In decades past, gluten-free foods were found primarily in health food stores. Now, however, gluten-free products line the shelves of every major food retailer, with many restaurants and other eateries offering gluten-free menu options as well. What has spurred the shift towards the gluten-free movement?

In part, the surge of gluten-free products has been an effort to accommodate individuals with Celiac disease, an autoimmune disorder which leaves its sufferers intolerant to the protein in even the smallest amounts. For those affected with it, gluten causes an immune response which damages intestinal lining and disrupts the absorption of key nutrients. In Celiac disease patients, consuming gluten can also lead to other serious health issues, including osteoporosis, infertility, nerve damage, and seizures. Because its symptoms also mimic many other medical conditions, diagnosing Celiac disease can be a years-long process. Oftentimes, eliminating gluten from the diet is one of the first methods of testing for a potential intolerance or sensitivity. For individuals who are avoiding gluten for health or preferential reasons, the food industry has responded by expanding its offerings of gluten-free products.

Yet, either becoming an entirely gluten-free facility or labeling certain products as gluten-free can pose many challenges. To ensure regulatory compliance, maintain brand credibility, and ensure no consumers come into contact with food that could put them at risk, food companies offering gluten-free products must take rigorous steps to develop an effective management scheme.

strategies for successful gluten-free management


The Food Industry’s Gluten-Free Movement: A Brief Background

In 2013, the FDA released its final rule defining gluten-free for food labeling. While gluten-free remains a voluntary claim that manufacturers can include on labels, the FDA has specific requirements determining what the claim actually means. Manufacturers are also responsible for presenting the claim in a way that is accurate and not misleading.

Under both the FDA and Canadian Food Inspection Agency (CFIA), any foods declared gluten-free must contain less than 20 parts per million (ppm) of gluten. This parameter was established by CODEX, the international authority on allergens, and determined to be safe for the majority of individuals with Celiac disease. Besides containing less than 20 ppm of gluten, the FDA permits the labeling of a food as gluten-free if it does not contain: wheat, rye, barley, or crossbreeds of these grains; an ingredient derived from these grains that has not been processed to remove gluten; or, an ingredient derived from these grains that has been processed to remove gluten but still contains more than 20 ppm of gluten.

The major difference among food sold in the U.S. and Canada, however, lies in the fact that food sold in Canada is deemed by the CFIA to be gluten-free if it is not called out on the label. The FDA’s Food Allergen Labeling and Consumer Protection Act of 2004 does not regulate the labeling of gluten, but it does include wheat among the eight allergens identified by the law.


Marketplace Demand

With an estimated one percent of the population suffering from Celiac disease, food manufacturing professionals may wonder whether there is a true marketplace demand for the production of gluten-free food. While offering gluten-free products helps to ensure the estimated 3 million Celiac disease sufferers in the U.S. have access to a variety of affordable and safe food choices, it also caters to the additional members of the population who actively avoid gluten.

Approximately 90 million Americans and 9 million Canadians maintain a gluten-free diet. An estimated 6% of the population has a gluten sensitivity, which also requires them to avoid gluten to prevent or minimize adverse health effects caused by diet. Another 22% avoid gluten voluntarily. In total, it is estimated that over half the North American population regularly purchases gluten-free products.

Many food manufacturers have caught on to this growing need for more gluten-free choices. Findings from a 2018 SafetyChain poll revealed that more than two-thirds of respondents (69%) currently offer gluten-free products. Indeed, the high demand makes going gluten-free a compelling option for many food manufacturers: while the gluten-free food market was valued at an $10.5 billion in 2013, sales from gluten-free and free-from gluten foods are projected to hit $23.9 billion by 2020 in the U.S. alone (

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What Do Gluten-Free Regulations Mean for the Food Industry?

Allergens continue to be the number one cause for recalls, and effective allergen management is an ongoing challenge in food manufacturing environments due to the many different types of food processes that take place. While gluten itself is limited in terms of the number of recalls it has caused, when combined with wheat (which also is encompassed by gluten-free recalls), it accounts for roughly 18% of recalls in Canada, with similar figures throughout the U.S. and other developed nations.

To ensure integrity and compliance with gluten-free specifications, a gluten-free management program must be developed and implemented throughout the supply chain. Effective management of a gluten-free program should encompass Hazard Analysis and Critical Control Points (HACCP)-based methodologies. At the most basic level, this includes the identification, prevention and control, and declaration of gluten. We will review detailed steps for creating a robust gluten management program in an upcoming section.


Considerations for Mitigation

Whether moving towards becoming a completely gluten-free facility or preparing for gluten-free labeling on a specific product or product line, food companies can take steps to mitigate the risks associated with gluten in their facilities.

  • Reexamine Relationships with Suppliers

One preliminary step food companies can take is to reassess vendor management. Consider supplier history and performance in the areas of audits, quality, safety, and testing to determine whether continuing to do business with a particular supplier will help or hinder successful gluten-free management.

  • Become Knowledgeable on Products

In order to determine a facility’s risk factors, it is necessary to first develop an in-depth understanding of where gluten may be found in its products or ingredients.

