What the FDA Has to Say About Gluten-Free Labeling
Gluten—a storage protein found in grains including wheat, rye, barley, and their hybrids—can trigger an immune reaction in the small intestine in some individuals. To help address this condition, known as celiac disease, the FDA created rules around gluten-free food labeling. According to the FDA, celiac disease affects an estimated three million people in the US and can put individuals at risk of serious health issues, including nutritional deficiency, osteoporosis, infertility, and cancers of the intestine.
Gluten-free food labeling benefits people who live with celiac disease, along with those who experience any intolerances, allergies, or sensitivities related to gluten containing foods. Effective labeling lets people with these conditions choose foods that won't cause discomfort or health complications, allowing them to live healthier lives.
FDA's 2013 Guidance on Labeling Certain Foods "Gluten-Free"
In food science, we know gluten has various uses. It is essential in many baked products and helps determine the quality of dough used in cakes, bread, pasta, crackers, and other items. Gluten is heat stable and acts as a binding and extending agent commonly used as an additive in processed foods to improve texture, moisture, and flavor. (Biesiekierski et al., 2017)
Often, gluten can be found in products ranging from thickened soups and gravies, soy sauce, salad dressing, cosmetics, candy, and seasonings. Obtaining gluten-free foods is necessary for those living with celiac disease and other gluten allergic populations. By establishing a definition of gluten-free, the FDA has created safe and truthful food labeling regulations for consumers.
The FDA guide for gluten-free labeling shares, importantly, that we in the food industry are not required to label foods as gluten-free. However, for the benefit of consumers, we can voluntarily label products as gluten-free. When we do so, our products must conform to the FDA's definition of gluten-free.
In 2013, the FDA issued its final rule, published in the Federal Register, which defines gluten-free. To be labeled a gluten-free product or gluten-free food, it must:
- Be inherently gluten-free, such as raw carrots
- Not contain a gluten-containing grain
- Not contain an ingredient that is derived from a gluten-containing grain
- Not contain more than 20 parts per million (ppm) of gluten in ingredients that have been processed to remove gluten, such as wheat starch
- Contain less than 20 ppm of gluten for any unavoidable presence, such as during processing in a gluten-containing grain facility
In a conversation with food experts, the FDA discussed the impact gluten-free labeling had in the three years following the creation of the rule. The agency said that we in the food industry did an exceptional job, allowing consumers to feel more confident in purchasing gluten-free products while helping people make informed decisions about what they're eating. Manufacturers are producing more gluten-free foods. This is directly aided by the FDA providing clear guidelines that spell out exactly what is required for gluten-free food labeling.
FDA's Guidance on Gluten-Free Labeling for Hydrolyzed or Fermented Food
In 2020, the FDA updated its requirements regarding gluten-free labeling for hydrolyzed or fermented foods. This is another step to ensure that those living with celiac disease receive truthful and accurate information when purchasing and consuming gluten-free products.
However, in the case of hydrolyzed and fermented foods, the FDA has no scientifically valid method of detecting and quantifying gluten protein content. For manufacturers using gluten-free food labeling, this means retaining records that assure that any ingredients used before fermentation or hydrolysis are gluten-free. Once the FDA has a scientifically valid method for determining the gluten content of hydrolyzed and fermented foods, it will no longer be necessary for manufacturers to retain these records.
What Does the FDA's Gluten-Free Food Guidance Mean for Food Companies?
The FDA's final rule, which defined gluten-free for food labeling on August 2, 2013, still applies to many products. In 2020, the FDA issued an updated final rule to include hydrolyzed and fermented foods.
Food processors and producers need to be aware of both rules and apply the correct requirements to their product sets. The FDA created the Guidance for Industry Gluten-Free Labeling of Foods Guide to help with voluntary gluten-free food labeling compliance. In addition to providing other helpful guidance, this guide discusses food testing requirements. Effective measures may include testing gluten content, requesting certificates of gluten analysis from ingredient suppliers, and/or participating in third-party gluten-free certification programs.
Effective Testing for Gluten-Free Food Labeling
Did you know the presence of food allergenic proteins is one of the main reasons for recalls costing companies millions of dollars annually? Be sure you have not only a rigorous supplier verification plan, but also a robust environmental monitoring and sanitation plan as well.
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