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Proposed rules on gluten finish the thought on food allergens law

Under its proposed rule, FDA defines ‘gluten’ as proteins that occur naturally in a ‘prohibited grain’ and that may cause adverse health effects in those with celiac disease.”

At the start of last year, when a new federal law started requiring food labels to reveal the presence of eight major food allergens, the seeds of another effort were also planted. The law also required the Food and Drug Administration to work up some rules to provide for food label statements about when foods are “gluten free” to help those with celiac disease avoid the component.

The proposed rule doesn’t require food makers to use the statement, since the decision to add the statement will be voluntary. The proposed rule merely sets standards for when it can be used.

Anyone can offer comments on the proposed rule from now until April 23, 2007. FDA will consider the comments and make any changes they deem appropriate, then issue the final rule by August 2008. It would become effective at a specified time after that.

It’s estimated that as many as 3 million people suffer from celiac though only about 40,000-60,000 have been diagnosed with the disease by a doctor. The disease causes chronic inflammation of the small intestine upon eating proteins called “glutens.” The disease is genetic in origin. Gluten shows up in many cereal grains.

Like allergies, celiac disease cannot be cured as such, but sufferers avoid symptoms by avoiding ingesting glutens. FDA says many consumers have reported that having a reliable, consistent, gluten-free labeling claim on food labels “makes it easier to grocery shop, saving the consumers both time and the frustration experienced when reading often lengthy and complicated ingredients lists” they often don’t understand. Industry, too, says there is no consistency in the way “gluten-free” is interpreted and utilized, so a uniform definition and standard would help create fair competition.

This syndrome is not uncommon with label issues. Regulatory standardization of the meaning of environmental claims like “recyclable” or “biodegradable,” and food content claims like “light,” made for consistency in the way these terms were used. That cut down on false claims, too.

Right now, there is not an FDA regulation defining or governing the use of the term “gluten-free.” FDA has previously advised packagers only that a gluten-free claim could be used on a label as long as the claim was truthful and not misleading.

Then the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) told FDA to make a rule defining and permitting the use of the term “gluten-free” on food labels. The proposed rule was to be issued by August 2006 (whoops, it came out a little late, in January 2007), and the final rule is due by August 2008.

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