April,
2007
Today’s
CPE — Gluten-Free Labeling: Decisions and Dilemmas
By Cynthia Kupper, RD, CD
Today’s Dietitian
Vol. 9 No. 4 P. 10
Learning Codes: 4030, 5110, 7100, 7120;
CDR Level I
Intact storage proteins in wheat, rye, barley,
and hybrids of these grains, such as kamut and triticale, are
known by the generic term gluten. Gluten is the insoluble protein
component of wheat and other grains. Intolerance to these proteins
produces various diagnoses, including celiac disease (CD), an
immune-mediated disease of malabsorption caused by inflammation
that damages the microvilli and villi of the small intestine.
Also known as celiac sprue, sprue, or nontropical
sprue, CD was once considered a rare childhood disease. Now,
it affects an estimated one in 133 Americans (approximately
3 million people) and more women than men, and the average age
at diagnosis is 40 to 50. It is believed that many with the
condition are undiagnosed.
A recent trade article on FoodNavigator.com
(USA) reported an anticipated 10-fold growth in the worldwide
known number of people with CD in the next few years.1 Creating
a gluten-free (GF) dietary regime is paramount in treating these
patients, as well as the growing number of people with other
conditions who follow a GF diet: people with autism, gluten
intolerance, and those who have a wheat allergy or choose a
grain-free diet. The total GF market may be as high as 9 to
10 million people.
This article will explore some consumer attitudes
and concerns about GF foods, labeling, and marketing, focusing
on actual and proposed regulation of labeling terminology.
Historically, rice, corn, and potato were substitutes
for gluten-containing grains. Today, other nutrient-dense grains,
seeds, legumes, and nut flours offer increased variety, improved
palatability, and higher nutritional quality. These include
amaranth, buckwheat, flax, Indian rice grass, millet, teff,
quinoa, and sorghum.
A few years ago, the number of GF products was
limited. Those involved in the Gluten Intolerance Group of North
America have seen increased interest by manufacturers in the
GF market, probably as the low-carb diet fad has waned. In the
past several years, with growing consciousness of CD, many companies
have begun producing and marketing GF products. In August 2005,
SPINS, Inc., a market research and consulting firm for the natural
products industry that provides quantifiable information on
sales, retail trends, and consumer and market dynamics, reported
at an FDA hearing that the GF market experienced a 14.6% growth
during 2005.2
SPINS reported that during a 52-week period
between 2004 and 2005, GF product sales increased by 13% ($79.2
million). More than 3,150 products on the market carried GF
label claims. The conventional market experienced an increase
of 18% (188 products) in new GF product introductions during
that time period compared with 9.1% (179 products) in natural
supermarkets.
SPINS provided the FDA with information in nine
key product areas: chips, pretzels, and snacks; puddings and
shelf-stable desserts; candy and individual snacks; frozen entrees,
pizzas, and convenience foods; breads and baked goods (both
frozen and nonfrozen); baking mixes, supplies, and flours; soups;
cookies and snack bars; and entrees and mixes. They provided
comparisons between natural and conventional supermarkets.
Natural food markets experienced nearly 12%
growth in GF products, with the majority of growth in candy
and individual snacks (47.1%); frozen entrees, pizzas, and convenience
foods (28.1%); breads and baked goods (22.9%); and baking mixes,
supplies, and flours (18.6%). Overall growth in conventional
markets was 17.8%, with the greatest growth in soups (47.1%);
cookies and snack bars (30.5%); entrees and mixes (30%); candy
and individual snacks (28.4%); breads and baked goods (26.4%);
and baking mixes, supplies, and flours (24.1%).
When GF product sales were compared with traditional
product sales in the same markets, traditional product sales
saw an increase of 17.8% in conventional markets and 16.9% in
natural markets. FoodNavigator.com reported that in 2001, the
market for GF products was valued at $210 million and has increased
at a compound annual growth rate of 27% to reach $696.4 million
in 2006. The market is estimated to continue growing at 25%
per year until 2010. It is also noted that major food marketers
have not largely entered into the market yet because they are
reluctant to invest in research and product development until
fixed regulations for GF are in place.3
Manufacturers are clearly more interested in
identifying and capturing the GF market, which is both good
and bad. Dietitians and GF consumers will have more products
to choose from but must be concerned about the trustworthiness
of GF product claims. If gluten-free becomes a marketing term
like natural or organic, the potential for abuse of the term
grows. Inevitably, the devil is in the details. As we’ve
seen with the organic foods industry, definitions and standards
are negotiable and difficult to enforce, and penalties for misrepresentation
are few.
