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Five Years Later: Still No FDA Rule on Gluten-free Food Labeling 02/15/2013 - If you think the FDA has dropped the ball on gluten-free food labeling, you are not alone.

Photo: CC--mandbergIn 2004, the Food Allergen Labeling and Consumer Protection Act (FALCP) gave the FDA four years to create and implement final rules for gluten-free food labeling.

The FALCP requires manufacturers to identify these allergens by their common names (i.e. wheat, milk, or soy) on labels so that consumers can easily identify them.

In 2007, the FDA followed FALCP's mandate by issuing a proposed rule "Food Labeling: Gluten-Free Labeling of Foods." The proposed rule states that a food is gluten-free if the food does not contain any of the following:

  1. an ingredient that is any type of wheat, rye, barley, or crossbreeds of these grains;
  2. an ingredient derived from these grains and that has not been processed to remove gluten;
  3. an ingredient derived from these grains and that has been processed to remove gluten, if it results in the food containing 20 or more parts per million (ppm) gluten; or
  4. 20 ppm or more gluten. -- "Food Labeling; Gluten-Free Labeling of Foods," 72 Fed. Reg. 2795 (proposed January 23, 2007) (to be codified at 21 CFR Part 101).

The FDA's proposed rule was based on the fact that currently-adopted analytical methods can reliably detect gluten at or above 20 parts per million in most foods. Also, under that rule, food manufacturers looking to market products as 'gluten-free' would voluntarily test those products prior to labeling.

However, the FDA allowed the comment period for the proposed rule to pass with no action, and issued no final rule for gluten-free labeling.

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In 2011, the FDA announced a second comment period for their proposed rule, but that comment period also closed with the FDA taking no action.

A full year and a half later, on Dec. 14, 2012, the FDA issued a new proposed rule titled "Request for Comments and Information on Initiating a Risk Assessment for Establishing Food Allergen Thresholds; Establishment of a Docket."

They opened comment period on this proposed rule until Feb. 12, 2013, and scheduled an advisory committee meeting of the FDA for March 7, 2013 from 8 a.m. to 5 p.m.

It has been eight years, since FALCP mandated the FDA to devise standards for gluten-free labeling, and five years since the legal deadline for final gluten-free rule, and the FDA has yet to accurately define the term "major food allergen," establish safe gluten thresholds for food products, and meet its statutory mandate to create and implement final rules for gluten-free food labeling.

Until the FDA formally adopts a final rule for gluten-free labeling, there is no legal definition for what makes food "gluten-free" in the United States, and people with celiac disease will no clear assurance that when a product claims to be gluten-free, it is safe to consume.

Please go to the Federal Register and comment on the FDA's latest ofrmulation of their rule (Docket No. FDA-2012-N-0711) regarding gluten-food. welcomes your comments below (registration is NOT required).

Spread The Word

13 Responses:

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said this on
18 Feb 2013 6:44:12 AM PDT
The FDA does not work for the American people. It works for the food, drug and chemical companies that own it. Don't expect any action on what gluten-free means on a label, or the words natural, or anything else that would help people in their food choices.

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said this on
18 Feb 2013 12:04:19 PM PDT
Thanks for including a link to comment. Can't get it to work now but will keep trying. I am so tired of the "unknown" ingredients, such as maltodextrin and "natural flavors" that may or may not be a problem.

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said this on
18 Feb 2013 2:21:42 PM PDT
I wish this article had come out before Feb. 12th instead of now.

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said this on
19 Feb 2013 10:03:24 AM PDT
Learning how to eat gluten free has been an interesting journey. I realized that labels were not always accurate very early on when I had reactions to so called gluten-free foods. Cooking from scratch, eating fruits/vegetables/grains, and buying organic meats goes a long way to nourishing my body without harmful or painful reactions.

David Bennett
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said this on
18 Feb 2013 2:31:30 PM PDT
From a UK/EU viewpoint (we have benefited from improving labeling and availability for some time) the scenario you describe is unbelievable. But then again, US politicians often look like they're on another planet. Or they're even more in the pocket of big business than our own. Is it resistance from food companies? It's tempting to compare them to those nutters in the NRA.

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said this on
18 Feb 2013 3:27:15 PM PDT
This situation is disgraceful.

Another problem for individuals with celiac disease, which will not be solved even by the gluten-free labels: the addition of transglutaminase without labeling to many foods, including low fat dairy products (yogurt and cheeses) as well as deli meats. It looks like it can even be added to foods labeled "organic" (and I am having trouble getting responses from some food manufacturers to my email inquiries about whether this is added or not to their product). I have heard from an expert on celiac (a MD and researcher) that transglutaminase may not be safe for celiac patients and may provoke reactions as well, even in the absence of gluten. This additive has been classified as "GRAS- generally recognized as safe" and it may be added without being listed on ingredient list. Finding safe food for celiac patients (indeed for everyone) is becoming more difficult. The FDA does a poor job of protecting the interests of the public.

