CFSAN Constituent Update - FDA Sampling Finds High Level of Compliance with Gluten-Free Standards

Center for Food Safety and Applied Nutrition

Constituent Update

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FDA Sampling Finds High Level of Compliance with Gluten-Free Standards

May 30, 2017

More than 99.5 percent of sampled food products labeled “gluten-free” are in compliance with FDA’s requirement that such foods have less than 20 ppm (parts per million) of gluten.

This is the finding of an FDA sampling assignment in which 702 samples from more than 250 products labeled “gluten free” were collected and analyzed. Only one of those products was found to not comply with one of the major FDA requirements that went into effect in August 2014 for manufacturers using the term “gluten-free” on their labeling. This product was recalled and subsequent sampling by the FDA did not find levels of gluten that violated the regulation.

FDA set standards for gluten-free labeling to give consumers with celiac disease confidence about what the term “gluten-free” means on foods that carry this label. May is Celiac Awareness Month. People with this disease are at risk of very serious health problems if they eat gluten, found in breads, cakes, cereals, pasta and many other foods containing wheat and related grains. The sampling was undertaken from July 2015 to August 2016 to gauge the level of compliance with one of the major requirements of the gluten-free labeling rule.

For More Information

• Gluten-Free Food Product Surveillance Sampling
• Gluten-Free Labeling of Foods
• Food Facts: Gluten and Food Labeling: FDA’s Regulation of “Gluten-Free” Claims
• Questions and Answers: Gluten-Free Food Labeling Final Rule

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Additional Updates from the FDA Center for Food Safety and Applied Nutrition