Labeling GF Foods
The first phase of the Food Allergen Labeling and Consumer Protection
Act (FALCPA) went into effect January 1, 2006. All food products
that contain any of the top eight allergens (wheat, eggs, milk,
soy, tree nuts, peanuts, shellfish, and fin fish) must include
an allergen statement on their labels. (The USDA is considering
a similar requirement.) The allergen must be labeled in plain
language after the ingredient (eg, whey [dairy]) or in an allergen
statement at the end of the ingredient listing, starting with
“Contains…”.
The second part of FALCPA is essentially a consumer
protection act, which requires the FDA, in part, to define gluten-free
for labeling purposes. In January, the FDA released the proposed
rule for labeling GF products.4 The document runs 95 pages,
which indicates the complexity of the issue. The following is
a summary.
It is important to note that GF labeling is
voluntary; a product that contains no gluten need not state
that fact. Under the proposed rule, companies that do choose
to make “gluten-free” claims for their products
must use the following guidelines:
• Gluten-free is defined as “containing
less than 20 parts per million (ppm) of gluten.”
• Gluten-free for labeling means that
the food does not contain any of the following:
- an ingredient that contains any species of
the grains wheat, rye, barley, or a crossbred hybrid of these
grains, known collectively as prohibitive grains (The FDA is
not proposing to include oats in the definition of a prohibitive
grain.);
- an ingredient that is derived from a prohibitive
grain and has not been processed to remove the gluten (such
as wheat flour);
- an ingredient that is derived from a prohibitive
grain and has been processed to remove the gluten (such as wheat
starch), and if the use of that ingredient results in the food
having 20 parts per million or more gluten; and
- 20 parts per million or more gluten in the
food.
• Foods that carry the claim “gluten-free”
and do not meet these standards will be considered “misbranded”
(meaning making a false or misleading claim) under the following
conditions:
- if a gluten-free claim is made on foods inherently
gluten-free, and if the claim does not refer to all foods of
the same type also being gluten-free (eg, “milk, a gluten-free
food” or “all milk is gluten-free”); and
- a food made from oats (or an ingredient derived
from oats) that bears a gluten-free claim in its labeling would
be deemed misbranded if the claim suggests that all such foods
(containing oats) are gluten-free or if 20 parts per million
or more gluten is present in the food.
To make a Determination of Compliance with the
proposed regulation, the FDA is proposing to conduct a safety
assessment study for gluten. The FDA has expressed concerns
that analytical methods are currently not available that are
consistent in detecting levels below 20 parts per million. Until
the safety study is completed, use of an analytical methods-based
approach will be used to establish the 20 parts per million
threshold. The FDA has tentatively determined ELISA (Enzyme-Linked
ImmunoSorbant Assay)-based methods (Mendez R-5 ELISA-based methodology)
to be acceptable tentative testing methods. The FDA also states
that determination of compliance does not need to be based on
analysis of a food. The FDA may use various techniques in the
enforcement of food labeling claims and may use any of the following
methods to enable them to determine whether a food is misbranded:
label reviews, on-site inspections of food manufacturers, and/or
analysis of food samples.
The GF Community
Consumers who follow a GF diet have a strong interest in FALCPA
and GF labeling. GF consumer community members are strong self-advocates,
well-connected, and outspoken. However, at times, these consumers
make decisions based on misunderstanding, misinterpretation,
or mistrust of research, testimonial and anecdotal experiences,
or fear.
The Gluten Intolerance Group of North America
conducted two surveys related to consumer beliefs and buying
habits related to GF purchases. In September 2005, a survey
of 783 people was completed (and used as part of an expert presentation
during an FALCPA hearing at the FDA). In August 2006, 2,161
people responded to a similar Internet survey. Both studies
limited participation to those who had Internet access and were
included on the celiac e-mail lists where the surveys were posted.
Thus, these surveys represent only GF consumers described above
who acquire most of their GF diet information from the Internet,
support groups, and e-mail listservs. Table
1 profiles the consumers who responded to the surveys.
When asked what labels marked “gluten-free”
mean to consumers, 54% in the first survey and 58% in the second
survey said it means a product that contains no wheat, rye,
barley, oats, or products made from them, such as wheat starch.
