A golf instructor once told me that to play consistent golf, I needed to focus on the process first, not the result. For a novice golfer, this was the perfect time to hear this tidbit of wisdom. It is also representative of my life as a parent of a son with severe, multiple food allergies. The process of raising him with dietary restrictions involves diligence, awareness, research, teamwork and incredible trust in the food industry. The result is a healthier life.

Understanding Consumers with Allergies    
Gluten-free food sales in the U.S. have already reached $2.6 billion and, according to a survey by Packaged Facts, the gluten-free market “will exceed $5 billion by 2015.”[1] The global food allergy and intolerance products market is expected to surpass $26.5 billion by 2017, according to a report released by Global Industry Analysts Inc.[2] The growth projections underscore the need for attention to providing quality safe food products to consumers with food allergies or intolerances.

Consumers who must avoid specific foods become very informed shoppers. This is a population of parents, teens and children who learn to be allergen, gluten or food enzyme detectives. Their shopping behavior includes reading labels each and every time before purchase, speaking with customer service representatives about shared lines, processing schedules and cross-contamination and enlisting help from others who have similar dietary needs regarding the safety of a food product. This global com-munity of consumers is well connected to each other through social media. They are a vast group who support, commiserate with and follow each other. When an allergic reaction or illness occurs due to undeclared allergens or gluten, the news often spreads like a virus. The offending brand becomes a villain that is ostracized from an entire community.

According to the U.S. Centers for Disease Control and Prevention, the number of Americans with food allergies, celiac disease and other food-related intolerances has steadily risen over a short period of time. The following statistics illustrate how prevalently these diseases affect the U.S. population:
• From 2004 to 2006, there were approximately 9,500 hospital discharges per year with a diagnosis related to food allergy among children under age 18.[3]
• The American Academy of Allergy, Asthma and Immunology reports that “it is estimated that the number of cases of anaphylaxis from foods in the U.S. increased from 21,000 per year in 1999 to 51,000 per year in 2008, based on long-term population studies of anaphylaxis from the Mayo Clinic in Minnesota.”[4]
• More than 2 million people in the United States have celiac disease.[5]
• Gluten-reactive patients account for roughly 10 percent of the general population.[6]

Clearly, these statistics suggest a consumer market that requires food that does not make them sick or die when ingested. Absolutely no contamination by allergens or gluten is their foremost criteria for safe consumption.

Accommodating Food Sensitivities
The increase in food-related disease is widely responsible for the rise in consumer demand for safer food products in the U.S. With the enactment of the Food Safety Modernization Act (FSMA), the food industry is receiving rapt attention by, in part, implementing more stringent regulations and more thorough inspections, particularly at the food processing stage. What is not on par with this hefty legislation is the quality assurance that food is not contaminated by allergens or gluten along the entire supply chain. This assurance is especially inconsistent at the growing, harvesting, storing and transport stages with various allergens, such as grains, soy and corn. 

Today, there is heightened awareness and improved sanitization control during manufacturing through Hazard Analysis and Critical Control Points systems that are implemented properly. In addition, many large manufacturers have been leading the pack in quality control of allergen and gluten contamination. Midsize and smaller manufacturers have not been found to be consistent in reducing exposure to allergens and gluten in a variety of ways, according to the U.S. Department of Health and Human Services in their report on labeling practices.7 In recent findings during a case study of the cookie industry, Steven Atkins and Marcia Hagen reported, “poor training accounts for the most frequent human error with adding wrong ingredients.”[8

Evolving from FSMA is a requirement for manufacturers to have an allergen-control plan. The framework of this plan supports the development of an internal process for detecting and preventing cross-contamination by allergens or gluten. According to Steven Taylor, Ph.D., at the University of Nebraska Food Allergy Research and Resource Program, the use of the allergen-control plan developed at the university in larger manufacturing companies is a “mainstream practice.” The use of enzyme-linked immunosorbent assay testing for detection of allergens and gluten is also part of this framework, as is the need for manufacturers to know whether an ingredient or raw material has been contaminated so labeling can be accurate.

Reporting of Allergen and Gluten Contamination: The Reality
The story here begins at the production site where food is harvested and continues with storage, transportation and processing. The law that requires labeling of the top eight most common allergens, the Food Allergen Labeling and Consumer Protection Act (FALCPA), excludes raw agricultural commodities (FALCPA section 203). In 2006, after FALCPA went into effect, a report was released by the secretary of the Department of Health and Human Services that indicated “when receiving raw materials for products, 55% of the facilities that used allergenic food as ingredients identified ingredients as allergens or segregated these ingredients, or both. Smaller facilities were less likely than larger facilities to identify or segregate allergenic ingredients.”[7] As a result, consumers who rely on accurate labeling and product disclaimers to make informed decisions about the safety of a product are driven to lobby for new regulations that require better standards for reporting, identifying and segregating allergens and gluten at every level of food production and distribution.

The Use of Disclaimers: Why Is It Voluntary?
The use of disclaimers on packaging is voluntary. Even with a disclaimer, the consumer oftentimes is unsure about the safety of the product. This is a valid concern. Recall events due to undeclared allergens have multiplied since FALCPA went into effect, validating this concern. A recent report by Stericycle found “undeclared allergens or other allergen concerns remained the primary cause of recalls during the fourth quarter, accounting for more than one third of food recalls initiated in the quarter.”[9] This report continues, stating, “Recalls due to undeclared allergens reached a new high in the fourth quarter, surpassing levels recorded in at least five quarters.” A continued increase in the number of allergen-related recalls may intensify pressure on the industry to make disclaimers mandatory.

