FDA Unveils the Draft Ruling for GF Labeling.

On Jan 22, 2007 the Food and Drug Administration released the Proposed Rule for Food Labeling: Gluten-Free Labeling of Foods. (Docket No. 2005N-0279).

The draft ruling defines the guidelines for voluntary Gluten-Free labeling of foods.

A summary of the 95 page document:

ü Gluten-free labeling is voluntary
ü Gluten-free is defined as less than 20 ppm gluten in food
ü Gluten-free for labeling means that foods do not contain any of the following:

• An ingredient that contain any  species of the grains wheat,  rye, barley, or a crossbred hybrid of these grains (known collectively as “prohibitive grains”)
• An ingredient that is derived from a prohibitive grain and has not been processed to remove the gluten (such as wheat flour)
• An ingredient that is derived from a prohibitive grain and has been processed to remove the gluten (such as wheat starch), and if the use of that ingredient results in the food having 20 ppm or more gluten.
• 20 ppm or more gluten in the food.

Misbranding: The ruling states that:

ü foods that carry the claim “gluten-free” and do not meet these standards will be considered misbranded.

ü if a gluten-free claim is made on foods inherently gluten-free, and if the claim does not refer to all foods of the same type also being gluten-free (e.g., "milk, a gluten-free food" or  "all milk is gluten-free") .

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

Click here to review the entire document.

A document titled “Questions and Answers on the Gluten-Free Labeling Proposed Rule has been prepared by FDA and is available at the following web-link: http://www.cfsan.fda.gov/~dms/glutqa.html

GIG, as a member of the  American Celiac Disease Alliance (ACDA) applauds the FDA on today's release of its proposed rule on gluten-free labeling.    The proposal was required as part of the Food Allergen Labeling and Consumer Protection Act of 2004, which the ACDA strongly supported.   members of the American Celiac Disease Alliance provided background information and collaborated with the FDA on this measure.

GIG and the American Celiac Disease Alliance look forward to reviewing the proposed rules and providing our comments to the FDA.

The public will have 90 days from the date of publication to submit comments on this proposal. See the document for instruction on how to comment.

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