In what the agency characterized as an attempt to protect the health of Americans with celiac disease, the Food and Drug Administration released a standard definition of products labeled “gluten-free.”

The new guidance also covers labels like “no gluten,” “free of gluten,” and “without gluten.” To be labeled as such, “a product must either be inherently gluten-free or 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 parts per million (ppm) or more gluten in the food. Also, any unavoidable presence of gluten in the food must be less than 20 ppm.”

“Establishing in this final rule a regulatory definition of the food labeling term ‘gluten-free’ and uniform conditions for its use in the labeling of foods is necessary to ensure that individuals with celiac disease are not misled and are provided with truthful and accurate information with respect to foods so labeled,” according to the final rule. “A 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.”

“Gluten” refers to naturally occurring proteins in wheat, rye, barley, and crossbred hybrids of these grains, the FDA explained. For the approximately 3 million Americans with celiac disease, such products trigger the production of antibodies that damage the lining of the small intestine and lead to other serious health problems like intestinal cancers, infertility, and nutritional deficiencies.

“Adherence to a gluten-free diet is the key to treating celiac disease, which can be very disruptive to everyday life,” FDA Commissioner Margaret A. Hamburg, M.D., said in a statement. “The FDA’s new ‘gluten-free’ definition will help people with this condition make food choices with confidence and allow them to better manage their health.”

The final rule comes six years after the agency first published its proposed rule in January 2007. Although the new rule takes effect in September, companies have one year to comply with the deadline of Aug. 5, 2014. The rule covers all products voluntarily labeled “gluten-free” and applies to all FDA-regulated foods, including dietary supplements. The rule also applies to restaurants and other retail food-service establishments.

To read the FDA’s new rule on gluten-free labeling, click here.

Why it matters: Although the FDA’s rule does not specifically require testing to ensure the accuracy of a “gluten-free” label, the agency noted that “manufacturers are responsible for ensuring that foods bearing a gluten-free claim meet the requirements of the final rule.” To achieve compliance, the agency suggested that manufacturers use quality-control tools like employing a third-party laboratory to conduct in-house gluten testing or requesting certificates of gluten analysis from ingredient suppliers. The FDA also reminded companies that it plans to “use the full range of its routine post-market monitoring activities to enforce the final rule,” including “periodic inspections of food manufacturing facilities, food label reviews, follow-up on consumer and industry complaints reported to the agency, and when needed, gluten analyses of food samples.”