The compliance date was established in the final rule one year ago to allow the food industry sufficient time to make changes needed in the formulation or labeling of their foods that voluntarily bear a gluten-free claim in the United States. The final rule provides a uniform standard definition to help consumers with celiac disease manage a gluten-free diet.
Gluten-free foods must contain less than 20 parts per million (ppm) gluten. Foods may be labeled “gluten-free” if they are inherently gluten free; or do not contain an ingredient that is: 1) a gluten-containing grain (e.g., spelt wheat); 2) derived from a gluten-containing grain that has not been processed to remove gluten (e.g., wheat flour); or 3) derived from a gluten-containing grain that has been processed to remove gluten (e.g., wheat starch), if the use of that ingredient results in the presence of 20 ppm or more gluten in the food.
On June 25, 2014, the FDA issued a guide for small food businesses to help them comply with the final rule’s requirements. Outreach will be conducted to assist the industry, as needed, to ensure that the provisions of the rule are fully understood. In addition, the FDA will use its existing compliance and enforcement tools, such as inspection, laboratory analysis, warning letters, seizure, and injunction, to ensure that the use of the claim on food packages complies with the definition.
While the rule only applies to packaged foods, given the public health significance of gluten-free labeling, the FDA urges restaurants and other establishments making a gluten-free claim on their menus to be consistent with agency’s definition.
As of Aug. 5, all foods labeled gluten-free must meet all requirements of the U.S. Food and Drug Administration’s (FDA) gluten-free labeling final rule published in August 2013. The requirements apply to packaged foods labeled on or after Aug. 5, 2014.