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U.S. FDA Releases a New Food Labeling Rule for Gluten-free

On August 2, 2013, the Food and Drug Administration (FDA) released a final rule to define the term “gluten-free.” FDA’s rule on the definition of “gluten-free” affects all food manufacturers that use the term on their packaging. Prior to this rule, the specific requirements for “gluten-free” labeling were undefined.

FDA’s final rule defines the term “gluten-free” to mean that the food bearing the claim does not inherently contain gluten, or does not contain:

1. An ingredient that is a gluten-containing grain;

2. An ingredient that is derived from a gluten-containing grain and that has not been processed to remove gluten;

3. An ingredient that is derived from a gluten-containing grain and 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.

FDA also requires that “any unavoidable presence of gluten in the food [be] below 20 ppm.” Food manufacturers using wheat should be careful with the term “gluten-free.” All products that contain wheat and use the term “gluten-free” will be deemed misbranded unless the labeling also clarifies that the wheat has been processed to allow the food to meet FDA requirements for “gluten-free.”

In addition, any food that bears the claim “no gluten,” “free of gluten,” or “without gluten” in its labeling and fails to meet the requirements for a “gluten-free” claim will be deemed to be misbranded. Food manufacturers selling misbranded food may be subject to penalties, fines, or be denied entry at the port.

Registrar Corp, an FDA compliance firm, assists food, beverage, or dietary supplement manufacturers comply with U.S. FDA regulations. Registrar Corp’s Label & Ingredient Review service can help food companies wishing to use the term “gluten-free” comply with FDA. For more information about food ingredients, labeling and other FDA regulations, please contact Registrar Corp 24/7 livehelp or call us at +1-757-224-0177.





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