The proverbial saying, ‘one man’s meat is another man’s poison,’ provides an apt description of the role of gluten in our diet. Gluten is a protein in cereal grains, but its presence in food products can cause serious health problems in those afflicted with celiac disease or non-celiac gluten sensitivity (NCGS).  Consumer confidence in the accuracy of “gluten-free” food labels is the backbone of a multi-billion dollar market developed around a food safety issue as well as a nutrition fad. 

Due to the potential health implications of gluten, the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) mandated a consistent standard for “gluten-free” food labeling claims. The Food and Drug Administration (FDA) issued a final rule for the use of gluten-free labeling claims in 2013, and the agency recently finalized a new rule establishing the requirements for gluten-free labels on hydrolyzed and fermented foods.

Food companies should be aware of FDA post-marketing monitoring activities such as sampling and food label reviews that evaluate compliance with the gluten-free labeling regulation. Gluten testing and compliance with a gluten-free certification program are recommended for any business planning to comply with the U.S. regulatory criteria for using gluten-free labeling claims.

Reasons to Avoid Gluten 

Gluten is a protein in cereal grains, particularly wheat, rye, and barley.  Gliadin, a component of gluten, cannot be digested by certain individuals who are predisposed to have an immunological response to the protein.  For consumers afflicted with celiac disease or NCGS, the avoidance of gluten through a strict gluten-free diet is the only mitigation method.

In the case of celiac disease, the consumption of gluten can cause an immune response leading to the destruction of the lining of the small intestine and eventually more serious medical complications.  Celiac disease is commonly undiagnosed or misdiagnosed since the clinical features of the disease mimic various gastrointestinal problems and the symptoms can vary widely among individuals. 

Non-celiac gluten sensitivity refers to a condition in which individuals experience an adverse reaction to gluten yet fail to meet the medical criteria for celiac disease or wheat allergy.  Gluten sensitivity is assumed to be a commonly self-diagnosed condition, which has fueled the growing demand for gluten-free food products.  

While celiac disease impacts roughly 1% of the American population, market surveys have suggested 20-44% of consumers purchase gluten-free foods for reasons other than gluten intolerance or sensitivity.

Labeling Rules for “Gluten-Free”

In 2013, the FDA issued a final rule for gluten-free labeling claims, which defined a ‘gluten-containing grain’ as any one of the following grains:  wheat, rye, barley, and crossbred hybrids of wheat, rye, or barley (e.g. triticale).  The regulation for voluntary gluten-free labeling claims requires that food products do not contain any of the following:

  • an ingredient that is a gluten-containing grain;
  • an ingredient that is derived from a gluten-containing grain that has not been processed to remove gluten;
  • an ingredient that is derived from a gluten-containing grain that has been processed to remove gluten, if the use of that ingredient results in the presence of 20 parts per  million (ppm) or more gluten in the food; or
  • 20 ppm or more gluten in the food.

In August, the FDA finalized a long-awaited rule to expand the compliance requirements for “gluten-free” claims on fermented and hydrolyzed foods, or foods that contain fermented or hydrolyzed ingredients.

The gluten proteins in hydrolyzed and fermented foods are no longer intact, which makes it difficult to quantify the gluten protein content.  According to the FDA, “no scientifically valid analytical method is effective in detecting and quantifying with precision the gluten protein content in fermented or hydrolyzed foods in terms of equivalent amounts of intact gluten.” Under the new rule, food manufacturers planning to use the voluntary labeling claim must verify the gluten-free status of food prior to fermentation or hydrolysis.

Fermented or hydrolyzed foods can include foods such as cheese, yogurt, vinegar, sauerkraut, pickles, green olives, beers, and wine, or hydrolyzed plant proteins used to improve flavor or texture in processed foods such as soups, sauces, and seasonings.

Ensuring ‘Gluten-Free’ Foods

Any company seeking to enter the gluten-free market should consider the implementation of a testing program as well as certification to an international standard for gluten-free manufacturing.

Validated methods are recommended for testing raw materials, final products and products during processing to ensure the 20 ppm gluten threshold is not exceeded.  During processing, gluten proteins may be broken down into smaller parts that are undetected by some test methods.  Additionally, manufacturers should consider the natural variations of gluten content in their product formulation.  Beyond product testing, swab testing of equipment contact surfaces is highly recommended to evaluate the risk of cross-contact due to the presence of gluten on the same line before sanitation or within a facility due to migration through dust or other transfer.

The implementation of a gluten-free certification program is an industry best practice for food manufacturers and brand owners committed to producing gluten-free products.

The BRCGS Gluten-Free Certification Program (GFCP) is a voluntary, systems-based program involving the implementation of risk-based and preventative gluten-free controls combined with a globally recognized food safety management system.  The GFCP certification process involves a comprehensive evaluation of everything from ingredient sourcing to employee training.  

The GFCP certification program and trademark logo are endorsed by North America’s leading celiac organizations, Beyond Celiac and the Canadian Celiac Association. Moreover, the program complements GFSI-benchmarked food safety standards, and will build consumer trust in gluten-free product claims.

Certification of a manufacturing facility and its gluten management system is contingent upon an annual third-party audit conducted by an approved ISO 17021 accredited certification body using certified GFSI food safety auditors. The BRCGC standard has established stringent requirements for the qualifications, training and experience of auditors approved for conducting GFCP audits. All testing for gluten must be conducted by an ISO 17025 accredited laboratory and the gluten test method should be validated for the food or ingredient matrix prior to testing.


Mérieux NutriSciences offers auditing to support compliance with the BRCGS gluten-free certification program.   We offer a range of audit services to provide an impartial and independent assessment of your food safety and quality programs. Our consultants can assist manufacturers and distributors with the development and enhancement of food safety programs to prepare for certification against one of the GFSI benchmarked schemes.

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