Healthnotes Newswire (March 1, 2007)—The US Food and Drug Administration (FDA) has proposed a rule that will help people with celiac disease easily identify which foods are safe for them to eat. The rule will define “gluten-free” and give food manufacturers the opportunity to label their products accordingly.

Celiac disease is a chronic inflammatory disorder of the small intestine caused by a reaction to proteins found in wheat and related grains—collectively called gluten.

When people with celiac disease eat gluten-containing foods, it triggers an abnormal immune response, damaging the intestine’s cells and often leading to health problems related to nutrient deficiencies. Untreated celiac disease increases the risk of diabetes and certain types of cancers.

What grains contain gluten?

Avoiding all sources of gluten in the diet is essential for managing celiac disease. Currently, there are no rules regarding the labeling of foods as “gluten-free,” which makes it difficult for people with the disease and their caregivers to determine which foods are safe. Once enacted, the proposed rule will take some of the guesswork out of shopping and help protect the health of people affected by the disease.

The FDA is proposing to define “gluten” as “proteins that naturally occur in a prohibited grain and that may cause adverse health effects in persons with celiac disease.” These grains contain gluten and are considered “prohibited grains” under the proposed rule:

• Wheat—Including durum wheat, spelt, and kamut; examples of foods made from wheat include flour (unless the source is stated otherwise), farina, semolina, and vital gluten

• Rye

• Barley—Foods made from barley, including barley malt extract or flavoring and malt vinegar

• Crossbred hybrids of these grains—Such as triticale, a cross between wheat and rye

What grains are gluten-free?

The following grains do not contain gluten, and are therefore safe for people with celiac disease to eat:

• Amaranth

• Buckwheat

• Corn

• Indian ricegrass

• Job’s tears

• Millet

• Quinoa

• Ragi

• Rice

• Sorghum

• Teff

• Wild rice

What about oats?

Although a small percentage of people with celiac disease may have an adverse reaction to oats, the consensus of the National Institutes of Health and the American Dietetic Association is that oats should not be excluded from the diet of people with the disease. Because of this, the FDA is not planning to include oats on the prohibited grains list.

Oats in their pure form contain no gluten, but they may become contaminated by “comingling” with other gluten-containing grains during handling and storage. Some farmers take steps to ensure that there is no contamination of their oat crops with gluten-containing grains. Foods made from oats raised on these farms will be allowed to bear the “gluten-free” label.

Under the proposed rule, a food may be labeled “gluten-free” if it does not contain an ingredient from a prohibited grain—unless it has been processed so that the final product contains only a small amount of gluten (less than 20 parts per million). Any food that contains more than 20 parts per million of gluten—such as a product made from oats which “comingled” with gluten-containing grains during storage or production—cannot be labeled as “gluten-free.”

According to the FDA, “A standardized definition for the term ‘gluten-free’ can serve to protect the public health by providing consumers with celiac disease the assurance that the foods bearing this labeling meet a clear standard established and enforced by the FDA.”

A final rule regarding gluten-free labeling will be published by August 2008.

(Department of Health and Human Services, Food and Drug Administration; Docket No. 2005N–0279)