FYI on proposed FDA gluten-free definition.

by angelaskitchen on January 24, 2007

I received the following email from csaceliacs.org

The FDA has issued its proposed definition of “Gluten-Free” as required by the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA).


This is YOUR opportunity to speak up. The proposed FDA definition for “Gluten-Free” is not simple. There are 95 pages in the docket. In summary, the proposed, voluntary use of the term “gluten-free”


* does not contain wheat, rye, barley or cross bred hybrids of these grains

* does not contain an ingredient derived from one of the above grains if use of that grain results in greater than 20 ppm gluten in the food

* does not contain 20 ppm or more of gluten


Concerning oats:


* all oats cannot be claimed to be “gluten-free”

* oats products with 20 ppm or greater of gluten cannot be claimed to be gluten-free


The FDA is seeking comments and scientific information from the public on the following points:


* appropriateness of 20 ppm gluten as the proposed threshold level as determined using an ELISA based method.

* effect the adoption of a lower threshold level would have on individuals with celiac disease and on industry

* scientific data or other information that addresses the question of whether the adoption of a lower threshold level would be of benefit to individuals with celiac disease

* effect of a lower threshold level on the availability in the US of foods labeled gluten-free and whether that reduced availability could negatively impact individuals with celiac disease

* proposal to restrict the types of gluten-free labeling claims that can be made for oats



Comments will be accepted for 90 days beginning Jan. 23, 2007.


The site is http://www.fda.gov/OHRMS/DOCKETS/98f…79-npr0001.pdf or a direct link to the FDA docket can be accessed from the CSA website at www.csaceliacs.org.


Note, while this FDA definition uses the ppm limits to DEFINE the product, the CSA Recognition Seal schedules tests at 3 ppm to VERIFY that the Product, Process and Packaging are as “risk-free” as possible for eliminating Wheat, Barley, Rye and Oats, their crosses and their derivatives from the diet.


The entire docket is very thoughtful reading.

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