Key Steps to Ensuring the Gluten-Free Status of Food Products

For food manufacturers, ensuring that a product meets gluten-free standards requires careful attention to the ingredients used to make the food as well as the manufacturing environment in which it is made.

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The appeal of gluten-free products extends well beyond the approximately 1 percent of the population that has celiac disease, likely playing into the general interest consumers have in eating foods that they consider healthier and the overall growing desire for ingredient disclosure and "free-from" labeling. Considering these strong trends, it is understandable that food manufacturers also have a growing interest in producing products they can confidently label gluten-free.

The potential for confusion over how to accurately define gluten-free led the FDA in 2013 to issue a rule that any product labeled “gluten-free” must contain a gluten limit of less than 20 ppm (parts per million). For food manufacturers, ensuring that a product meets this gluten-free (GF) standard requires careful attention to the ingredients used to make the food, as well as the manufacturing environment in which it is made. As with any critical process, science and best practices play an important role in advancing knowledge about safe GF food manufacturing that will ultimately lead to successful results.

Everything Starts With the Ingredients

It stands to reason that the GF integrity of a finished food product is only as good as the GF integrity of the ingredients used to make it. For a food manufacturer, that may mean inspecting the manufacturing processes of ingredient suppliers and testing ingredients to ensure that they are GF.

Understanding a supplier's processes is extremely important. In the case of flour blends, for example, it is essential to know whether a miller does an analysis on raw materials before mixing them into a proprietary blend. While studies have found that oats are safe for the majority of those with celiac disease, they can become contaminated by wheat, rye or barley during farming, processing and storage. A best practice is to operate a thorough suppler approval program, conducting on-site audits or off-site document reviews of the supplier’s CGMPs, preventive controls, grower contracts, Allergen and Gluten Control programs, certificates of analysis (COA) and other relevant information before raw materials are ever purchased.

Moreover, in the case of oats, our organization, The Gluten Intolerance Group (GIG), collaborated with leading oat processors to publish an industry agreed-upon definition and the requirements for operating under a “Purity Protocol” — a claim made by processors for the provision of gluten-free oats. Purity Protocol is a farm-to-plate method of ensuring that oats are gluten-free and have met requirements for seed stock purity as well as criteria for field preparation, planting, harvesting, transport, storage and processing.

Similar precautions may be warranted for other ingredients that are deemed higher risk. For example, back in 2015, Gluten Intolerance Group (GIG) conducted a survey of gluten levels in retail single-ingredient spices. GIG examined 25 samples of eight common spices (cumin, coriander, cloves, fenugreek, sage, thyme, white pepper and mace) from multiple suppliers. Of the samples, 32 percent had gluten levels that were confirmed by a second test method. While the reason for this contamination was unknown, GIG subsequently increased its risk level for all spice ingredients and began recommending that all manufacturers of GF foods conduct testing of spices whenever they change their supplier or when their supplier changes its sources.

Ensuring Accurate Testing Procedures

Another key component in ensuring the safety of GF ingredients and foods is ongoing verification of testing competency. As part of our audit procedures, GIG routinely recommends food manufacturers evaluate the competency of their testing staff by providing them with unknowns — samples where management knows the sample make-up but the testing staff do not — to determine if they get the right results. If they do not, the manufacturer will need to figure out why. It might be that the test kit has expired or wasn't used correctly. Verifying testing performance in this way is essential to avoid the possibility of false test results.

Ongoing Research Continues to Change Practices

Scientific studies continue to inform our decision-making about the safety of ingredients as well. For example, for a long time vinegar was thought to be unsafe for persons with celiac disease. However, we have since learned that gluten protein does not carry over through the distillation process, so vinegar is safe. Similarly, oats used to be considered unsafe, but we now know that most varieties do not contain the harmful protein sequence as wheat, rye and barley, and do not cause harm for persons with celiac disease.

Another example of the way science is advancing industry understanding is the recent study GIG performed concerning gluten-removed beer. The study used blood samples from individuals with celiac disease to see whether the proteins in gluten-free beer and gluten-removed beer were recognized by antibodies that were already present in the blood. The study found that no blood samples reacted to the gluten-free beer. However, a percentage of blood samples did react to gluten-removed beer.

Sanitizing Versus Cleaning for safety

Cleaning methods are another important consideration in ensuring safe ingredients and finished products. When implementing allergen and gluten protocols, steps that may be sufficient to sanitize may not be adequate to avoid cross-contamination. Unlike efforts to sanitize, effective cleaning requires using procedures to ensure that no gluten contaminants are present where the GF food is prepared.

Establishing Procedures Internally Versus Engaging a Third-Party

While food manufacturers have the option of setting up purely internal procedures to ensure compliance with the FDA's requirement, accomplishing this can be a complex task, particularly in facilities that do not exclusively process gluten-free products. Achieving compliance may involve implementing safeguards such as segregated production lines and areas for receiving and storing ingredients, developing procedures for proper handling and labeling of ingredients, sequencing gluten-containing and gluten-free production, determining engineering parameters for air handling systems, equipment and controls, and determining appropriate sanitation procedures, among other considerations.

Employing the expertise of a third-party gluten-free certification program holds several potential benefits for a food manufacturer. It reduces the risk of improperly designating a product as gluten-free and gives the manufacturer the credibility, recognition and support that they have provided a gluten-free product meeting or exceeding the FDA standards. Audits conducted by certification inspectors also verify that the company is guided by and meeting high standards in producing their product.

Accurate Gluten-Free Labeling Supports Consumers and Manufacturers

Gluten-free labeling provides an important benefit to consumers by giving them confidence that a product they are purchasing meets applicable gluten-free standards. This provides valuable information that consumers can use when making purchases and saves the consumer time that would otherwise be required to ascertain the gluten-free status of products from a manufacturer.

In turn, manufacturers can provide food products that are in demand by consumers while building good will and brand reputation with them by meeting their desire to know more about the food products they purchase and consume.

Cynthia Kupper is CEO of the Gluten Intolerance Group (GIG) and is a registered dietitian and expert in celiac disease management. GIG’s food safety certification programs, the Gluten-Free Certification Organization (GFCO) and Gluten-Free Food Services (GFFS), have been recognized leaders in the gluten-free community for more than 20 years. The GFCO certification logo is the symbol of trust for the gluten-free community, with more than 40,000 products certified worldwide. For more information, visit

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