
| How seal is used |
Food manufacturers only. (Restaurants are
endorsed under a restaurant-specific program.) |
Food manufacturers, restaurants, and books |
| Symbol |
 |
 |
Too Much Information?
A 2007 survey of more than 5,000 consumers of gluten-free products
showed that 96% of consumers are brand loyal, seeking those
they trust. While certification is a new concept for gluten-free
products, approximately 64% of consumers surveyed were already
looking for certification marks on packaging to indicate a higher
standard for gluten-free products. Consumers make buying decisions
based on the information on labels and want to see products
labeled gluten free. They are unsure whether they should trust
products with voluntary labeling statements such as “Produced
in a plant with…”
These new labeling requirements have the potential
to provide valuable information to consumers so they can make
smart buying decisions. However, they may also cause confusion,
which may require consumer education. The following are some
potentially confusing areas:
• COOL may not provide the information
a customer is seeking. In a recent discussion with
a raw materials and finished product quality control manager,
I was asked, “Do consumers really want to know the country
of origin or the origin of the source ingredient? They most
likely are not the same.”
For example, a U.S. company imports oats for
the gluten-free market. The oats are repackaged or used in processed
foods (eg, granola), and the label contains two labeling statements:
“Gluten free” and “Product of the U.S.”
This labeling sends up a red flag for the gluten-free–seeking
consumer because, immediately, the oats are in question. Where
did they originate? If they are not from one of the companies
known to have uncontaminated gluten-free oats, should the consumer
trust them? In this situation, the label provides only part
of the information consumers want and need to have confidence
in the product.
Keep in mind that COOL is not required for this
product. But if one follows the COOL guidelines, repackaged
oats should be labeled “Product of _____ country, processed
in the U.S.” or simply “Product of ______.”
The granola should identify the source of oats, such as “Oats
(product of Canada)…”
Customers may need more specific information
about the country or state of source of an ingredient if this
is an issue for them.
• Foods labeled as gluten free
may also contain allergen statements listing wheat.
We are already seeing labels that have an allergen statement
listing wheat, and yet the products are marked gluten free.
This could be very confusing for consumers. Educating them is
important, as is fully explaining and assuring them of the safety
of the gluten-free definition of 20 parts per million.
In the near future, we may see changes in voluntary
disclaimers, such as “may contain” and “processed
in” statements. The use of these statements appears to
be skewed, causing consumer confusion. It is important that
dietitians have a unified way to deal with such statements.
Today, experts in celiac disease and the gluten-free diet do
not present a unified message to consumers about these statements.
This adds to the confusion consumers have about their value.
While changing labeling regulations are good and should assist
the consumer, they also require a component of education about
the changes and how best to use the information.
— Cynthia Kupper, RD, CD, is the
executive director of the Gluten Intolerance Group of North
America.
References
1. Agricultural Marketing Service at the U.S. Department of
Agriculture. Country of origin labeling. Available at: http://www.ams.usda.gov/cool
2. Library of Parliament. Country-of-origin
labelling (PRB 03-02E). Available at: http://www.parl.gc.ca/information/library/PRBpubs/prb0302-e.htm
3. Kansas State University Research & Extension.
Country of origin labeling — COOL. Available at: http://www.oznet.ksu.edu/ansi/cool
Learning Objectives
After completing this module, the student will be able to:
1. Explain the reasons for and details of new country of origin
labeling (COOL) regulations.
2. List four kinds of establishments that are
exempt from COOL regulations.
3. Discuss what commodities are exempt from
COOL requirements.
4. Discuss the problems of implementing COOL
regulations for processed food products and those with components
from different countries.
5. Briefly explain the history of gluten-free
product labeling and explain how that will culminate in effective
regulation in 2008.
6. Identify and discuss two areas of likely
consumer confusion over new labeling regulations.
Examination
1. Country of origin labeling (COOL) will be required for the
following products in September 2008:
a. Chicken, beef, pork, and fish
b. Wild and farm-raised fish and shellfish
c. Peanuts, tree nuts, and fruits and vegetables
d. Wild and farm-raised fish and shellfish; beef, lamb, and
pork; fruits and vegetables; and peanuts
2. The Food Allergen Labeling and Consumer Protection
Act (FALCPA) and gluten-free labeling of products cover which
of the following products?
a. Milk products, cheeses, eggs, and lunch meat
b. Cereals, breads, baked goods, and pasta
c. Wheat, eggs, milk, soy, shellfish, fish, nuts, and peanuts
d. Medications, nutritional supplements, and vitamins
3. Codex defines gluten free as:
a. 20 parts per million.
b. ingredients without wheat, rye, barley, or oats and less
than 20 parts per million gluten.
c. ingredients rendered gluten free that are less than 20 parts
per million.
d. None of the above
4. The FDA-proposed gluten-free definition includes:
a. no wheat, rye, barley, or their hybrids and under 20 parts
per million gluten.
b. oats that are under 20 parts per million may be labeled gluten
free.
c. ingredients may be from wheat, rye, or barley that have been
rendered to contain less than 20 parts per million gluten.
d. All of the above
5. Gluten-free certification programs are regulated
by:
a. the USDA.
b. the FDA.
c. the Bureau of Alcohol, Tobacco and Firearms (BATF).
d. the certifying agency.
6. Products regulated by the USDA are not mandated
to abide by FALCPA.
a. True
b. False
7. It could be possible to find products labeled
gluten free with wheat on the label, according to FALCPA and
the proposed gluten-free labeling requirements.
a. True
b. False
8. For products “rendered gluten free,”
the World Health Organization and Codex state:
a. they may be labeled gluten free.
b. they may not be labeled gluten free.
c. they may contain between 20 and 100 parts per million gluten.
d. b and c
9. The FDA will allow terms such as the following
to be synonymous with gluten free:
a. Free of gluten
b. Without gluten
c. No gluten
d. All of the above
10. COOL is required on products regulated by:
a. the FDA.
b. the USDA.
c. the BATF.
d. All of the above
