(21 CFR 101.91 Gluten free labeling of food - final rule)

FDA allows manufacturers to label a food "gluten-free" if the food does not contain any of the following:

  • an ingredient that is a gluten-containing grain (wheat, barley, rye or cross-breeds of these grains)
  • an ingredient that is derived from these grains and that has not been processed to remove gluten (e.g. wheat flour)
  • an ingredient that is derived from these grains and that has been processed to remove gluten (e.g. wheat starch) if it still results in the food containing 20 ppm or more gluten

Foods that are naturally gluten-free may not use the claim if they become contaminated with levels above 20 ppm as a result of cross-contact with gluten containing foods.

An estimated 3 million people in the United States have celiac disease. In people with celiac disease, foods that contain gluten trigger production of antibodies that attack and damage the lining of the small intestine. Last year FDA issued a rule on food labeling to improve life for people with celiac disease. The rule ensures that voluntary “gluten-free” claims on food packages are reliable and consistent. It provides a clear definition of the term so that all packaged food products bearing the claim “gluten-free” contain less than 20 parts per million (ppm) of the protein.

As of August 5, 2014, this rule is now in effect and manufacturers using a gluten-free label on their packaging must comply with the FDA’s labeling rule.

The gluten limit of less than 20 ppm applies to foods that carry the label “gluten-free,” “no gluten,” “free of gluten,” or “without gluten” and means that that to be labeled as free of gluten, each kilogram of the product must contain less than 20 milligrams (mg) of the protein. This is consistent with the threshold established by other countries and international bodies that set food safety standards.

In addition, participation in third-party gluten-free certification programs requires that manufacturers go beyond the FDA's standards for gluten-free products. These certification programs require validated gluten-free management systems that set a limit at less than 10 ppm and lower if possible.

Where labeling is used, FDA monitoring for compliance to the rule will include sampling, 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.

Conducting gluten testing of ingredients or finished foods using a scientifically valid method is an effective tool manufacturers can use to ensure that their foods labeled “gluten-free” meet FDA or gluten-free certification program standards.

Accurate gluten-free labeling will strengthen consumers’ confidence in the products that carry it. Deibel Labs can help clients assure that gluten-free claims are compliant to the rule by providing expert analytical services. More information can be obtained at the following websites:

2015-03-25 16:05:35