Gluten proteins are commonly found in bread, cereal, pasta, cakes, and many other foods containing barley, rye, wheat, kamut, spelt, or triticale. Gluten is also defined as any modified gluten protein or protein fraction derived from any of the aforementioned grains.

  • Obtain Certification

Completing a gluten-free certification program can help companies develop a clear and effective gluten management program and reduce risks. Certification from a reputable gluten-free program can also aid in building trust and loyalty among customers seeking gluten-free products, and it can also help products go to market effectively by supporting brand credibility.


How to Create an Effective Gluten-Free Management Program

Because gluten can be characterized as an allergen for individuals with Celiac disease, a gluten management program very closely resembles an allergen control SOP. While programs will need to be tailored to fit the precise processes and supply chain practices from one facility to the next, the following framework can be used for establishing a baseline for proactive gluten-free management.


1    Identify Risks

A thorough risk assessment is the first step in any comprehensive gluten control management system. Risks should be assessed across every facet of your supply chain, as well as your internal operations. From receiving to packaging and shipment, identify the ingredients, processing aids, and products that contain or do not contain gluten, noting all paths of gluten in your facility. Assess key points including receiving, storage, mixing and processing, and labeling. Facilities processing gluten will need to identify risks for cross-contamination, mislabeling, and any other potential issues that could arise.


2    Develop Controls

Once risks have been identified, the next step is to put controls in place for mitigating these risks. The greatest risks call for the most rigorous planning. To reduce the potential of undeclared gluten, the following tactics should be put in place: supplier and ingredient control, controlled onsite food storage, segregating processing and/or handling of products or ingredients, specified equipment selection and use, and control of labels and packaging. For certified companies, audits are also an effective means of ensuring controls are being developed and implemented properly.


3    Train Employees

Once a gluten control program has been developed, personnel must be properly trained on every aspect. Although cross-contamination is a central area of focus on which employees must be trained, sanitization processes and rework procedures must also be addressed thoroughly. Educating employees on the risks associated with gluten contamination should also be a pillar of every training program.


4    Perform Continuous Monitoring

Lastly, food manufacturers and processors must develop methods for routinely monitoring the effectiveness of their gluten control procedures. This includes determining the frequency with which allergen control efforts should be analyzed, as well as the metrics which will be used to gauge performance. Upgrading to an automated food safety platform can help monitor performance using real-time analytics, which brings us to our next section.

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How Technology Fits into Gluten-Free Management

Managing a gluten-free program alongside other regulatory and customer requirements can be challenging and complex. Yet, the safety of your consumers and the integrity of your brand depend on the effectiveness of your gluten-free management program. It is therefore essential to ensure your program requirements are being met daily – a demanding task in an environment with multifarious products, ingredients, and processes.

To support compliance with their gluten-free programs, reduce errors, and eliminate inefficiencies, food manufacturers are increasingly turning towards food safety management systems. This technology supports the various activities surrounding food safety, including gluten-free management. Explore the benefits and considerations for choosing a solution to fit your facility’s needs below.


Complete Program Management

Modern food safety technology includes features such as mobile forms, automated task scheduling, corrective actions, and notifications to facilitate comprehensive gluten-free management. These tools allow you to instantly update all of your associated documentation, records, programs, and tasks with real-time data for time savings and increased visibility. Up-to-the-moment analytics provide food safety personnel the ability to closely monitor performance against compliance standards. In addition to gluten-free programs, these tools can also support regulatory, customer, and other non-regulatory compliance efforts, giving your facility a well-rounded system for managing the full scope of your food safety and quality programs.


Recall Prevention/Mitigation

With many tasks and procedures to manage, certain elements of your food safety program could be at risk of falling through the cracks. Food safety technology unlocks the potential of the food safety data from your plant floor by providing you with instant visibility into operations, allowing you to ensure all program requirements – including those of your gluten-free management plan – are being met consistently.


Visibility into Nonconformances

Mobile forms don’t just eliminate tedious data entry tasks; they also empower your food safety teams to catch and manage any nonconformances promptly – before they escalate. The intelligent system can trigger alerts for any instance in which data does not meet program requirements, allowing personnel to step in and address a nonconformance at the earliest possible stage to minimize its potential impact.


Supplier Programs & Vendor Management

With a centralized system for all program data, food companies can simplify supplier compliance and ensure inbound information and data align with their facility’s program requirements. Additionally, vendor management tools such as partner portals make it easy to complete key tasks, such as tracking letters of guarantee from suppliers. Mobile apps and analytics also streamline verification of supplier shipments to prevent use of noncompliant ingredients, then provide key insights into performance to ensure vendors are consistently satisfying program requirements.


Audit Preparedness

Food safety technology provides the infrastructure needed to organize the full spectrum of food safety data in one easily accessible location, enabling 24/7 preparedness for audits and inquiries. All documents and program data, including monitoring, direct observation records, CAPAs, and more are time- and date-stamped, which makes preparing for an audit as simple as logging in.

From receiving to finished product review, audit automation tools can capture and store all of your food safety data in a secure portal for on-demand audits to satisfy compliance requirements for your gluten-free certification or any other non-regulatory, regulatory, or customer requirements. Additionally, on-demand and internal audits allow you to simulate an inspection, thereby ensuring any gaps in your program are addressed in advance.


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