On August 5, 2014, the FDA’s “gluten-free” labeling of foods will go into effect.
This is a voluntary label for manufacturers who wish to make a “gluten-free” claim for their products. These products must contain less than 20 ppm of gluten (equivalent 20 mg gluten/1 kg). The gluten-free claim can also be used for products that characteristically do not contain gluten. The FDA has made available a “Guidance for Industry” document on labeling which can be found here.
Although the FDA will not require manufacturers to test for the presence of gluten it will hold them responsible for complying with the rules. If the FDA finds any foods that are labeled “gluten-free” but are not complying with the rules they will consider them misbranded.
Because wheat is a widespread ingredient in the food industry, it is crucial that manufacturers trace the ingredients that will be used in gluten-free products. Another important area to focus on is preventing cross-contamination during manufacturing when equipment and/or facilities are used for both gluten-free and gluten containing products. For manufacturers that wish to ensure that they are in compliance with the new regulations, developing a traceability system is essential.
The FDA encourages manufacturers to request certificates of gluten analysis from ingredient suppliers and also to test these ingredients, whether in-house or through an external laboratory. There are a number of detection methods available for determining the presence of gluten. Among these methods the most common and specific one is an ELISA test (enzyme-linked immunosorbent assay).
Other methods include testing for the presence of proteins in the sample or DNA (PCR- polymerase chain reaction). ATP swab tests can be used to test for general food safety and cleanliness of surfaces. A thorough description of testing methods is provided by the Institute of Food Technologists here. The FDA has prepared a useful Q&A document regarding the guidelines for gluten-free labeling, which can be found here.
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Dr. Claudia Fajardo-Lira is a Professor in Food Science within the Nutrition, Dietetics and Food Science option and is Executive Director of the Marilyn Magaram Center for Food Science, Nutrition and Dietetics at California State University, Northridge. She is a member of the Food Science Communicators Committee for the Institute of Food Technologists and served on the Executive Committee for the Southern California Section of the Institute.
In the “Traceability and Beyond” blog series, Dr. Fajardo-Lira will bring us news about the latest in Food Safety issues and trends, with a focus on improving quality and appropriate standards in industry.