What's Happening with the Gluten-free Label?

In 2004, the FDA enacted the Food Allergy Labeling Consumer Protection Act. The regulation stipulated that all food products packaged under FDA list the top 8 allergens on the label. The act also contained a directive that  FDA define "gluten-free."  In January 2007, the FDA issued a proposed definition.  The proposal was made available in the Federal Register for public comment.  The FDA needed to get the best available scientific information on the threshold of gluten that would be safe for Celiacs before making a definition.  The issue has languished at the FDA since. However, at this present moment, the comment period has been re-openned.  To understand what the holdup is, it is necessary to understand the facts that FDA had to consider in coming up with a gluten-free label. There were two options for the FDA to use in determining the level of gluten that could safely be defined as "gluten-free."  First was the "safety based" approach.  This would base the level of gluten on the amount shown in studies to be safe. The second approach is to determine the level of gluten based on the testing techniques available.  While it might seem like a no-brainer to chose the "safety" approach, the problem is that there is very little data on what is a safe level of gluten for most Celiacs.  Very few studies have been done in this area and the studies were very small. The analytical approach would determine the level that the most sensitive technique can detect. Since 2007, laboratory techniques were introduced and these needed to be carefully studied before a choice was made. The FDA has chosen to go with the testing approach. The current thinking is that the latest testing method, the R-5 ELISA test is the best option.  This method can test gluten down to 20ppm of a product.  It is not zero gluten.  While the test will show that a gluten-free product does not contain more than 20ppm, it may actually contain less than that and the test can not determine that.  The test only  shows that the level is lower than 20ppm. Another way to look at it is that a person would need to consume a little over a pound of food that was 20ppm gluten in order to consume 6 mg of gluten.  This level of gluten would be safe for the vast majority of Celiacs. If you would like to be a more active participant in the FDA process, check out a advocacy group at  www.1in133.org  There is information about the proposed label, expert comment as well as suggestions on supporting the effort to get a gluten-free label.

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