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.

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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.