Yet, in the later study, only 30% said they would not include
wheat starch or oats in their diet—even if they were determined
safe and met the definition standards of GF by the FDA. Part
of the reason for this discord could be a lack of understanding
about the safety of processed ingredients that could render
them GF (without the problematic proteins) or concerns about
contamination, such as in the case of oats. At the same time,
there is a desire to add oats and possibly wheat starch-based
products to the diet. These products could also improve compliance
with the GF diet by providing products that are potentially
better-tasting with better texture.
Consumers preferred (87% and 84%) the term gluten-free
to mean “zero or no detectable gluten.” This poses
questions such as:
• Do consumers truly understand that zero
gluten is unattainable and cannot be tested?
• If a standard of zero or undetectable
were set, would this cause fewer labeled GF products to be available
to consumers?
• Would it affect consumer compliance
if there were fewer products labeled GF?
• How many manufacturers would be able
to meet such a definition?
• How many specialized GF manufacturers
could meet the definition?
• How many companies would even want to
try to meet such a definition?
This is one area where consumer understanding
about how thresholds are set and the safety factors built in
is lacking. It is also an area that seems to stir a lot of emotional
involvement.
In a training meeting on allergens conducted
by the Food Allergy Research and Resource Program, one major
manufacturer indicated that during 2004, 90% of calls to their
consumer hotline dealt with gluten. This is no surprise since
many people with CD are instructed to call manufacturers when
they need to be sure a product is GF. In fact, consumers reported
that the way they determine whether a product is GF is by reading
labels (96% and 92%) and calling manufacturers (72% and 74%).
Twenty-two percent and 26% only purchased products with GF claims.
As noted, the FDA’s proposed rule for
GF labeling is voluntary. In the past several months, some manufacturers
have chosen to remove the GF label from their packaging, waiting
for the FDA to present its proposed rule. Still others have
purposefully added wheat or wheat starch to products in an effort
to avoid the issue. Consumers have said that if given the choice
between two identical products—one labeled GF and the
other not—they are extremely likely to purchase the product
labeled GF (76% and 82%, respectively). To complicate matters,
manufacturers, in an effort to be responsible, have begun using
voluntary label statements on their packaging, such as “processed
in a plant with wheat.” This type of label statement causes
confusion and mistrust with the consumer.
Consumer GF Purchasing
Decisions
Shoppers on a GF diet are not unlike others in making decisions
about what products they purchase. The two primary factors influencing
their decision to purchase are cost and taste. GF foods can
cost as much as three times more than similar wheat-based products.
However, in the year between the two surveys, cost as a factor
in decision making dropped from 93%to 64%. At the same time,
consumers looking for GF certification on the package was at
an all time high of 66%. GF certification, as administered by
the Gluten-Free Certification Organization (GFCO), provides
an extra measure of assurance about the safety of GF products
through on-site inspections and testing, as well as periodic
testing of products from consumer shelves. The standards used
by GFCO are set stricter—at 10 parts per million—than
the proposed FDA rule. GFCO has promoted the use of an indicia,
similar to those indicating “kosher” or “organic.”
Consumers are being advised to look for the
certification indicia on products. The indicia becomes even
more important as consumers start to see labels that include
wheat in the ingredient list yet indicate that the product is
GF. The FALCPA law requires that all ingredients that originate
from an allergenic food be labeled as including that allergen,
unless an exemption has been filed and approved by the FDA.
The request for exemption requires the company
filing to prove no allergenicity in the ingredient. Thus far,
only a handful of exemptions have been filed, and none have
been approved. Therefore, if an ingredient was made with the
aid of an allergenic ingredient, it must be labeled to indicate
that ingredient (eg, flavoring [wheat]), even if the finished
product could meet the proposed rule for being labeled GF. Thus,
a product that contains an allergen can also be labeled GF.
This confuses the consumer. The manufacturing
processes that would remove proteins from ingredients, such
as highly refined flavoring agents, are foreign to GF product
consumers and not easily trusted. As an example, the issue of
whether alcohol is legitimately GF has been fought for years.
Technically, no matter what grain is used to start the mash,
the distillation process removes proteins and, therefore, gluten
from the end product. But, until a company applies for an exemption,
if it originated from one of the top eight allergens, it must
indicate that. A similar situation exists with vinegar.
