As of Aug. 5, all foods labeled gluten-free must meet all requirements of the gluten-free labeling final rule published in August 2013.

The requirements apply to packaged foods labeled on or after Aug. 5. FDA recognizes that many foods currently labeled as gluten-free may already meet the new federal definition.  However, consumers should be aware that there may be some products still on store shelves that were produced and labeled before the compliance date for FDA’s rule.

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.  FDA will continue to work with, educate and monitor industry on the use of the gluten-free claim.

Outreach will be conducted to assist the industry, as needed, to ensure that the provisions of the rule are fully understood.  In addition, 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.

FDA recognizes that people with celiac disease are also interested in being able to identify gluten free foods served in restaurants and other retail establishments that serve prepared foods to customers. The gluten-free final rule applies to packaged foods, which may be sold in some retail and food-service establishments such as some carry-out restaurants. Given the public health significance of “gluten-free” labeling, FDA says that restaurants and other establishments making a gluten-free claim on their menus should be consistent with FDA’s definition.  State and local governments play an important role in oversight of these establishments.

FDA said it looks forward to working with the states, the restaurant industry and other stakeholders to support education and outreach on the appropriate use of the term gluten-free.