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FDA to Issue Gluten-Free Allergy Labeling Rule in 2012 04/26/2012 - A recent statement by the FDA announces that the agency is gathering data to respond to calls for an "alternative approach" to determining a specific gluten threshold level other than the proposed level of under 20 parts per million gluten as one of the criteria to define the term “gluten-free.”

The statement directly acknowledges that people with celiac disease must avoid gluten for life in order to prevent harmful health effects.

Photo: CC--ms4jahThe statement also notes that, in 2011, the Agency, through its Center for Food Safety and Applied Nutrition (CFSAN) conducted the following actions involving accurate gluten labeling of food products: 

It finished a safety assessment of gluten exposure in individuals with celiac disease, and that it had gotten that assessment peer-reviewed.

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This was done to gather more data regarding possible alternative approaches to establishing a specific gluten threshold level as one of the criteria to define “gluten-free.”  

These would be alternative approaches that differ from the "analytical methods-based approach" used by the FDA in its proposed rule for "gluten-free" products. That proposal established product ingredients under 20 parts per million gluten as one of the criteria for defining the term “gluten-free.”

The FDA statement also noted that CFSAN had published a Federal Register notice in August 2011, reopening the comment period on the Agency’s proposed rule on “gluten-free” food labeling. 

The notice announces the publication of the FDA's safety assessment on gluten exposure in people with celiac disease, and asks for public comment on the safety assessment, and on any other issues that might affect the definition of the term “gluten-free” in the Agency's final rule. 

Lastly, the statement announces that the FDA will review and consider those public comments before issuing its final rule defining “gluten-free” for labeling food products, including dietary supplements. The FDA intends to complete the entire process and issue the rule by the end of fiscal year 2012.

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12 Responses:

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said this on
26 Apr 2012 2:24:07 PM PDT
Wonder what the "alternative approaches" are?

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said this on
26 Apr 2012 8:55:49 PM PDT
This was a long time coming! Good information, thanks.

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said this on
30 Apr 2012 8:59:53 PM PDT
Does not really explain what (if anything) is changing - but it is nice to see that the FDA is taking the issue seriously.

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said this on
30 Apr 2012 9:53:24 PM PDT

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said this on
01 May 2012 1:42:19 PM PDT
By definition "gluten-free" denotes that a product is "free" of all gluten proteins--as in Zero...(or am I missing something?)
As a newly diagnosed celiac I'm concerned about any gluten exposure. I have been the recipient of cross-contamination (griddle not cleaned). It was not pretty.
Wondering what the threshold for PPM might be before patients experience symptoms.

( Author)
said this on
01 May 2012 1:49:33 PM PDT
There is not test for gluten that goes down to zero, so a level must be set somewhere. The lower the level, the more expensive the tests are. 20 ppm is a level deemed safe by many experts, and one that will not cause a drastic increase in price for products labelled "gluten-free."

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said this on
02 May 2012 8:49:15 PM PDT
Am I the only one who is worried that the "alternative approach" they may be aiming for is something that does not include an actual measurement? For example, we know many things are "naturally gluten free", will that be sufficient to pass their labeling standards? I hope not, since it doesn't address cross-contamination! An analytical method is the only one that will make me happy.

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said this on
04 Jun 2012 1:53:43 PM PDT
Be careful about your reading here. The FDA is NOT calling for an alternative approach. They are responding to calls FOR an alternative approach; most likely so they can then dismiss those calls and stick to the prevailing scientific approach. I would look for the FDS to set the level under 20ppm, similar to the European standard.

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said this on
31 Oct 2012 5:42:33 AM PDT
I agree. So many people who don't have celiac disease don't understand how a small amount of contamination affects us people with celiac disease, especially in restaurants. They say the item is gluten-free but then fry it in the same oil that has been contaminated.

Denise Bryan
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said this on
05 May 2012 4:26:02 PM PDT
You are not the only one worried about their "alternative approach". I sure hope they don't do it that way. That would ease the requirements too much for some of us Celiacs that are sensitive to even the smallest amount of gluten.

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said this on
19 Jul 2012 8:12:11 PM PDT
What I want to know is how can we all help? There must be something we can do to encourage new legislation that will protect our health!

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said this on
18 Sep 2012 4:50:53 PM PDT
All I need is a list of foods that are free of gluten, not pages and pages of pure nonsense.

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