Consumers want to know that their money is not
wasted on products that do not taste good. Unfortunately, the
nutritional quality of GF foods has little influence over buying
decisions. Small percentages of consumers rated it as important
to their decision-making process. Fifty-one percent are more
concerned with the baking characteristics of the products and
30% care about the manufacturer’s knowledge of GF foods.
See Table 2 for how consumers
make buying decisions.
The GF market is growing both in products and
consumers. Straightforward labeling is key to consumers being
able to choose safe products. FALCPA requires labeling the top
eight allergens plainly on packages. This single act has made
a big difference for people shopping for GF items. The FDA’s
proposed rule for GF labeling should add another level of confidence
for consumers.
But the work doesn’t end there. There
is a lot of education to be done—in the food industry
and with consumers. Consumers following a GF diet have a healthy
skepticism of research and science, and they are even more distrusting
of the food industry. Helping consumers understand basic requirements
of the food industry and science of food processing is important.
Helping manufacturers understand and respect gluten sensitivity
as much as other food allergies is also critical to being able
to meet consumers’ needs.
— Cynthia Kupper, RD, CD, is the executive director of
the Gluten Intolerance Group of North America, a national organization
devoted to the education of the public and health professionals,
research, and support of people with gluten intolerance diseases.
References
1. “Rice, potato pancake good alternative
to wheat, says ARS.” FoodNavigator.com (USA). January
17, 2007. Available here.
2. “SPINS Participates in FDA Public Hearing
on Gluten-Free Labeling.” Available here.
3. Packaged Facts. Gluten-Free Foods and Beverages
in the U.S. July 1, 2006.
4. Food and Drug Administration. Proposed Rule
for Food Labeling; Gluten-Free Labeling of Foods. Docket No.
2005N-0279. Available here.
Examination
1. The following statements are true about labeling products
as gluten-free (GF):
a. It is voluntary.
b. It allows oats to be labeled GF.
c. It includes oats as a prohibitive grain.
d. It considers labeling naturally GF products as misbranding,
unless the label says all such products are GF.
e. a, b, and d
2. Which of the following are appropriate labeling
examples for allergens?
a. May contain: Wheat, Milk, Eggs
b. Contains: Wheat, Milk, Eggs
c. Processed in a plant with Wheat, Milk, Eggs
d. Semolina (wheat), milk, albumin (eggs)
e. b and d
3. GF food manufacturing:
a. outpaced sales of similar wheat-containing products.
b. is expected to continue growing rapidly.
c. is the newest niche market.
d. all of the above
4. The FDA is proposing 20 parts per million
gluten as the definition for GF labeling. They will monitor
compliance by:
a. label review.
b. testing products.
c. plant inspections.
d. any of the above
e. none of the above
5. Consumers would prefer “gluten-free”
to mean a product contains zero gluten. What are the potential
problems and ramifications of this labeling?
a. Testing methods do not measure to zero; therefore, this would
have to be defined as a value above zero.
b. Zero as a definition may reduce the number of GF products
available to consumers.
c. Studies indicate that levels at 20 parts per million are
safe for the majority of celiac consumers, and zero is therefore
an unnecessary burden for manufacturers.
d. Consumers may find that products previously labeled GF will
no longer be labeled as such.
e. All of the above
6. What are the FDA’s recommendations
regarding oats?
a. They should be included in the prohibitive grains.
b. They should be misbranded if a GF claim is made without further
explanation.
c. They should not be allowed to be labeled GF.
d. a and b
e. all of the above
7. The following are examples of voluntary labeling
and are not regulated by the FDA:
a. “This product is made in a plant which processes wheat.”
b. “May contain traces of nuts, peanuts”
c. “Gluten-free certification”
d. All of the above
e. None of the above
8. GF certification is growing in importance
to consumers.
a. True
b. False
9. Consumers make decisions about buying GF
products based on the following:
a. price
b. taste
c. fiber content
d. enrichment
e. price and taste
10. Education related to the Food Allergen Labeling
and Consumer Protection Act and the proposed ruling for GF is
needed in the following area:
a. Consumers need to know how to verify that the FDA is monitoring
plants for compliance.
b. Consumers need education on simple allergen control methods
and food processing.
c. Consumers need to teach manufacturers how to make products
GF.
d. Manufacturers need to educate consumers on trade secrets
for food processing.
e. The FDA needs to educate manufacturers on how to properly
make GF products.
