Celiac.com 03/07/2007 - The Food and Drug Administration (FDA) recently proposed the following rule regarding the labeling of foods as "Gluten-Free (GF). The rule appears in the Federal Register, Docket No. 2005N-0279, titled Food-Labeling: Gluten Free Labeling of Foods," and includes a definition of the term "gluten-free."

There is no current Federal regulation to define the term "gluten-free" for labeling food. By clearly defining the term the FDA seeks to help those with celiac disease, along with their caregivers, to better identify packaged foods that are safe for consumption.

The FDA proposes to set the standard acceptable gluten level for products labeled "gluten-free" at no greater than 20 parts of gluten per million. More specifically, the FDA proposes that the term "gluten-free" on food labels will apply to food that is free of any or all of the following:

  • "Prohibited grains," meaning any species of wheat (e.g., durum wheat, spelt wheat, or kamut), rye, barley or their hybrids;
  • Ingredients derived from "prohibited grains," (e.g., wheat flour), that have not been treated to remove gluten.
  • Ingredients derived from "prohibited grains," (e.g., wheat flour), that HAVE been treated to remove gluten, but which results in 20 ppm (parts per million) or more of gluten per gram of food.
  • 20 ppm or more of gluten per gram of food.

Foods that are labeled "gluten-free," or claim to be "free of gluten," without gluten, or to contain no gluten," and which fail to meet the terms of the proposed definition of "gluten-free" would be designated as "misbranded."

One aspect of the FDA rules that seems to have caused some confusion concerns the status of oats. One recent posting making the rounds among celiac support groups claims that page 2798 of the Federal Register states: that None of the four U.S. celiac associations that responded to the survey considered oats to be an acceptable food for individuals with celiac disease. This quotation is from an April 2000 article by Tricia Thompson, titled: Questionable food and the gluten-free diet: Survey of Current Recommendations. However, page 2798 of the Federal Register actually states the CURRENT positions held by the organizations:

According to more recent position statements of 3 of the 4 major celiac associations in the United States that responded to the earlier survey conducted by Thompson (Ref. 57), one of these associations continues to take the position that oats are not an acceptable food for individuals with celiac disease; but, the other two of these associations are not opposed to the inclusion of oats in the diets of individuals with celiac disease, provided that the oats do not contain gluten from other grains and that the daily amount of oats consumed is limited to 1 cup cooked (Ref. 56)."

The FDA held an initial public comment meeting for "gluten-free" food labeling in August 2005. Comments received during this meeting, coupled with other information compiled by the FDA, indicate that there is no consensus among either consumers or U.S. food manufacturers as to the nature of foods labeled "gluten-free." The FDA feels strongly that the establishment of clear definitions of "gluten-free," and of uniform guidelines for applying the term in labeling foods, will enable persons with celiac to obtain accurate and truthful information about the foods they purchase, and help to make sure they avoid the adverse health affects that can come consuming food that is mislabeled.

For more information the FDA has prepared a document titled:
Questions and Answers on the Gluten-Free Labeling Proposed Rule" The document is available for review through the following web-link:
http://www.cfsan.fda.gov/~dms/glutqa.html.

Act Now!
There is a 90-day public comment period for the proposed rule. Submit your comments by April 23, 2007 by clicking here, or comments can also be submit it in writing to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305) Rockville, MD 20852.

Celiac.com supports the FDA proposals, and encourages those with celiac disease and their supporters, to review the FDA document and to share your comments in support of these standards.

As always, Celiac.com welcomes your comments (see below).