The FDA proposed new rules today to better define "gluten free" claims that food manufacturers can use to label a food that is gluten-free.

The following is some information about the proposal and celiac disease cited from the document the FDA released today.

The Food and Drug Administration (FDA) is proposing to define the term "gluten-free" for voluntary use in the labeling of foods, to mean that the food does not contain any of the following:

An ingredient that is any species of the grains wheat, rye, barley, or a crossbred hybrid of these grains (all noted grains are collectively referred to as "prohibited grains");

An ingredient that is derived from a prohibited grain and that has not been processed to remove gluten (e.g. wheat flour);

An ingredient that is derived from a prohibited grain and 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; or 20 ppm or more gluten.

A food that bears the claim "gluten-free" or similar claim in its labeling and fails to meet the conditions specified in the proposed definition of "gluten-free" would be deemed misbranded.

FDA also is proposing to deem misbranded a food bearing a gluten-free claim in its labeling if the food is inherently free of gluten and if the claimed does not refer to all foods of that same type (e.g., "milk, a gluten-free food" or "all milk is gluten-free").

In addition, a food made from oats that bears a gluten-free claim in its labeling would be deemed misbranded if the claim suggested that all such foods are gluten-free or if 20 ppm or more gluten is present in the food.  

Establishing a definition of the term "gluten-free" and uniform conditions for its use in the labeling of foods is needed to ensure that individuals with celiac disease are not misled and are provided with truthful and accurate information with respect to foods so labeled. This proposed action is in response to the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA).

Any comment should be submitted within 90 days after the proposal is polished in the Federal Register on Tuesday Jan. 23, 2007.   Submission of comments should be identified by Docket No. 2005N-0279.   Comments can be electronically submitted at http://www.regulations.gov or at http://www.fda.gov/dockets/ecomments.   Comments can also be submitted by fax to 301-827-6870 or mailed to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fisher Lane, rm. 1061, Rockville, MD 20852

Celiac disease also known as celiac spruce and gluten-sensitive neuropathy is a chronic inflammatory disorder of the small intestines in genetically susceptible individuals trigged by ingesting certain storage proteins, commonly referred to as "gluten," that naturally occur in some cereal grains.  

In individuals with celiac disease, the consumption of gluten stimulates the production of antibodies and inflammatory cells, resulting in an abnormal immune response, which damages the tiny, fingerlike protrusions called "villi" that line the small intestine and function to absorb nutrients from food. Over time, continued dietary exposure to gluten can destroy the intestinal villi of individuals who have celiac disease, leading to a lack of adsorption of nutrients and wide variety of other serious health problems.

Celiac disease affects 0.4 to 1 percent of the U.S. population or about 1.5 million to 3 million Americans with 40,000 to 60,000 diagnosed by a physician, according to the FDA.