Recalls Damage Brand Integrity
Recalls are an expensive testament to the need for better control of allergen and gluten exposure as well as for better reporting of contamination. Once a recall is publicized, the community of those with food allergies and gluten intolerances chat about it on social media engines worldwide. With the use of social media, bad information spreads quickly and has a long residual effect. Information about recalls remains constant on a variety of websites; yet, how the manufacturer corrects the problem remains a mystery to the public. The fear of illness or death from potential consumption and lack of information about correcting the problem degrades the reputation of the brand. The consequence is that brand integrity declines, carrying with it decreased loyalty and less demand. Under these circumstances, it is difficult for a manufacturer to improve the integrity of the brand and climb out of debt. As a case in point, 5 or 6 years ago, a story about an allergic reaction after someone ate a Snyder’s pretzel was told via an online food allergy support group. The pretzel apparently had peanut contamination. The group had a large following throughout the U.S., and the many parents who heard this story avoided the entire product line. This story has continued to affect the purchasing behavior of many families. The good news is that the packaging now states the possibility of cross-contamination with peanuts. This sole statement may prevent another child or adult from possible peanut exposure.

What Do Consumers Want?
Consumers want to be safe from exposure to any food that may cause illness or death. Communication is a less costly method of informing the consumer of inherent risk. The consumer also wants knowledge about how a problem was solved and whether management is following an allergen-control plan. With these communication tools in place, the consumer can make a conscious decision whether a particular food is safe for consumption.

What Are the Trends in this Emergent Market?
The demand for variety, quality assurance, accurate labeling and improved taste are ever present in this emergent market. A survey by Allergy Free Passport, a global health-consulting firm, of consumer trends in the gluten- and allergen-free marketplace suggests the need for expanded training, better taste and a wider selection of products.[10]

Here are two examples of successful product development with allergen and gluten controls in place:
1. ConAgra Mills, a large miller in the U.S., contracts with a dedicated facility to mill gluten-free flour.
2. Canyon Bakehouse (Loveland, CO) has grown exponentially with sales of gluten- and allergen-free breads and muffins. This company uses a dedicated facility and provides the consumer with necessary information about allergen and gluten exposure on both the label and the website.

How Can Food Manufacturers Benefit from Consistent Reporting and Allergen Control?
Food manufacturers want to maintain the quality and integrity of their brand. Typical media advertisements do not persuade this unique customer population to purchase products; instead, they look at the reputation of the safety of a product, confer with other consumers like themselves, consider the allergenic and gluten properties of the brand’s product line and assess whether Good Manufacturing Practices (GMPs) and an allergen-control plan have been implemented correctly. They want to be assured that the manufacturing facility has employed these practices and that any possibility of cross-contamination at every stage has been disclosed. The result is favorable word of mouth and word-on-the-web advertising with a projected reach of millions of people. 

What Are the Next Steps?
Due to the voluntary nature of disclosure, the next steps by the consumer may be the following:
1. Lobbying for additional regulations for strict allergen and gluten reporting
2. Lobbying to ensure appropriate allergen-control plans are in place throughout the supply chain
This unique consumer base requires these changes for their end result, that is, good health. 

Manufacturers have the opportunity to voluntarily monitor and improve their method of detecting and reporting allergens and gluten prior to any newly introduced legislation. The technology is available for these processes to be better than the current standard. It is completely appropriate to require suppliers of raw ingredients to disclose allergen and gluten exposure, implement an allergen-control plan, provide accurate disclosure on food labels and regularly train their employees to uphold GMPs. Companies using this process can benefit from the resulting increased demand, consumer loyalty and long-term growth.

Julie Trone is founder and CEO of Allergy Free Table LLC, a company that provides both free and affordable resources for families, educators and caregivers who manage food allergies. Over the last decade, her philanthropic work has spanned food allergy safety, advocacy, education, family support and promoting wellness. She is currently working on two pocket guides: Food Allergies & Grandchildren: Pocket Guide for Grandparents and Food Allergies & Camps: Pocket Guide for Camp Leaders, Scout Leaders, and Staff.

1. www.packagedfacts.com.
2. www.strategyr.com/Food_Allergy_and_Intolerance_Products_Market_Report.asp.
3. www.cdc.gov/nchs/data/databriefs/db10.pdf.
4. www.aaaai.org/about-the-aaaai/newsroom/allergy-statistics.aspx.
5. digestive.niddk.nih.gov/ddiseases/pubs/celiac/#common.
6. www.biomedcentral.com/1741-7015/9/23.
7. Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition, Food Allergen Labeling and Consumer Protection Act of 2004, Public law 108-282, Report to the Committee on Health, Education, Labor, and Pensions, United States Senate and The Committee on Energy and Commerce, United States House of Representatives, July 2006.
8. Atkins, S. and M. Hagen. 2012. An integrated approach to food quality and safety: A case study in the cookie industry. Food Safety Magazine 2:46–54.
9. www.expertrecall.com/wp-content/uploads/Quarter-Four-ExpertRECALL-Index.pdf.
10. www.slideshare.net/KimKoeller/what-gluten-and-allergy-free-consumers-want-global-market-research-executive-summary.