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said this on
18 Feb 2013 4:51:28 PM PDT
Health Canada has passed legislation as of August 2012 (with 18 months to implement labeling prior to this date) manufacturers are required by law to identify allergens on all food ingredient labels,if the gluten (or any other allergen) has not been added but may have been processed in a facility with any allergen then the "may contain" statement must appear.This is not a voluntary requirement, it's mandatory! Shopping is so much easier now that I know I can trust what I'm buying. Proudly Canadian!

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said this on
19 Feb 2013 12:51:27 AM PDT
Does the celiac community agree with the 20ppm as an acceptable level for declaring gluten-free? It's ridiculous to say that gluten can't be detected with accuracy below 20ppm.

Peter Olins, PhD
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said this on
28 Feb 2013 7:12:21 AM PDT
Breaking news! The FDA has just submitted its gluten free labeling rules for final approval.

William Narcowich
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said this on
28 Feb 2013 11:41:29 AM PDT
It would be helpful to have a short statement to send to members of Congress.

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said this on
01 Mar 2013 9:33:23 AM PDT
Why are there no proposed regulations for personal care products? I was diagnosed 10 days ago and this has driven me to distraction. I want gluten-free toothpaste, lip gloss, lip balm, etc.

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said this on
27 Mar 2013 9:35:03 AM PDT
They have extended the deadline for comments until May 12, 2013.

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said this on
08 May 2013 4:32:14 PM PDT
Where can we submit comments? Does anyone know if there's a lobbying group or organization who's in charge of leading this effort so we can support them? I have two celiac kids and I rely on lots of "kid" foods since everything realistically can't be homemade (although I try). Thanks!!

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Make sure that you ask the doctor how long she has to stop the supplements before you have her levels tested and be sure to take them all with you when you have the appointment so the doctor knows what she is taking.

Talk to your doctor. With your family history and symptoms he/she may be able to diagnose based on resolution of your symptoms and family history. Also check with your local hospital if it has it's own lab. Mine covered any labs at a greatly reduced cost based on a sliding fee scale. Did you have an MRI before they did the spinal? Celiacs with neuro impact will have white spots on an MRI that resemble the lesions found with MS. Many neuro doctors don't know this. I went through what you did and they did a spinal on me also based on the MRI results. If my doctor had know what the UBOs (unidentified bright objects) were I would have been diagnosed a couple years sooner than I was. Make sure if you supplement that you ask your doctor which ones you need to stop taking and for how long before they do a blood test to check levels. Sublingual B12 is a good idea when we have nervous system issues, but needs to be stopped for at least a week for an accurate blood level on testing. I hope you get some answers and feel better soon.

Thanks for that. Will get her tested for deficiencies. I did take her to a naturopath and get her on a bunch of vitamins, but she never was tested via bloods, so will get on to that, thanks

Hi Could a mod please move this post: and my reply below to a new thread when they get a chance? Thanks! Matt

Hello and welcome Firstly, don't worry about it but for ease your post (and hopefully my reply) will probably be moved to its own thread. That will make it easier for others to see it and reply and also help Galaxy's own thread here on track and making sense. The antibodies that the celiac tests look for can drop very quickly, so... maybe? Celiac is difficult to test for, there are different tests and sometimes someone doesnt test on one but does on the other. If you can get a copy of the tests and post it here the community may be able to help explain the results. It may have shown damage to the villi, the little tendrils in your intestine that help you extract nutrients from your food. Celiac is one, but not the only, way in which they can get damaged leading to a vast number of potential symptoms and further making diagnosis a tricky proposition. Definitely, there's a connection. Here's a page that explains it in detail: Fantastic It sounds as if your doctors were happy to diagnose you on the basis of the endoscopy? It may be then that you've found your answer. I hope so, you've clearly had a rotten and very scary time. I'm sure with the positive reaction to the diet you want to go on and get healthy, but I would only add that you should discuss this with your doctors, because they may want to exclude other potential causes if they've not confirmed celiac at this point. Check out the advice for newly diagnosed here: To your family I'd simply say that celiac is a disease of the autoimmune system, the part of our body that fights diseases and keeps us safe. In celiac people the autoimmune system see's the gluten protein found in wheat, barley, or rye grains as a threat to the system and it produces antibodies to attack it and in doing so attacks it's own body as well. It's genetic in component so close family members should consider a test if they have any of the many symptoms. There's roughly 1 person in 100 with celiac but most of them don't know it and are risking getting or staying sick by not finding out. There's further info for them and you here: I'm going to ask a mod to move your post and my reply to a new thread, but wanted to give you an answer first The good news is you've found a great site and there will be lots of support for you here. You've also got 'lucky' in that if you're going to have an autoimmune condition, celiac is a good one Most react really well to the gluten free diet and you will hopefully have much more healing to come! Best wishes Matt